Program for the Protection of Human Subjects

  1. IRB Guidelines and Policies Manual pdf
  2. Advertising, Recruitment, Screening for Research Subjects
    1. Advertising
      1. Guidelines for Clinical Trial Advertisements
      2. Clinical Trial Web Advertisement Approval System (Sinai Central) [opens new browser window]
      3. Hard Copy Submissions
    2. Recruitment
    3. Screening
  3. Consent Process and Forms
    1. Consent Process
    2. Modifications to the Consent Process
      1. Face to Face
      2. Faxing
      3. Mailing
      4. Telephone
      5. Computer/Internet
      6. Third-Party Consent
    3. Forms for Downloading
  4. Costs and Reimbursements to Subjects
    1. Costs to Subjects in Research
    2. Incentives for Study Participants
  5. Data Issues
    1. Certificates of Confidentiality: the Why and How Word Document new
    2. Data Confidentiality and Subject Privacy
    3. Data Monitoring
    4. Data Repositories and Registries
    5. Recording Research Subjects (Audio, Video, Photo)
    6. Data Security
      1. Medical Center Data Security Policies (Sinai only)
      2. Data Security in Human Subject Research (HIPPA Presentation)
  6. Design and Methodology Issues
    1. Case Studies
    2. Clinical Trial Phases
    3. Concurrent Participation in More Than One Research Study
    4. IND/IDE Information
    5. Medical Record Reviews
      1. Standard pdf new
      2. HIV Information Word Document new
    6. Placebo Use
    7. Repositories (Data and Biological Material)
    8. Retrospective Collection of Tissues/Stored Tissues
  7. Information about Certain Medical Tests/Procedures in Research
    1. Autopsy
    2. Blood Drawing
    3. Devices
      1. Medical Devices SOP Word Document new
      2. FDA Table for Expanded Access Mechanism Word Document new
    4. Fetal Tissue Donation
    5. Genetic Research
    6. HIV
    7. Lumbar Punctures
    8. Prospective Collection of Tissue
    9. Radiation and Radioactive Substances
    10. Sedation/Anesthesia
    11. Stem Cell
  8. Researcher Obligations
    1. Adverse Event Reporting
      1. Policy Word Document new
      2. Forms
        1. Internal Adverse Event/Unanticipated Problem Report Form Word Document new
        2. Report of Death on a Protocol Form Word Document new
        3. Annual Adverse Event Report Form Word Document new
    2. Maintaining IRB Approval
    3. GCP: Investigator Responsibilities
    4. Protocol Deviations, Exceptions, Violations pdf
  9. Special Subject Populations
    1. Non-English Speaking subjects
    2. Vulnerable Populations
      1. Children
      2. Elderly
      3. Employees
      4. Minorities
      5. Normal controls (Healthy Volunteers)
      6. Students
    3. Women
  10. Special Topics
    1. Good Clinical Practice Guidelines
    2. IND/IDE Information
  11. Frequently Asked Questions

Please note that information above is forthcoming.

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