Guidelines for Researchers

Volume IV, Issue 1

A Guide to Establishing Effective Mutually-beneficial

Research Partnerships with American Indian Tribes,

Families and Individuals

March 2019

The Partnership for Native American Cancer Prevention, U54CA143924

Tucson, Arizona

The Partnership for Native American Cancer Prevention (NACP) Outreach

Core

The goal of the NACP Outreach Core is to improve the health of American Indian and Alaska Native people by

addressing cancer health disparities. The Guideline for Researchers is a tool for researchers who work with or

are interested in engaging with tribal communities, families and individuals.

For more information, please contact:

Francine C. Gachupin, PhD, MPH

UA NACP Outreach Core

Office: 520-621-5072

Email: [email protected]

University of Arizona

Department of Family and Community Medicine

PO Box 210491

655 N Alvernon Way, Suite 228

Tucson, AZ 85711

NACP Outreach Social Media Outlets

Facebook

www.facebook.com/The-Partnership-for-Native-American-Cancer-Prevention

Instagram

@nacp_outreach

Twitter

@NacpOutreach

Suggested Citation:

Gachupin FC, Lameman B, Molina F. Guideline for Researchers. Tucson, Arizona: University of Arizona,

Department of Family and Community Medicine, College of Medicine, March 2019.

Social Media Updated Daily

Purpose

This document is a guideline for researchers on how to conduct respectful and beneficial research in American

Indian and Alaska Native (AI/AN) communities. These guidelines cover a variety of topics, including

recognizing AI/AN as sovereign nations, how to perform ethical research, understanding AI/AN health

disparities, how to navigate the research process, what documentation is needed to perform research, and where

to search for additional resources.

The Guidelines for Researchers is part of a series that the University of Arizona NACP Outreach has created

and are available through our office or online on our website, www.uacc.nacp.outreach.

The other guides in the series includes:

How to Build and Sustain a Tribal IRB, Volume I

This document is a guide for American Indian and Alaska Native (AI/AN) tribal communities on:

 How to build a Tribal research review board or an Institutional Review Board;

 How to conduct protocol reviews; and,

 How to register a Federalwide Assurance (FWA) or an IRB

How to Review Research to Benefit Tribal Communities, Volume II

This document is a guide for tribal communities on:

 Research in American Indian and Alaska Native Communities;

 Questions to Ask during the Research Review Process; and,

 Community-based Participatory Research

How to Conduct Research, Volume III

This document is a guide for researchers on:

 Tribal Sovereignty;

 American Indian/Alaska Native Cancer Health Disparities;

 Researcher Sensitivity and Responsibility; and

 Research Checklist

These resources are intended to provide useful and pertinent information to tribes and researchers so that

outcomes can benefit tribal members and tribal communities. These guidelines are written specifically for

research that would involve people, usually called human subjects. Most of the procedures and policies

contained within these guides are based on current federal regulations, called Code of Federal Regulations

(CFR), 45 CFR 46, for human subjects protection.

Ultimately, the research being conducted should minimize risks and maximize benefits for AI/AN communities

from a cultural/traditional, physical, psychological, spiritual, social, economic, and legal perspective.

Table of Contents

The Partnership for Native American Cancer Prevention (NACP) Outreach Core ................................................ 1

NACP Outreach Social Media Outlets ................................................................................................................... 1

Purpose .................................................................................................................................................................... 2

Background ............................................................................................................................................................. 4

The Nuremberg

Code ..............................................................................................................................................

The Belmont Report ................................................................................................................................................5

Research with American Indian and Alaska Native (AI/AN) Tribes ..................................................................... 5

The Diabetes Project with the Havasupai Tribe .

...........................................................................

............................. 6

Hantavirus Outbreak ................................................................................................................................................ 6

Traditional Ecological Knowledge ...........................................................................................................................7

Community-Based Participatory Research (CBPR) ................................................................................................... 8

Tribal Participatory Research (TPR) ...........................................................................

.............................................. 8

American Indian/Alaska Native Cancer Health Disparities ...................................................................

................ 8

Conducting Research in AI/AN Tribes – A Checklist ............................................................................................ 9

The Review and Approval Steps........................................................................................................................... 10

The Tribal Review Process ......................................

................................................................................................ 10

The Indian Health Service (IHS) ............................................................................................................................ 10

University-based Institutional Review Board (IRB) ................................................................................................. 14

Elements of an IRB Review ................................................................................................................................ 14

Institutional Review Board Decisions .................................................................................................................16

Questions to Ask During the Research Design Process.........................................................................................17

The Research Protocol .......................................................................................................................................... 20

Results Interpretation and Dissemination ............................................................................................................. 22

Resources .............................................................................................................................................................. 23

For More Information .............................................................................................................................................. 23

Independent Tribal IRBs ................................................................................................................

......................... 24

References ............................................................................................................................................................. 27

Appendices ............................................................................................................................................................ 28

B. University of Arizona: What is Human Research?..............................................................................................35

A. Developing a Protocol...............................

...................................................................................................... 29

C. University of Arizona: Determination of Human Research.................................................................................3

D. University of Arizona: Application for Human Research....................................................................................44

Declaration of Helsinki ...........................................................................

................................................................. 4

Background

Historically, there have been both domestic and international research initiatives that have caused harm, including death,

and which serve as the basis of human subjects protections and regulations that currently exist. In this section, we provide

a broad overview of the basis of protections that exist for human subjects: the Nuremburg Code, the Declaration of

Helsinki, and the Belmont Report. The next section provides an overview of considerations for conducting research with

tribes. In the last section, we provide tools for researchers including checklists and sample documents.

Research is defined as an investigation designed to develop or contribute to generalizable knowledge.

A human subject is described as a living individual from whom an investigator conducting research gathers

either data or identifiable private information through the intervention or interaction with the human subject.

The Nuremberg Code

Resulting from the unethical research conducted by the Nazis in Germany and neighboring countries, the

Nuremburg Code was established as a direct action from the “Trials of War Criminals Before the Nuremburg

Military Tribunals Under Control Council Law” from October 1946 to April 1949. In total, there are ten codes

that make up the Nuremburg Code and they are outlined below:

1. The voluntary consent of human subjects is absolutely essential. Human subjects should have the legal right

to give consent, to exercise their free power of choice, and to have no intervention of force, fraud, deceit,

duress, overreaching, constraint, or coercion to participate in the research project. Human subjects should be

given sufficient knowledge and comprehension of the research project so that they make a knowledgeable

and enlightened decision.

2. The research experiment should produce positive results for society as a whole that could not be produced

by other methods of study. The experiment should not be random and unnecessary.

3. The research experiment should be designed and based on the results obtained from animal experimentation.

Combined with knowledge of the natural history of the disease or associated problems, the experiment can

be justified based on anticipated results.

4. The research experiment should be conducted in a manner that avoids all unnecessary physical and mental

suffering and injury.

5. No research experiment should be conducted when there is a reason to believe that a death or disabling

injury will occur; except, perhaps, in experiments where experimental physicians also serve as subjects.

6. The degree of risk of the research experiment should never exceed the humanitarian importance of the

problem to be solved by the experiment.

7. Proper preparations should be made and adequate facilities provided to protect human subjects from the

possibilities of injury, disability, or death.

8. Research experiments should only be conducted by qualified personnel. The highest degree of skill and care

are required for all stages of the research project.

9. Human subjects are allowed to stop the experiment at any interval if they believe that their physical or

mental abilities have been reached and that continuation of the research project is impossible.

10. Researchers must be prepared to terminate the experiment at any given point if they believe that the

continuation of the experiment could result in injury, disability, or death of the human subject.

Declaration of Helsinki

The Declaration of Helsinki states that it is the duty of researchers to promote and safeguard the life, health,

privacy, and dignity of human subjects. Above all else, it is the responsibility of researchers to protect the well-

being of human subjects over the interests of science and society. Researchers are therefore subjected to

practicing ethical standards that promote respect for all human beings and for carefully assessing the need for

research in a given population. Before proposing a research project, the researcher should determine if the

potential benefits outweigh the possible risks and burdens.

Special attention is given to vulnerable population that may need additional protection when research projects

are introduced into the community. The needs of the economically and medically disadvantage must be

recognized and only certified scientific researchers can conduct research in any population. All participating

human subjects must be volunteer and be fully informed of all procedures and protocols associated with the

project. Researchers must also consider if a participant is unable or may refuse to give consent. Special

consideration should be considered for human subjects who may be given consent under duress, who will not

benefit personally from the research, and for those whom the research is combined with care.

The Belmont Report

The Belmont Report identifies the basic ethical principles that should underlie the conduct of biomedical and

behavioral research involving human subjects and developing guidelines to assure that such research is

conducted in accordance with these principles as a result of the National Research Act of 1974. The three basic

principles are respect for persons, beneficence, and justice.

Human subjects should be treated as autonomous agents and subjects with diminished autonomy are entitled to

protection. When subjects are presented with sufficient information about the research project they have to give

their informed consent and be given the opportunity to choose what shall or shall not happen to them.

Beneficence is an obligation that enforces the concept of not harming the subject, while, maximizing possible

benefits and minimizing possible harms. Researchers must enforce justice by providing fair procedures and

outcomes in the selection of research subjects.

Research with American Indian and Alaska Native (AI/AN) Tribes

There are a total of 573 federally recognized American Indian/Alaska Native (AI/AN) tribes in the United

States and a total of 22 federally recognized tribes in Arizona alone (see Figure 1). Each one of the federally

recognized tribes are Sovereign nations. With sovereignty comes the establishment of tribal governments,

including the ability to protect a tribe’s cultures and traditions.

Research with AI/AN is not the same as working with other

underserved, minority or rural populations.

When working with tribes, researchers need to familiar with and

to be sensitive to culture, traditions, and wishes and/or

expectations of a given AI/AN community. Each tribe is unique

and needs to be treated as an autonomous entity. Researchers are

encouraged to establish participatory-type relationships with

tribes and to have established these relationships prior to

proposing research. For research focused on health, the partners

should include the local community health department, and, as

applicable the Health Board and/or the Indian Health Service. As

the research protocol develops, tribal leadership should be

included for review and approval. No research should begin

until there is tribal clearance for the research to begin. Usually,

the Institution-based review and approval process is also

required. The timing of the processes are situation dependent. It

is best to seek guidance from both the tribe and your institution.

In working with tribes, it is important to note that the harms and benefits to be assessed are not

necessarily the same as for other populations.

It is imperative to understand the community’s

 right to decline participation,

 self-assessment of harms and benefits,

 recognition of community-level harms and benefits,

 (dis)trust of research,

 experience(s) with stereotyping, discrimination or stigmatization,

 preference for ownership of data,

 request for ways to protect participant and tribal privacy, including how identification occurs in

presentations or publications,

 preference for how to handle dissemination and implementation,

 preference for how to handle incidental findings,

 requirement to return results in a timely manner, and

 requirement for transparency, especially related to secondary uses of data.

