From the Guidelines
The primary job of institutional review boards is to protect the rights, health, and well-being of patients participating in research by reviewing proposed methods and ensuring appropriate measures are taken to minimize risks and maintain ethical standards. According to the most recent and highest quality study 1, institutional review boards (IRBs) apply research ethics by reviewing in advance the methods proposed for research to ensure that appropriate measures are taken to protect the rights, health, and well-being of patients participating in the research.
Key Responsibilities of IRBs
- Reviewing research protocols to ensure they meet ethical standards and minimize risks to participants
- Evaluating whether the potential benefits of research outweigh the risks
- Verifying that participant selection is equitable and that privacy and confidentiality are maintained
- Conducting ongoing monitoring of approved research to ensure continued compliance with ethical guidelines As noted in 1, IRBs also play a crucial role in preventing exploitation or harm to participants, particularly vulnerable populations, and ensuring that researchers are transparent and accountable.
Importance of IRB Review
IRB review is essential to ensure that medical research involving human subjects conforms to the Declaration of Helsinki and follows good clinical practice (GCP) guidelines, as stated in 1. By prioritizing the protection of human subjects, IRBs serve as an independent check on research activities, preventing exploitation or harm to participants and maintaining public trust in the research enterprise.
From the Research
Role of Institutional Review Boards
The primary job of institutional review boards (IRBs) is to protect human research participants by overseeing the implementation of federal regulations regarding protection of human subjects 2. IRBs provide a core protection for human research participants through advance and periodic independent review of the ethical acceptability of proposals for human research 3.
Key Responsibilities
Some key responsibilities of IRBs include:
- Reviewing and monitoring research involving humans to ensure protection of their rights and welfare as research participants 4
- Overseeing the implementation of federal regulations regarding protection of human subjects 2
- Approving research protocols to ensure that research is conducted in a manner that protects human participants 4
- Ensuring that research participants are protected from any likely harm 5
Challenges and Requirements
IRBs face several challenges, including:
- Inconsistencies in IRB review and application of federal regulations 3
- Pressure to speed reviews and potential conflicts of interest 6
- Limited resources and lack of standard operational procedures and guidelines for submission and evaluation of protocols 5 To address these challenges, IRBs require:
- Efficient secretariats with dedicated staff to serve as clearing houses for protocols to be approved 5
- Training and re-training of members to ensure they are equipped to review and monitor research protocols effectively 5
- Institutionalization of IRBs with official policies and procedures in place to ensure that all research is approved and monitored 5