The procedures and forms related to the IRB are available in the Sharepoint of WCS, here: IRB Documents. Applications should be sent to wcsirb@wcs.org. The documents to be submitted to the IRB are the following:
*Understanding Expedited vs. Exempt IRB Review
Expedited Review : Most human subjects research in WCS qualifies for expedited review, which means that the research does not pose greater than minimal risk to participants.
Exempt Review : Some WCS research qualifies for exemption from IRB review. To qualify for exemption, research must meet two criteria:
Important Note About "Exempt" Review : The term "exempt" can be misleading because the IRB still has to review the research to determine that it qualifies for exemption. This means that applying for an exemption does not require appreciably less work than applying for expedited review.
Organizational Responsibility Triggers - Under federal regulations, IRB review is required when WCS:
Important Note: When any of these conditions apply, WCS bears the same level of responsibility as if they were conducting all aspects of the research themselves, regardless of whether the research is conducted by their own staff, consultants, or people employed by partner institutions. This includes ensuring that all team members (including partners) complete ethics training, disclose conflicts of interest, and comply with ethical standards.
Research Purpose and Dissemination - The intended use and dissemination of research results also determines IRB requirements:
When in Doubt: If there is uncertainty about whether research contributes to generalizable knowledge or requires IRB review, the prudent approach is to submit it for review.
Institutional Review Boards (IRBs) are required under federal regulations to review research projects as complete entities. Key aspects of this comprehensive review include:
Most WCS research involving human subjects requires some form of IRB review, but the level of review may vary:
Address the following questions in your research protocol:
When research involves participants who may face involuntary displacement, resource access changes, or other vulnerabilities:
Informed consent is a process that begins with the recruitment and screening of a subject and continues throughout the subject's involvement in the research. It includes:
When conducting research involving human participants, obtaining proper consent is essential for ethical research practice. While written signatures are not always required, researchers must ensure that all participants provide informed consent appropriate to their circumstances and the nature of the research.
When working with indigenous, communal, or other organized groups:
When your research involves different types of participants (e.g., community members, government officials, NGO representatives):
For group research activities:
Remember that obtaining meaningful consent is an ongoing process, not just a one-time documentation requirement. The goal is to ensure participants can make informed decisions about their involvement in your research.
Reliance agreements are formal arrangements between two federally registered IRBs that allow one IRB to rely on the review conducted by another, eliminating the need for duplicate reviews of the same research project.
Requirements for Reliance Agreements:
When Reliance Agreements Apply:
Scenario: Collaborative International Research When planning collaborative research with international partners:
Minimum vs. Additional Standards
International Context Considerations
Remember that IRB review is designed to protect research participants and ensure ethical conduct of research. Whether through reliance agreements or dual review processes, the goal is to maintain high ethical standards while facilitating valuable research collaborations.
When you need to modify an approved research protocol, submit a change request that includes:
Best Practice: Submit change requests before implementing modifications rather than after making changes.
Why This Matters: If proposed changes increase the level of risk for participants, the IRB may need to nullify its original approval. Submitting requests in advance eliminates this possibility and ensures continuous compliance with ethical standards.
While most changes to approved protocols are unlikely to result in approval withdrawal, following proper procedures protects both researchers and participants by ensuring all modifications receive appropriate ethical review before implementation.
Federal regulations require that anyone involved in human subjects research complete appropriate ethics training. This includes:
Many organizations, including WCS, subscribe to CITI (Collaborative Institutional Training Initiative) online training, which allows:
For consultants, partner organization staff, or others without institutional access:
When completing full CITI training is not practical:
Before beginning research activities:
Remember that ethics training is not just a regulatory requirement but an essential foundation for conducting responsible and ethical research with human participants.