Research with Humans
Human research participants are an essential link in biomedical research. Before a drug, procedure or device can come be brought to the marker regulations require: a. testing with animal models; b. phase 1 testing with a small number of human subjects (often less than 20 people); c. phase 2 testing with an enlarged number of human subjects, and finally; d. phase 3 testing with sometimes several thousand human subjects.
The U.S. Food and Drug Administration (FDA) and Department of Health and Human Services (DHHS) protect the rights, welfare, and wellbeing of human subjects that are involved in this phased testing process. Primarily the day to day protections are controlled and monitored by federally-approved Institutional Review Boards (IRBs). IRBs meet to to review, approve and monitor research protocols to ensure that that human beings who are volunteering to participate in medical research receive the highest level of ethical consideration and appropriate care.
Ensuring the protection of human research participants is an integral responsibility of the committee members who serve on IRBs. These protections are also a prime focus for IRB staff, researchers, compliance office personnel, organizational leaders, and communications professionals.
NWABR trainings enhance our researchers' ability to protect the research volunteers engaged in protocols at their institutions. We encourage dialogue with the public about their role in clinical trials and their expectations regarding their safety, and the use of their information (including the use of donated blood, tissues or DNA).
By some accounts less than 1% of Americans participate in research. Building the public's trust in the research process is a key outcome of the work undertaken by NWABR with researchers and IRBs.
NWABR’s Institutional Review Board (IRB) conferences bring together IRB professionals to discuss best practices, facilitate understanding of emerging regulatory issues, and consider trends in the protection of research volunteers.