8.3 Institutional review boards

Institutional review boards (IRBs) are crucial for protecting human subjects in research. They ensure studies follow ethical guidelines and minimize risks to participants. IRBs review protocols, assess potential harms and benefits, and enforce informed consent procedures.

IRBs consist of diverse members with varied expertise. They conduct different types of reviews based on risk levels. Researchers must submit detailed protocols for approval and adhere to approved procedures. IRBs provide ongoing oversight, including continuing review and handling noncompliance issues.

Purpose of institutional review boards

• Institutional review boards (IRBs) play a critical role in overseeing research involving human subjects to ensure their rights and welfare are protected
• IRBs are independent committees established by research institutions, universities, or other organizations conducting human subjects research to provide ethical and regulatory oversight

Protection of human subjects

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• IRBs are responsible for safeguarding the rights, safety, and well-being of human research participants
• They review research protocols to assess potential risks and benefits to participants and ensure that risks are minimized and reasonable in relation to anticipated benefits
• IRBs ensure that vulnerable populations, such as children, prisoners, or mentally disabled individuals, receive additional protections and considerations

Ensuring ethical research practices

• IRBs enforce ethical principles and guidelines for human subjects research, such as those outlined in the Belmont Report (respect for persons, beneficence, and justice)
• They ensure that research is conducted with integrity, transparency, and adherence to ethical standards
• IRBs review informed consent procedures to ensure that participants are fully informed about the study, its risks and benefits, and their rights as research subjects

Structure of IRBs

• IRBs are typically composed of a diverse group of individuals with varying backgrounds and expertise to provide a comprehensive review of research protocols
• The composition and structure of IRBs are regulated by federal guidelines to ensure their independence, objectivity, and effectiveness in protecting human subjects

Composition of members

• IRBs must have at least five members with diverse backgrounds, including at least one member whose primary concerns are in scientific areas and one whose primary concerns are in nonscientific areas
• The membership should include individuals with different professions, genders, and cultural backgrounds to provide a broad perspective on research ethics
• IRBs often include community members or representatives who are not affiliated with the institution to provide an outside perspective and represent the interests of research participants

Expertise of members

• IRB members should have the necessary expertise to review the specific types of research protocols submitted to the board
• This may include expertise in scientific disciplines relevant to the research (medicine, psychology, social sciences), as well as knowledge of ethical principles, research methodology, and applicable regulations
• IRBs may also consult with external experts or invite ad hoc members with specific expertise when reviewing complex or specialized research protocols

IRB review process

• The IRB review process is designed to systematically evaluate research protocols and ensure they meet ethical and regulatory standards before human subjects are enrolled in a study
• Researchers must submit detailed protocols outlining the study's objectives, methods, risks, benefits, and informed consent procedures for IRB review and approval

Types of IRB review

• Full board review: Required for research involving more than minimal risk to participants or vulnerable populations; the entire IRB reviews and discusses the protocol at a convened meeting
• Expedited review: Allowed for research involving no more than minimal risk and fitting into specific categories; the review is carried out by the IRB chair or designated member(s)
• Exempt review: Certain types of low-risk research (educational tests, surveys, interviews) may be exempt from full IRB review but still require institutional determination of exemption

Criteria for IRB approval

• IRBs use a set of criteria to determine whether a research protocol can be approved, including:
  1. Risks to subjects are minimized and reasonable in relation to anticipated benefits
  2. Selection of subjects is equitable and free from coercion or undue influence
  3. Informed consent is obtained and documented appropriately
  4. Adequate provisions are in place to protect the privacy of subjects and maintain confidentiality of data
  5. Appropriate safeguards are included to protect vulnerable populations

Informed consent requirements

• Informed consent is a critical aspect of human subjects research, ensuring that participants understand the nature of the study, its risks and benefits, and their rights as research subjects
• IRBs review informed consent documents to ensure they include all required elements (purpose, procedures, risks, benefits, alternatives, confidentiality, contact information) and are written in plain language understandable to participants
• Special considerations for informed consent may apply to vulnerable populations (children, cognitively impaired individuals) or when using deception in research

Researcher responsibilities

• Researchers have a primary responsibility to protect the rights and welfare of human subjects and to conduct research ethically and responsibly
• They must adhere to IRB policies and procedures, obtain IRB approval before initiating research, and maintain open communication with the IRB throughout the study

Submitting protocols for review

• Researchers must prepare and submit detailed research protocols to the IRB for review and approval before beginning any human subjects research
• Protocols should include a clear description of the study's objectives, methods, risks, benefits, and informed consent procedures, as well as plans for data protection and confidentiality
• Researchers should also provide any relevant supporting materials (questionnaires, recruitment materials, data collection tools) for IRB review

Adhering to approved protocols

• Once a research protocol is approved by the IRB, researchers must adhere to the approved procedures and not deviate from the protocol without prior IRB approval
• Any proposed changes to the protocol, including modifications to study procedures, informed consent documents, or study personnel, must be submitted to the IRB for review and approval before implementation
• Researchers must also promptly report any unanticipated problems, adverse events, or noncompliance to the IRB for review and guidance

