Institutional Review Board Approval

November 12, 2012

Institutional Review Board Approval

Institutional review board (IRB) oversees the rights and welfare of human subjects during their participation in research and clinical trials. The IRB approves research projects based on regulations issued by the FDA and the Office of Human Research Protections.

Mission of IRB

American University’s Institutional Review Board was created to maintain high standards of ethical conduct during research involving human participants. This department is responsible for the scientific, ethical and regulatory oversight of research. The IRB reviews, modifies, approves and disapproves research protocols based on the provisions of the Protection of Human Subject in the Code of Federal Regulations and the supporting materials such as the Belmont Report. This will help create awareness about the rights of human participants and help the researchers conduct their studies in a timely and orderly manner.

Who Needs IRB Approval

Although most classroom research projects, many oral history projects, and some reviews of preexisting data do not require IRB approval, any research that collects data through interaction with living individuals, or obtains identifiable private information from them require approval of the agency. The IRB identifies research as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” So, if your study falls into this category, you may have to apply for IRB approval.

Process of IRB Approval

If you are unsure whether your research requires IRB approval or not, you may begin by submitting the Human Subjects Research Determination Form. The IRB coordinator will inform you if you require an approval. Your next step would be to fill the IRB approval form, which would be reviewed by the IRB committee that meets twice each month. The committee may recommend changes or approve your proposal right away. Your IRB approval is usually valid for three months. Any changes in the project can be made only after a modification request is approved by the committee.

The research team may also have to complete ethics training and submit its proof to the IRB. The training can be completed online or at your campus.

Noncompliance Investigations

The IRB reviews any allegations of noncompliance with the approved protocol. The investigations aim to protect the participants of the study, and look for:

  • Injury or risks to participants or others.

  • Serious or continuing noncompliance with IRB determinations or federal regulations.

  • The investigation may result in withdrawal of IRB approval, or the committee may suggest specific actions or steps to maintain the approval.

Tags: , ,

Category: Articles