Version Date: February 16, 1998
The increasing application of genetic technologies in human research has led to growing concern that subjects could suffer discrimination and other nonphysical harms as a result of their participation in research. Issues of particular concern include 1) the ability to identify subjects according to the information provided with tissue samples, and 2) whether subjects retain ownership of samples. These issues are subjects of ongoing discussions within the ethics and scientific communities at local and national levels. The Office for Human Research Protections (OHRP) (formerly known as the Office for Protection from Research Risks OPRR) and others at the NIH have addressed these issues in great detail and have developed guidelines for the conduct of this research. At the same time, OHRP had made it clear that local institutional review boards are ultimately responsible for setting policies and guidelines for use at their institutions, and insuring that reviewed protocols are in compliance prior to approval. In response, the Genetics Subcommittee was formed to review existing guidelines from other institutions, to discuss components that are controversial, and to develop guidelines for UW Health Sciences investigators and their collaborators for protocols subject to our jurisdiction. The resulting guidelines are enclosed.
The Subcommittee and the Health Sciences Institutional Review Boards (HS-IRBs) recognize that these considerations create new burdens and responsibilities for investigators, and considerable effort was put into making the guidelines as workable as possible. Investigators must realize, however, that addressing these issues on a large scale is a relatively new effort; experience at this and other institutions is not yet sufficiently extensive to provide clear guidance. As that experience grows and workability of the guidelines is tested, revisions may become necessary.
The following definitions were used by the Subcommittee in the development of these guidelines:
- Genetic study: any research protocol involving the analysis of DNA, RNA, chromosomes, proteins, or certain metabolites which might act as or identify markers associated with a known or suspected predisposition to disease.
- Identifiable sample: any sample accompanied by codes or data that could facilitate 1) recontacting the subject or 2) gaining access to identifiable private information about the subject.
Purpose and Expectations
These guidelines will serve as standards by which protocols involving genetic technologies or the use of storable tissues will be reviewed by the HS-IRBs. It is recognizable that some modification of the guidelines during the course of the review will be necessary in some cases. For example, the definition of an identifiable sample (above) is dependent on sample size; data that would not facilitate identification of subjects in a large study (e.g., birth date) might do so in a small one (use age instead). It is up to the HS-IRBs to apply this definition to individual protocols. Individual review of protocols may include ad hoc review by the Subcommittee and appropriate consultants. This process may lengthen the time necessary for review, although every reasonable effort will be made to review protocols in a timely manner.