The IRB at Clark Atlanta University safeguards the confidentiality of research data and ensures the protection of human subjects in all research projects. We are committed to minimizing physical, psychological, social, and legal risks in both biomedical and behavioral research, promoting ethical standards and compliance throughout the research process.
The IRB is made up of a diverse group of members, including faculty, scientists, non-scientists, and community representatives. This mix ensures a broad perspective in reviewing research involving human subjects, promoting ethical standards and compliance with federal regulations.
IRB applications should be emailed to irb@cau.edu.
A complete IRB application should provide all the information needed to review your study for ethical compliance. This includes:
- Study details: Title, purpose, and objectives
- Research procedures: How the study will be conducted
- Participant information: Recruitment methods and eligibility criteria
- Informed consent documents: Clear, understandable consent and assent forms
- Risk and benefit analysis: Potential risks and steps to minimize them
- Confidentiality plan: How data will be protected
- Compliance documentation: Required training certifications and approvals
- Supporting materials Include Surveys, interview guides, recruitment flyers, and other relevant documents.
Mandatory Training for Researchers Using Human Subjects
All investigators conducting research with human subjects at Clark Atlanta University are required to complete mandatory training through the Collaborative Institutional Training Initiative (CITI) Program at www.citiprogram.org. This program replaces the previous NIH-sponsored training and provides modules tailored to different research roles.
Who Must Complete Training?
Training is required for:
- All key personnel involved in human subjects research (faculty, staff, assistants, and students)
- Faculty sponsors of student research
- IRB board members and administrative staff
- Graduate students conducting thesis or dissertation research
Exceptions:
Undergraduate students assisting with research or conducting course-related projects are exempt; their faculty instructor assumes responsibility.
Learner Groups at CAU
The following Learner Groups are available for CAU-affiliated researchers:
- Social & Behavioral Research – For studies involving surveys, interviews, focus groups, etc.
- Responsible Conduct of Research (RCR) - Core principles of ethical research: authorship, collaboration, conflicts of interest, data management, mentoring, peer review, use of human/animal subjects, and research misconduct.
- Biomedical Research – For studies involving physiology, medical interventions, or invasive procedures.
- Undergraduate Students – Introductory modules on research ethics.
- IRB Members & Staff – For IRB reviewers and administrative personnel.
IRB - Frequently Asked Questions
Navigating research compliance can feel complex, but we’re here to make it easier. This FAQ section answers the most common questions about the Institutional Review Board (IRB), including when IRB approval is required, how to apply, and what to expect during the review process. Whether you’re a faculty member, student researcher, or part of a collaborative team, these resources will help you conduct ethical research and stay compliant with federal and institutional guidelines.
What is the IRB and Why Is it Required?
The IRB ensures research involving human subjects is ethical and compliant with federal regulations. Its primary role is to protect participants’ rights and welfare.
Do I Need IRB Approval?
You need IRB approval if your project involves living individuals, identifiable private information, or systematic research intended to contribute to generalizable knowledge.
What is Research?
Research is a systematic investigation designed to develop or contribute to generalizable knowledge. This includes activities intended to test hypotheses, draw conclusions, or inform scholarly understanding. If your project involves collecting data to publish, present, or share broadly, it is likely to qualify as research under IRB guidelines.
What are Human Subjects?
A human subject is a living individual about whom an investigator (professional or student) conducting research obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens.
Intervention or interaction in human subjects research includes:
- Data through intervention or interaction (e.g., surveys, interviews, experiments), or
- Identifiable private information (e.g., medical records, personal identifiers).
If your study involves people directly or uses identifiable data, IRB review is required.
This does not include activities whose sole purpose is instructional, or activities whose purpose is related to routine course or program development. However, when such research involves students outside of the course, the investigator should submit the appropriate application.
What is a Systemic Investigation?
A systematic investigation refers to a structured process for collecting and analyzing data to answer a research question or test a hypothesis. This includes:
- Predefined methods and procedures
- Data collection and analysis plans
- Intent to contribute to generalizable knowledge
Examples include surveys and questionnaires, interviews and focus groups, the evaluation of educational and social programs, cognitive and perceptual experiments, clinical trials, behavioral studies, and educational assessments, etc.
Where can I find the IRB application?
Researchers can access the fillable IRB application using the link below. This form is intended for the submission of research protocols requiring IRB review and provides step-by-step guidance for completing all required sections. Investigators should download and complete the application in its entirety before submitting it along with any required supporting documents.
Is there a guidance manual for CAU IRB procedures?
The CAU IRB Guidance Manual serves as a comprehensive resource for researchers, faculty, staff, and students involved in human subjects research. It provides practical guidance on IRB policies, regulatory requirements, submission procedures, and ethical considerations to help ensure research is conducted responsibly and in compliance with applicable standards.
Please note that this version of the guidance manual is currently under review. Future edits and additions are expected.
Information for External Researchers
The Clark Atlanta University Institutional Review Board (CAU IRB) reviews research involving human participants that is sponsored by members of the University’s faculty, staff, or administration. Investigators affiliated with institutions other than Clark Atlanta University who wish to conduct research involving CAU students, faculty, staff, facilities, records, or other University resources must obtain sponsorship from a CAU faculty member before applying to the IRB.
To request IRB review, external investigators must:
- Identify and secure a CAU faculty sponsor before submitting an IRB application.
