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Policies and Procedures

General OSP Policies:

Grants Administration:

Research Integrity and Compliance:

Agreements with Non-Federal Sponsors

Advance Account Requests

- See Advance Account Request Form

Glossary

Community Outreach

Application Submission for Faculty with Dual Appointments

Additional Protections for Vulnerable Subjects

Consultants, Obtaining Approval to Hire

- See Request for Review and Approval of Consulting Services Form

Award Close out

Applicability of Local and International Laws

Intellectual Property Policy

Calculating Salaries and Calendar Months for Grant Submissions

Concerns, Complaints, and Questions about the Human Research Protection Program

International Travel and Foreign Collaborations

Cost Sharing

- See Cost Share Calculator

Conduct of IRB Meetings

Policy & Procedure Development and Implementation

Cost Transfers

- See Cost Transfer form

Continuing Review

Prep-to-Research Reviews of PHI Prior to Conducting Research

- See Prep-to-Research Attestation Form

Direct Costs and Expenditures

Data and Safety Monitoring Plans

Research Misconduct

Export Control and Restricted Party Screening in Procurement and Payment

Equitable Selection of Research Participants

Research Records Retention and Destruction

External Activities

Ethical and Legal Standards and Practices for Human Subjects Research

Training

Facilities and Administration Costs (F&A)

Financial Conflict of Interest of Researchers and Research Staff

Gifts

Human Research Protection Program Oversight

Honorarium

Informed Consent

Industry Sponsored Research

Initial Expedited Review

One-Year, No-Cost Extension, requesting a

- See Request for a one-year, no-cost extension form

Initial Full Review

Procurement, Grant Related

IRB Authority and Undue Influence of IRB Members

Program Income

IRB Composition and Membership Appointments

Proposal Review

IRB Meeting Minutes

Requisiting for Goods and Services

IRB Member and Consultant Conflicts of Interest

Research Participant Incentives

IRB Record of Retention

Research Signature Authority

IRB Use of Consultants

Residual Research and General Purpose Funds, Use of

Multi-Site Research

Scientific Overlap

Organizational Financial Conflicts of Interest in Research

Subcontractor, Vendor (Contractor), Consultant

Performance Evaluation of IRB Chair, IRB Members and IRB Staff

Subrecipient Monitoring

Privacy and Confidentiality of Research Subject Information

Time & Effort Certification

Quality Assurance and Quality Improvement Program

Reporting and Review of Adverse Events, Protocol Deviations, Protocol Violations, and Unanticipated Problems

Researcher Qualifications

Responsibilities of the Institutional Official

Review of Modifications to Approved Research

Risk-to-Benefit Analysis

Scientific or Scholarly Validity of Proposed Research

Termination or Suspension of IRB Approval

Do you have concerns about a particular research study? Harvard Pilgrim Health Care Institute provides you with access to two hotlines on which you can share your concerns:

  • Research Participant Concerns: 1-800-807-6812
  • Research Misconduct Concerns: 1-617-867-4817