Disclosure of Individualized Research Results: A Precautionary Approach

Abstract

Assessing and managing risks to participants is a central point of contention in the debate about disclosing individualized research results. Those who favor disclosure of only clinically significant results think that disclosing clinically insignificant results is risky and costly, and that harm prevention should take precedence over other ethical considerations. Those who favor giving participants the option of full disclosure regard these risks as insubstantial, and think that obligations to benefit participants and promote their autonomy and right to know outweigh the obligation to prevent harm or financial considerations. The risks of disclosing clinically insignificant research results are currently not quantifiable, due to lack of empirical data. The precautionary principle provides some insight into this debate because it applies to decision-making concerning risks that are plausible but not quantifiable. A precautionary approach would favor full disclosure of individualized results with appropriate safeguards to prevent, minimize, or mitigate risks to participants, such as: validating testing methods; informing participants about their options for receiving tests results and the potential benefits and risks related to receiving results; assessing participants' comfort with handling uncertainty; providing counseling and advice to participants; following-up with individuals who receive tests results; and forming community advisory boards to help investigators deal with issues related to disclosure.

Stability of Attitudes to the Ethical Issues Raised by the Return of Incidental Genomic Research Findings in Children: A Follow-Up Study

“…The majority of parents responded that each of these factors should be considered to some degree, although a substantial proportion were either ambivalent or felt that these issues were not important. Concerns voiced in the literature about the potential harms from receiving research results are shared by at least some respondents [39,40,41]. This is an important area to continue to monitor and to incorporate in deciding whether to return results, as the prevalence of sharing both clinical and research genomic findings continues to expand [30].…”

Amnestic MCI Patients’ Perspectives on Volunteer Participation in a Research Context

“…This finding highlights the difficulties some participants had in understanding the differences between a clinical and research setting [11,12]. For example, most research subjects may be unaware that the main goal of research is to produce new general knowledge in a particular field of inquiry, not to produce and return individual bits of knowledge to a research participant [13,14]. This blurring of the boundary between clinical practice and research in the minds of research participants is often mentioned in the literature as an argument against the disclosure of these results [11][12][13][14][15].…”

“…For example, most research subjects may be unaware that the main goal of research is to produce new general knowledge in a particular field of inquiry, not to produce and return individual bits of knowledge to a research participant [13,14]. This blurring of the boundary between clinical practice and research in the minds of research participants is often mentioned in the literature as an argument against the disclosure of these results [11][12][13][14][15]. Yet, there are also counter-arguments, such as the return of the IRRs would make research more transparent for society, who ultimately benefits and often funds the research [16].…”

Potentials and Challenges of the Health Data Cooperative Model

“…Nevertheless, this possibility has been criticized. The main argument is that clinical study outcomes cannot always be guaranteed to be accurate [25]. Even though diagnostic testing methods provide essential information for clinical decision making, they have a risk of generating incorrect or unreliable test results [54].…”

“…Thirdly, it might also guide individuals in making medical, reproductive, or lifestylerelated decisions. Another reason for sharing the study results with the participant is that it is simply their right to obtain this information because they have contributed decisive information to the study [25]. Additionally, there is a population benefit associated with the data enquiry regulation of the HDC model.…”