The Wildlife Conservation Society has an Institutional Review Board (IRB) that reviews research with people in which WCS is involved. The WCS IRB ensures that all social science research and conservation projects involving human participants meet ethical standards and safeguard the rights, dignity, and welfare of participants. The committee reviews research protocols to assess informed consent procedures, data protection measures, potential risks to participants, and compliance with local and international ethical guidelines. Researchers submit their protocols through a formal review process, and the IRB provides feedback and recommendations to strengthen the ethical framework of the research. All principal investigators and management team members are required to complete ethics training, while field staff must complete minimum standards training. The IRB operates transparently with clearly defined procedures and maintains records that undergo regular institutional audits to ensure ongoing compliance with ethical research standards.

Research is defined as the systematic collection of data from human subjects that will be used to generate generalizable knowledge. Understanding this definition is key to determining whether IRB review is needed.

Key Components:

1. Systematic Collection: Regular, structured data gathering using consistent methods (surveys, interviews, observations) rather than occasional, informal conversations

2. Human Subjects: Information collected directly from living individuals about themselves

3. Generalizable Knowledge: Results intended to be shared beyond internal use, including:

   • Publications in journals or books

   • Presentations at conferences or professional meetings

   • Reports to external stakeholders (government agencies, donors)

   • Contributions to broader understanding that could inform practice or policy beyond your specific project

Secondary Data Exception: If you are analyzing data that someone else collected and the dataset contains no identifiers that could link back to individual participants, IRB review is typically not required for your analysis.

Project evaluations (6-month reports, annual reports, final reports) require IRB review when they involve systematic data collection from human subjects:

• Evaluations collecting perceptions, opinions, or experiences from community members

• Socioeconomic surveys to design projects (e.g., alternative livelihoods assessments)

• Baseline or endline surveys with project beneficiaries

• Any evaluation whose findings will be shared externally or contribute to generalizable knowledge

May Not Require Review:

• Internal monitoring tracking only project outputs (number of trainings held, materials distributed)

• Pre-post surveys to evaluate an internal training in which the data will not be used outside of WCS. 

• Analysis of existing administrative records without new data collection from people

Once you've determined your activity qualifies as research, IRB review is required in the following circumstances:

1. WCS Organizational Involvement

IRB review is required when WCS:

• Provides financial support for the research

• Provides logistical support for the research

• Has staff involved in data collection, analysis, or supervision

• Will be using the data from the research

Important: When any of these conditions apply, WCS bears full responsibility for ethical compliance, regardless of whether the research is conducted by WCS staff, consultants, partner institutions, or subgrantees.

2. External Dissemination of Results

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

Internal Use Only Exception: Research conducted exclusively for internal organizational purposes (program planning, effectiveness assessment) that will never be shared externally or contribute to generalizable knowledge may not require IRB review. However, if there's any uncertainty, submit for review.

3. Working with Consultants, Subgrantees, and Partners

Consultants:

• If WCS hires a consultant to collect data, IRB review is required

• The consultant can submit the application, but should complete CITI training or receive minimum standards training from a CITI-certified WCS staff member

• All ethics requirements apply to consultants as they would to WCS staff

Subgrantees and Partner NGOs:

• If WCS provides funding to another organization for research involving human subjects, IRB review is required

• If WCS will use data collected by a subgrantee or partner, IRB review is required

• Partner organization staff must complete appropriate ethics training

• All team members, regardless of their employer, must meet WCS IRB requirements

Partner Universities and Research Institutions:

If the partner has a U.S. federally registered IRB:

• A reliance agreement can be established between WCS and the partner institution

• Only one IRB review is needed (either institution can serve as the reviewing IRB)

• WCS can accept their review in place of conducting our own

• A formal reliance agreement must be documented (see section below on Reliance Agreements)

If the partner does NOT have a U.S. federally registered IRB:

• The research should be submitted to WCS IRB for review

• The partner's ethics review remains valuable and should still be conducted

• Both reviews may be required to ensure compliance with all applicable standards

• This is common with international university partners and government review processes

4. Journalism and Media Collaborations

Pure journalistic storytelling and documentary work have an exception from IRB review

When IRB Review IS Required:

• Content from media work will be used to generate generalizable knowledge (academic publications, research reports)

• WCS staff will systematically collect research data alongside or through the media project

• The project goes beyond storytelling to include structured research activities

When IRB Review IS NOT Required:

• Documentary or journalistic work intended solely for public awareness, education, or communication

• Traditional news reporting or storytelling

When in Doubt: If there is uncertainty about whether your activity qualifies as research or requires IRB review, contact wcsirb@wcs.org. It's always better to ask before starting data collection than to seek retroactive approval (which cannot be granted).

Publishing Reminder: A growing number of journals require evidence of IRB review before publication. Without prior IRB approval, your research may not be accepted for publication.

The WCS IRB cannot retroactively approve data collection or research protocols. 

