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.
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).
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.
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.
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?
A year after its public meeting on the Support study, the Office of Human Research Protections (OHRP) issued a draft guidance to clarify its thinking on the disclosure of reasonably foreseeable risks in standard of care research.
For years now, IRB managers have been developing and using tools, including checklists and templates. The goal is to improve IRB review consistency and to expedite the approval turnaround process. While checklists and tools are useful, they can also be a problem.
IRB board member self-evaluations are crucial for determining how members view their IRB service and measuring the performance of the HRPP itself. But IRB administrators who are looking for self-evaluation tools may have a hard time deciding where to start, or which issues should be the focus.