First Do No Harm: Ethical Concerns of Health Researchers That Discourage the Sharing of Results With Research Participants

Ethical Considerations in Clinical Trials for Disorders of Consciousness

“…Determination of whether, when and how to disclose research results demands case-by-case consideration, given the plurality of factors that might bear on these decisions and their potential impact on participants, surrogates and research data integrity. These questions should be proactively discussed during the study design phase and written into the protocol and consent procedure [147][148][149][150][151]…”

“…The determination of whether, when, and how to disclose research results requires case-by-case consideration, given the plurality of factors that might bear on these decisions and their potential impact on participants, surrogates, and research-data integrity. These questions should be proactively discussed during the study design phase and written into the protocol and consent procedure [ 147 , 148 , 149 , 150 , 151 ]. Consensus has been growing among ethicists, legal scholars, and regulators in favor of more regular return of research results, where appropriate [ 152 ], and a 2018 Consensus Study Report of the National Academies of Sciences, Engineering, and Medicine (NASEM) details a vision for “Returning Individual Research Results to Participants: Guidance for a New Research Paradigm” [ 149 ].…”

Return of aggregate results to study participants: Facilitators, barriers, and recommendations

“…Patient partners' perspectives in this study underscored investigators' views, emphasizing that participants have a right to receive aggregate study results and adding that returning results regardless of the study outcome encourages trust in researchers and future research participation and potentially informs health decisions. Unlike other studies [ 9 , [14] , [15] , [16] ], investigators did not express concerns about patients' health literacy or the potential for results to do harm. Rather, they emphasized, and patient partners reiterated, important strategies for results return, including using plain language, simple and concise formats, and channels tailored to the audience.…”

“…Some researchers cite barriers, such as financial or logistical obstacles and Institutional Review Board (IRB)-related policies [ 11 , 14 ]. In addition, researchers in some studies expressed concerns about participants' health literacy and the potential for results to cause emotional harm [ 9 , 11 , [14] , [15] , [16] ].…”

Disseminating results to participants: An obligation to those who make research possible

“…Additional ethical implications should also be considered in these sections including (1) Distressparticipants may experience emotional distress or stigma, (2) Understanding-lack of sufficient understanding or therapeutic misconception, and (3) Privacy-violating privacy policies or loss of confidentiality. 15…”