Human Research Protection Program

IRB Governance and Operating Procedures​​​​​

Definition of Human-Subjects Research

Case 'Reporting' and Research Related to Medical Records

Innovative Therapy and Diagnosis

Quality Measurement Initiatives

• See also Clinical Quality Improvement Checklist

​Stem Cell Research: ESCRO​

Principal Investigator (PI) Responsibilities

PI Delegation of Responsibilities

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

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

Required GCP Training: New NIH Policy (effective 1/17/17 M​emo # 2)​

​​​Instruc​​tions for Adding CITI GCP Course to CITI Course List​​

• See also: Human Research Committee (HRC) Webpage, Education & Training (CITI Program—Internal Navigator Link)

Study Staff Informatio​n Sheet

Non-Brigham and Women's Hospital/Non-Massachusetts General Hospital Employees As Co-Investigators/Study Staff​

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

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​ ​

Individual ​Co​nflic​ts of​ Interest

Financial Conflicts of Interest Policy

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 HRC Approval

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

Proposed Changes in Approved Human-Subjects Research and Exceptions

Unanticipated Problems in Human-Subjects Research​

Noncompliance in Human-Subjects Research

Suspension or Termination of Human-Subjects Research​

Reporting to Institutional Officials, Regulatory Agencies and Accrediting Organizations

Requirements for Ancillary Committee Approval of Human-Subjects Research​

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

Reporting Unanticipated Problems in Human-Subjects Research Including Adverse Events

• See also: QI Program Adverse Events Tracking Log​

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

Needlesticks in Research​

Reporting Unapproved Deviations in PHRC-Approved 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)

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​

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

Guidance on R​esearch Involving​ Prisoners​

Informed Consent of Research Subjects

Individuals Who Can Obtain Consent in Human Subject Research

• See also: NIH Policy on Certificates of Confidentiality (CoC)

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

Consent Form Reviewer Worksheet and Checklist

​Compliance Reminder 

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)​

Informed Consent in Online Research​

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

Frequently Asked Questions - Enrolling Non-English Speakers​

'Short Forms' for Non-English Speakers 

Translation Services & Resources

Exception from Informed Consent Requirements for Emergency Research

Recruitment of Research Subjects​

Guidelines for Advertisements for Research Subjects

MGN IRB-369205 Procedure: Request to Receive Unencrypted Email

FAQs: Email Com​munication with Research Participants and Potential Research Participants​​

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​

Cash Control and Accountability for Payments to Human 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 (U.S. & International)​

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

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

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

Guidance on Genomic Data Sharing

Flowchart for Depositing Human Genomic Data Into NIH Controlled-Access Repositories

Genomic Data Sharing Consent Checklist​

Return of Research Results in Genetic Research Points to Consider

Genetics Research Guidelines​

Genetics 101​​

Genetics Research Advisory Panel (GAP) Report​

Appendix​

New NIH Policy Regarding Large-scale Genome Research​

NIH Genomic Data​ Sharing (GDS) Policy Guidance Memo #2

Bonus Payments in Clinical Trial Agreements​

Human-Subjects Research Supported by the Department of Defense​

NIH Good Clinical Practice (GCP) Training Requirements

Instructions for Adding CITI GCP Course to CITI Course List

NIH Policy Regarding Large-Scale Genomic Research

NIH Genomic Data Sharing (GDS) Policy Guidance Memo #2

NIH Policy on Certificates of Confidentiality (CoC)

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

Single IRB Review Policy

Blood Sampling Guidelines ​

Community-based Participatory Research (CBPR)​

Deception and Incomplete Disclosure in Research​

Digital Health Research

Information Security Guidelines on Zoom

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

Patient Centered Outcome Research (PCOR) and IRB Points to Consider​

Portable Device Security Handbook

Pregnancy Testing in Research Studies Involving Ionizing and Non-Ionizing Radiation​

TWIN IRB Review Process Guidance for Mass General Brigham Investigators