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JHM Office of Human Subjects Research - Institutional Review Boards

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Guidelines

The guidances listed below were updated/created during the 2010-2011 AAHRPP reaccreditation process.

Application of GCP to the Conduct of Clinical Research

Approval Notices Issued by the JHM IRBs

Changes in Research

Clinical Engineering Services

Clinical Research Network (CRN)

Department of Defense (DoD) Requirements for the Conduct of Human Subjects Research

Exempt Research

FDA Test Articles

Incidental Findings

I ND Safety Reports

Investigator Brochure

Investigator Inquiry to the FDA about IND

Investigator Responsibilities

Pharmacy Bayview

Protocol Deviations

Reasonable Payment (Remuneration)

Recruitment and Referral - Patient

Recruiting Study Subjects

Reporting Death of a Participant

Research with a Community Focus

Training Requirements for Human Subjects Research

AAHRPP

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U.S. Dept. Health & Human Services, Office for Human Research Protections (OHRP)

U.S. Food and Drug Administration

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