Conducting research with human participants without prior IRB approval is a serious compliance issue with significant consequences:

• Publication barriers: Peer-reviewed journals typically will not publish research conducted without proper IRB approval

• Participant protection: Without IRB review, participants may be exposed to unnecessary risks, and their rights to informed consent, fair recruitment, and voluntary participation may be compromised

• Institutional liability: This creates potential legal and reputational risks for both the researcher and WCS

• Ethical standards: The WCS IRB exists to ensure that all research protects the rights, dignity, and welfare of participants

If the study is on-going, interaction with human participants must cease until the IRB has reviewed and approved all study procedures. In some cases, the IRB may require that investigators inform participants of the investigator’s lack of compliance with the IRB procedures, and solicit permission from the participants to use the data collected. 

The review time typically ranges from 5 business days to one month, depending on the complexity of your submission and whether all required documents are included. We strongly recommend planning for the full one-month review period and submitting your application as early as possible to avoid delays in your fieldwork.

To help expedite the review process:

• Ensure your submission is complete: Missing documents, signatures, dates, or unchecked boxes are common reasons for delays.
• Check for consistency: Forms, research summaries, and consent procedures should align.
• Provide detailed information on confidentiality measures and participant protection.
• Include consent procedures for each research method (e.g., interviews, surveys, focus groups). If working with Indigenous Peoples, explain how you will obtain collective consent and address data sovereignty.
• Review previously approved research as a reference to avoid common mistakes.

Typical review steps include:

1. Completeness check – Are all required materials provided, relevant forms signed and dated?
2. Detailed review – Includes methodology, informed consent, confidentiality provisions, investigator qualifications, and compliance with legal and cultural requirements.

Applications that are well-prepared and address IRB recommendations upfront move faster through the process.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

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: 

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:

   1. 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.

   2. 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

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.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

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.

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

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.

A grievance is any good faith complaint about an action or inaction that is reasonably believed to contribute to or cause harm, whether perceived or otherwise, to an individual, community, or other stakeholder. There are different types of grievances from low to high severity. An example of a high severity grievance is a human rights abuse or violation.

A grievance redress mechanism (GRM) is a transparent and unbiased system where credible grievances are tracked in a confidential, secure database across standardized procedural steps to assess, address, and mitigate or resolve concerns. A GRM enables Indigenous Peoples and Local Communities (IPs and LCs), WCS staff, project staff, and any other affected stakeholders, to submit grievances and seek resolution when they experience or perceive a negative impact arising as a result of an organization’s activities. It is a key way to mitigate, manage, and resolve potential or realized negative impacts, and to keep organizations and their staff accountable for their actions, inactions, or for the outcomes of their projects. A GRM is a social safeguards tool through which IPs and LCs can exercise their voice and claim their rights. 

More than a grievance tracking system, a GRM also facilitates two-way communication. It can be built into an organization’s overall communication strategy, providing an opportunity for trust-building and broader conflict resolution. 

The GRM applies to projects or activities undertaken or sponsored by WCS that are reasonably believed to contribute to or cause human rights abuses, safeguarding violations, or violation of the human rights of individuals or communities. The GRM can also handle all other types of complaints or suggestions as a process for ensuring open dialogue between WCS staff and any one affected by WCS activities or sponsored programs. 

The purpose of the GRM is to:

1. Provide a mechanism for affected individuals or communities, and others with knowledge of the circumstances, to raise good faith grievances about the impacts of projects or activities undertaken or sponsored by WCS; and

2. Provide a structure to ensure that human rights and safeguarding grievances are handled, responded to and documented in a fair and timely manner.

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

• 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

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

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.

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.

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". 

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

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)

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

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)

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

• 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.

The US Office of Human Rights Protection  offers a variety of free online trainings for the research community on human research protections based on the principles of the Belmont Report and the requirements of the revised Common Rule (or 2018 Requirements).

• Review the Educational Resources for Investigators [PDF, 112 KB]
• Take the free Human Research Protection Foundational Training (5 lessons)
• Take the free Participant-Centered Informed Consent Training (6 modules)

The US Office of Human Rights Protection offers a variety of free online trainings for the research community on human research protections based on the principles of the Belmont Report and the requirements of the revised Common Rule (or 2018 Requirements).

• Review the Training Checklist for Someone Working with IRBs [PDF, 226 KB]
• Take the free training on Considerations for Reviewing Human Subjects Research

When your research involves sensitive topics (illegal activities, stigmatized behaviors, controversial practices):

Special Techniques Available:

• Indirect questioning methods
• Randomized response techniques
• Aggregate reporting without individual attribution
• Anonymous data collection procedures

Additional Protections:

• Enhanced confidentiality measures
• Certificates of Confidentiality (when applicable)
• Careful consideration of data storage and security
• Clear protocols for handling potentially incriminating information

IRB Review Considerations:

• Research involving sensitive behaviors may require full board review rather than expedited review
• Your protocol should clearly describe how you will protect participants from potential risks
• Include specific plans for maintaining confidentiality and managing any mandatory reporting obligations

Contact wcsirb@wcs.org early in your planning process for guidance on appropriate methodologies for sensitive research topics.