In Indian Country (the broad reference to all tribes in the U.S.), there has been research done that has harmed

AI/ANs. Here we provide two research studies that underscore the importance of respectful research with

AI/AN. The first study used data for unapproved secondary uses and the second study that violated tribal

community requests for privacy. We also provide approaches that can be implemented to recognize tribal world

views and ways to optimize partnerships.

The Diabetes Project with the Havasupai Tribe

In 1989, Arizona State University (ASU) researchers embarked on a research partnership with the Havasupai

tribe on a project entitled “The Diabetes Project with the Havasupai Tribe.” The objectives of the project were

to provide health education, collect and test blood samples, and implement genetic association testing to search

for links between genes and diabetes risk for the tribe. Despite years of research, the researchers were not able

to find a genetic link to Type II Diabetes among the Havasupai. The researchers then began to change their

research project, without the knowledge or consent of the Havasupai tribe, by performing additional studies that

were unrelated to the original project. The researchers used collected blood samples to study schizophrenia,

migration, and inbreeding. Carletta Tilousi, a Havasupai member and participant of the study, attended a lecture

at ASU in March 2003 where she learned that her DNA sample, along with everyone else who participated in

the diabetes research project, was being used in non-diabetes-related genetic studies (Garrison, 2012)

Hantavirus Outbreak

In May 1993, an unknown and fatal illness broke out in the Four Corners region of the Unites States that covers

the states of Arizona, New Mexico, Colorado, and Utah (Fred, 1994). The outbreak of hantavirus on the Navajo

Nation sparked a national investigation of the illness. Major media outlets that included USA Today, CBC

News, the New York Times, and the Arizona Republic titled articles associated with the outbreak as “Navajo

Flu,” “Navajo Disease,” “Navajo Epidemic,” and “In Navajo Land of Mysteries, One Carries a Deadly Illness”

thus promoting an atmosphere of fear focused on the Navajo, stereotyping of the Navajo, invasion of privacy by

naming places and identifying the outbreak by a tribe’s name, and causing discrimination against the Navajo.

It is important to remember that the purpose of tribal governments is to govern their respective societies,

which is an inherent right to self-government. Tribes are sovereign nations. Tribes have the right to

approve or disapprove proposed research. Tribes have the right and responsibility to optimize the benefits

of the research for the participants and for the tribal community at large.

Traditional Ecological Knowledge

Introduced in the 1980s, Traditional Ecological Knowledge (TEK) is a concept that highlights Indigenous

Knowledge (IK) systems and is used to bring about awareness of the existence and value associated with IK

(Issac et al., 2018). Knowledge, practices, and beliefs have been handed down for generations regarding the

relationships of living beings and the environment creating the concept of TEK (see Figure 2).

AI/AN people have the historical knowledge concerning their own traditional practices and the environment

which they have been resided in for thousands of years. In addition, the TEK framework allows the researcher

to bridge the gap of perspectives and understandings of the cultural significance of tribal and social practices

within the community.

Figure 2. Traditional Ecological Knowledge components

Traditional Ecological Knowledge allows for:

 An approach to local knowledge for physical, mental, and environmental health.

 Connections between tribally based and scientific research.

 Cross-cultural integrations of disciplinary approaches to environmental and health-based knowledge.

Traditional Ecological Knowledge can be incorporated through:

 Language of the AI/AN community.

 Design of the research activities around traditional practices and beliefs.

 Considering community connections, natural resources security, education, cultural use and practices,

self-determination, traditional practices, etc.

 Incorporate talking circles and other methods to involve the community voice.

Environment

Human and

Animal

Relationships

Spirituality

Community-Based Participatory Research (CBPR)

Community-based Participatory Research (CBPR) is a partnership approach to research that equitably involves

community members, organizational representatives, and researchers in all aspects of the research process and

in which all partners contribute expertise and share decision-making and ownership (Israel et al., 2005). CBPR

is an increasingly acceptable approach to tribal communities for establishing research partnerships. Although

CBPR exists on a continuum, most partnerships are built on the following fundamental principles:

 Recognize community as a unit of identity.

 Build on strengths and resources of the community.

 Facilitate collaborative partnerships in all phases of the research.

 Integrate knowledge and action for the mutual benefit of all partners.

 Promote a co-learning and empowering process that attends to social inequalities.

 Involve a cyclical and iterative process.

 Address health from both positive and ecological perspectives.

 Disseminate findings and knowledge gained to all partners.

Tribal Participatory Research (TPR)

Tribal Participatory Research (TPR) approaches are viewed as particularly ethical and respectful of research

partnerships with sovereign tribal nations (Fisher and Ball, 2003; Thomas et al., 2010). TPR partnerships allow

research to be responsive to community needs, to be culturally appropriate, and to be strengths-based while

being mindful of the unbalanced and often harmful research previously conducted in tribal communities.

American Indian/Alaska Native Cancer Health Disparities

According to the Indian Health Service (IHS), heart disease and cancer are the top two leading causes of death

for AI/AN people (2018) (see Table 1). For cancer, AI/ANs are more likely to be diagnosed with advanced stage

cancer compared to Whites (Hoffman et al., 2014) and have higher incidence of kidney cancer, uterine cancer,

liver cancer, stomach cancer, gallbladder cancer, and myeloma than Whites (Batai et al., 2018). Related to these,

AI/ANs experience varying degrees of issues related to access to health care, such as social structural, physical

(transportation and physical distance), supportive, and cultural barriers (Itty et al., 2014). Research to understand

the aforementioned is necessary, albeit on AI/AN terms.

Table 1: Top Leading Causes of Death, AI/AN and US All Races Rates.

2010 Census, age-adjusted mortality rates per 100,000 population.

Cause/Disease

AI/AN Rate 2009-2011

US All Races Rate 2010

AI/AN to U.S. All Races

Heart Disease

194.7

179.1

1.1

Cancer

178.4

172.8

1.0

Accidents

93.7

38.0

2.5

Diabetes

66.0

20.8

3.2

Respiratory Diseases

46.6

42.2

1.1

Tribal Priority

Capacity

Building

Indigenous

Ways of

Knowing

Data

Ownership

Credit to

Community

Open

Forum

Conducting Research in AI/AN Tribes – A Checklist

 Get to know the tribal communities and establish relationships.

 Attend meetings and gatherings as a means to develop an appreciation for the history and culture of the

tribe.

 Get a clear understanding of the historical trauma experienced by the tribe.

 Demonstrate respect for the community and its indigenous expertise through a Memorandum of

Understanding.

 Hire members of the community to serve as consultants on various aspects of the research, such as, data

collection.

 A tribe’s schedule for tribal ceremonies or tribal rituals should be accommodated.

 Appreciate the Native community’s strengths, assets, and challenges.

 Engage the community in the partnership with respect to tribal culture, language, and values.

 Be transparent.

 Undergo tribal and Institutional Review Board (IRB) review and approval.

 Respect the privacy of the tribal community.

 Employ blended research methods that include “indigenous ways of knowing”.

 Limit scope of research to focus of questions only.

 Data sources, measures, and collection of information should be fully discussed with the tribe.

 Discuss intellectual and cultural property rights of the information including tribal data ownership.

 Keep the community fully informed as the study progresses and recognize contributions of community

members.

 Study findings should be discussed with tribal leadership first.

 Have tribal leaders and key community members review all abstracts, reports, and publications.

 Jointly determine how study results will be presented to the community and public.

 Consider sharing the results of the study in a public open community forum.

 Acknowledge and give credit to the community for the scientific results from the study.

 As applicable, consider including key community members as co-authors who participate in writing reports

and publications.

 Discuss with the tribal community how they want to be recognized in publications and reports.

 Assist the tribal community in how to address findings of the research.

 Discuss with the tribe the storage and/or destruction of data, especially duration and access.

 Discuss with the tribe any next steps, especially for how data will be stored, for how long, and who has

access and responsibility for the project materials and data.

The Review and Approval Steps

The first step to the research process is determining if the AI/AN tribe wants and/or needs the project to be

completed within their community, using aforementioned recommended approaches. All research involving

AI/AN communities must receive the approval of the appropriate tribal governments or organizations. To obtain

this approval, researchers should involve all concerned groups as early as possible in the process.

If more than one tribe or tribal organization is involved, a researcher must obtain approval from each entity. If

the research project involves academic institutions or the Indian Health Service (IHS), you will need to obtain

approval for the project from the academic institutions and IHS as well. Following we provide a brief overview

of recommendations for approaching and undergoing tribal, Indian Health Service, and University Institutional

Review Board (IRB) review. In the Appendices, we provide some sample documents to use as reference.

The materials that should be submitted include, but are not limited to:

 A cover letter with a list of all the participating researchers and a contact person with a telephone number.

 As applicable, a completed research application.

 As applicable, the Indian Health Service collaborator letter of support.

 As applicable, approval letter from your University IRB.

 A detailed protocol that explains the sampling, recruitment, study design, analyses, timelines, evaluation,

reporting, funding, collaborations, and community involvement (see Appendix A).

 The informed consent and assent forms (consent templates may be found at https://rgw.arizona.edu/

compliance/human-subjects-protection-program/HSPP-forms/consent-templates).

 Any other attachments, such as copies of flyers, scripts, questions, and/or survey(s) that will be used,

materials that will be distributed, etc.

The Tribal Review Process

Any time you are going to engage a tribe in a research project, you must present your idea to them for their

review. In many instances, tribes have formed tribal review processes and/or tribal review boards or

committees. If these exist, all policies and procedures established by these tribal entities should be followed.

The tribal entities to also be included should be those projects or programs most impacted by the research topic.

Similarly, the segment of the population most likely to be recruited for participation should be approached, but

only at the introduction by and knowledge of the aforementioned project or program personnel. These

individuals, in turn, will serve as the connection to tribal leadership, who have ultimate responsibility to

approve or disapprove a project.

The Indian Health Service (IHS)

The Indian Health Service (IHS) has responsibility to provide health care services to AI/AN people. Through

Public Law 93-638 Contracting and Compacting, Indian Trust Self-Governance and Self-Determination, many

tribes have taken over their health care delivery system and if this is the case, the aforementioned tribal review

process should be undertaken. If the research involves any IHS staff, facilities, data, or program, the IHS

review and approval should be sought.

The IHS is hierarchical in structure and the level that is closest to the research project should be engaged (see

Figure 3). Within IHS, the IRBs are overseen either directly by IHS personnel or by tribal entities. The

National IHS IRB (oversees research in Bemidji Area and Tucson Area) and Oklahoma Area are overseen by

IHS. The other Area IRBs are overseen by tribal entities such as the tribal consortia in that Area. In the latter

instance, research occurring on tribal lands within that region may be included within the purview of research

review.

