Considerations and costs of disclosing study findings to research participants

The disclosure of study findings to participants in research reflects the moral obligation of researchers, founded in the ethical principle of respect for human dignity, to avoid treating human participants as a means to an end. Human dignity is respected through proper procedures of obtaining informed consent, and an offer to provide research results to participants extends this respect. Unfortunately, researchers adhere inconsistently to this responsibility,1^,2 and little guidance is provided in regulatory policies3^,4 even though a desire for such information has been expressed by research participants.5Recently there has been a compelling call to offer research results to participants in clinical trials;6we have extended this argument to include all participants in human research.7

Funding agencies should support the allocation and use of research monies in an ethical manner and, thus, should support the appropriate disclosure of results to individual participants and to communities.8 However, the disclosure of results has economic implications for researchers in planning their budgets and for funding agencies in determining an appropriate level and duration of funding. In this article, we briefly review the rationale for offering to disclose research results, focus on specific factors that influence the cost of such a practice and suggest an approach for researchers and funding agencies to consider when developing or assessing research grant applications.

The rationale for disclosure

The offer and receipt of research results has many potential benefits for participants and may have a direct impact on their quality of life. For example, research has shown that women who received mantle radiation for Hodgkin's disease as teenagers are at high risk for secondary breast cancer;9 providing research results to these women may benefit them directly. Participants also benefit from the affirmation of the key role they play in the conduct of research. Disclosure of results may also benefit research as a whole by demonstrating its tangible benefits to the public and by engaging public enthusiasm and support for the principle of research.7

The receipt of results is not without potential for harm and thus requires informed consent and careful design of disclosure programs.7 The possible harms encompass immediate effects, for example distress at learning that one has participated in an inferior arm of a clinical trial, and longer-term harms, including a potential impact on the ability to obtain insurance by those with an anticipated high rate of late effects.

Research participants have indicated that results should be shared in a timely manner.10^,11The need for peer review before disclosure to study participants has very significant implications for researchers and funding agencies.7 The resulting increase in the time from the end of data collection to peer review and subsequent publication will require substantially longer periods of research funding than are usually allowed for.12^,13 Thus, the moral imperative to offer to return research results will require changes in funding practice to allow for this time frame.

It should be emphasized that no participant is obligated to receive results that he or she does not wish. Participants must be informed of the potential harms and benefits of receiving results.14^,15^,16 We argue solely for the universal offering of results with appropriate support.

Assessing the cost of disclosure

Factors that affect the complexity of returning research results, and thus costs, fall into 3 broad categories: the risks associated with nontherapeutic and therapeutic procedures of the study;17 the short- and long-term consequences of disclosure, including harms; and the logistics of the study, including its duration and the number and geographic location of the participants. Assessment of these factors can then be used to determine the requirements for returning results (Table 1), following a template of basic elements (Box 1).

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Box 1.

Summary

Estimating the costs of dissemination will be relatively straightforward for many studies but will be more challenging when it is necessary to quantify the differences in cost due to intrinsic risk, consequences and time elements. Researchers and granting agencies should consider the offer to return results to research participants as a mandatory part of practice and adjust budgets and duration of funding accordingly. If the disclosure is expected to be associated with harm, and if that harm can be minimized through direct disclosure, then direct disclosure ought to be offered. It is essential to determine the wants and needs of participants with respect to how best to offer and disseminate research results, and we are currently exploring these questions.