Documents Related to Consent

Informed Documents 
Form D - Research Consent + AuthorizationSubmit this form if applicable to your .    
For non-VA studies only.    
Combined + HIPAA .    
For studies contributing to another , refer to the informed instructions for repositories.    
For assistance with drafting the Concise Summary, scroll down to next section on this page.
 
Form D-1 - Research Consent + AuthorizationSubmit this form if applicable to your .    
For VA studies and studies where VA is a site.    
Note: If study the includes optional components or sub-studies, submit separate Form D-1 for each component/sub-study    
For studies contributing to another , there must be a separate repository form.    
For assistance with drafting the Concise Summary, scroll down to next section on this page.
 
Form D-PP - Pregnant Consent + AuthorizationFor studies collecting outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. 
Form D-1-PP - Pregnant ConsentSubmit this form if applicable to your .    
For VA studies and studies where VA is a site.    
For studies collecting outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant.
 
Form E - Repository Consent + AuthorizationSubmit this form if applicable to your .    
For non-VA studies only.    
Combined + HIPAA .    
For assistance with drafting the Concise Summary, scroll down to next section on this page.
 
Form E-1 - Repository Consent + AuthorizationSubmit this form if applicable to your .    
For VA studies and studies where VA is a site.    
Submit a Form H-VA to VA R&D office.
 
GDPR Addendum Consent

European Union (EU) General Data Protection Regulation (GDPR)

GDPR Guidance

 
Concise Summary Templates 
Concise Summary Template: / StudiesTemplate includes a fillable flow diagram and tables that can be used to describe complex trials, so that participants can better visualize the process and the risks, benefits, and alternatives to participation. 
Concise Summary Template: Early Feasibility/First in Human StudiesTemplate includes important considerations for early feasibility/first in human studies in clear language to facilitate participant understanding. 
Concise Summary Template: Social/Behavioral StudiesTemplate includes four (4) examples for formatting the concise summary in social-behavioral , including key considerations that are specific to social-behavioral research. 
Concise Summary Tool: Study TimelineTemplate includes three (3) fillable timeline tools to help visualize the schedule. Intended to provide a brief snapshot of the research process – more information about the procedures should be provided in the body of the document. 
Concise Summary Tool: Image BankA bank of open-source images of common and medical procedures that can be used to supplement the concise summary and/or body of the document. 
Documents Related to To Be Used After Approval 
Short FormSubmit an to request IRB approval to utilize a SHORT FORM process for potential subjects or LARs that are non-English speaking and there is not enough time to obtain a translation. The English version is provided here to be translated in the appropriate language. 
Form D WithdrawalUse this form for continued follow-up after withdrawal from interventions. 
Form H-1 - Translation Certification FormTo be turned in with translated form. Pertains to subjects from any foreign culture.