Guidance and Policies

Policies define how the MSSM PPHS operates in the pursuit of human subjects' protection. Policies apply to all MSSM research staff. Guidance is designed to assist the researcher and IRB member in understanding, interpreting, and applying the regulations and policies. Standard Operating Procedures describe the expectations for what and how a task should be accomplished.

Guidance
Guidance for submitting a research study limited to medical record review
Guidance for submitting an advertisement

1. Guidelines for Human Research Advertisements
2. Submitting Advertisements for IRB review online:
   1. Clinical Trial Web Advertisement Approval System (Sinai Central) [opens new browser window]
3. Certificates of Confidentiality: the Why and How [Word Document]
4. Data Security
   1. 1. Medical Center Data Security Policies (Sinai only)
      2. Data Security in Human Subject Research (HIPPA Presentation)
      3. PPHS Data Security Standards [Word Document]

Policies
Human Research Protection Plan
Investigator Manual [DOC]

Standard Operating Procedures