Offering results to research participants

Do participants of research trials wish to be offered a summary of the trial results? This practice is being encouraged as a means of demonstrating greater respect for research participants: it recognises the central role of participants in the completion of research studies and avoids treating them as a means to an end.1,2 The International Ethical Guidelines for Biomedical Research Involving Human Subjects stipulate that offering results to subjects after study completion is an essential obligation of researchers (guideline 5, article 7).3 However, many national policies on research ethics do not mention this practice, and few research ethics boards or committees have policies or guidelines governing the process.4 This is mirrored in the low prevalence of offering to return results, which is documented in a wide variety of research settings.5 A paper by Dixon-Woods and colleagues in this issue (p 206) reports a study in which they offered a summary of the results of the ORACLE trial of antibiotics for preterm labour and preterm rupture of the membranes to 11 154 pregnant women.6 They also conducted a qualitative study of 20 participants who received a summary of the trial results. The authors, perhaps surprisingly, found that fewer than a fifth of women in the ORACLE trial desired a summary of the results.6 This finding contrasts with those of other published reports.7-9 Perhaps there are other factors peculiar to this study design that resulted in such a low level of interest among participants. Possible explanations are the means by which the offer was communicated, the somewhat unusual request to reaffirm the desire to receive results, the lack of an obvious informed consent process (describing both benefits and risks) to receive the results, the lack of an offer of personal communication of results that have a potentially negative connotation, and the fact that a primary outcome of interest was not just the mother's health but also that of the infant. The potential benefits of offering disclosure of research results are numerous.1,2 They include having a potential positive impact on the future health of the participants, affirming appreciation to the participant of their central role in the conduct of research, and improving the overall perception of research in the public sphere by allowing participants to directly see the impact of their contribution to scientific knowledge.1,2 These benefits are encompassed in the offer of results, not just in the receipt of results. The participants in the Dixon-Woods study showed that receiving results is not a harmless act. Potential emotional harms to the research participant who is offered research results include having to relive a difficult time, learning that they participated in an inferior arm of the trial, or learning that they (or in this study, their child) were at increased risk for health problems.1,2 A process of informed consent for the receipt of research results would ensure that providing results is not a forced paternalistic act but rather a fully considered decision which takes into account these potential harms. Moreover, it does not follow that participants who made an informed decision to see the results, and who later found this emotionally difficult, would be better off having not received the results. A study of survivors of retinoblastoma who were informed of risks of second cancers found that most participants wanted the information, even if it was upsetting.7 An informed decision to accept a summary of results should be left to the participant. The onus is on researchers to offer a summary of results, presenting harms and benefits, and provide appropriate subsequent supports for those who may have difficulty. Dixon-Woods and colleagues found that many participants were interested in receiving individual rather than summary results. Most authors acknowledge that individualised results should have high validity and reliability before being provided to participants. This is particularly true, but not unique to, individualised results of gene testing, which may have far reaching consequences.10 In addition, the results should be clearly communicated. Only half of participants in this study found the leaflet clear, pointing to the need for extremely careful preparation. We have recently shown that adolescents with cancer and parents of paediatric oncology patients overwhelmingly wish to be provided with results of research and feel they have a right to them. However, they also ask that results with “bad” connotations should be provided personally, not just by pamphlet.11 This research needs to be extended to ascertain additional nuances in other types of study design. While Dixon-Woods and colleagues correctly argue caution in providing results to participants, their study should not deter other researchers from meeting the ethical obligation to offer results and to subsequently provide them to those who want them, in a respectful and supportive manner.