Figure 3. Schematic of the Indian Health Service, Service Areas

In select instances, the Area IRB and the National IHS IRB may request simultaneous review. If there are

questions on which IRB review is needed, a researcher should call and seek guidance from any of the IRB

Chairs or IRB Coordinators, see following:

Indian Health Service Institutional Review Boards (IRB)

National IRB (NIRB) at IHS Headquarters, Rockville, Maryland: IRB00000646

Rachael Tracy, Chair, IHS National IRB (NIRB)

Indian Health Service

5600 Fishers Lane, MS 09E10D

Rockville, MD 20857

Phone: 301-443-4700

Fax: 301-443-0114

Submit projects electronically to [email protected] with complete hard copy to Rachael Tracy

Alaska Area: IRB00000636

Dr. Shanda Lohse, Chair, Alaska Area IRB

Terry Powell, Administrator, Alaska Area IRB

4315 Diplomacy Drive - RMCC

Anchorage, AK 99508

Phone: 907-729-3924 or 907-729-3917

Email: [email protected]

Submit project electronically to IRBNet.org , Alaska Area IRB

Bemidji Area

Antonio Guimaraes, MD Chair, Bemidji Area Publication Review Committee

(Human participants research clearance is referred to the NIRB)

522 Minnesota Avenue, NW

Bemidji, MN 56601

Phone: 218-335-3200

Fax: 218-444-0498

Billings Area IHS/Rocky Mountain Tribal: IRB00000638

Vernon Grant, PhD, Chair

Karen Manzo, PhD, MPH, IRB Coordinator

711 Central Ave, Suite 220

Billings, Montana 59102

Phone: 406-252-2550; 406-697-2436 (c)

Fax: 406-254-6355

Great Plains Area: IRB00000635

Dewey Ertz, EdD, Chair, Great Plains Area IRB

Marsha Stevens, GPIRB Coordinator

Phone: 605-226-7493

Fax: 605-226-7214

Toll Free: 866-331-5794

Nashville Area: IRB00000640

John Shutze, MPH, Chair, Nashville Area IHS IRB

711 Stewarts Ferry Pike

Nashville, TN 37214

Phone: 615-467-1669

Fax: 615-467-1585

Navajo Area: IRB00000641

Beverly Becenti-Pigman, Chair, Navajo Nation Human Research Review Board (Navajo Area IHS IRB)

Michael Winney, Administrative Assistant

Office of Planning, Research, Evaluation Program

Navajo Department of Health

P.O. Box 1390

Window Rock, Arizona 86515

Phone: 928-871-6929/871-6352

Fax: 928-871-6255

Oklahoma City Area: IRB00000642

Greggory Woitte, MD, FACOG

Ryan Schupbach, PharmD, BCPS, CACP

CAPT, U.S. Public Health Service

Co-Chairman, Institutional Review Board

Indian Health Service, Oklahoma City Area

701 Market Drive, Oklahoma City, OK 73114

Phone: (405) 951-3928

Phoenix Area: IRB00000643

Cynthia Claus, PhD, MPH, Chair, Phoenix Area IHS IRB

Two Renaissance Square

40 North Central Avenue Suite 600

Phoenix, AZ 85004

Phone: 602-364-5169

Portland Area: IRB00000645

Rena Macy, Co-Chair, Portland Area IHS IRB

Portland Area IHS

1414 NW Northrup St Suite 800

Portland, OR 97209

Phone: 503-414- 5540

CAPT Thomas Weiser, MD, MPH, Co-Chair

Portland Area IHS IRB, Northwest Portland Area Indian Health Board

2121 SW Broadway #300, Portland OR 97201

Phone: 503-416-3298

Mobile: 503-927-4467

Tucson Area

Robert Price, Public Health Advisor

Office of Tribal Self-Determination/Tribal Programs (Human participants research clearance is referred

to the NIRB)

7900 South J. Stock Road

Tucson, AZ 85746

Phone: 520-295-2403

Fax: 520-295-2540

University-based Institutional Review Board (IRB)

If a researcher is based at a University, institutional review is required if the research includes human subjects

(see Appendices B and C). The IRB will have an application and submission process that needs to be

followed (see Table 2 and Appendix D). All IRB processes and procedures are responsive to the Belmont

Report and federal regulations per 45 CFR (Code of Federal Regulations) 46. Most Universities will require

researchers to complete human subjects protection training (for example, CITI training – Collaborative

Institutional Training Initiative), conflict of interest training, and HIPAA training (Health Insurance

Portability and Accountability Act of 1996).

If there are multiple investigators from different universities, one of the Universities can serve as the IRB of

record with deferrals from the other IRBs. Tribal IRBs do not usually defer to University IRBs.

Table 2: Institutional Review Boards of Universities known to be conducting research in Arizona

Institution

Contact

Information

Website

University of Arizona

(520) 626-7575

https://rgw.arizona.edu/compliance/human-subjects-

protection-program

Northern Arizona

University

(928) 523-9428

https://nau.edu/nau-research/research-safety-and-

compliance/human-research-protection-program/

Arizona State University

(480) 965-6788

https://provost.asu.edu/committees/human-subjects-

institutional-review-board

University of New Mexico

(505) 277-0472

https://irb.unm.edu/

New Mexico State

University

(575) 646-7177

https://compliance.nmsu.edu/irb/

University of Colorado

(303) 724-1058

https://www.ucdenver.edu/research/comirb/Pages/COMIR

B.aspx

Colorado State University

(970) 491-5727

https://www.research.colostate.edu/ricro/irb/

University of Utah

(385) 419-0712

https://irb.utah.edu/

Utah State University

(435) 797-0567

https://rgs.usu.edu/irb/

University of Nevada, Las

Vegas

(702) 895-2794

https://www.unlv.edu/research/ORI-HSR

University of Nevada, Reno

(775) 327-2367

https://www.unr.edu/research-integrity/human-research

John Hopkins University

(410) 955-3008

https://www.hopkinsmedicine.org/institutional_review_bo

ard/about/

The Universities will also often provide templates from which to complete consent forms and assent forms, for

example. In these Guidelines we provide forms from the University of Arizona as sample documents. The IRB

is assessing respect for persons, beneficence, and justice.

Elements of an IRB Review

1. Understand the research

It is the IRBs responsibility to understand the type and purpose of the research being presented. This is

achieved by reading through all of the materials submitted by the researcher. The review board should

identify the risks and benefits for both the individual participants and the tribal community. The review

board should look at who is included or not included in the research and why. Special attention should

be paid to how individuals are being consented and whether the process is sufficient. For example, is a

translator or interpreter needed? All information that is being collected should be protected and kept

secure. The review board should assess how the tribal community is involved. Are all these adequate

and sufficient?

2. Ensure the consent process fully informs and freely consents potential participants

Participants should have the legal capacity to give consent, exercise free power of choice without being

tricked or forced to participate, have sufficient knowledge and understanding of the research proposal to

make a clear decision.

Voluntary informed consent is an ongoing process, not a piece of paper or discrete moment of time.

Researchers should ask for consent only under circumstances that provide the prospective participant or

his/her representative sufficient time to consider whether or not to participate in the project.

A researcher should include the following elements when designing a consent form:

 The title of the research study.

 A statement that this is research.

 Reason of eligibility of the subject to participate in the study.

 Approximate number of subjects participating in the study.

 Explanation of the scientific purpose of the study.

 Explanation of the procedures, the time required, and which procedures are experimental.

 Description of reasonably foreseeable risks and discomforts.

 Description of risks to the subject or fetus if the subject becomes pregnant.

 Description of potential benefits to the subject, others or society in general.

 Description of alternatives to participation, which, may be advantages to the subject.

 Disclosure of costs to the subject and a description of any payment for participating in the study.

 Explanation of available treatment and compensation, if subject is injured.

 Information about who to contact with questions regarding the study or subject’s rights.

 A statement describing how confidentiality will be maintained.

 A statement describing that participation is voluntary and the subject can withdraw without penalty.

 Circumstances for which a researcher can terminate the subject’s participation.

 Disclosure of researcher’s financial interest related to the research.

 A consent section for the dated signature of the subject and researcher.

 The name and phone number(s) of researcher(s) and study personnel.

3. Minimize potential harms

Consider potential cultural/traditional, biological, medical, spiritual, psychological, and social harms to

the individual, family, and the community, and require steps to ensure potential harms are minimized.

4. Maximize potential benefits

Consider potential cultural/traditional, biological, medical, spiritual, psychological, and social benefits

to the individual, family, and the community, and require steps to ensure potential benefits are

maximized.

5. Ensure justice

Look at who is being included in the study and assess that all those who could benefit from participation

are being included.

6. Obtain additional information

Decide if additional expertise is needed to understand what is being proposed. This may include

involving additional experts (researchers, health educators, administrators, etc.) to clarify or provide

assistance with the review.

Institutional Review Board Decisions

When an IRB has reviewed a research protocol, they vote and the decision could be to:

 Approve the Research-the research can start and the IRB can request that a researcher provide updates with

the time specified, for example, annually.

 Approve with Recommendations-the research can start and there are items given to the investigators to

make the research project more responsive to local tribal circumstances.

 Approve with Conditions-the research cannot start and there are concerns that must be addressed first. The

revised research protocol is reviewed once changes have been made.

 Defer-the research cannot start and a decision is not made at all because there are key elements missing. The

revised research protocol is reviewed once changes have been made.

 Disapprove-the research is disapproved and cannot proceed.

Questions to Ask During the Research Design Process

Significance

• How is the research addressing tribal needs?

• How is the tribe benefitting from the research?

• What are the potential harms? Are they being addressed adequately?

Approach

• How is the information being collected?

• What information is being collected?

• Who is going to be collecting the information?

Data/

Information

• Will personal information be collected?

• How is the information being protected? Who has access to the information?

• How long is the information going to be stored? Where?

• Will the tribe own the data?

Participants

• Who is being included?

• How many individuals are being included?

• Are there children, or others that may need additional considerations being included?

Consent

•Is the consent written in a way that will be easily understood?

•Are translators needed? Is an interpreter needed?

•Are all elements of the project included in the consent form?

•Are individuals being given enough time to make a determination of whether or not to participate?

Questions

•What questions are being asked?

•Are the questions okay to be asked?

•How long will it take to ask the questions?

•If questions are sensitive, is privacy being secured?

Biospecimens

•What is being collected?

•How is the information being protected? Who has access to the information?

•How long is the information going to be stored? Where?

•Will the data be able to be destroyed?

Privacy/

Confidentiality

•How are personal identifiers being handled, for example, name, phone numbers, etc.

•Are participants being told how their information will be protected?

•How is the tribal community being protected?

Referrals

•Are individuals receiving referrals in case there is need for follow-up?

•Are individuals receiving contact lists of someone to call in case they need to talk with someone?

•How are individuals needing follow-up being identified?

Liability

•Who is responsible if something goes wrong?

•Are there conditions under which data might be released? e.g., court order

•What happens if anyone is physically, emotionally, or spiritually hurt?

Capacity

Building

•How are tribal community programs being included?

•Are tribal community members being included to help with the research?

•What resources are being allocated to the tribe?

Reporting

•How frequently should the researchers provide updates?

•How will the community be informed of findings?

•Will the tribe review before public dissemination?

NOTES:

Publication

•What are the tribal requests for how abstracts, manuscripts, and reports will identify the tribe?

•Will tribal partners and/or the tribe be co-authors?

Next Steps

•What happens to the information that was collected?

•How long will it be stored? Who has access?

•How will data be destroyed? By whom?

