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President Barack Obama's long-stated goal for universal health insurance could have a ripple effect on the human subjects research field, possibly removing an incentive for people to enter clinical trails. That is one of several possible changes on the horizon as a new administration takes the helm, experts tell IRB Advisor.
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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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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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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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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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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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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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A list of all IRB Advisor articles published in 2002, organized by topic.
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A new federal advisory panel that will provide ethical guidance for researchers engaged in studies involving human subjects has been charged by the Bush administration to consider human embryos to be human subjects, deserving of the same protections currently afforded fetuses, children, and adults.
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The Council for International Organizations of Medical Sciences (CIOMS) published in October 2002 its revised and updated International Ethical Guidelines for Biomedical Research Involving Human Subjects. Here is a brief look at the new and revised guidelines.
