"In addition to Dr. PI, your DNA may also be studied by Drs. X, Y, and Z. In the future, the All-
Gene Corporation or another company performing pharmaceutical research may study your DNA
in order to learn more about ..."
Confidentiality is critical for Category 3 DNA research, especially if information from DNA sequences
may affect future health, employment, or insurability. The consent must state how the investigator will
deal with this issue. If DNA information obtained as part of a research study is included in the patient's
medical record, this might compromise the confidentiality of very sensitive data. When dealing with
sensitive data, the IRB often suggests that an investigator obtain a “Certificate of Confidentiality” which
protects the data from Court subpoenas and makes it a crime to disclose the information. If one has been
obtained for the project, this should be stated in the consent.
If the study involves genetic testing, the following should be included in the consent:
“Federal and State laws generally make it illegal for health insurance companies, group health
plans, and most employers to discriminate against you based on your genetic information. This
law generally will protect you in the following ways: a) Health insurance companies and group
health plans may not request your genetic information that we get from this research. b) Health
insurance companies and group health plans may not use your genetic information when making
decisions regarding your eligibility or premiums. c) Employers with 5 or more employees may not
use your genetic information that we get from this research when making a decision to hire,
promote, or fire you or when setting the terms of your employment.”
2) What are my rights to my DNA sample? Who will have control of it and who will own it?
SUBJECTS MAY NOT BE ASKED TO GIVE UP THEIR RIGHTS TO THE DNA. BOTH OHRP
AND FDA MAKE IT CLEAR THAT THE CONSENT DOCUMENT MAY NOT CONTAIN
EXCULPATORY LANGUAGE. UNDER 45 CFR 46.116, “NO INFORMED CONSENT, WHETHER
ORAL OR WRITTEN, MAY INCLUDE ANY EXCULPATORY LANGUAGE THROUGH WHICH
THE SUBJECT OR THE REPRESENTATIVE IS MADE TO WAIVE OR APPEAR TO WAIVE ANY
OF THE SUBJECT’S LEGAL RIGHTS….”
In order to assure that this occurs, the investigator must put a “Moore Clause” in the consent:
"Biospecimens (such as blood, tissue, or saliva) collected from you for this study and/or
information obtained from your biospecimens may be used in this research or other research, and
shared with other organizations. You will not share in any commercial value or profit derived
from the use of your biospecimens and/or information obtained from them.”
3) Can I withdraw my DNA sample from a study at any time?
Once a subject's DNA or DNA-containing specimen becomes a part of the study, the investigator has the
discretion to retain it for legitimate scientific purposes. If an investigator adopts this position, it must be
clearly stated in the consent. As an example,
"If you decide later that you do not want the specimens collected from you to be used for future
research, you may tell this to Dr. PI, who will use his/her best efforts to stop any additional studies.
However, in some cases, such as if your cells are grown up and are found to be generally useful, it
may be impossible to locate and stop such future research once the materials have been widely
shared with other researchers."