Division of Research
HRPP/IRB Policies and Guidance
HRPP Toolkit
The Human Research Protection Program (HRPP) Toolkit is a centralized resource for investigators, research staff, IRB members, and institutional partners involved in human subjects research. It includes key forms, templates, standard operating procedures (SOPs), worksheets, and checklists to support the work of the HRPP, IRB staff, and the broader research community.
IRB Position Statements
From time to time, the IRB considers questions regarding the protection of human subjects research participants that are not addressed in federal regulation or institutional policy. When a particular question arises repeatedly, a subcommittee of the IRB may consider the question and develop a position statement for IRB review, which will be voted on and adopted at a convened meeting of the board. These position statements are intended to assist investigators with developing research protocols for IRB review that will satisfy the expectations of the board.
Adopted position statements will be reviewed as needed to address changes in risk determinations, University policy or federal regulations for human subjects research.
Human Subjects Research Guidance
Research Involving Special Populations
When reviewing human subjects research involving prisoners, federal law requires that the Institutional Review Board (IRB) include a prisoner or prisoner representative with the appropriate background and experience to represent the participant population and be knowledgeable about the vulnerabilities of prisoners, and how they may be subject to coercion or undue influence.
Brown Institutional Review Board (IRB) requires researchers to obtain assent from all children participating in research unless a clear justification of waiver or alteration of assent is provided and approved.
Study Procedures and Ongoing Research Considerations
Recruitment is often the first contact between potential participants and a research study. Because recruitment can shape who volunteers and what they understand about the study, all recruitment strategies must protect participants, promote equitable subject selection, and support informed decision-making.
Compensating research participants is a way to thank them for contributing their time and recognize their willingness to take on some of the research-related risks of study activities. As compensation is an expression of gratitude by researchers for their participants, it is not a benefit of participation, and it must be fair and equitable. However, offering compensation is not required or expected.
When seeking consent from participants in research, researchers must include in the document essential elements of informed consent as described in federal regulations or request an appropriate waiver. The Human Research Protection Program (HRPP) provides templates and guidance to support researchers in developing consent forms for different study populations and study procedures.
One of the regulatory criteria for approval is that research provides adequate provisions for monitoring data to ensure the safety of participants and research integrity.
Brown provides guidance to assist the research community with understanding the relationship between research and protected health information (PHI) that is covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA).
The Human Research Protection Program (HRPP) is committed to ensuring the ethical and compliant conduct of research involving human participants. As part of that commitment, all research personnel who are engaged in human subjects research are required to have appropriate education and training to protect participants in research.
As a researcher, you are responsible for protecting the rights and safety of participants—not just during study design and recruitment, but throughout the life of your research. One critical part of this responsibility is reporting Reportable New Information (RNI) to the IRB in a timely and complete manner.
A Certificate of Confidentiality (CoC) helps minimize risks to research participants, adds an extra level of protection for maintaining the confidentiality of private information and protects investigators and Brown University from being compelled to disclose information that could identify research participants.
Special responsibilities are required of researchers who intend to provide participants with misleading information about research or deliberately withhold information from them. This guidance lays out these responsibilities and expectations, and the considerations required of the IRB when reviewing research requesting to use deception or incomplete disclosures.
The HRPP and the IRB provide careful review of research protocols to ensure compliance with federal and state regulations and Brown policies regarding the ethical conduct of biomedical or social/behavioral research.In some situations, allowances can be made to alter or omit elements of requirements provided certain criteria have been met and processes are in place for participant protection.
Special Types of Research
Along with review by the Institutional Review Board (IRB), research studies involving human subjects may require review by other departments or committees at Brown before research activities can begin. You may contact the applicable departments or committees to start these ancillary reviews before, during or after your submission to the IRB.
All Brown University investigators conducting a clinical trial are required to comply with the consent form posting requirements included in federal regulations. The Human Research Protection Program (HRPP) team is responsible for general oversight and support of ClinicalTrials.gov registration and enforcement of Brown’s statement of compliance.
The Human Research Protection Program (HRPP) provides guidance to principal investigators (PIs) and licensed practitioners responsible for the medication management component of Brown University research studies with human subjects that include the use of prescription drugs for investigational purposes.
Additional Resources
Part of Research Integrity and reporting to the Senior Director, Brown’s Quality Assurance / Quality Improvement (QA/QI) Program focuses on supporting human subjects research and animal research at Brown.
Additional Research Topics
Search for a variety of forms, templates, and other research topics that apply to your project.