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Institutional Review Board

Consent Documents

In order for the IRB Office to insert an approval stamp into the header of your consent document, you MUST submit the document in Microsoft Word, and leave the header open for IRB office use.  We will return documents submitted in pdf format.

Please select the appropriate consent, scripts or forms for your study using the descriptions and links below.

If your study involves radiation or imaging procedures, please review the "Additional Consent Form Language" items below.

Type of Adult Study – no signature required 

Oral Consent Script

International: Minimal Risk data collection (surveys, focus groups) – no collection of sensitive private information

Oral Consent Script 1

International collection of sensitive private information (surveys, focus groups, biospecimen collection – no genetics)

Oral Consent Script 2

US Based Minimal Risk  data collection (surveys, focus groups, biospecimens – no genetic information) – no collection of sensitive private information, no HIPAA

Oral Consent Script 3

US Based Collection of Sensitive Private Information (surveys, focus groups, biospecimen collection – no genetics)

Oral Consent Script 4

US Based Collection of Personal Health Information from Covered Entity/HIPAA

Oral Consent Script 5*

*requires privacy board approval of waiver of HIPAA authorization

Instructional

Oral Consent Script_General Instructional Template

Oral Consent Script 6



Type of Adult Study – signature required

Consent Form Template with Signature/Mark Page

US or International Based Collection of Biomedical or other Information for which Signature is Required

Consent Form Fill-In

Storing Biospecimens for Future Research Use; signature required.   May be used independently or incorporated into Consent Form Fill-In Template

Consent Form for Storing Biospecimens for Future Research

Instructional

 

Instructions provided for how to complete the consent form template, fill-in version

Consent Form Instructional Template



Type of Study with Children

Script/Form

Minimal risk study, no signature required

Oral Assent Script

Biomedical Study, signed Assent required

Research Assent Form

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Intervention/Procedure

Additional CF Language

Radiation Procedures:  X-ray, CT scan, etc.

Radiation Risk Consent Form Language

Imaging Studies: MRI, etc.  conducted at JHU facilities

Incidental Findings Language

Required and Additional Elements for Consent Documents

Certification of Translation for Non-English Consent Form(s)

Embedding Foreign Language Fonts in Word 2007

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