Introduction
Research involving human subjects is associated with various ethical concerns, hence there is the need for a regulatory body to approve clinical studies before they are conducted. Institutional Review Board (IRB) is an “administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution with which it is affiliated” (Oregon State University, 2020, para. This paper discusses the primary responsibilities and priorities of IRBs and the specific guidelines that the Medical College of Wisconsin (MCW) applies when conducting research using at-risk human populations, such as women, children, minorities, and cognitively impaired subjects.
Main body
The primary responsibility of IRBs is to ensure that all the appropriate measures are taken to safeguard the welfare and rights of human subjects in research. Therefore, all researches involving human subjects, whether funded or not, have to undergo review by the respective IRB. Therefore, this body could approve, ask for modifications, disapprove, and monitor any given study using human participants. The priority of IRBs is on human rights, welfare, and rights. The mandate of these bodies is specified by both institutional policies and federal regulations. In the US, IRBs are regulated by the US Food and Drug Administration (FDA).
According to the FDA (n.d.), IRBs are required to use certain protocols and group processes when reviewing various studies and related materials before approval. The Guidance for Institutional Review Boards and Clinical Investigators offers a framework of guidelines that IRBs should follow when executing their mandates. The regulations to be followed are outlined in the Good Clinical Practice and Clinical Trials, which is a “comprehensive list of regulations governing human subject protection and the conduct of clinical trials” (FDA, n.d., para. 3). Other regulations are outlined in Information for Health Professionals, Clinical Safety Data Management, FDA Compliance Programs 7348.809, and 7348.811 (FDA, n.d.).
At the MCW, the MCW-IRB is mandated to approve and monitor all researches involving human subjects. According to MCW Office of Research (n.d.), the Human Research Protection Program (HRPP) Office, which is a part of the MCW, “must review all human subjects research in which we are engaged by MCW IRB policies and MCW Corporate Policy RS.HS.040 – HRPP” (p. 3). The MCW’s guidelines when dealing with groups at risk require such participants to be subjected to the protocols involving human subjects. Therefore, informed consent must be obtained before participants can take part in the study. In cases, where the subjects cannot give informed consent, such as children and the mentally impaired, a guardian is expected to sign the consent on behalf of the participant. The subjects should be fully informed about how the data or specimens will be collected and used together with the purposes of the study. Personal information should be kept private and labeled using aliases or numbers to conceal the identity of the participants. In cases where private data or biospecimen need to be identified by the researcher, such information should be communicated to the participants for their explicit authorization.
Conclusion
IRBs are regulatory bodies whose purpose is to ensure that human rights, welfare, and privacy are observed when conducting research using human subjects. Therefore, IRBs have the authority to approve or disapprove a request to conduct a given study. At MCW, the IRB has its policies based on institutional guidelines and federal regulations to govern how research involving at-risk populations is conducted as explained in this paper.
References
FDA. (N.d.). Institutional review boards (IRBs) and protection of human subjects in clinical trials.
MCW Office of Research. (N.d.). Definition and determination of human subjects research. Web.
Oregon State University. (2020). What is the institutional review board.