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 expected for an IRB review are the following:
IRB Application Form: either 2017-05-16 WCS IRB_ExemptionApplication_Form.docx or 2021-11-09 WCS IRB_Expedited-FullReviewApplicationForm.docx. Read the 2020-06-01 WCS IRB Procedures.pdf to check whether your study qualifies for exemption.
Research Summary
Survey/research tool, including the Informed Consent Procedure
Proof of completion of ethics training:
For people listed in the management team of your IRB application form, this means the CITI certificate of course completion. Instructions on how to access the CITI training are available below.
For surveyors, they should go through the WCS Minimum Standards training (must be administered by someone who has completed CITI training). We will need the name of people completing the training, completion date and the name of the person who administered the training. The power point is here, and the training confirmation form here.
CV of the people in charge of the study
WCS IRB Conflict of Interest Disclosure Form
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:
Minimal Risk: The research does not pose greater than minimal risk to participants
No Identifiable Information: You will not be collecting information that allows participants to be identified either directly or through identifiers linked to the subjects (such as GPS coordinates of their residence)
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:
Provides financial or logistical support for research involving human subjects
Has staff involved in data collection, analysis, or supervision
Will be using the data from the research
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:
Internal Use Only: Research conducted exclusively for internal organizational purposes (program planning, effectiveness assessment) may not require IRB review if it does not contribute to generalizable knowledge
External Dissemination: Research becomes subject to IRB review when results will be shared externally through:
Professional meetings or conferences
Reports to government agencies or donors
Journal articles or publications
Any other form of public or professional dissemination
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:
Holistic Assessment: IRBs cannot review individual components (such as questionnaires) in isolation; they must evaluate the entire research project
Team Qualifications: Verification that all research team members have completed required ethics training
Consent Procedures: Review of how informed consent will be obtained and documented
Participant Protection: Assessment of whether the study population includes vulnerable participants who may face different or heightened risks
Most WCS research involving human subjects requires some form of IRB review, but the level of review may vary:
Expedited Review: Research that poses minimal risk to participants (no greater than those encountered in daily life) may qualify for expedited review
Special Considerations: Certain research topics, such as gathering information about illegal activities, may require additional scrutiny and potentially full board review
Risk Evaluation: IRBs assess whether research creates risks beyond those participants face in their normal daily activities
Address the following questions in your research protocol:
Who owns the collected information?
Who bears legal responsibility for data security?
What will happen to the data after the research is completed?
How will data be stored and protected during the research period?
When research involves participants who may face involuntary displacement, resource access changes, or other vulnerabilities:
Clearly identify whether your research findings will be used in ways that could directly impact participants
Consider relevant international safeguard standards that may apply
Ensure participants understand how their information may be used and any potential implications
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:
Providing specific information about the study to subjects in a way that is understandable to them.
Answering questions to ensure that subjects understand the research and their role in it.
Giving subjects sufficient time to consider their decisions.
Obtaining the voluntary agreement of subjects to take part in the study. The agreement is only to enter the study, as subjects may withdraw at any time, decline to answer specific questions, or complete specific tasks at any time during the research.
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.
Obtain collective consent from relevant organizations or community leaders first
Clearly communicate to individual participants that they retain the right to decline participation, regardless of organizational authorization
Avoid creating ambiguity about whether documentation requirements apply to individual participants when collective consent has been obtained
Consider whether name collection is necessary and appropriate for your research context
Develop informed consent procedures appropriate to each group's specific situation and needs
Consider that some categories of participants may require or prefer documented consent for their own records
Tailor consent language and procedures to be culturally and professionally appropriate for each group
Use specialized consent forms that address the unique confidentiality limitations of group settings
Clearly explain that while researchers will maintain confidentiality, they cannot control what other participants share outside the group
Remind participants to exercise their own judgment about what information they choose to share
Clearly specify in your methodology which situations qualify for exemption from documented consent
Ensure consistency between your exemption requests and actual consent procedures
Address any apparent contradictions in your consent documentation approach
Flexibility: Adapt consent procedures to fit the cultural, legal, and practical context of your research
Transparency: Clearly communicate the purpose, risks, and benefits of participation
Voluntary Participation: Ensure all participants understand their right to decline or withdraw
Appropriate Documentation: Match your documentation approach to the sensitivity of the research and needs of participants
Ongoing Communication: Remain available to address participant questions or concerns throughout the research process
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.
