Policy for Accessing Tissue Specimens or Information at OHSU for Anonymous or Coded Genetic Research. What qualifies as genetic research?
What is required for submitting a new genetic research project to the IRB?
Special Considerations for Anonymous and Coded Genetic Research
Retaining Samples, Tissue Banks
Recontact (disclosure of research results to subjects)
Documents of Interest
Web Links of Interest
OHSU is subject to the Oregon Genetic Privacy Law (ORS192.531-192.549), enacted in 1995 in order to protect individuals from genetic discrimination that could result from disclosure of genetic test results. The law has gone through several revisions primarily surrounding research provisions. The most recent revision can be found here.
This page has been constructed to assist OHSU investigators who are involved in genetic research, or research using genetic samples or information. Requirements for projects involving biological tissue are discussed at length in the OHSU Policy for Collection and Use of Human Biologic Material in Research. Specific points of this policy are outlined below, as well as some additional information and other helpful resources.
Genetic research does not mean only research that involves looking for mutations in DNA. Research that involves looking at the differences between proteins in individuals with or without a certain disease can also qualify as genetic research. Records research involving information that was derived from a previous genetic test can also qualify as genetic research. See definitions below.
- Genetic research: Research using human DNA samples, genetic testing or genetic information.
- Genetic information: Information about an individual or the individual's blood relatives obtained from a genetic test.
- Genetic test: A test for determining the presence or absence of genetic characteristics in a human individual or the individual's blood relatives, including tests of nucleic acids, such as DNA, RNA, and mitochondrial DNA, chromosomes or proteins in order to diagnose or determine a genetic characteristic.
- Genetic characteristic: A gene, chromosome or alteration thereof that may be tested to determine the existence of or risk for acquiring a disease, disorder, trait, propensity or syndrome, or to identify an individual or a blood relative. "Genetic characteristic" does not include family history or a genetically transmitted characteristic whose existence or identity is determined by means other than through a genetic test.
- Additional Definitions
- Investigators proposing to conduct coded or anonymous genetic research must submit the project for review by the IRB.
- When an investigator wishes to conduct genetic research using biological specimens or information from OHSU patients or subjects and does not have informed consent for the use of anonymous or coded biological specimens or information in the specific genetic research project, the following requirements must be met:
- The individual(s) from whom the biological specimens(s) or information will be or has been obtained must have been provided with the “Notice of Your Right to Refuse Participation in Future Anonymous and/or Coded Genetic Research” and did not exercise his/her right to refuse to participate in coded or anonymous genetic research (opt out), as verified by appropriate genetic opt out review; or
- The individual(s) from whom the biological specimen(s) or information will be or has been obtained has granted consent for genetic research generally; or
- The individual(s) from whom biological specimen(s) or information will be obtained is deceased (or specimen or information was obtained in emergency circumstances but the individual died before receiving opt out notice); or
- The biological specimen(s) or information was obtained prior to July 29, 2005.
- If the specimen(s) or information are coded, the following additional requirements apply:
a) The code is:
(i) Not derived from individual identifiers;
(ii) Kept securely and separately from the specimens and information; and
(iii) Not accessible to the investigator unless specifically approved by the IRB.
b) The information is stored securely in password protected electronic files or by other means with access limited to authorized personnel.
c) The information is limited to elements required for analysis and meets the criteria in 45 C.F.R 164.514(e) for a limited data set.
Whether or not an activity qualifies as tissue banking depends on the researcher's intent. Here are some examples:
- If extra blood is drawn and stored as a back up in case a test to which research subjects have already consented needs to be repeated, but once the test results are in the extra samples are destroyed, this is not tissue banking even though tissue samples are stored.
- However, if you want to collect extra samples in case you want to do additional analysis later on that was not included in the original, IRB-approved protocol, that is tissue banking and you must get IRB approval and subject consent to do so. After the additional test has been conducted, the sample should be destroyed, unless the subject has consented otherwise.
- If you want to collect extra samples to keep on hand for other investigators to use or for use in another study, that is tissue banking.
- If you have samples stored in case tests need to be repeated, but then decide you would like to perform an additional test (based on interesting preliminary results, for example), you must get IRB approval and subject consent to do so. After the additional test has been conducted, the sample should be destroyed, unless the subject has consented otherwise.
The basic rule is this: if you are storing tissue for any additional uses not specified in the consent form signed by the research subject and approved by the IRB, you are banking tissue. HIPAA requires that collection and storage of samples be explicitly authorized by the subject on the HIPAA authorization form. Additionally, the Genetic Privacy Act requires that research subjects give their consent if samples collected for a genetic test are to be stored rather than destroyed.
Recontact means disclosure of genetic research findings to a research subject or the subject's physician through use of personal identifiers. In general, recontact should not occur unless:
- The research findings are scientifically valid and confirmed (done in a CLIA approved lab);
- The findings have significant implications for the subject's or the public's health; and
- A course of action to ameliorate or treat the subject's or the public's health concerns is readily available.
IRB approval is required before recontact can occur.See Information Required For Submission, III-F , for more information.
- Policy for Accessing Tissue Specimens or Information at OHSU for Anonymous or Coded Genetic Research
- Oregon Genetic Privacy Law
- Oregon Genetic Privacy Administration Rules
- HIPAA Research Handbook
- Genetic Opt out Clinical Flowchart
- Genetic Opt out Research Flowchart
- The Genetic Information Nondiscrimination Act of 2008: Information for Researchers and Health Care Professionals