The Research Protocol

The research protocol should provide in detail how the project will be carried out, how the data will be collected

and analyzed, and what will be done with the results. Provided below are some points that should be addressed

within the research protocol.

Introduction and Background

 Provide relevant research background and explain why this research project is necessary or important.

 Explain why it is necessary to include AI/AN subjects in the research project.

 Explain how the burdens and benefits of the research will be equally distributed.

 Explain if there are other equally suitable groups who could be recruited for this study and why they are

not being recruited.

 Described the potential impact of the proposed research on AI/ANs.

 If a resolution or support letter from the AI/AN tribe has not been obtained, describe how and when it

will be. The resolution or support letter should be forwarded to the IRB once it is received.

Study Design

 A complete description of the study design, sequence, and timing of all study procedures that will be

performed need to be provided.

 Provide the information for the pilot, screening, intervention, and follow-up phases.

 Include all the materials that will be used in the study, such as surveys, scripts, questionnaires, etc.

 Attach flow sheets if they will help the reader understand the procedures.

 Describe how the study procedures will differ from the standard care that is already available, if it exists.

 If any deception or withholding of complete information is required, explain why this is necessary and

attach a debriefing statement.

 Describe where the study will take place.

Participants

 Explain how the nature of the research requires or justifies using human subjects.

 Provide the approximate number and ages for the control and experimental groups.

 Describe the gender and minority representation of the subject population.

 Describe the criteria of selection for each subject group.

 Describe the exclusion criteria for each subject group.

 Describe the source for subjects and attach letters of cooperation from agencies, institutions, or other

means of recruitment.

 Explain who will approach the subjects and how they will be approached.

 Explain what steps will be taken to avoid coercion and how to privacy will be protected.

 Submit all advertisement documents, flyers, contact letters, and phone contact protocols.

 Explain if subjects will receive payments, services without charge, or extra course credit.

 Explain if subjects will be charged for any study procedures.

Risk and Benefits

 Describe the nature and amount of risk injury, stress, discomfort, invasion of privacy, and other side

effects from all of the study procedures, drugs, and devices.

 Describe the amount of risk the individuals or community may be subjected to.

 Describe how due care will be used to minimize risks and maximize benefits.

 Describe the balance between risks and benefits will be continually reassessed.

 Describe the data and safety monitoring committee, if one exists.

 Describe the expected benefits for individual participants, the community, and society.

Adverse Effects

 Describe how adverse effects will be handled.

 Discuss if the facilities being implemented are adequate to handle possible adverse effects.

 Explain who will be financially responsible for treatment of physical injuries resulting from study

procedures.

Confidentiality of Research Data

 Explain if the data will be anonymous with no possible links to identifiers.

 If there are identifiers, explain if they are coded and if the key to the code will be stored separately from

the data.

 Explain if any other agency or individual will have access to the identifiable data.

 Explain how the data will be protected.

Consent Forms and Assent Forms

 If the consent form is written, submit copies of all consent and assent forms for each subject group.

 If an oral consent or assent script will be used, submit written scripts for each group.

 If you will not use a consent form or script, submit written justification of waiver of consent per 45 CFR

66.116 (d).

Consent or Assent Processes to Consider

 Would a waiver of consent violate any state or federal statue or customary practice regarding entitlement

to privacy or confidentiality?

 Could the research design be modified to eliminate the need for an incomplete disclosure?

 Will the subjects be given more information after completing their participation?

 Is the consent form given and received in a reasonably quiet, unhurried setting?

 Is there a knowledgeable individual present who can answer the questions in a clear manner, using

simple terms?

 If children under the age 18 are involved in the study, do you have a parental consent form?

o If the study involves minimal risk, then the consent of only one parent is needed.

o If the study involves more than minimal risk, then the consent of both parents is needed.

 If the child is old enough to make some decisions themselves (approximately ages 5-6 years old), is

there a form and process that has been set up for their assent?

 Who will explain the research to the potential participants?

 Should someone in addition to or other than the investigator be present?

Drugs, Substance, and Devices

 List all non-investigational drugs or other substances that will be used during the study and include the

name, source, dose, and method of administration.

 List all investigational drugs or substances to be used in the study and include the name, source, dose,

method of administration, IND number, and phase of testing.

o INDs must be registered with the appropriate institutional pharmacy. Provide a concise summary

of drug information prepared by the researcher, including toxicity data, reports of animal studies,

description of studies done in humans, and drug protocol.

 List all investigational devices to be used and provide the name, source, description of purpose, method,

and Food and Drug Administration IDE number.

o If no IDE is available, explain why the device qualifies as a non-significant risk. Attach a copy

of the protocol, descriptions of studies in humans and animals, and drawing or photographs of

the device.

Research Involving Biospecimens

Many AI/AN have special cultural values and concerns related to the patenting of genes, cloning, and the use of

blood and other tissues. Make sure to ask and address the following questions regarding biospecimen collection.

 Does the biospecimen collection and analysis process violate or conflict with cultural values? If so, how

will these be addressed? By whom?

 Will the procedures to store biospecimens for use during the project violate or conflict with cultural

values? (location and duration of storage of biospecimens)

 Will the procedures to dispose of the collected biospecimens violate or conflict with cultural values?

 Will the biospecimen be stored for future “secondary” studies?

 Are secondary uses of the biospecimen approved by the tribe? What are the terms?

 Is the nature of use adequately described in the research protocol and consent form?

 Make sure to provide signed written agreements to ensure that researchers and others with access to the

biospecimen will comply with all procedures to conduct secondary studies.

Additional Information

 Describe the medical, academic, or other personal records that will be used.

 Describe the type of audio-visual recordings, tape recordings, or photographs that will be made.

 Describe if a data safety monitoring board is being included.

 Describe if a Certificate of Confidentiality will be obtained.

Results Interpretation and Dissemination

After the completion of a research project, the collected data and results must be interpreted, analyzed, and

reported back to the tribal community in a respectful and understanding manner. Researchers should travel to

the tribal communities to present their findings and to discuss with tribal leadership if the research findings

should be published or not.

The following are considerations for interpreting and distributing results back to a tribal community.

Interpreting Results

 The information gathered in the study should be relayed to the tribe, research community, and the

general public, for example, through a community open forum.

 The researcher’s interpretation should be shared with the tribe for feedback and input.

 The results should be explained to the program director, tribal health director, health board, and tribal

council.

 The information, as applicable, should be stratified by age and sex, and compared with other races, with

respect to cell sizes to protect privacy.

 As the results are being written, the tribe should be consulted on findings and narration of tribal identity.

 Results should be relayed through a resilience lens and not a deficit lens.

Reporting and Dissemination

 The tribe needs to approve the final report, manuscript, and dissemination.

 The tribe may require they approve abstracts.

 The tribe should be the first to see and know the results, i.e., before public release.

 Upon approval, the results can then be shared with the tribal community, and then the general public.

 The tribe should be seen as a co-author on publications.

 All peer-reviewed articles should be shared with the tribal community and tribal partners.

Research

Designed

to Address

Need

Research

Protocol

submitted

for

Review

Research

Review

Process

Research

Commences

& Results back

to Tribe

Tribal

Needs

Follow-Up (Next) Steps

 Based on the results, the research project should specify additional follow-up or next steps that will be

pursued.

 The follow-up or next steps need to be approved by the tribe before continuing.

 All closure understandings should be documented, for example, what happens to collected data, who has

access, how long data will be retained, how data will be destroyed, etc.

Resources

For More Information

The University of Arizona Native Peoples Technical Assistance Office provides research support; training and

education; and technical assistance for tribal community development at: https://nptao.arizona.edu/

The University of Arizona Subjects Protection Program provides information on IRB Assurance and

Registration, IRB Roster, Statements of Regulatory Adherence, and fee changes at:

https://rgw.arizona.edu/compliance/human-subjects-protection-program/about-the-irb

The Northern Arizona University Protocols for Native American Archival Materials contains information about

tribal sovereignty and how to conduct respectful research at: https://www2.nau.edu/libnap-p/protocols.html

The Northern Arizona University Center for American Indian Resilience has information about community

assets, traditional knowledge, and cultural strategies at: https://in.nau.edu/cair/

The Arizona State University American Indian Policy Institute supports American Indian tribes for cultural

sovereignty, public-policy analysis, and research at: https://aipi.clas.asu.edu/content/areas-expertise

The National Congress of American Indians has information about the foundations, ethics, and practices of

research resulting in the construction of AI/AN codes, contracts, and IRBs at: https://www.ncai.org/policy-

research-center/initiatives/research-regulation

The Indian Health Service provides additional resources regarding IRBs, grants, research studies, and programs

at: https://www.ihs.gov/dper/research/researchresources/

The Office for Human Research Protections issues written guidance’s, registers IRBs and FWAs, and provides

information about the New Common Rule at: https://www.hhs.gov/ohrp/

PRIM&R is a leader for public responsibility in medicine and research providing educational programs and

professional development opportunities that can be found at: https://www.primr.org

For further information about the Belmont Report, the Nuremberg Code, and Helsinki, please visit the OHRP

website at: https://www.hhs.gov/ohrp/international/ethical-codes-and-research-standards/index.html

Independent Tribal IRBs

An increasing number of Tribes are forming their own IRBs (below) under 45 CFR 46. Research projects at

IHS direct care facilities serving a Tribal Nation that has its own IRB must have the approval of both the Tribal

IRB and the IHS IRB. Projects at facilities managed by Tribal Nations with their own IRB and Federal Wide

Assurance (FWA) require approval of only the Tribal IRB. Protocols approved by Tribal Research Review

Committees that do not meet the formal requirements of 45 CFR 46 for an IRB should also be forward to the

IHS IRB for approval. A formal letter of approval from the Tribal Research Committee or IRB is required for

consideration by an IHS IRB. This generally takes the place of the Council Resolution or approval letter from

an authorized Tribal Health Official that would ordinarily be required. Tribal IRBs that serve a dual role as both

a Tribal IRB and an IHS Area Office IRB (Such as the Navajo Nation's IRB) are listed under "IHS IRBs."