Reporting adverse events

• Researchers have an obligation to report any serious adverse events or unanticipated problems that occur during the course of the research to the IRB in a timely manner
• Adverse events may include physical or psychological harm to participants, breaches of confidentiality, or other unexpected risks or complications
• The IRB will review the reported events and determine any necessary actions (protocol modifications, additional participant protections, suspension or termination of the study) to ensure the safety and well-being of research subjects

IRB oversight and monitoring

• IRBs have an ongoing responsibility to oversee and monitor approved research to ensure it is conducted ethically and in compliance with regulations and institutional policies
• This oversight includes continuing review of approved research, handling of noncompliance, and the authority to suspend or terminate research if necessary

Continuing review of approved research

• IRBs are required to conduct continuing review of ongoing research at intervals appropriate to the degree of risk, but not less than once per year
• Continuing review ensures that the research remains ethically sound, risks to subjects are minimized, and any new information that may impact the risk-benefit assessment is considered
• Researchers must submit progress reports and any proposed changes to the protocol for IRB review and approval as part of the continuing review process

Handling of noncompliance

• IRBs are responsible for investigating and addressing instances of noncompliance with IRB policies, federal regulations, or ethical standards
• Noncompliance may include failure to obtain IRB approval, deviations from approved protocols, or failure to report adverse events or unanticipated problems
• IRBs may impose corrective actions (additional training, protocol modifications, increased monitoring) or sanctions (suspension or termination of research, restriction of researcher privileges) depending on the severity and nature of the noncompliance

Suspension or termination of approval

• IRBs have the authority to suspend or terminate approval of research that has been associated with unexpected serious harm to subjects or serious or continuing noncompliance
• Suspension of approval is a temporary halt to research activities until the IRB can review the issue and determine the appropriate course of action
• Termination of approval is a permanent halt to research activities, typically reserved for the most serious cases of noncompliance or harm to subjects
• Researchers must comply with IRB directives regarding suspension or termination of research and take necessary steps to protect the rights and welfare of enrolled subjects

Challenges and controversies

• While IRBs play a critical role in protecting human subjects and ensuring ethical research, they also face challenges and controversies in balancing the risks and benefits of research and navigating complex ethical issues
• These challenges can lead to variability in IRB decisions, delays in research, and ongoing debates about the appropriate level of oversight and regulation

Balancing risks vs benefits

• One of the primary challenges faced by IRBs is determining whether the risks of a research study are reasonable in relation to the anticipated benefits to participants or society
• This assessment can be complex and subjective, requiring careful consideration of the nature and magnitude of risks, the likelihood of harm, and the potential benefits of the research
• IRBs must weigh the importance of the research question, the adequacy of risk minimization strategies, and the voluntary and informed nature of participant consent in making this determination

Variability in IRB decisions

• Despite efforts to standardize IRB policies and procedures, there can be significant variability in IRB decisions across different institutions and even within the same institution over time
• This variability can be influenced by factors such as the composition and expertise of IRB members, institutional culture and risk tolerance, and local interpretations of federal regulations
• Inconsistency in IRB decisions can lead to frustration among researchers, delays in research, and potential inequities in the protection of human subjects across different studies or institutions

Delays in research due to IRB review

• The IRB review process can sometimes result in significant delays in the initiation or progress of research, particularly for multi-site studies or research involving vulnerable populations
• These delays can be due to the time required for IRB review and approval, the need for revisions or clarifications to protocols, or the coordination of multiple IRB reviews for collaborative research
• While some delays are necessary to ensure the protection of human subjects, excessive or unwarranted delays can impede the timely conduct of important research and potentially delay the development of new knowledge or interventions

International research and IRBs

• The conduct of research in international settings presents additional challenges and considerations for IRBs in ensuring the protection of human subjects and adherence to ethical standards
• These challenges may include navigating cultural differences, ensuring appropriate informed consent processes, and collaborating with foreign institutions and IRBs

Cultural considerations in human subjects protection

• When reviewing research conducted in international settings, IRBs must be sensitive to cultural differences that may impact the interpretation and application of ethical principles and regulations
• This may include differences in social norms, power dynamics, or attitudes towards research participation that could influence the voluntary nature of informed consent or the perception of risks and benefits
• IRBs should work with local collaborators and community representatives to ensure that research procedures are culturally appropriate and respectful of local customs and values

Collaborations with foreign institutions

• International research often involves collaborations between U.S. institutions and foreign institutions, requiring coordination and communication between their respective IRBs
• These collaborations may involve different regulatory requirements, ethical standards, or institutional policies that need to be reconciled to ensure consistent protection of human subjects
• IRBs should establish clear agreements and lines of communication with foreign collaborators to facilitate the review and oversight of international research and to address any issues or concerns that may arise

Navigating multiple IRB approvals

• When conducting research at multiple international sites, investigators may need to obtain IRB approval from each participating institution, which can be a complex and time-consuming process
• Differences in IRB policies, review timelines, and regulatory requirements across institutions can lead to delays or inconsistencies in the approval and oversight of research
• Researchers and IRBs should work together to streamline the review process, harmonize policies and procedures when possible, and establish clear roles and responsibilities for ongoing oversight and communication throughout the study