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Policy and Guidance


How and When a Principal Investigator Should Report Death of a JHM Research Participant

Humanitarian Use Devices (HUD)

I. Informed Consent Guidance

II. Informed Consent Guidance - How to Prepare a Readable Consent Form

III. Informed Consent Guidance - FDA Regulated Studies

Investigational Medical Devices

Investigators as Study Participants (Self-Experimentation)

Reporting Protocol Deviations

Research Using FDA Test Articles


Organization Policy on Reports of Unanticipated Problems Involving Risks to Participants or Others (Policy No. 103.6(b))

Organization Policy on Investigator Non-Compliance (Policy No. 103.7)

Organization Policy on Complaints from Research Participants, Investigators and Research Staff, the Community, etc. (Policy No. 109.3)

Organization Policy on Monitoring the Consent Process and Research Procedures in Ongoing Research (Policy No. 109.8)

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