From the Committee on Human Research
Interdisciplinary and multi-site studies: Ethical challenges for psychologists
By APA Committee on Human Research (CHR)
This commentary is one in an occasional series for PSA in which CHR addresses current ethical and regulatory issues surrounding human subject research. These commentaries are not official APA policy but represent the consensus view of the committee members and are intended to inform and stimulate thinking among researchers and administrators.
In today’s research environment, psychologists are increasingly involved in collaborative human participant research across multiple disciplines and/or research sites. In such studies, each principal investigator and institution engaged in research with human participants is responsible for safeguarding participants’ welfare and rights, as specified in the federal regulations (45 CFR 46.114). Further, researchers are required to design and manage their studies to ensure data integrity. These responsibilities raise important considerations and challenges in the planning, review, and conduct of safe and ethical collaborative research.
Competency -- When a collaborative project is planned, investigators need to consider carefully the competency of each team member. There may be many methods of ensuring competency, including first-hand knowledge of skills and abilities. However, this can be challenging when investigators do not know one another. Competency can also be assessed through a careful peer evaluation of the team members’ prior research experience and accomplishments.
Coordination and Communication -- Before a multi-site project begins, it is recommended that investigators craft a detailed plan for the management and dissemination of information across study sites. Such a plan will help the sites communicate with one another, and can facilitate reporting relevant information, including adverse events or unanticipated issues involving risk to the participants, protocol modifications, and site-specific non-compliance to institutional review boards (IRBs).
Data Sharing -- When data are shared across institutions, protection of privacy and confidentiality in the maintenance, storage, and transfer of records may pose additional challenges. If the study involves a coordinating center, a separate IRB protocol may be required to ensure that the responsibilities of the coordinating center are met. A written plan to which all sites agree before a collaborative project begins can reduce the likelihood of subsequent communication problems.
IRB Approval -- In multi-site studies, obtaining review and approval of research with human participants at each institution can require substantial effort and time. Identical protocols presented to different IRBs may receive discrepant reviews, and protocol and consent document changes may be required that reflect local standards and approaches to handling human research participant issues. These multiple reviews can be a burden that creates additional work for IRBs and investigators while adding little to research participant protection. The burden can be reduced if, to the extent possible, investigators discuss with their IRBs approaches that can be used to avoid duplication of effort. These approaches may include approval by a designated IRB, or approval by the IRB at the lead institution pursuant to an agreement to act as the designated IRB (OHRP guidance, May 10, 2010).
Data Integrity -- Ensuring the integrity and safety of research procedures in multidisciplinary studies can be particularly challenging as necessary expertise becomes more specialized. One investigator may not have the training required to evaluate the integrity or relevance of data collected by other investigators. For example, in a psychotherapy trial in which functional brain activity at baseline is evaluated as a possible moderator of treatment success, the principal investigator may need to rely heavily on other investigators with the necessary skills and experience to interpret brain scans.
In such cases, clearly articulated decision rules agreed on by all team members can reduce the likelihood of misunderstandings. Including a second expert as a consultant for occasional procedural assessments can also strengthen the project. Furthermore, when conducting collaborative research across multiple disciplines and sites, assuring the integrity of large and complex data sets may require special infrastructure and novel methodologies. In general, issues relating to safe and ethical conduct of research and to data integrity should be considered explicitly whenever a project with multiple disciplines, sites, and/or principal investigators is planned.
Finally, when all of these issues are considered together, there is a growing realization that the complexities of multi-disciplinary, multi-site science may exceed the expertise and abilities of a single individual. In such cases principal investigators in these types of projects may feel the weight of the responsibility that they bear for circumstances that appear beyond their control. This responsibility can be profoundly uncomfortable, especially for those newly engaged in such projects. Determining how to resolve this discomfort remains an ongoing challenge – and a potentially valuable area for discussion and empirical study – as psychologists continue to be involved in team science.
CHR members are: Thomas Eissenberg (chair), Miriam F. Kelty, Daniel C. Marson, Vivian Ota Wang, Barbara Stanley, Mieke Verfaellie, and Frank Wong. Sangeeta Panicker serves as the staff liaison to the committee.
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