The Roles of Fellows and Trainees in NIH Supported Clinical Trials

NIH encourages fellows supported on NIH NRSA Fellowship awards and trainees supported on NIH NRSA Training awards to receive training in clinical research, including in the conduct of clinical trials. Under a mentor’s guidance, fellows and trainees can gain experience in the wide variety of research skills specific to clinical trials including, but not limited to: developing a clinical trial protocol; applying the principles of informed consent and requirements for human subjects research; learning about random assignment of participants to different intervention arms; analyzing trial endpoints; and/or implementing quality control standards. Continue reading

Streamlining IRB Review of Multi-Site Clinical Research Studies

For many decades now the Department of Health and Human Services (HHS), and consequently NIH, has required institutional review board (IRB) review of research involving human subjects. …. as the clinical research landscape evolves, so should our policies to assure that NIH-funded research can more quickly generate research results without compromising protections for those who volunteer to participate in clinical studies. …. Today, NIH released a draft policy proposing that all NIH-funded multi-site clinical studies carried out in the US should use a single IRB’s review, rather than working through the IRB approval process of each participating institution. …. Continue reading