American Indian Healing Center, Inc.: IRB00008253 IORG0006887

John Andrews, MPH, Executive Director

12456 E. Washington Blvd.

Whittier, CA 90602

Phone: 562-693-4325

Fax: 562-693-1115

Association of American Indian Physicians: IRB00002261 IORG0001788

Margaret Knight, Executive Director

1225 Sovereign Row, Suite 103

Oklahoma City, OK 73108

Phone: 405-946-7072

Fax: 405-946-7651

Blackfeet Nation: IRB00005802 IORG0004865

Lola Wippert, Chairwoman

Blackfeet Community College

P.O. Box 819

Browning, MT 59417

Phone: 406-338-5421, ext 2252

California Rural Indian Health Board (CRIHB): IRB00004400 IORG0003711

Susan Dahl, MHA, RHIA, CHC, CHP, Chair, CRIHB IRB

4400 Auburn Blvd., 2nd floor

Sacramento, CA 95841

Phone: 916-929-9761 Ext 1400

Fax: 916-929-7246

Cherokee Nation: IRB00001237 IORG0000872

Sohail Kahn, MBBS, MPH, CIP, Co-Chair, Cherokee Nation IRB

Roger Montgomery, MD, Chair, Cherokee Nation IRB

P.O. Box 948

Highway 62

Tahlequah, OK 74465

Phone: 918-453-5602

Fax: 918-431-4148

Chickasaw Nation: IRB00004394 IORG0003705

Sheryl Goodson, Chair, Chickasaw Nation Research Review Committee (RRC)

Carl Albert Indian Health Facility

1001 N. Country Club Road

Ada, OK 74820

Phone: 580-421-4548

Fax: 580-421-6208

Bobby Saunkeah, RN, BSN, CDE, RRC Secretary

Phone: 580-421-4532, Ext. 800

Fax: 580-521-4572

Choctaw Nation: IRB00004293 IORG0003613

David F. Wharton, MPH, RN, Facilitator, Choctaw Nation IRB

Choctaw Nation Health Services

Choctaw Nation Health Clinic - Idabel

902 E Lincoln Road

Idabel, OK 74745

Phone: 580-286-4724

Fax: 580-286-4718

College of Menominee Nation: IRB00007956 IORG0006633

Donna Powless, PhD, Vice-President of Academic Affairs

P.O. Box 1179

N172 State Hwy 47/55

Keshena, WI 54135

Phone: 715-799-5600, Ext. 306

Fax: 715-799-5951

Haskell Indian Nations University: IRB00003557 IORG0002948

Freda Gipp, Administrative Assistant

155 Indian Avenue

Lawrence, KS 66046

Phone: 785-749-8407

Fax: 785-749-8411

Ho-Chunk Nation IRB

Brenda Owen, IRB Chair

Joan Greendeer-Lee, Secretary

N6520 Lumberjack Guy Road

Black River Falls, WI 54615

Phone: 715-284-9851 ext. 5052

Southwest Tribal IRB (Albuquerque Area)

Marvin Sarracino, Chair

Rachell Tenorio, Coordinator

5015 Prospect Ave NE

Albuquerque, NM 87110

Phone: 505-764-0036

Fax: 505-764-0446 Email: [email protected]

Oglala Sioux Tribal Research Review Board (OSTRRB) (Great Plains)

Katie Blindman, OSTRRB Data Research Assistant

P.O. Box 5011

Pine Ridge, SD 57770

Phone: 605-867-1704

Email: [email protected]

Sisseton-Wahpeton Oyate Local Research Review Board (SWOLRRB) (Great Plains)

Heather Larsen, Research Specialist

Local Research Review Board

Education Department

Sisseton-Wahpeton Oyate of the Lake Traverse Reservation

P.O. Box 509 Agency Village, C.P.O.

Sisseton, SD 57262

Phone: 605-698-8411

OR Dr. Sherry Johnson, Education Director

Phone: (605) 698-8298

Website: SISSETON WAHPETON OYATE OF THE LAKE TRAVERSE RESERVATION

RESEARCH OFFICE

Tribal Nations Research Group (TNRG) (Great Plains)

Anita Frederick

Tribal Nations Research Group

P.O. Box 1906

Belcourt, ND 58316

Phone: (701) 477-5526

Website: Tribal Nations Research Group

References

Bales, Fred (1994) Hantavirus and the Media: Double Jeopardy for Native Americans. American Indian Culture

and Research Journal: 1994, Vol. 18, No. 3, pp. 251-263.

Batai K, Gachupin FC, Estrada AL, Garcia DO, Gomez J, Kittles RA (2018). Patterns of Cancer Related Health

Disparities in Arizona. Cancer Health Disparities 2:e1-e20. Doi:10.9777/chd.2018.10019

Centers for Disease Control and Prevention. (2018). Cancer Health Disparities Among American Indians and

Alaska Natives. Retrieved February, 2019, from

https://www.cdc.gov/cancer/healthdisparities/what_cdc_is_doing/aian.htm

Fisher PA, Ball TJ. Tribal participatory research: Mechanisms of a collaborative model. American Journal of

Community Psychology. 2003; 32(3-4):207-216. [PubMed: 14703257]

Garrison, Nanibaa’ A. (2012). Genomic Justice for Native Americans. Science, Technology, & Human Values,

38(2), 201-223.doi:10.1177/0162243912470009

Hoffman RM, Espey DK, Rhyne RL, Gonzales M, Rajput A, Mishra SI, Stone SN, Wiggins CL (2014).

Colorectal cancer incidence and mortality disparities in New Mexico. J Cancer Epidemiol 2014, 8.

Indian Health Service. (2019). About IHS. Retrieved February, 2019, from https://www.ihs.gov/aboutihs/

Indian Health Service, Phoenix Area, Disparities | Fact Sheets, Apr. 2018, Retrieved from

www.ihs.gov/newsroom/factsheets/disparities/

Isaac G, Finn S, Joe JR, Hoover E, Gone JP, Lefthand-Begay C, & Hill S. (2018). Native American

Perspectives on Health and Traditional Ecological Knowledge. Environmental Health

Perspectives, 126(12), 125002. doi:10.1289/ehp1944

Israel BA, Eng E, Schulz AJ, Parker EA, editors. Methods in Community-Based Participatory Research for

Health. First ed. Jossey-Bass; San Francisco: 2005.

Israel BA, et al. Review of community-based research: Assessing partnership approaches to improve public

health. Annual Review of Public Health. 1998; 19:173-202

Itty TL, Hodge FS, & Martinez F. (2013). Shared and Unshared Barriers to Cancer Symptom Management

Among Urban and Rural American Indians. The Journal of Rural Health, 30(2), 206-213.

doi:10.1111/jrh.12045

National Congress of American Indians. Tribal Governance, Retrieved February, 2019, from

https://www.ncai.org/policy-issues/tribal-governance

Native American Center for Excellence, Substance Abuse Prevention, Steps for Conducting Research and

Evaluation in Native Communities. Available at: https://www.samhsa.gov/sites/default/files/nace-steps-

conducting-research-evaluation-native-communities.pdf

Office for Human Research Protections, & Ohrp. (2016). Ethical Codes & Research Standards.

Retrieved February, 2019, from https://www.hhs.gov/ohrp/international/ethical-codes-and-research-

standards/index.html

The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research

(1979). The Belmont Report: Ethical principles and guidelines for the protection of human subjects of

research. Retrieved February, 2019, from www.hhs.gov/ohrp/regulations-and-policy/belmont-

report/read-the-belmont-report/index.html

Thomas LR, Donovan DM, Sigo RLW. Identifying community needs and resources in a Native community: A

research partnership in the Pacific Northwest. International Journal of Mental Health and Addiction.

2010; 8(2):362-373.

U.S. Fish & Wildlife Service. 2011. Traditional Ecological Knowledge for Application by Service Scientists.

Retrieved from http://www.fws.gov/nativeamerican/pdf/tek-fact-sheet.pdf(link is external).

Appendices

A. Developing a Protocol.....................................................................................................29

B. University of Arizona: What is Human Research?..........................................................

C. University of Arizona: Determination of Human Research.............................................39

D. University of Arizona: Application for Human Research................................................44

Appendix A: Developing a Protocol

The quality of science is often improved when study objectives and methods are clearly thought through and

described. A written protocol facilitates high quality science and is an invaluable tool to investigators as they

develop and conduct studies.

Regardless of the scientific discipline in which the study is undertaken, the same scientific method is used.

Further, while the scientific content will differ across studies, the general elements of the study protocol will be

similar.

The Excellence in Science committee at the Center for Disease Control and Prevention (CDC) has developed a

general protocol checklist and companion guide to assist scientists in preparing protocols. The checklist is

intended as an aid in suggesting a format for writing protocols and in identifying issues that scientists should

consider as they design the study.

The checklist was developed to have utility in conducting laboratory and basic science studies, epidemiogic

studies, and behavioral and social science studies employing a variety of study designs. In using checklist,

investigators should select the items that apply to their types of studies. It is unlikely that any protocol would

include every item on the checklist.

This checklist is intended as an aid in suggesting a format for writing protocols and in identifying issuees that

scientists should consider as they design a study or surveillance system. When using the checklist, investigators

should select the items that apply to their specific project. It is not expected that every item on the checklist is

applicable to each protocol for a study or surveillance system.

General Protocol Checklist

Section

Item

√

PROJECT OVERVIEW

Title

Protocol summary

Investigators & roles/collaborators & roles/funding sources

PROJECT OVERVIEW

• Title: Summarize the main idea under investigation. The title should be able to stand alone as an

explanation of the study.

• Protocol summary: Give a concise overview of the project. Describe the purpose of the study, including

problem to be investigated and hypothesis (es) to be tested, the population, and the methods that will be

used. Avoid the use of acronyms. Include the expected benefit of the study.

• Investigators/collaborators/funding sources: Include the names and degrees of all investigators and their

roles in the project. Note any conflict of interest for each investigator and acknowledge all funding sources.

Section

Item

√

INTRODUCTION

Literature review/current state of knowledge about project topic

Justification for study

Intended/potential use of study findings

Study design/locations

Objectives

Hypothesis or questions

General approach

INTRODUCTION

• Literature review/current state of knowledge about project topic:Discuss relevant information about the

subject of the project based on a review of the literature. In the Reference section, attach a bibliography of

the sources used.

• Justification for study: Explain the public helath and scientific importance of the study. In the context of

previous studies, describe the contribution this study will make.

• Intended/potential use of study findings: Define the primary target audiences and discuss the expected

applicability of study findings.

• Study design/locations: Describe the study design and the locations where the study will be conducted.

• Objectives: Clearly and concisely list the objectives that the project will address.

• Hypotheses or questions: List the clear and focused question(s) that the study will answer. State the type of

hypothesis(es) that will be explored or tested.

• General approach: Describe whether the approach used will be descriptive, exploratory (hypthesis-

generating), confirmatory (hypothesis testing), or developmental (focused on corrective action).

Section

Item

√

PROCEDURES/METHODS

DESIGN

How study design or surveillance system addresses hypothesis and

meets objectives

Audience and stakeholder participation

Study time line

PROCEDURES/METHODS - DESIGN

• How study design or surveillance system addresses hyptheses and meets objectives:Explain the

appropriateness of the study design to the project and to the question and objectives previously outlined.

Distinguish between procedures that are experimental and those that involve routine care. Identify specific

design attributes that characterize the study design (e.g., description of the system as active or passive,

defining reported cases as individuals versus aggregate and as laboratory confirmed or not).

• Audience and stakeholder participation: Define the primary audiences for the project. Assess the major

stakeholders and describe ways they can (and cannot) participate in the study. Explain the process by which

those affected by the study can express their views, clarify their needs, and contribute to the project.

• Study timeline: Provide a calendar with estimated dates for implementing and completing key activities.

