Suchergebnisse

ABSTRACTIn response to researcher noncompliance with ethical and regulatory provisions governing research with humans, protocol deviations, and unanticipated problems with research, institutional review boards (IRBs) or institutions sometimes impose restrictions on the use of research data, although specific cases in which this happens are unlikely to be known publicly. We review IRB policies at top research institutions in the United States about restrictions on the use of research data and describe potential reasons for restricting the use of such data in the context of ensuring compliance with human subjects research standards. We also discuss ethical considerations related to restricting the use of research data and argue that IRBs have limited regulatory authority to take such actions. Finally, we offer recommendations regarding decision‐making about restricting the use of research data and call for additional guidance in this area.

This second edition of Beyond Consent adds new content in two different ways, first by asking authors to examine the issues identified in the first edition taking into account what new issues arise in the contemporary environment, and second by adding chapters to take on issues that are salient today and looking forward

ABSTRACTA leading concern about single IRB (sIRB) review for multisite studies, as is now required by federal policies, is whether and how sIRBs consider local context in their review. While several types of local context considerations have been proposed, there is no shared agreement among those charged with the ethics oversight of human subjects research as to the goals and content of local context review, nor the types of research studies for which sIRB review might be inappropriate. Through a scoping review of published scholarship, public comments, and federal guidance documents, we identified five assumed goals for local context review: protecting the rights and welfare of local participants; ensuring compliance with applicable laws and policies; assessing feasibility; promoting the quality of research; and promoting procedural justice. While a variety of content was proposed to be relevant, it was largely grouped into four domains: population/participant‐level characteristics; investigator and research team characteristics; institution‐level characteristics; and state and local laws. Proposed characteristics for exclusion from sIRB requirements reflected both protection‐ and efficiency‐based concerns. These findings can inform ongoing efforts to assess the implications of policies mandating sIRB review, and when exceptions to those policies might be appropriate.

Long informed consent forms (ICFs) remain commonplace, yet they can negatively affect potential participants' understanding of clinical research. We aimed to build consensus among six groups of key stakeholders on advancing the use of shorter ICFs in clinical research. Partnering with the HIV Prevention Trials Network (HPTN), we used a modified Delphi process with semistructured interviews and online surveys. Concerns about redundancy of information were common. Respondents supported three strategies for reducing ICF length: (a) 91% agreed or strongly agreed with grouping study procedures by frequency, (b) 91% were comfortable or very comfortable with placing supplemental information into appendices, and (c) 93% agreed or strongly agreed with listing duplicate side effects only once. Implementing these strategies will facilitate adoption of the proposed changes to U.S. regulations on ICF length, should they be enacted.

Little research has explored the possible effects of government institutions in emerging economies on ethical reviews of multinational research. We conducted semi‐structured, in‐depth telephone interviews with 15 researchers, Research Ethics Committees (RECs ) personnel, and a government agency member involved in multinational HIV Prevention Trials Network (HPTN ) research in emerging economies. Ministries of Health (MOH ) or other government agencies often play pivotal roles as facilitators or barriers in the research ethics approval process. Government agency RECs reviewing protocols may face particular challenges, as they can lack resources, be poorly organized, have inconsistent review processes and limited expertise, and use differing definitions of national interests, including upholding national reputation and avoiding potential exploitation and stigma of the country's population. The MOH /governmental review body may be affected by power dynamics and politics in study reviews; may consider issues both related and unrelated to research ethics as understood elsewhere; and may prioritize particular diseases, treatments, or interventions over other topics/types of research. Poor communication and deeply‐rooted tensions may exist between sponsor and host countries, impeding optimal interactions and reviews. Investigators must understand and plan for the potential effects of governmental agencies on multinational collaborative research, including preserving adequate time for agency review, and contacting these agencies beforehand to address issues that may arise. Better understanding of these issues can aid and advance appropriate global scientific collaboration.

Many professional organizations and governmental bodies recommend disclosing financial conflicts of interest to potential research participants. Three possible goals of such disclosures are to inform the decision making of potential research participants, to protect against liability, and to deter conflicts of interest. We reviewed US academic medical centers' policies regarding the disclosure of conflicts of interest in research. Forty-eight percent mentioned disclosing conflicts to potential research participants. Of those, 58% included verbatim language that could be used in informed consent documents. Considerable variability exists concerning the specific information that should be disclosed. Most of the institutions' policies are consistent with the goal of protection from legal liability.