Guidelines Relating to Consent

• I.  Informed Consent Guidance
   What is informed consent?
• II. Informed Consent Guidance - How to Prepare a Readable Consent Form
• III. Informed Consent Guidance - FDA Regulated Studies
  How do Good Clinical Practice (GCP) Guidelines for research involving investigational drugs or devices affect the written consent form and process?
• HIPAA Combined Informed Consent/Authorization Template

• Informed Consent
  Children
• Sample Research Assent Form for Children
• Obtaining Consent from Both Parents
• Federal Requirements for Obtaining Permission from Both Parents
  Federal rules about consent from parents in studies of pregnant women or fetuses, children and/or neonates.
• Informed Consent for Minors in Research Studies
  Minors who can consent for themselves
• Research Projects Involving Social Services Administration of the State of Maryland Department of Human Resources Department of Social Services (Foster Children)
  Foster children
• DSS Submission Form

• Adults lacking capacity to consent for themselves
  Who may give informed consent for ADULTS to participate in a research study?

Expired Protocols and Consent Forms 

• Expired Protocols and Consent Forms in Human Subject Research

• Humanitarian Use Devices (HUD)

• Humanitarian Use Device (HUD) Informed Consent and Privacy Authorization

• State of Maryland Law and Consent for HIV Testing

• Plans for Detecting and Managing Incidental Findings Associated with Research Imaging Procedures

• Organization Policy on Review of In Vitro Diagnostic Device Protocols (with or without Commercial Sponsors)

• MRI Resonance Imaging Standard Language for Consent Documents
• Administration of Gadolinium for Research MRI Procedures
  

• Obtaining and Documenting Informed Consent Of Subjects Who Do Not Speak English
• Informed Consent Document for Research Participants Who Do Not Speak English (Short Form)

Pregnant women

• What special considerations are there for pregnant women, fetuses, and neonates?

• Changes to, or Waiver of, the DHHS or FDA Requirements for Informed Consent

• Oral Consent
• Oral consent script template

• Informed Consent
  Basic elements of consent (regulatory requirements)
• Assessing subject comprehension 
• JHM IRB consent form template
• Short form for non-English speakers
• Humanitarian Use Device (HUD) Consent form