Human Research Protections at Brown | Does my Project need IRB Review? | Study Procedures & Ongoing Research Considerations | Research Involving Special Populations | Special Types of Research | IRB Operations | IRB Position Statements
IRB Guidance & Policies
Brown's IRB and HRPP have established guidance and policies to facilitate human subjects research activities conducted under the auspices of the University. Currently the Brown HRPP is converting its comprehensive Policies and Procedures Manual into individual, stand-alone policies, for the ease of access to topic-specific information for our research community. While this is in process, the Policies and Procedures Manual will co-exist with the below individual policies; the below policies will take precedence over any information that may inadvertently appear in the Manual and below. Thank you for your patience as we continue this conversion process.
Do you have feedback on an IRB-approved policy that you would like the Board to consider or recommendations for a new policy, guidance document or SOP? Please contact us to let us know.
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 Research Protections at Brown University
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Guidance
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WHEN TO REFERENCE
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RELATED POLICIES
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This policy describes who is eligible to serve as a Principal Investigator on a Brown University research study. Included in the policy are Advisor qualifications and processes for requesting exceptions.
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Process and responsibilities for reporting and reviewing events that meet reporting criteria and occur in the context of a human subjects research study approved by the Brown IRB or HRPP.
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**UPDATED**
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Training required in order to remain current and/or to receive an exempt determination or approval for new applications, amendments, and continuing review of human subjects research.
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The goal of this program is to promote a culture of integrity and excellence at Brown related to human subjects research, and to provide exceptional support and services to our research community in the form of education and outreach.
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This Guidance provides information to assist the Brown research community with understanding the relationship between PHI that is covered by HIPAA and research. This includes describing various ways in which PHI may be obtained and used for research purposes and the compliance obligations of the Brown research community related to the use of PHI in research.
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Study Procedures and ongoing research considerations
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Guidance
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WHEN TO REFERENCE
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RELATED POLICIES
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HRPP has a One Application Policy in accordance with Title 45 CFR 46.115 (Health and Human Services, IRB Records) and Title 21 CFR 56.115 (Food and Drug Administration, IRB Records). All new initial studies (Exempt/Expedited/Full Board) reviewed by the HRPP/IRB after May 1, 2022 will receive stamped IRB Approved Documents upon approval, which must be submitted for all future amendments and progress reports in order to maintain a single, active application that incorporates all IRB-approved amendments.
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The IRB will review and determine that the amount is reasonable and not so large as to unduly induce participation. All information concerning payment, including the amount and schedule of payment should be clearly stated in the application and reflected in the consent documents.
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Information as it relates to the recruitment process in order to prevent coercion and undue influence when recruiting participants.
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Criteria required to ensure research provides adequate provisions for monitoring data to ensure safety of participants and research integrity.
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Research Involving special populations
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Guidance
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WHEN TO REFERENCE
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RELATED POLICIES
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When conducting research with participants who may interact with the justice system.
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When you propose to involve minor children in your research.
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When your study may involve assessing decisional capacity in prospective adult participants in human research applications that are greater than minimal risk and to establish who may serve as an LAR for research purposes.
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Expectations and responsibilities of researchers when conducting human subjects research that targets individuals with whom they have a known interpersonal relationship (i.e., students, employees, friends, family, colleagues, patients, etc.).
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special types of research
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Guidance
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WHEN TO REFERENCE
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RELATED POLICIES
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For use when research activities require review from a department outside of the IRB.
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Guidance on Certificates of Confidentiality, which helps protect participants in studies collecting or using identifiable, sensitive information.
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For use when a study meets the federal definition of a clinical trial.
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Guidance for minimal risk studies that provide participants with misleading information about the research (deception) or withhold information from participants about the purpose of the study (incomplete disclosure).
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When study procedures include administering prescription medications to study participants.
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For use in activities involving identifiable information if personal data is being collected from research participants physically located in the EEA at the time of data collection.
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**NEW**
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For use when protocols with multiple sub-studies (PMSS) are eligible as a single protocol submission, including details on submission requirements, and PI and sub-study lead investigator responsibilities.
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IRB Operations
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Guidance
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WHEN TO REFERENCE
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RELATED POLICIES
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IRB members and consultants to the IRB should reference this Policy when determining their obligations when they have a potential conflict of interest being review by the Board.
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Possible determinations for Full Board review of human subjects research.
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Appointed members of and consultants to the IRB should reference this Policy to understand the authority, roles, and responsibilities of Brown IRB service.
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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.
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Position Statement
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background
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Relevant dates
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For use with research protocols in which the investigator proposes to conduct pregnancy testing of children. Such testing may be intended to protect the health and well-being of the child participant, the health of a fetus, and/or the integrity of the research.
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Adoption: September 17, 2020
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*NEW*
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For use in all study materials, including recruitment material, consent documents, and surveys. This requirement is consistent with The Belmont Report’s principles of Respect for Persons, Beneficence, and Justice, which are the pillars of the human subjects protection regulations.
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Adoption: April 15, 2021
Revised: October 21, 2021
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