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.

Use of Commercial (central) IRBs
Commercial IRB Screen Shots [PDF]
Central Commercial IRB [PDF]

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

1. Guidelines for Human Research Advertisements
2. Certificates of Confidentiality: the Why and How [Word Document]
3. 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]
4. Use of Commercial (Central) IRBs 
   1. 1. Central Commercial IRB [Word Document]
      2. Commercial IRB Screen Shots [Powerpoint]

Policies
Human Research Protection Plan
Investigator Manual [DOC]
Exempt Research Determinations [PDF]
Study Personnel Changes [PDF]

Statement of Compliance [PDF]

Standard Operating Procedures