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Should researchers report results to tissue donors?

Should researchers report significant results to tissue donors? This is a preference for some IRBs who consider collaborations. In clinical research, the issue of post research communication with human subjects is controversial. NBAC's report, Research Involving Human Biological Materials, cites disagreement that exists on this issue.

Recommendation 14 NBAC, links the subject's right to know with the usefulness of valid and confirmed findings:

"IRBs should develop general guidelines for the disclosure of the results of research to subjects and require investigators to address these issues explicitly in their research plans. In general, these guidelines should reflect the presumption that the disclosure of research results to subjects represents an exceptional circumstance. Such disclosure should occur only when all of the following apply:

1. the findings are scientifically valid and confirmed,
2. the findings have significant implications for the subject's health concerns, and
3. a course of action to ameliorate or treat these concerns is readily available."

In contrast, a strong autonomy view would require that research subjects have the choice to receive research results that are valid and confirmed even if there is no significant implication for their health.

NBAC makes two related recommendations.

Recommendation 15:
"The investigator in his or her research protocol should describe anticipated research findings and circumstances that might lead to a decision to disclose the findings to a subject, as well as a plan for how to manage such a disclosure."

Recommendation 16:
"When research results are disclosed to a subject, appropriate medical advice or referral should be provided."

In tissue donation to repositories, the issue of contacting donors with research findings is more complex and could only apply to linked tissue that is traceable back to the donor. In tissue collection protocols where tissue is used for numerous studies that produce only preliminary data, reporting research results back to donors may be a daunting task. Add to this the fact that much of the research is at such a basic stage it yields no practical value for tissue donors. In addition, it can be overwhelming for a donor (or his/her physician) to receive notifications from numerous researchers from around the world of research results from various studies that most physicians will not understand. Would such communication produce anxiety, false hope, or confusion for donors? Who would assess the validity of the findings? For these reasons, not to mention the logistics of finding a current address or contact for donors, post-communication about repository tissue is typically not done. It is routine for donors to forego receipt of any research findings from repositories or collection staff.