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Research with adolescents who are at risk for suicide can create daunting ethical and practical challenges for investigators and IRBs.
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Despite general agreement that medicine and medical research need to do more to meet the needs of pregnant women, there still are serious roadblocks that prevent wider enrollment of women during pregnancy.
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Helen McGough, MA, CIP, is retired from the office of research at the University of Washington in Seattle, WA, and has worked as a faculty member of PRIM&R. McGough also has worked with the Collaborative IRB Training Initiative (CITI), and she served on an IRB for many years.
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Federal regulations require researchers to maintain an equitable selection of participants, and IRBs take this into consideration when reviewing study protocols. But what are the ethical implications when a study has difficulty recruiting or retaining subjects? From an IRB perspective, recruitment must not be coercive, but how can researchers ensure participants are truly willing volunteers in small studies that require a major physical commitment?
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Its a long-standing issue with IRBs: Studies are approved, participants are enrolled, study interventions and visits occur and someone complains. But then what?
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IRB Advisor asked Diana T. Chingos, MS, MFA, executive director of the Noreen Fraser Foundation in Los Angeles, to tell readers a little more about herself and her hopes and goals for the Secretarys Advisory Committee on Human Research Protections (SACHRP), to which she was appointed in October 2014.
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Blogs, message boards, and patient communities are being used not only by patients, but also by research participants. In some cases, this reveals whether or not a participant is taking actual medication or placebos, compromising the studys validity.
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The agencys Notice of Proposed Rulemaking (NPRM), released in November, expands clinical trial registration and reporting guidelines for clinical trials that are required to register with ClinicalTrials.gov under the U.S. Food and Drug Administration Amendments Act (FDAAA).
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Community-based participatory research (CBPR) brings members of the community into a study as partners who are involved with subject recruitment, study design, informed consent, and other aspects of research. Community partners can include tribal councils, religious organizations, neighborhood groups, and other social organizations.
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Once a final decision is made regarding some proposed research involving very young children and an older smallpox vaccine, there could be long-term repercussions for IRBs nationwide.