Federal Registration: Both institutions must have U.S. federally registered IRBs
Formal Agreement: A written reliance agreement must be established between the institutions
Equivalent Standards: The reviewing IRB must apply standards that meet federal requirements
Scenario: Collaborative International Research - When planning collaborative research with international partners:
Check Registration Status: Determine whether the partner institution has a U.S. federally registered IRB
Most U.S.-based universities and research institutions have federally registered IRBs
Some international institutions with significant U.S. research funding may also be registered
Registration status should be verified rather than assumed
If Partner Has Federal Registration:
A reliance agreement can be established
Only one IRB review is required (either institution can serve as the reviewing IRB)
Both institutions can comply with their respective requirements through the single review
If Partner Lacks Federal Registration:
Both institutions must conduct separate ethics reviews
Each institution must comply with its own oversight requirements
Dual review ensures compliance with both domestic and international standards
This situation commonly occurs with government review processes and international partner institutions that may have rigorous but non-federally registered review systems
Early Coordination: Discuss IRB requirements and potential reliance agreements during project planning stages
Documentation: Maintain clear records of which IRB is conducting the review and any reliance agreements in place
Communication: Ensure all team members understand which IRB has primary review authority
Efficiency: Eliminates duplicate review processes
Consistency: Ensures uniform ethical standards across collaborative projects
Resource Optimization: Reduces administrative burden on research teams
Timeline Management: Can significantly reduce time from project conception to implementation
Federally registered IRBs apply regulations that constitute minimum standards for ethical research
These standards may not address all relevant considerations for diverse international research settings
Organizations may choose to apply additional or more rigorous standards where appropriate
For example, research with Indigenous peoples may require documentation of collective consent processes based on Indigenous decision-making procedures, which exceeds basic federal requirements
Many countries have their own government processes for reviewing and approving human subjects research
Partner institutions may have rigorous ethics review processes that are not federally registered
The absence of international standardization means that multiple reviews may be necessary even when partner review processes are robust and effective
Verify Registration: Always confirm the federal registration status of potential partner IRBs
Plan Early: Address IRB requirements and potential reliance agreements during project development
Document Agreements: Maintain clear documentation of any reliance agreements or dual review arrangements
Communicate Clearly: Ensure all stakeholders understand the review process and requirements
Allow Adequate Time: Factor IRB review timelines into project schedules, whether single or dual review
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:
Clear Description: A detailed statement of what you changed
Justification: An explanation of why the change was necessary
Updated Documentation: New versions of any modified research instruments or materials
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.
Click on the following link: https://www.citiprogram.org/index.cfm?pageID=154&icat=0&ac=0®ion=10&message=0
Choose the “Select your organization affiliation” button
Write "Wildlife Conservation Society"
Check the box for the terms and conditions and the one to affirm you are with WCS
Click on "Create a CITI Program account".
Fill in the requested information, make sure to use your WCS email address.
Once you have completed registration, find the course entitled "Human Subject Research (HSR) - Social & Behavioral Research".
Federal regulations require that anyone involved in human subjects research complete appropriate ethics training. This includes:
Individuals who directly collect data from human subjects
Those who supervise data collection activities
Research team leaders and coordinators
Many organizations, including WCS, subscribe to CITI (Collaborative Institutional Training Initiative) online training, which allows:
Staff with institutional email addresses to register and complete training at no cost
Access to comprehensive, standardized ethics training modules
Certification that meets federal regulatory requirements
For consultants, partner organization staff, or others without institutional access:
Independent learner registration is available (typically around $129 USD)
Organizations may choose to reimburse this cost for project personnel
Training content and certification are equivalent to institutional access
New users can find registration guidance at support resources provided by CITI here: https://support.citiprogram.org/s/article/updated-guide-to-getting-started
Training modules are tailored to different types of research (social/behavioral, biomedical, etc.)
Completion certificates are valid for a specified period (typically 3 years)
When completing full CITI training is not practical:
A condensed "minimum standards" training may be acceptable
Typically used for field assistants, enumerators, and data collectors
Must be administered by someone who has completed full CITI training
Can be translated into local languages and adapted to local conditions
Covers essential ethical principles and practical considerations
Training completed through other accredited institutions may be accepted
Must be documented and completed within the required timeframe (typically within 3 years)
Should cover equivalent content to CITI requirements
Requires review and approval by the relevant IRB or ethics board
Before beginning research activities:
Review all team members who will be involved in human subjects research
Identify who needs full CITI training versus minimum standards training
Plan training completion well in advance to avoid project delays
Consider language and accessibility needs for international team members
Full CITI Training Required:
Principal investigators and co-investigators
Research coordinators and supervisors
Anyone with leadership responsibilities in data collection
Minimum Standards Training May Be Sufficient:
Field assistants and enumerators
Interview assistants
Data entry personnel (when not involved in direct data collection)
Plan Early: Ethics training requirements can become a bottleneck if not addressed in advance
Budget Appropriately: Include training costs in project budgets, especially for independent learners
Document Completion: Maintain records of all training certificates and completion dates
Regular Updates: Monitor certification expiration dates and plan for renewal training
Local Adaptation: When using minimum standards training, adapt materials to reflect local cultural contexts and conditions
Different institutions and funding sources may have varying training requirements
Some projects may require additional specialized training beyond basic CITI modules
International research may need to comply with both local and home country requirements
Documentation of training completion is typically required for IRB/ethics board review
Remember that ethics training is not just a regulatory requirement but an essential foundation for conducting responsible and ethical research with human participants.