CAN YOU EXPLAIN THE PROCESS OF OBTAINING NECESSARY CLEARANCES FROM INSTITUTIONAL REVIEW BOARDS

Institutional review boards (IRBs) are committees that are mandated by law to review and approve human subject research in order to protect the welfare and rights of research participants. Any research conducted by investigators affiliated with an institution that involves human subjects, their data, or their biological samples requires IRB review and approval prior to beginning the research. This includes research conducted by faculty, staff, and students affiliated with colleges, universities, hospitals, or other institutions.

The first step in obtaining IRB approval is to submit an application to the IRB of the institution with which the researcher is affiliated. IRB applications typically require researchers to describe in detail the purpose and design of the study, the participant population, recruitment methods, data collection procedures, potential risks and benefits to participants, confidentiality protections, and plans for obtaining informed consent from participants. Researchers must also provide copies of all materials that will be used to recruit and communicate with participants, such as advertisements, consent forms, surveys, and interview questions.

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Once an application is submitted, it undergoes an initial administrative review by IRB staff to determine whether it is complete or requires clarification, modification, or additional information. Incomplete applications will not be reviewed until all requested information has been provided by the researcher. Complete applications are then reviewed during a convened meeting of the full IRB board or a designated subcommittee. The IRB may approve the research, request modifications to secure approval, or defer the research for further review and revisions. Factors considered include the study’s risks and anticipated benefits, selection of participants, informed consent process, data privacy and confidentiality protections, and compliance with regulatory requirements and ethical standards.

If modifications are requested, researchers must submit a response describing the changes made and addressing each IRB concern. The revised application then undergoes further review. Once all issues have been adequately addressed and the research deemed to satisfy ethical and regulatory standards, the IRB will issue an approval letter specifying any ongoing requirements for the approved project period, usually one year. Annual renewals are then required along with reporting of any changes to the approved research protocol, unanticipated problems, protocol deviations or violations.

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For studies involving more than minimal risk to participants, expedited review is not permitted and the convened IRB board must review and approve the research. Some research may qualify for exemption from full board review but still requires determination of exemption status from the IRB. International research involving non-U.S. sites or participants or sponsored by external funders also has additional IRB requirements for protection of human subjects beyond U.S. borders. Federally funded research is also subject to oversight from federal funding agencies like the Office of Human Research Protections to ensure compliance with regulations and policies governing human subjects protection.

IRB review is intended to be a collaborative process between researchers and the board to ensure research protections while avoiding unnecessary delays or restrictions on ethical studies. Undergoing IRB approval can be time-consuming as additional clarifications, modifications or paperwork are often requested in multiple review rounds before final approval is granted. Researchers need to plan for this multi-step process requiring patience and responsiveness to address all IRB feedback and concerns adequately prior to approval and initiation of participant recruitment and data collection activities. Following IRB determinations and ongoing oversight helps guarantee research participants are respected and protocols satisfy ethical standards of scientific inquiry involving human subjects.

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Obtaining IRB clearance requires detailed disclosure and review of a research study design and protocol, with the goal of protecting the rights and welfare of human participants. This involves submitting comprehensive IRB applications, working collaboratively through potentially multiple review rounds, and complying with determination letters, ongoing reporting requirements and established ethical guidelines. Careful planning and responsiveness to IRB feedback are important for navigating this mandatory human subjects research review and approval process.

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