The majority of the research projects that had been granted prior approval by the ethics committee and were investigated (49 of 70) did not include any information on the management of findings with possible clinical implications in its project documents. This is consistent with a similar international study, in which such information was absent in 45 of 85 research biobanks examined (18). This absence of plans for managing research findings with possible clinical implications in the project documents may have several causes:
The issue has not been considered.
The issue has been considered, but the likelihood of making such findings has been deemed insignificant and no plan has therefore been prepared.
The issue has been considered and a plan has been prepared, but not appended to the project documents submitted to the regional ethics committee.
The absence of written documentation does not necessarily mean that the researchers fail to follow up such findings adequately when they deem them to be of clinical relevance. Nearly all patient-oriented projects, which have the greatest likelihood of clinically relevant findings, were undertaken by doctors who recruited the participants from the ongoing clinical activities at the hospital. The project participants may thus have been offered completely appropriate follow-up, irrespective of whether this was stated in the project-related documents or not.
This investigation includes only one university hospital, and it cannot be assumed that the results are representative for other organisations that undertake medical and health research. However, the regional committees for medical and health research are public bodies, and good administrative practices call for equal treatment of all project applications. Since the committee apparently had no particular focus on the handling of findings with possible clinical implications with regard to the applications included in this study, we have reason to assume that the committee has followed the same practice in its review of project applications from other research organisations.
Risk can be regarded as a combination of the probability that a given incident will happen and the effect of this incident. Appropriate risk management requires a documentable process that includes identification, assessment and prioritisation of risks, as well as measures to reduce these risks as required (19). The likelihood of findings and the clinical implications of such findings will both depend on the type of research project in question. All of the 70 research projects included in our study involved examinations of humans, human biological material and/or health information. The majority of the projects involved direct interaction with project participants (mainly patients), as well as examinations of human biological material and/or imaging techniques. We may therefore assume that there was a real possibility of making findings that could have clinical implications for the participants. One could argue that those 21 projects that included written plans for how such findings were to be managed represented projects in which such findings were both highly likely and of substantial clinical relevance, whereas this was not the case for the remaining projects. However, many of the studies that involved imaging and/or genetic examinations made no reference to the issue in their documentation (Table 1). Varying practices among different researchers appear to be a more likely explanation of the observed difference in the frequency of references to this issue.
In a review article on ethical issues concerning provision of feedback or no feedback of genetic findings to project participants, Steinsbakk and Solberg concluded that «irrespective of the conclusion arrived at, the conclusion and the justifications must be communicated clearly and understandably to the participants. This is the unquestionable obligation of the researchers and the research institutions to the participants» (20). I share this view. In Norway, however, the Personal Data Act stipulates a general entitlement for individuals to receive information on how their personal data are handled, including the type of data that have been collected (21). Even if no feedback of research findings to individual project participants has been planned, the participants may request access to the data. Consequently, it will be expedient to make provisions for project participants to access all findings, and to plan the projects on this basis.
The researcher’s role is different from the clinician’s. Nor can we presume that all those who use information generated by medical and health research possess clinical knowledge and experience. Planning of how findings with possible clinical implications shall be managed does not mean that the individual researcher must assume a personal responsibility for following up such findings. The responsibility lies in considering what may come to light, who will assess the findings and how they should be followed up, if relevant. If this research is undertaken in a hospital environment, one solution could be that findings with possible clinical implications should be reported to the head of the department in which the biological material originated or in which the project participants were recruited (15).
In 2012, the Council of Europe’s steering committee for bioethics issued a manual for members of ethics committees. The manual states that project participants are entitled to receive health-related information that emerges as a result of research. It states further that the project application to an ethics committee must contain sufficient information to permit a thorough assessment (22). In December 2013, the Presidential Commission for the Study of Bioethical Issues in the USA issued a report on the handling of intended and incidental findings made in the context of clinical activity, research and direct-to-consumer testing. One of the commission’s five general recommendations was that those affected should be informed about the likelihood of such findings associated with specific tests or procedures. Moreover, they should be informed about any plans for information and management of the findings, including of the types of findings for which no such feedback is planned. With regard to research projects, the commission recommended that researchers prepare plans for the management of such findings and that these plans should be reviewed and approved by an ethics committee (23).
As written information on the plans for managing findings with possible clinical implications was absent from 49 out of 70 research projects, this will necessarily have reduced the opportunity of the regional ethics committees to assess them. Checklists are used for purposes of quality improvement in a number of areas, including medicine and peer reviews (24) – (26). Nevertheless, we cannot assume that professionals use such tools in practice (27). A clearly defined topic and an opportunity for autonomous professional assessment are crucial for users to accept a checklist (26). With regard to research findings with possible clinical implications, a practical approach could be to introduce a separate item for this issue on the form to be submitted to the regional ethics committee when the researcher applies for prior approval of the project. On the basis of his or her own professional assessment, the researcher may then describe how this issue will be managed and design the information in the participant information/consent forms accordingly. The committee will then be better equipped to assess the adequacy of the researcher’s proposal.