Responsible Research Protections
Human Subjects Protections
- Institutional Review Board (IRB) review – Obtain IRB approval prior to initiating research involving human subjects and adhere to approved protocols.
- Informed consent – Obtain and document informed consent that clearly explains the purpose, risks, benefits, and voluntary nature of participation.
- Privacy and confidentiality protections – Implement safeguards to protect participant privacy and maintain confidentiality of identifiable information.
- Data de-identification – De-identify data where appropriate and assess re-identification risks, especially when combining or sharing datasets.
- Protections for vulnerable populations – Apply additional safeguards for vulnerable populations (e.g., minors, economically disadvantaged groups) and justify their inclusion.
- Secondary use of data – Ensure secondary use of data complies with consent agreements, legal requirements, and ethical standards.
Indigenous Knowledge and Community-Engaged Research
- Respect for Tribal sovereignty – Recognize and respect Tribal sovereignty, governance structures, and decision-making authority.
- Prior and informed consent – Obtain free, prior, and informed consent from Indigenous communities before initiating research.
- Data sovereignty considerations – Ensure Indigenous communities retain appropriate control over their data and its use.
- Co-production of knowledge – Engage communities as partners in the research process, including design, interpretation, and dissemination.
- CARE Principles – Apply the CARE principles of Collective Benefit, Authority to Control, Responsibility, Ethics in data governance and research practices.
Animal Welfare
- Institutional Animal Care and Use Committees (IACUC) – Submit a detailed animal use protocol to the appropriate IACUC and obtain approval prior to acquiring animals or conducting animal research.
- Replacement, Reduction, Refinement – Justify use of animals and species selection and replace animals where possible, reduce the number used, and refine procedures to minimize pain, distress, and invasiveness.
- Study design and statistical justification – Provide scientific and statistical justification for animal numbers; design studies to yield valid, reproducible results.
- Humane treatment and endpoints – Monitor animals regularly for signs of pain or distress, use appropriate anesthesia, analgesia, and sedation. Define and implement humane endpoints to prevent unnecessary suffering.
- Transparent reporting of animal use – Accurately report animal use, methods, and welfare considerations in publications. Allow inspections, where applicable, and promptly report adverse events or non-compliance.
- Post-study animal care – Follow IACUC-approved plans for animal disposition, such as continued care, adoption or transfer, or humane euthanasia.
Questionable or Detrimental Research Practices (To avoid)
- Conducting human subjects research without Institutional Review Board (IRB) approval (including research involving only surveys), or deviating from approved protocols without authorizations.
- Using coercive practices, incomplete disclosures, or consent processes that participants cannot reasonably understand.
- Disclosing identifiable information about individuals without authorization or failing to secure sensitive data.
- Reusing data beyond the scope of original consent or without appropriate approvals.
- Treating Indigenous data as freely available without regard to community rights and interests.
- Avoiding available alternatives to animal research; using animals unnecessarily or failing to minimize harm.
References
- The Common Rule (45 CFR 46)
- U.S. Department of Health and Human Services, Office of Human Research Protections (OHRP) Guidance
- NOAA Guidance and Best Practices for Engaging and Including Indigenous Knowledge in Decision-Making
- UN Declaration on the Rights of Indigenous Peoples
- CARE Principles
- Animal Welfare Act, as amended
- NIH Animal Research Guidance
- NIH Guidance on Institutional Animal Care and Use Committees
Quick Links
NOAA Scientific Integrity Policy
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Guidance on Scientific and Professional Activities
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Annual NOAA Scientific Integrity Reports
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