Section

Item

√

PROCEDURES /METHODS

STUDY POPULATION

Description and source of study population and catchment area

Case definitions

Participants inclusion criteria

Participants exclusion criteria

Justification of exclusion of any sub-segment of the population

Estimated number of participants

Sampling, including sample size and statistical power

Enrollment

Consent process

PROCEDURES/METHODS - STUDY POPULATION

• Description and source of study population and catchment area: Demographically and in terms of the

specific public health conditions to be studied, defined the population from which the participants, sample,

or surveillance subjects will be drawn and to what population inferences will be made.

• Case definitions: Provide descriptions of illness, condition or health event which defines a study participant

as having that condition.

• Participant inclusion criteria: Describe conditions or characteristics applicable to the identification and

selection of participants in the study and the conditions necessary for eligible persons to be included.

• Participant exlusion criteria: Describe characteristics that would disqualify otherwise eligible participants

from the project.

• Justification of exclusion of any sub-segment of the population: If a sub-population as define by gender,

race/ethnicity, or age is excluded, provide reasons.

• Estimated number of participants: State the estimated number of participants for the study. For a project

established or using data from a surveillance system, this may include the expected numbe of reported cases

per reportig period for epidemic and non-epidemic periods.

• Sampling, including sample size and statistical power: Describe the sample (e.g., the sample will be one

of convenience, a population-based representation or systematically chosen for some other purpose). State

the sampling units and units of analysis. Estimate required sample sizes to answer questions and test

statistical hypotheses (based on available information from pilot studies or previous reports). Include

statistical power estimates. Explain the conditions under which sampling estimates would be revised. If

group-level or aggregated information will be collected (e.g., from focus groups), explain how the groups

will be comprised, or what procedures will be followed to create appropriate groups.

• Enrollment: Describe the manner in which potential participants will be contacted, screened, and registered

in the study. Describe procedures for tracking the numbre of persons who withdraw from the study. Explain

the procedures for assigning participants to different groups. Include a discussion of how departures from

the intended enrollment procedures will be handled and documented.

Section

Item

√

PROCEDURES/METHODS

VARIABLES/INTERVENTIONS

Variables

Study instruments, including questionnaires, laboratory instruments

and analytic test (including abstract form, paper and electronic)

Training for all study personnel

PROCEDURES/METHODS - VARIABLES/INTERVENTION

• Variables: List and briefly describe the categories, topics, or domains of information to be explored and

variables to be collected. Address consistency of definition of variables for data collected from multiple

sources. Traditionally, for outbreak investigations, “time”, “place”, and “person” would be collected to

construct the epidemiologic curve. Explain how the variables will be utilized and the process by which

variables will be defined.

• Study instruments, including questionnaires, laboratory instruments, and analytic tests: Describe

strategies to elicit information, including specific techniques and study and laboratory instruments, and

explain how they will be used. Describe the attributes of those strategies/instruments as demonstrated in

other studies, including appropriateness, validity and reliability within the particular study populations,

sensitivity and specificity of instruments, how well they yield reproducible results and whether any

controversial methods are being used. Include a discussion of how changes to the study instruments will be

handled and documents.

• Training for all study personnel: Describe training, such as interviewer techniques, data collection and

handling methods or informed consent, provided to study personnel. Address how inter-observer differences

will be handled.

Section

Item

√

PROCEDURES/METHODS

DATA HANDLING AND

ANALYSIS

Data analysis plan, including statistical methodology and planned

tables and figures

Data collection

Data entry, editing and management, including handling data

collection forms, different versions of data and data storage and

disposition (including treatment data consolidation)

Quality control/assurance

Bias in data collection, measurement and analysis

Intermediate reviews and analyses (pilot test)

Limitations of study

DATA HANDING AND ANALYSIS

• Data analysis plan, inlcuding statistical methodology and planned tables and figures: Describe the

sampling methods, information collection procedures, methods to maximize response rates, test

procedures and relevant statistical quantities (e.g., variance, confidence intervals and power based on

data from the study) in sufficient detail that the methods are reproducible. This includes calculation of

relevant quantitative measures for methods and reproducible. This includes calculation of relevant

quantitative measures for test and instruments, such as sensitivity and specificity. In outbreak

investigations, it is common to employ an iterative process in the analysis (consisting of developing and

testing hypotheses and planning and evaluating interventions) to identify the source of the outbreak and

control it. For projects establishing or utilizing data from a surveillance system, this could include how

and how often the surveillance system will be evaluated. Describe what tables and figures are planned

to present study results.

• Data collection: Describe data collection procedures, processes and documentation. For data emanating

from a surveillance system, this would include frequency or reports.

• Information management and analysis software: Provide the names of data entry, management and

analysis software packages and computer programming languages to be used for the project.

• Data entry editing and management, including handling of data collection forms, different

versions of data, and data storage and disposition: Describe the overall procedures for management

of the data collected. Include in the description the process for entering and editing data. Describe how

study materials, including questionnaires, statistical analyses, unique reagents, annotated notebooks,

computer programs and other computerized information, whether used for publication or not, will be

maintained to allow ready, future access for analysis and review. Document operating procedures for

managing and accessing different versions of data sets. State who the data belong to and any rights to

and limitations to access for any primary and secondary data analyses and publications. Documents

procedures regarding confidentiality of the data, including how confidentiality will be preserved during

transmission, use and storage of the data and the names of persons or positions responsible for technical

and administrative stewardship responsibilities. Document what the final disposition of records, data,

computer files, and specimens will be, including location for any relevant information to be stored.

• Quality control/assurance: Describe the steps that will ensure no unintended conseqences that could

affect the quality of the data. Those steps might include methods to capture all reported data exactly as

received, assuring logical consistency among all parts of a record and ensuring that manipulation or

transformation of the data (e.g., from audio tape to transcribe text) produces no unintended changes, and

verifying that statistical and arithmetic calculations are performed as proposed in the data analysis plan.

For outbreak investigations, this would include verifying diagnosis and confirming the outbreak.

Describe procedures for ongoing data quality monitoring to assure that information of appropriate

depth, breadth, specificity is collected and remains consistent within and among staff over time, and

acceptable levels of such attributes as validity, reliability, reproducibility, sensitivity and specificity are

achieved.

• Bias in data collection, measurement and analysis: Describe the kinds of bias that may occur in

collecting the data or in the measurement or analysis phases, and the steps that will be taken to avoid,

minimize and compensate for the bias. Include factors in the study population or in study personnel that

could bias results, as well as the steps that will be taken to assure vaild self-reporting or recording of

observations. Include any randomization and blinding procedures that will be used to

eliminate/minimize bias by investigators, other study staff or participants (e.g., in selection of

participants, allocation to treatment groups, providing/receiving treatment).

• Intermediate reviews and analyses: Describe the ways that progress will be tracked and the study will

be evaluated prior to assessing final results.

• Limitations of study: Explain factors that might reduce the applicability of study results. Discuss

potential weak points or criticisms of the study, including alternative methods.

Section

Item

√

PROCEDURES/METHODS

DISSEMINATION,

NOTIFICATION, AND

REPORTING OF RESULTS

Notifying participants of study findings

Anticipated products or inventions resulting from the study and their

use

Disseminating results to public (including data publication guidelines

and manuscript writing roles)

REFERENCES

Literature searches

APPENDIX MATERIALS

Data collection forms

Proposed tables and figures

Other relevant documents

Appendix B: What is Human Research?

HSPP Use Only:

What is Human Research v2019-01

Overview

Any ‘agent’ of the University of Arizona (e.g. faculty, staff or students) requires IRB oversight

when the activity they are conducting is both ‘research’ that involves ‘human subjects.’ Please

see the guidance on ‘principal investigator (PI) eligibility’ at the University of Arizona.

First, is the activity research?

Research means a systematic investigation, including research development, testing, and

evaluation, designed to develop or contribute to generalizable knowledge. The following

activities are deemed not to be research:

(1) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary

criticism, legal research, and historical scholarship), including the collection and use of

information, that focus directly on the specific individuals about whom the information is

collected.

(2) Public health surveillance activities, including the collection and testing of information or

biospecimens, conducted, supported, requested, ordered, required, or authorized by a public

health authority. Such activities are limited to those necessary to allow a public health authority

to identify, monitor, assess, or investigate potential public health signals, onsets of disease

outbreaks, or conditions of public health importance (including trends, signals, risk factors,

patterns in diseases, or increases in injuries from using consumer products). Such activities

include those associated with providing timely situational awareness and priority setting during

the course of an event or crisis that threatens public health (including natural or man-made

disasters).

(3) Collection and analysis of information, biospecimens, or records by or for a criminal justice

agency for activities authorized by law or court order solely for criminal justice or criminal

investigative purposes.

(4) Authorized operational activities (as determined by each agency) in support of intelligence,

homeland security, defense, or other national security missions.

Second, does the activity involve human subjects?

If the investigator is conducting ‘research’ as described above, and the project involves a

human subject as defined below, then activity is ‘human research’ and requires IRB oversight.

Human subject

means a living individual about whom an investigator (whether

professional or student) conducting research:

•

Obtains information or biospecimens through intervention or interaction

with the individual, and uses, studies, or analyzes the information or

biospecimens; or

What is Human Research?

HSPP Use Only:

What is Human Research v2019-01

•

Obtains, uses, studies, analyzes, or generates identifiable private

information or identifiable biospecimens.

The definitions below will help frame and understand the terms listed in the definition of

human subject above:

•

Intervention includes both physical procedures by which information or

biospecimens are gathered (e.g., venipuncture) and manipulations of the

subject or the subject’s environment that are performed for research

purposes.

•

Interaction includes communication or interpersonal contact between

investigator and subject.

•

Private information includes information about behavior that occurs in a

context in which an individual can reasonably expect that no observation

or recording is taking place, and information that has been provided for

specific purposes by an individual and that the individual can reasonably

expect will not be made public (e.g., a medical record).

•

Identifiable private information* is private information for which the

identity of the subject is or may readily be ascertained by the investigator

or associated with the information.

*Note that if the private information is health information from a

healthcare covered entity (CE) it may be subject to the HIPAA rules.

•

Identifiable biospecimen* is a biospecimen for which the identity of the

subject is or may readily be ascertained by the investigator or associated

with the biospecimen.

*Note the biospecimen may be subject to the HIPAA rules if it is obtained

from a healthcare covered entity (CE).

Quality Improvement (QI) and Program Evaluation (PE)

There is no regulatory definition for Quality Improvement (QI) or Program Evaluation (PE), but

they are often described as being designed to bring about immediate (or nearly immediate)

improvements in delivery or system performance. These activities include changes to systems

or processes, development of guidelines, training and education, and access to private

information. The goal of these activities is to provide real-time evidence-based data related to

performance, needs, or output.

Strict QI/PE generally do not require review by an IRB because they do not meet the definition

of research (45CFR46.102.e).

What is Human Research?

HSPP Use Only:

What is Human Research v2019-01

QI or PE activities may be systematic in nature; however, many are not designed to develop or

contribute to generalizable knowledge even though the information may be shared throughout

the organization. Keep in mind, however, that QI/PE can and many times does have a dual

purpose – to find and document improvement in the organization AND to make generalizable

conclusions. When in doubt, contact the Human Subjects Protection Program to discuss.

