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Are the ethical issues in repository tissue collection the same as clinical trials?

Tissue collection for research repositories share many ethical issues with clinical trials:

1. individuals are involved as donors or human subjects
2. informed consent is required
3. risks/benefits must be evaluated
4. there should be an appropriate selection of individuals (as donors or human subjects)
5. there should be appropriate mechanisms for safeguarding the privacy of donor/human subject information

Ethical issues in repository tissue collection are distinct from clinical trials in the following ways:

1. Tissue collection is not research.
2. IRB review is not mandated for tissue collection although some repositories use IRBs to evaluate their policies and procedures.
3. Other human subject protections in the Common Rule do not apply to tissue collection.
4. The informed consent process is usually more general because repositories do not know in advance the research that will be conducted on the tissue or the end-users.
5. Reporting research findings to donors does not usually occur (though it does occur in many clinical trials).
6. Because of the possibility of making derivative products from a tissue sample, the number of researchers who potentially might conduct research on a donor's tissue is more open-ended than in clinical trials.
7. The tissue collection procedure may raise issues of institutional ethics.

Some research on excised tissue may replace the need for basic research on human subjects.

Despite the differences between tissue collections and clinical trials, some repositories use a clinical trials paradigm for tissue and blood banking. In these cases, pathologists function as Principal Investigators in "collection trials" and enroll tissue donors (presumably as human subjects) who wish to have their tissue banked and distributed to researchers. Collection trials are submitted to IRBs for approval.