Human Subjects Policies & Procedures

Medical Campus IRB

For the Medical Campus, please see BU Medical Campus IRB Guidance.

Charles River Campus IRB

The Institutional Review Board (IRB) is a committee of scientists/doctors and non-scientists whose charge is to oversee the safety and protection of human subjects in research based on those regulations and guidelines as they apply to individual research studies. Governmental regulations and institutional policies exist to protect the rights and welfare, including privacy/confidentiality rights, of all human research subjects.

Amendments/Modifications to Previously Approved Research

The purpose of this policy is to outline the procedure for review and approval of amendments/modifications to previously approved research.

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Certificate of Confidentiality

Certificates of Confidentiality (COCs) are issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure. They allow the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.

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Convened Meeting

The purpose of this policy is to outline the procedure for conducting reviews of human subjects research at a convened meeting (initial reviews, continuing reviews, and amendments).

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Continuing Review

The purpose of this policy is to outline the procedure for conducting continuing reviews of human subjects research.

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Device - (new)

The purpose of this policy is to outline the requirements for research with human subjects involving investigational devices, including Institutional Review Board (IRB) review and investigator responsibilities.

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Documentation of Informed Consent

The purpose of this policy is to outline the requirements for documenting informed consent for non-exempt research.

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Drugs - (new)

The purpose of this policy is to outline the requirements for research with human subjects involving investigational drugs, including Institutional Review Board (IRB) review and investigator responsibilities.

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Exception & Deviation Policy

The purpose of this policy is to outline the procedure for reporting and reviewing exceptions and deviations.

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Institutional Review Board (IRB) Policies and Procedures

The purpose of this policy is to outline the policies and procedures for drafting, reviewing, distributing, and revising IRB policies and procedures.

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IRB Composition and IRB Member Roles and Responsibilities

The purpose of this policy is to outline the composition of the IRB and to describe the roles and responsibilities of IRB members.

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IRB Recordkeeping

The purpose of this policy is to outline the policies and procedures for recordkeeping in the Charles River Campus (CRC) IRB.

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IRB Review of Human Subjects Research using Expedited Procedures

The purpose of this policy is to outline the procedure for conducting reviews of expedited human subjects research.

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IRB Review of Exempt Human Research

The purpose of this policy is to outline the procedure for conducting reviews of exempt human subjects research.

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Noncompliance in Human Subject Research

The purposes of this policy are to: 1) define noncompliance, 2) outline the procedure for reporting noncompliance to the IRB, and 3) describe the IRB actions.

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Recruitment and Advertising

The purpose of this policy is to describe the process for reviewing recruitment of research subjects (including advertisements) and to provide guidance on acceptable recruitment methods and advertisements.

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Reporting Incidents to Institutional Officials and Regulatory Agencies

The purpose of this policy is to outline the procedure for reporting: 1) unanticipated problems involving risks to subjects or others, 2) any serious or continuing noncompliance, or 3) any suspension or termination of IRB-approved human subjects research.

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Research Involving Human Subjects

The purpose of this policy is define activities that are subject to review and approval by the Charles River Campus (CRC) IRB.

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Reviewer Assignment

The purpose of this policy is to outline the procedure for assigning reviewers for studies that require review by the Institutional Review Board (IRB).

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Subject Payments - (new)

The purpose of this policy is to describe the process for reviewing payments to research subjects and to provide guidance on acceptable payment practices.

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Suspension or Termination of Research by the IRB

The purpose of this policy is to outline the procedure for suspending or terminating research approved by the IRB.

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Unanticipated Problems Involving Risks to Subject or Others & Adverse Events

The purpose of this policy is to outline the procedure for reporting and reviewing unanticipated problems involving risks to subjects or others and adverse events.

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Waiver or Alteration of Informed Consent

The purpose of this policy is to outline the requirements for waiving or altering informed consent.

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Federal Regulations & Guidance

The Federal Regulations links include the regulations that govern human subjects research. There are two separate sets of regulations: one from Health and Human Services and one from the FDA (which govern any research under the purview of FDA).

HHS Regulations
FDA Regulations
HHS and FDA Regulations Compared
NIH’s Office of Behavioral and Social Sciences Research
Certificate of Confidentiality Background