| Informed Documents | ||
| Form D - Research Consent + Authorization | Submit 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 + Authorization | Submit 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 + Authorization | For studies collecting outcomes of participants who inadvertently become pregnant or the participant’s partner who becomes pregnant. | |
| Form D-1-PP - Pregnant Consent | Submit 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 + Authorization | Submit 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 + Authorization | Submit 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) | |
| Concise Summary Templates | ||
| Concise Summary Template: / Studies | Template 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 Studies | Template includes important considerations for early feasibility/first in human studies in clear language to facilitate participant understanding. | |
| Concise Summary Template: Social/Behavioral Studies | Template 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 Timeline | Template 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 Bank | A 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 Form | Submit 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 Withdrawal | Use this form for continued follow-up after withdrawal from interventions. | |
| Form H-1 - Translation Certification Form | To be turned in with translated form. Pertains to subjects from any foreign culture. | |
