1. Scientific Merit and Rigor:
* Clear Research Question and Hypothesis: The study needs a well-defined research question and testable hypotheses. The methodology should be appropriate for addressing the question.
* Sound Methodology: The research design, data collection methods, and analysis plan must be scientifically sound and rigorous. This includes considerations of sample size, statistical power, and potential biases.
* Feasibility: The study must be realistically achievable within the proposed timeframe and resources.
2. Ethical Considerations (This is the most crucial aspect):
* Respect for Persons: This includes:
* Informed Consent: Participants must be fully informed about the study's purpose, procedures, risks, benefits, and their right to withdraw at any time without penalty. Consent must be voluntary and obtained using appropriate methods (written, verbal, etc., depending on the population and context).
* Autonomy: Participants have the right to make their own decisions about participating. Vulnerable populations (children, pregnant women, prisoners, individuals with cognitive impairments) require special protections and often need assent from a guardian or legal representative in addition to their own agreement.
* Privacy and Confidentiality: Researchers must protect the identity and sensitive information of participants. Data should be anonymized or de-identified whenever possible.
* Beneficence: The study must maximize benefits and minimize risks to participants. This requires a careful assessment of potential harms (physical, psychological, social, economic) and a plan to mitigate them. The potential benefits of the research should outweigh the risks.
* Justice: The selection of participants should be equitable and fair. Researchers should avoid exploiting or unduly burdening particular groups. The benefits and burdens of the research should be distributed fairly across different populations.
3. Compliance with Regulations and Guidelines:
* Adherence to relevant laws and regulations: The study must comply with all applicable federal, state, and local laws and regulations regarding human subjects research (e.g., HIPAA in the US, GDPR in Europe).
* Compliance with institutional policies: The study must adhere to the specific policies and procedures of the institution conducting the research.
4. Data Safety and Security:
* Data storage and security: Researchers must have a plan for securely storing and protecting participant data from unauthorized access or breaches.
* Data management: The IRB will assess the plan for data collection, storage, and disposal.
5. Conflict of Interest: Researchers must disclose any potential conflicts of interest that could influence the conduct or results of the study.
If a study fails to meet these criteria, the IRB may require revisions before approving it, or may reject the proposal altogether. The IRB's role is to protect the rights and welfare of human participants in research while ensuring that important scientific research can proceed ethically.