Differences between QI/PE and research

Points to consider

Research

QI/PE

Purpose

To test a hypothesis OR establish

clinical practice standards where

none are accepted

To assess or promptly improve a

process, program, or system; OR

improve performance as judged by

accepted/established standards

Starting Point

To answer a question or test a

hypothesis

To improve performance

Benefits

Designed to contribute to

generalizable knowledge and may

or may not benefit subjects

Designed to promptly benefit a

process, program, or system and may

or may not benefit patients or clients

Risks/Burdens

May place a subject at risk

Be design, does not increase risk

Data Collection

Systematic data collection

End Point

Answer a research question

Promptly improve a

program/process/system

Testing/Analysis

Statistically prove or disprove a

hypothesis

Compare to an established set of

standards

Can a project be both QI/PE and human research?

Yes, projects can be both QI/PE and human research. The following characteristics make it more

likely that a project involves both QI/PE and research. Consult with the IRB if you are uncertain.

• Randomization of patients into different intervention groups in order to enhance

confidence in differences that might be obscured by nonrandom selection (but not to

achieve equitable allocation of a scarce resource).

• Testing issues that are beyond current science and experience, such as new treatments.

• The involvement in key project roles of researchers who have no ongoing commitment

to improvement of the local care situation.

• Delayed or ineffective feedback of data, especially if feedback is delayed or altered in

order to avoid biasing the interpretation of results.

• Funding from an outside research organization with an interest in the use of the results.

• Secondary analysis of identifiable QI or PE data with the intent to develop or contribute

to generalizable knowledge is research and requires human subjects review.

• Intent to inform or change public policy.

If a study includes randomization, is it always considered HSR?

No, however, randomization is a trigger that the project should be discussed with the HSPP. An

example of a QA/QI study that involved medication compliance included the randomization of

What is Human Research?

HSPP Use Only:

What is Human Research v2019-01

patients to one of three conditions:

• In one condition patients were given a cell phone and a reminder call when it was time

to take their medication.

• Patients in a second condition were given a reminder call but no cell phone.

• Patients in a third condition took their medication while being directly observed by staff

(direct observation therapy--DOT).

Is it research if I intend to publish?

The intent to publish is an ‘insufficient criterion’ for determining whether a quality

improvement activity involves research, according to OHRP. When QI/PE is published or

presented, the intent is usually to discuss potentially effective models, strategies, assessment

tools or to provide benchmarks, rather than to develop or contribute to ‘generalizable’

knowledge.

What if I need to access PHI?

HIPAA makes an exception for QI/PE activities, including outcomes evaluation and development

of clinical guidelines or protocols. These activities fall under the category of ‘health care

operations’ for which no HIPAA Authorization or Waiver of Authorization needs to be sought.

The organization that owns the medical information must grant permission to access it for

QI/PI.

The UA requires that any access to health information in an electronic medical record,

regardless if it is human research, be submitted to the IRB for review. The 'Determination of

Human Research' form should be used to document access to this private information for

tracking purposes.

What to do next?

If it is not clear whether the project is human research, then the investigator should complete

the ‘determination of human research’ form found on the Human Subjects Protection Program

website. Submit the completed form to the HSPP for review. The investigator will receive a

formal letter of determination for their files.

If the project clearly IS human research, then the investigator should complete the ‘application

for human research’ form found on the HSPP website. The HSPP will review the activity and

submit it to the IRB for approval.

3838

Appendix C: Determination of Human Research

Determination of Human Research v Feb 2019

Delete

Line

Add

Line

This form should be used when it is unclear whether the proposed activities require review by an Institutional Review

Board (IRB).

If the proposed study clearly is Human Research, do not complete this form! Instead, please submit

the appropriate application for review and approval by the IRB.

Title (If funded, provide exact title of funded project)

Contact Information

Principal Investigator Name

Net ID

Email Address

College/Division

Department/ Unit

Status

Undergraduate Student Graduate Student Resident/Fellow Faculty Staff

Additional Contact (These individuals will receive copies of this correspondence):

Funding Information

Will the project be using/receiving any of the following funding types to support the research:

No funding supporting the proposed research

Federal funding (e.g., NIH, NSF, DoE, DoD)

Foundation Funding

Departmental Funds

Gift Funds

Industry Funded

Determination of Human Research

Determination of Human Research v Feb 2019

Determination of "Research"

45 CFR 46.102(l): Research - a systematic investigation, including research development, testing and evaluation,

designed to develop or contribute to generalizable knowledge.

A systematic approach involves a predetermined system, method or a plan for studying a specific topic, answering a specific

question, testing a specific hypothesis, or developing theory. A systematic approach includes the collection of information

and/ or biospecimens, and analysis either quantitative or qualitative.

Activities designed to develop or contribute to generalizable knowledge are those activities designed to draw general

conclusions, inform policy, or generalize outcomes beyond the specific group, entity, or institution (i.e., to elaborate, to be an

important factor in identifying or expanding truths, facts, information that are universally applicable).

Does the proposed activity involve a systematic approach?

Yes

Is the intent of the proposed activity to develop or contribute to generalizable knowledge?

Yes

If Yes to BOTH questions the study is Research. Proceed to Determination of "Human Subject."

If the answers to one or both questions are NO, proceed to Determination of "Human Subjects" per FDA Regulations.

Determination of "Human Subject"

45 CFR 46.102(e): Human subject - a living individual about whom an investigator (whether faculty, student, or staff)

conducting research: (1) obtains information or biospecimens through intervention or interaction with the

individual; and uses, studies, or analyzes the information or biospecimens; or (2) Obtains, uses, studies, analyzes, or

generates identifiable private information or identifiable biospecimens.

Intervention includes both physical procedures by which information is gathered and manipulations of the subject or the

subject's environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

Identifiable is where the identity of the subject is or may be ascertained by the researcher, or will be associated with the

information. The research could involve the use of coded data/specimens.

Does the activity involve obtaining information about living individuals through intervention or interaction

with the individuals?

Yes

Does the activity involve obtaining identifiable and private information about living individuals?

Yes

Determination of Human Research

Determination of Human Research v Feb 2019

If YES to either question, the research activity is research that involves human subjects. STOP and submit an IRB application for

approval of human research.

If the answers to both questions are NO, proceed to Determination of "Human Subjects" per FDA Regulations.

Determination of "Human Subject" per FDA Regulations

21 CFR 50.3(g): Human subject

an individual who is or becomes a participant in research, either as a recipient of the

test article or as a control. A subject may be either a healthy human or a patient.

*Test article means any drug (including a biological product for human use), medical device for human use,

human food additive, color additive, electronic product, or any other article subject to regulation.

In vitro diagnostic products are those reagents, instruments, and systems intended for use in the diagnosis of

disease or other conditions, including a determination of the state of health, in order to cure, mitigate, treat, or

prevent disease or its sequelae.

1. This is a clinical investigation involving a test article including in vitro diagnostics with a human subject(s) or their

biospecimens?

Yes

Note: The FDA regulations (21 CFR Parts 50 and 56) apply to all clinical investigations regulated by FDA, as well as

other clinical investigations that support applications for research or marketing permits. Therefore, all studies of

investigational IVDs that will support applications to FDA are subject to 21 CFR Parts 50 and 56, even if they are not

subject to most requirements of 21 CFR Part 812. For more information see the FDA Guidance on In Vitro

Diagnostic Device Studies - FAQs.

Does the activity involve the use of coded private

information/specimens? Yes

Were the information/specimens previously collected (or yet to be collected), specifically for the

currently proposed project?

Yes

Other Activities

(Please pick the most appropriate check boxes below)

Program Evaluation/Quality Improvement/Quality Assurance: The proposed activity will assess, analyze, critique, and

improve current processes of program or health care delivery in an institutional setting, involving data-guided, systematic

activities designed to bring about prompt improvements in a program or health care delivery?

Course-Related Activities: The proposed activity is limited to course-related activities designed specifically for educational

or teaching purposes?

Coded private information and/or human biological specimens per OHRP

Coded means a living individual's identifiable information such as name or social security number has been replaced

by a code, such as a number, letter, or combination thereof and there is a key to link the code to the identifiable

information of that individual. Coded data are considered identifiable under the Common Rule.

Determination of Human Research

Determination of Human Research v Feb 2019

Case Report: The proposed activity is a case report or case series of no more than three (3) cases describing an interesting

treatment, presentation, or outcomes?

Oral History: The activity is limited to oral history activities, such as open ended interviews that only document a

specific historical event or the experiences of individuals without the intent to draw conclusions or generalize findings.

Public Use Datasets: The activity is limited to analyzing information contained within a publically available dataset

(Meaning, any person can find and use the data). NOTE: This does not include reviewing or analyzing information from social

media.

Journalism/Documentary Activities: The activities are limited to investigations and interviews that focus on specific

events,

views, etc., and that lead to publication in any medium (including electronic), documentary production, or are part of

training that is explicitly linked to journalism. There is no intent to test a hypothesis?

Purchased cell lines: The activity involves commercially available, de-identified non-human embryonic cell lines.

Limited Data Set: A limited data set is a data set that is stripped of certain direct identifiers specified in the Privacy Rule.

A limited data set may be disclosed to an outside party without a patient’s authorization only if certain conditions are

met.

Please go to the following link to review the Use Agreement (DUA) from the HIPAA Privacy Program

dbGap: Receipt of data from dbGap that requires IRB approval, but the data you will receive.

Investigators must also submit an Institutional Certification form to be completed and signed by the Investigator and IRB.

Preparatory to Research: The activities are limited review of protected health information (PHI). No PHI is to be

removed

from the covered entity by the researcher in the course of the review.

PHI of Decedents: The use or disclosure is solely for research on the PHI of decedent, the PHI is necessary for research

purposes and if requested the Principal Investigator will be required to provide documentation of the death of the

individual(s).

Native American/Alaskan Native: The activity involves access to tribal resources (e.g. cultural artifacts, environmental

samples, or people), but the activity is not intended to produce generalizable knowledge.

Please attach a copy of completed Appendix for Vulnerable Populations.

Section 2: Summary

1. Provide a concise description of the purpose or objectives of the project.

2. Describe the proposed methods and study procedures.

3. Describe the subject population, or the type of information/specimens to be studied.

4. Explain where the information/specimens were collected/obtained (i.e. identify source of data/specimens).

NA- Activity does not involve the use of data/specimens

Determination of Human Research

Determination of Human Research v Feb 2019

Other

Banner University Medical Center- Medical Records

Data Warehouse

Other

Banner - University Medical Center

University of Arizona Cancer Center

University of Arizona Campus

Outside the U.S

Online

You have now completed this form. Next steps:

Please save a copy of this document for your records.

Email the form to the appropriate individuals for their approval.

3) Once it is ready email the application and attach all additional documents to vpr-irb@email.arizona.edu. Please

review HSPP Guidance for any additional documents that are needed.

Section 3: Location of Research

Principal Investigator

I certify that the information I provide in this application is correct and complete.

Attestation of Principal Investigator

Typed Name of Principal Investigator

Date

NOTE: A research proposal by a graduate or undergraduate student must have the following attestation statement

signed by an Advisor or Mentor.

