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

Guidance WHEN TO REFERENCE RELATED POLICIES

PI Eligibility & Advisor Qualifications

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.

PI Eligibility Policy

 

This policy describes the process and requirements investigators must follow when reporting events that meet reporting criteria to Brown University's Human Research Protection Program (HRPP).

Reportable Events Policy

CITI Instructions

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.

Policy on Education in the Conduct of Human Subjects Research

Quality Assurance/Quality Improvement Program

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.

 

HIPAA Privacy Rule Guidance for Brown University Researchers

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.

 

 

Study Procedures and ongoing research considerations

Guidance WHEN TO REFERENCE RELATED POLICIES

Compensation

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.

 

Recruitment 

Information as it relates to the recruitment process in order to prevent coercion and undue influence when recruiting participants.

Policy on the Recruitment of Research Participants

Data and Safety Monitoring

Criteria required to ensure research provides adequate provisions for monitoring data to ensure safety of participants and research integrity.

 

 

Research Involving special populations

Guidance WHEN TO REFERENCE RELATED POLICIES

Prisoners in Research

As a vulnerable population, categories of research in which prisoners may participate.

 

Children in Research

When you propose to involve minor children in your research.

 

 

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. 

Policy for Determination of Decisional Capacity to Consent by Adult Persons for Human Subject Research

 

special types of research

Guidance WHEN TO REFERENCE RELATED POLICIES

Studies Involving Drugs and/or Devices

Guidance on human subjects research that involves the use of drugs and/or devices.

 

General Data Protection Regulations (GDPR) & Human Subjects

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. 

 

Management of Human Research Studies Involving Drugs and Medications

When study procedures include administering prescription medications to study participants.  

 

 

IRB Operations

Guidance WHEN TO REFERENCE RELATED POLICIES

 

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.

IRB Member and Consultant Conflict of Interest Policy

IRB Committee Action Options

Possible determinations for Full Board review of human subjects research.

 

IRB POSiTion statements

Position Statement background date of adoption

Pregnancy Testing and Results Reporting of Child Participants

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. 

September 17, 2020