- Include documentation of the sponsor's endorsement with the IRB submission.
- Obtain the sponsor's signature on all required application materials.
- Submit all required study documentation in accordance with CAU IRB procedures.
Applications submitted without a CAU faculty sponsor will be considered incomplete and will not be reviewed by the IRB. No research activities involving Clark Atlanta University participants or resources may begin until all required approvals have been obtained.
The CAU faculty sponsor serves as the University's representative for the proposed research and is responsible for ensuring that the study is conducted in accordance with University policies, ethical standards, and applicable federal regulations. The sponsor also acts as the primary liaison between the external investigator and the IRB throughout the review and conduct of the study.
Sponsor Responsibilities -
- Reviewing and endorsing the research application before IRB submission;
- Ensuring that the proposed research is consistent with the University's mission, policies, and ethical standards;
- Facilitating communication between the external investigator and the IRB;
- Monitoring research activities conducted at Clark Atlanta University, as appropriate;
- Ensuring compliance with applicable University policies and federal regulations; and
- Promptly communicating any significant study changes, concerns, or compliance issues to the IRB.
External Investigator's Responsibilities -
- Complying with all CAU IRB requirements, institutional policies, and applicable federal regulations;
- Working collaboratively with the CAU faculty sponsor throughout the study;
- Obtaining all required approvals before initiating research activities; and
- Ensuring that all research activities are conducted in accordance with the approved protocol.
Student Research
Students enrolled at Clark Atlanta University, including both undergraduate and graduate students, are subject to the same IRB policies, procedures, and ethical standards that apply to faculty and staff engaged in human subjects research.
All research applications submitted by students must be reviewed and endorsed by a faculty or staff advisor who is knowledgeable about the proposed research and willing to oversee the conduct of the study. The faculty or staff sponsor assumes responsibility for providing appropriate guidance, ensuring compliance with applicable University policies and federal regulations, and overseeing the student's research activities.
The faculty or staff sponsor must review and sign the IRB application before submission. The sponsor's signature confirms support for the project and acknowledgment of their oversight responsibilities.
IRB applications submitted by students without the required faculty or staff sponsorship and signature will be considered incomplete and will not be reviewed by the IRB. No research activities involving human participants may begin until all required approvals have been obtained.
Submission of Applications
Any investigator proposing to conduct research involving human participants, regardless of whether the research is supported by a grant, contract, fellowship, or other source of funding, is responsible for submitting the project to the IRB for determination. At a minimum, investigators must apply for exemption or other appropriate review so that the IRB can determine whether the proposed activity constitutes human subjects research and whether IRB review or approval is required.
When a grant or contract proposal involves human subjects research, investigators should submit the IRB application sufficiently in advance of the sponsor's deadline to allow adequate time for IRB review and determination, if required.
All research involving more than minimal risk to participants must be reviewed and approved by the IRB before the initiation of any research activities. In addition, all doctoral dissertation research involving human participants and all research involving children must be submitted to the IRB for review and determination, regardless of the level of risk.
Investigators may not begin participant recruitment, informed consent activities, data collection, or any other research-related procedures involving human participants until they have received the appropriate written determination or approval from the IRB.
Approval, Continuing Review, and Renewal of Research
IRB approval is valid for a period of one (1) year from the date of approval, unless a different approval period is specified in the approval notification issued by the IRB Chair. Upon approval, investigators will receive an electronic notification that includes the study's IRB approval number and approval expiration date.
To ensure appropriate oversight of ongoing research activities, progress reports must be submitted every six (6) months for all approved studies, as required by the IRB.
Progress Reports and Continuing Oversight
To ensure appropriate oversight of ongoing research activities, investigators are required to submit a Progress Report every six (6) months for all IRB-approved studies, unless otherwise directed by the IRB. Progress reports enable the IRB to monitor study conduct, evaluate participant protections, assess any changes in risk, and ensure continued compliance with applicable regulations and institutional requirements.
Failure to submit a required progress report may result in administrative action, including suspension of study activities, withholding of continuing approval, or other actions deemed appropriate by the IRB.
Study Closure and Termination of Approval Report
When a research study is completed, terminated, suspended, or otherwise closed, the Principal Investigator (PI) must submit a Termination of Approval (Study Closure) Report to the IRB.
This report enables the IRB to document the final disposition of the study, verify that all research activities have concluded appropriately, and ensure that participant protections and regulatory obligations have been satisfied.
General Application Procedures
All research involving human participants must be submitted to the Institutional Review Board (IRB) for review and determination prior to the initiation of any research activities. Investigators are responsible for ensuring that all application materials are complete and submitted in accordance with IRB requirements and established deadlines.
Investigators must submit a complete IRB application package, which may include, as applicable:
- IRB Application Form;
- Informed Consent Form(s);
- Recruitment materials (e.g., advertisements, flyers, emails, social media postings);
- Data collection instruments (e.g., surveys, questionnaires, interview guides, focus group protocols);
- Letters of cooperation or site authorization;
- Research protocol or study description;
- Evidence of required CITI Human Subjects Protection Training;
Grant proposals or funding documentation, if applicable; - Evidence of approval of CAU Sponsorship (external applicants)
- Copies of Reliance Agreement and letter of approval (external applicants)
Any additional materials requested by the IRB. Incomplete applications may be returned to the investigator and will not be reviewed until all required documents have been received.