Advisor/ Mentor

By signing below, I, the Advisor/ Mentor, certify that I have accurately reviewed and mentored the student/resident

regarding completion of the items listed above.

Signature of Faculty Supervisor_______________________________

Date_______________

Print Name and Title of Faculty Supervisor ______________________________

NOTE: Actual signature is not required. The HSPP Office will accept either email confirmation or an actual

signature. This means that all signatures might not be on the same document. Attach email confirmations with

your submission.

Appendix D: Application for Human Research

Application for Human Research v Aug 2018

Title (If funded, provide exact title of funded project)

Contact information

Principal Investigator Name

Net ID

UA Email Address

College/Division

Department/ Unit

Status

Undergraduate Student Graduate Student Resident Faculty Staff

Alternate Contact (These individuals will also receive copies of all correspondence):

* List all additional Research Personnel on the Research Personnel Form and attach with your submission

General Information

What is the expected length of this project?

Is this an Investigator-initiated study? Yes No

Are we participating in a multi-site study? Yes No

Will the University of Arizona be the IRB of Record for multiple sites? Yes No

Is the research utilizing a single IRB for review that is not the UA IRB? Yes No

Is this project strictly a review of data or specimens? No recruitment, interaction, or consent? Yes No

Does this project involve investigating a Drug, Device or Biologic? Yes No

Does this project involve medical procedures which the PI is not licensed to conduct? Yes No

Is this project a Clinical Trial?

*A research study in which one or more human subjects are prospectively assigned to one or more

interventions (which may include placebo or other control) to evaluate the effects of the interventions on

biomedical or behavioral health-related outcomes.

Yes No

Funding Information

Will the project be supported by any funding?

Yes No

Location of Research

Banner - University Medical Center

University of Arizona Cancer Center

University of Arizona Campus

Data Warehouse

Outside the US

Online

Other

Add Line

Name

UA Net ID

Research Role

Institution

Email Address

Delete Line

Application for Human Research

Application for Human Research v Aug 2018

*To be up-to-date, an Investigator must have submitted a disclosure through the COI Disclosure System since the prior June 1.

2. Has any Investigator disclosed any outside financial or personal interest

though the COI Disclosure System?

Yes No

3. Is a drug, device or other investigational product being used or evaluated in this project?

Yes No

Project Abstract

Background: Provide the scientific or scholarly background for the proposed Human Research. Discuss relevant prior

experience or preliminary data (e.g., existing literature). (Limit 10000 Characters including spaces)

Purpose: Describe the purpose, specific aims, objectives, questions to be answered, hypotheses, and/or primary and

secondary study endpoints of the Human Research.

Lay Summary: Provide a brief description of the proposed research using terms that someone who is not familiar

with the science or your discipline can understand. (Limit 2000 Characters including spaces)

Resources: Describe the resources (personnel, facilities, time, emergency resources, etc.) available to recruit,

consent, conduct study procedures, and analyze data.

Population & Recruitment

Maximum number of participants to be enrolled in the study:

Please check all the categories of participants that will be included in the research:

Children (1-17 yrs old)

Prisoners

Cognitively Impaired Subjects

Refugees

Adults

UA Staff/ Faculty

Native Americans

UA Students

Pregnant Woman/ Neonates (0-2 yrs old)

Other – please explain below

What are the inclusion and exclusion criteria for study participation?

Indicate age range, gender, and ethnicity of your research population:

In order to submit this application, each Investigator must complete the University's Conflict of Interest (“COI”)

requirements.

Investigator is defined in the University's Individual Conflict of Interest in Research Policy, and generally means

anyone with responsibility for the design, conduct or reporting of the research.

If you are filling this out on behalf of other investigators, you will need to confirm the answers to this and any following COI

questions in this form directly with each Investigator. Each Investigator can log on to the COI Disclosure System to view the

current status of their disclosures. For an overview of the COI disclosure process for IRB submissions, see the COI FAQ webpage.

Financial Conflict of Interest Disclosure

1. Is each Investigator on the project up-to-date with COI disclosures?

Yes

Application for Human Research

Application for Human Research v Aug 2018

Please select the methods that will be used to recruit individuals. Provide copies of documents, as applicable.

Social Media

Flyers

Online Advertisements

TV, Radio, Print

SONA System

In Person Presentations

Phone Calls

Face to Face

Screening of the Electronic Medical Record (EMR)

Other – please explain below

Explain the recruitment process:

Where will recruitment take place?

When will recruitment occur? Provide a time frame with dates if applicable.

Informed Consent

Please indicate the informed consent process(es) and/or document(s) to be used in the study.Check all that apply.

Provide copies of documents, as applicable.

Informed Consent (ICF)– written form

Informed Consent – oral script/online/unsigned

Assent (participants under 18) – written form

Assent – oral script/online/unsigned

Parental Permission – written form

Parental Permission – oral script/online/unsigned

Translated Consent/Assent – written form(s)

Translated Consent/ Assent- oral script/online/unsigned

Combined ICF/PHI Authorization- form

Waivers of consent or waiver or alteration of PHI

Exception From Informed Consent (EFIC)

Broad Consent for future research

Debriefing Script

Protected Health Information (PHI) Authorization-written form

Short Consent Form- written from

Other – please explain below

Describe in detail the consent processes checked above:

Data Collection Procedures

Please select the methods of data collection that will be employed in this study (select all that apply):

Audio/Video recording

Anthropometric measures (e.g., height, weight, waist circumference,

etc.)

Benign Interventions

Biological Specimens (urine/feces, tissue, saliva, skin, hair, nails, nasal

swab)

Biological Specimens- Blood Draws

Biological Specimens- Clinical discarded of blood or specimens

Clinical Data Warehouse

Cognitive or behavioral measures, including daily diaries (Note- if surveys

will also be administered,please select the appropriate option above.)

CT Scans

Data previously collected for research purposes

Deception

Data collected using other communication/electronic devices (e.g., cell

phones, pagers and texting devices)

Interviews- Focus groups

Interviews- In person

MRI/ Ultrasound with contrast

MRI/ Ultrasound without contrast

Application for Human Research

Application for Human Research v Aug 2018

Participant Observation

Non- invasive instruments(e.g. external sensors applied to the body)

Screening Data

Self health monitoring (e.g., pedometers, food diaries, etc.)

Surveys- Paper

Surveys- Internet (including online and email based data collection)

Surveys- Telephone

Randomization with Control and Experimental Groups

Records- Billing

Records- Educational

Records- Employee

Records- Lab, pathology and/or radiology results

Records- Medical Review

Records- Mental Health

Records- Physician/Clinical

Records- Substance Abuse

Use of recombinant DNA

Use of Social Networking Sites

Use of Stem Cells

X-ray Scans

Other activities or interventions- Describe below

* Submit the appropriate approval from Biosafety Committee.

Please provide details of the research procedures and include the study population who will be completing them.

Please state the estimated time commitment for subject participation.

If "Biological Specimens" is checked above, please state the amount and frequency at which it will be collected?

Benefits, Costs, Compensation & Risks

Describe the anticipated benefits of this study to society, academic knowledge or both.

Describe any benefits that individuals may reasonably expect from participation.

Describe any costs, monetary and non-monetary, that subjects may incur.

Discuss the amount of compensation (monetary and/or non-monetary) subjects may receive. Describe if

compensation will be prorated.

Please describe all physical, psychological, social, legal, and/or economic risk you feel are associated with

participation in this research. NOTE: Risks not directly related to the research need not be included in this section.

Discuss what steps have been taken to minimize risk to subjects/data.

Describe the provisions for medical care and available compensation in the event of research related injury. If the

Human Research has a clinical trial agreement, this language should reflect what is stated in the agreement.

Privacy and Confidentiality

Application for Human Research

Application for Human Research v Aug 2018

Will the research team be accessing medical records, educational records or employee records

during the research?

Yes No

Where will the data be stored?

REDCap

Clinical Data Warehouse

Box@UA Health

Box@UA

Password Protected Drive

Encrypted Drive

External Drive (USB, Flash drive)

Department Drive

Cloud Server

UA Records Management & Archives

Departmental Office

Other – please explain below

For each of the storage location checked above, discuss the type of data to be stored (including if the data is

identifiable), who may have access to the data, and how long the data will be kept.

*NOTE: You are responsible for following University policy and guidelines for proper transmission and storage of Confidential or

Regulated Data, including PHI.

Will you be transmitting/receiving any subject data to/from an outside group? Yes No

Discuss how, when and why subjects/data may be removed from the study. If abrupt withdrawal is necessary,

discuss how subjects will be withdrawn so that they are not put at increased risk. Discuss what happens if a subject is

withdrawn from one part of the study but asked to continue with other parts, such as ongoing follow-up.

Describe steps, if any, to protect the privacy of the subjects throughout their participation in the Human Research

(e.g. during the recruitment process, consent process, and/or research procedures).

Use of Data/Specimens

In which of the following formats will the data be stored?

Identifiable Coded De-Identifed

What security controls (e.g. administrative, physical, technical) are in place to make sure data/ specimens are

secure?

Will data/ specimens be kept for future research, including unspecified future

research, genetics and/or whole genome sequencing?

Yes No

Will subjects receive results for any future research?

Yes No

Will the data /specimens be stored in a repository?

Yes No

Will the data/specimens be shared with collaborating entities? Yes No

Will the data/specimens be sold to pharmaceutical companies?

Yes No

Provide a brief lay discussion of the plan to monitor for subject safety, if applicable. Describe how the data will be

evaluated, include a timeline of when the review(s) will occur, who will review the information, and what information

will be reviewed. If there will not be a way to monitor for subject safety, please explain.

Remember to attach the following documentation to your submission email:

Application for Human Research

Application for Human Research v Aug 2018

 PI/Co-PI CV or Biosketch

 List of Project Personnel

 Appendices (if applicable)

 Recruitment Material

 Informed Consent Documentation

 Data Collection Tools

 Email confirmations from Advisor (required for all students and residents), Scientific/ Scholarly Reviewer and

Department Head.

Principal Investigator

I certify that the information I provide in this application is correct and complete.

Attestation of Principal Investigator

Typed name of Principal Investigator

Date

Scientific/Scholarly Review (See HSPP Guidance on requirements for Scientific/Scholarly Assessment)

Nationally based, federal funding organization (NIH, NSF) subject to full peer review

Nationally based, non-federal funding organization (March of Dimes, Amer Academy of Pediatrics) subject to peer

review

Locally constituted peer review (signature required)

Department/Center/Section Review

I have reviewed this application and determined that all departmental requirements are met and that the investigator

has adequate resources to conduct the Human Research.

Signature of Department/ Center/ Section Review

Date

Print Name and Title

NOTE: Actual signature is not required. The HSPP Office will accept either email confirmation or an actual

signature. This means that all signatures might not be on the same document. Attach email confirmations with

your submission.

You have now completed this form. Next steps:

1) Please save a copy of this document for your records.

2) Once it is ready email the application and attach all additional documents to [email protected]. Please

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