How do I submit an application to the IRB? 

WCS Procedures for Ethical Review of Research with People

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: 

1. 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*.
2. Research Summary
3. Survey/research tool, including the Informed Consent Procedure
4. 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.
5. CV of the people in charge of the study
6. WCS IRB Conflict of Interest Disclosure Form

*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:

1. Minimal Risk: The research does not pose greater than minimal risk to participants
2. 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.

 

Is IRB Review needed?

When IRB Review is Required

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.

 

What does the IRB review entail? 

 

Comprehensive Project 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

Risk Assessment and Review Types

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

Data Ownership and Security

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?

Vulnerable Populations

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

What is Consent?

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.

How do I obtain consent

 

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.

Community-Based Research

When working with indigenous, communal, or other organized groups:

• 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

Multiple Participant Categories

When your research involves different types of participants (e.g., community members, government officials, NGO representatives):

• 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

Focus Groups and Group Settings

For group research activities:

• 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

Signature requirement

• You may request a waiver to document consent
• 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

Best Practices

1. Flexibility: Adapt consent procedures to fit the cultural, legal, and practical context of your research
2. Transparency: Clearly communicate the purpose, risks, and benefits of participation
3. Voluntary Participation: Ensure all participants understand their right to decline or withdraw
4. Appropriate Documentation: Match your documentation approach to the sensitivity of the research and needs of participants
5. 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.

 

Can I use a review by another organization instead of WCS’ IRB? 

 

Reliance Agreements

 

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:

• 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

When Reliance Agreements Apply:

Scenario: Collaborative International Research When planning collaborative research with international partners:

1. 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
2. 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
3. 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

 

Planning for Reliance Agreements

• 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

Benefits of Reliance Agreements

• 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

Understanding Regulatory Standards

Minimum vs. Additional Standards

• 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

International Context Considerations

• 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

Key Recommendations

1. Verify Registration: Always confirm the federal registration status of potential partner IRBs
2. Plan Early: Address IRB requirements and potential reliance agreements during project development
3. Document Agreements: Maintain clear documentation of any reliance agreements or dual review arrangements
4. Communicate Clearly: Ensure all stakeholders understand the review process and requirements
5. 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.

 

I have an IRB, but my research plan is changing, what do I do?

 

Submitting Change Requests

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

Timing of Change Requests

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.

Process Considerations

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.

 

How do I take the required training? 

Guidelines for online CITI training

1. Click on the following link: https://www.citiprogram.org/index.cfm?pageID=154&icat=0&ac=0&region=10&message=0 
2. Choose the “Select your organization affiliation” button
3. Write "Wildlife Conservation Society" 
4. Check the box for the terms and conditions and the one to affirm you are with WCS
5. Click on "Create a CITI Program account".
6. Fill in the requested information, make sure to use your WCS email address.
7. Once you have completed registration, find the course entitled "Human Subject Research (HSR) - Social & Behavioral Research". 

When is the CITI training required

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

CITI Training Options

Institutional Access

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

Independent Learner Registration

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

Getting Started with CITI

• 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)

Alternative Training Options

Minimum Standards Training

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

Existing Training Recognition

• 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

Planning Considerations

Team Assessment

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

Training Categories by Role

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)

Implementation Tips

1. Plan Early: Ethics training requirements can become a bottleneck if not addressed in advance
2. Budget Appropriately: Include training costs in project budgets, especially for independent learners
3. Document Completion: Maintain records of all training certificates and completion dates
4. Regular Updates: Monitor certification expiration dates and plan for renewal training
5. Local Adaptation: When using minimum standards training, adapt materials to reflect local cultural contexts and conditions

 

Compliance Notes

• 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.