According to Klitzman in views and experiences of IRBs concerning research integrity, most consent forms direct subjects with complains to the IRB not to a compliance office. true or false
The correct answer and explanation is:
Correct Answer: True
Explanation (300 words):
In “Views and Experiences of IRBs Concerning Research Integrity” by Robert Klitzman (2008), one of the key findings is that most informed consent forms direct research subjects with complaints to the Institutional Review Board (IRB) rather than to a separate research compliance office. This reflects how IRBs are often positioned as the primary oversight body for ethical conduct in human subjects research within institutions.
IRBs are charged with protecting the rights and welfare of human research participants, and they are typically the main point of contact for subjects who have concerns or complaints about a study. Informed consent documents, which are reviewed and approved by IRBs, usually include contact information for the IRB office. This allows participants to report problems, ask questions, or voice concerns about their rights, the study procedures, or the conduct of researchers.
Klitzman’s interviews with IRB members and administrators revealed that many IRBs assume this role because participants are often unaware of other compliance bodies, and institutions do not always have clearly defined alternative pathways for handling research misconduct or regulatory violations. Furthermore, many institutions lack a separate, visible compliance office with public-facing functions. Even when compliance offices exist, the information provided to subjects tends to highlight the IRB as the responsible body for participant protection.
However, this practice may blur the boundaries between ethical oversight and institutional compliance functions. IRBs are not always equipped to handle serious allegations of research misconduct, which ideally fall under the jurisdiction of research integrity or compliance offices. Klitzman emphasizes the need for clearer delineation of roles and better education for research participants about where and how to report various concerns.
In summary, it is true that most consent forms direct participants to IRBs rather than compliance offices, a practice that reflects both institutional norms and the public-facing role of IRBs in research oversight.