Human Research Protection Program

IRB Governance and Operating Procedures​​​​​

Definition of Human-Subjects Research

Case Reports

​Stem Cell Research: ESCRO​

Considerations for International research

Principal Investigators and Delegation of Study-Related Tasks

Study Staff in Human Subject Research: Engagement and Responsibilities

• See also: QI Program Staff Signature/Delegation of Responsibility Log

• See also: Multi-Site Investigator-Initiated Collaborative Research​

Human-Subjects Protection Education and Training Requirements for Investigators and Study Staff

Recordkeeping and Record Retention Requirements​

​Electronic Storage of Research Documents

21 CFR11 Compliance Letter​

QI Program Study Checklists, Study Logs, Annotated Case Report Forms, Tools and Guidance Documents

PI Leave of Absence, Sabbatical, or Moving to Another Institution​​

PI Transfer Out (Research) for the Brigham

PI Trans​fer​​ Out (Research) for Mass General​

Institutional Conflicts of Interest

Individual ​Financial Co​nflic​ts of​ Interest

• See also: eCOI FAQs​
  

Bonus Payments in Clinical Trial Agreements​

Harvard Medical School Faculty Policy on Conflicts of Interest and Commitment

Mass General Brigham Code of Conduct, including Conflicts of Interest Policy (internal link)

IRB Member Conflicts of Interest​

Exempt Human-Subjects Research

Expedited Review (Initial, Continuing and Amendment)​

Full Board Convened Meeting Review (Initial, Continuing and Amendment)​

Continuing Review and Expiration of MGB IRB Approval and Expedited Check-In

• See also: QI Program, Study Close O​​​​ut Guidance

Proposed Changes in Approved Human-Subjects Research and Exceptions

Modifying and Existing Study vs Submitting a New Study​

Unanticipated Problems in Human-Subjects Research​

Reporting Events Guidance – When and How to Report to MGB

Other Event Reporting Worksheet

Noncompliance in Human-Subjects Research

Suspension or Termination of Human-Subjects Research​

Reporting to Institutional Officials and Regulatory Agencies

Requirements for Ancillary Committee Approval of Human-Subjects Research​

• See also: Human Research Committee (HRC) Webpage: Instructions & Forms for submission requirements
  

Reporting Unanticipated Problems

• See also: QI Program Adverse Events Tracking Log​

Questions, Concerns, or Complaints from Subjects or Family Members​

Reporting Unapproved Deviations in Human Subject Research

• See also: QI Program Minor Deviation/Violation Tracking Log

Requirement for Investigational New Drug (IND) for Human-Subject Research​

• See also: QI Program Drug Accountability Log

Emergency Use of an Investigational Drug or Biological Product, or Unapproved Medical Device​

• See also: 'Emergency Use of Drugs or Biologics' (guidance and instructions)

Research Involving Investigational Devices

Requirements for Investigational Device Exemption (IDE) for Human-Subjects Research

• See also: QI Program Device Accountability Log

Humanitarian Use Device (HUD): Responsibilities & Checklists​

Emergency Use of an Investigational Drug or Biological Product, or Unapproved Medical Device​

Guidance for Research, Testing, and Clinical Deployment of Medical Image-based Software

Review of Human Subject Research Involving Vulnerable Populations​: includes children, wards of the State, nonviable neonates and neonates of uncertain viability, and pregnant women and/or fetuses.

Research Involving Prisoners

Informed Consent of Research Subjects

Participant Re-Consent Requirements

Individuals Who Can Obtain Consent in Human Subject Research

• See also: Certificates of Confidentiality

• Se​e also: QI Program Informed Consent Compliance Checklist

Consent Form Reviewer Worksheet and Checklist

Fact/Information Sheet Outline and Examples

• Fact/Information Sheet Outline

• Sample Fact/Information Sheet (1)
  

• Sample Fact/Information Sheet (2)​

• Sample Fact/Information Sheet (3)​

Surrogate Consent (internal link only)

​Obtaining and Documenting Informed Consent of Non-English Speakers​

'Short Forms' for Non-English Speakers (Internal link only)

Translation Services & Resources

Exception from Informed Consent Requirements for Emergency Research

Recruitment of Research Subjects​

Authorization to Release Contact Information for Recruitment

FAQs: Recruitment in Human Subject Research

Guidelines for Advertisements for Research Subjects

MGB IRB-369205 Procedure: Request to Receive Unencrypted Email (internal link only)

Pre​-Screening of Research Subjects During Recruitment​

• See also: QI Program Pre-Screening Log

Remuneration for Research Subjects​

Bonus Payments in Clinical Trial Agreements

Payments to Subjects for Participation in Research​

Subject Payment Spreadsheet    

Data and Safety Monitoring Plans in Human-Subjects Research

• See also: QI Program Monitoring Plan Template​

QI Monitoring Log

Notice of Extension of Effective Date for Final NIH Policy on Single IRB Review of Multi-Site Research​

Memo on NIH Policy on the Use of a Single IRB​

Review of Human-Subjects Research Conducted Offsite

Review of Multi-Site Human-Subjects Research: Investigator-Initiated Collaborative Research​

Review of Operations Centers or Coordinating Centers for Multi-Site Research​

Repository Protocols Guidance

Human Tissues: Brief Primer on Research Use and Requirement for Mass General Brigham IRB Review​

Research Tissue Banks/Repositories​

• See also QI Program Tissue Log

Tissue Transfer to Third Parties​

Investigator Checklist for Transfer of Tissue/Data to Academic Institutions/Collaborators

Letter of Agreement Between Academic Collaborators for Transfer/Receipt of Coded Data/Limited Data Sets

Letter of Agreement Between Academic Collaborators for Transfer/Receipt of Non-Identifiable Tissue

Genomic Data Sharing Consent Checklist​

Return of Research Results in Genetic Research Points to Consider

Genetics Research Guidelines​

Bonus Payments in Clinical Trial Agreements​

Research Supported by the Department of Defense​

Federally Funded Research  

Certificate of Confidentiality

Single IRB Review Policy

Blood Sampling Guidelines

Communicating with Research Participants

Dana-Farber/Harvard Cancer Center Protocol Review Requirements

Deception and Incomplete Disclosure in Research​

Information Security Guidelines on Zoom

Internet Research: Survey Research Using Web-based Survey Tools​

Portable Device Security Handbook

MyCap IRB Submissions and FAQs