Study information
Study title, protocol number, the PI, co-PI and study coordinator with VA email and phone, purpose of submission, IRB and R&D approval dates, type of review, study status and study sponsor.
10-250
VHA Research Protocol Privacy Review Checklist
- Agency
- VA
- Revision
- August 2019
- Fillable fields
- 94
- Pages
- 5
- Official source
- VA form page
- Checked
- October 20, 2026
VA Form 10-250: VHA Research Protocol Privacy Review Checklist
VA Form 10-250 is the U.S. Department of Veterans Affairs VHA Research Protocol Privacy Review Checklist. VA's form page lists it under VHA. The Principal Investigator or other research study personnel complete the study information before sending it to the Privacy Officer, who reviews the human subject research study for privacy and confidentiality requirements.
The form has a preliminary review, done before the study goes to the IRB, or to R&D if no IRB reviews it, and a final review after IRB or R&D Committee approval, even if the study is IRB Exempt. Each requirement is marked compliant Yes, No or N/A with comments, and each review ends with the Privacy Officer's signature and date.
The PDF has five pages. It is a research compliance checklist completed by study personnel and Privacy Officers, not a Veteran benefits form. You can fill out the PDF free in your browser on this page and download the result without an account.
What's on VA Form 10-250
PHI/IIHI and data storage
Whether PHI/IIHI is accessed, collected or disclosed, written authorization, contractor or non-VA access, CMS data, how and where research data is stored, and any bio-specimen or data repository.
Section 1: general requirements
Privacy interests, data use, access with and without authorization, disclosure to a non-VA entity, de-identification under VHA Directive 1605.1, Appendix A, and bio-specimen labeling.
Sections 2 and 3: HIPAA authorization and waiver
Whether a Research HIPAA Authorization is combined with the informed consent form and has the listed elements, and whether a waiver of HIPAA Authorization request has the required statements.
Sections 4 and 5: notice and records
For non-Veterans in clinical trials, a process to provide the VHA Notice of Privacy Practices and get the signed VA Form 10-0483, and custody of VA Federal Records under RCS 10-1.
Sections 6 and 7: final review
Whether deficiencies from the preliminary review were corrected and whether the documented approval of a waiver contains all required elements, then the Privacy Officer's signature and date.
How VA Form 10-250 is completed
- 1
Complete the study information
The PI or study personnel fill in page 1 before sending the form to the Privacy Officer.
- 2
Check the purpose of submission
New protocol, or continuing review or amendment. The form says a continuing review or amendment needs review only if the changes affect the safeguarding and protection of privacy and confidentiality of human subjects and study data.
- 3
Preliminary review
The Privacy Officer marks Sections 1 to 5 Yes, No or N/A with comments, then signs and dates the preliminary review. The form says recommended changes or concerns are addressed before approval by IRB or R&D.
- 4
Final review
After IRB or R&D Committee approval, the Privacy Officer completes Sections 6 and 7 and signs and dates the final review.
- 5
File the checklist
The form says the checklist should become part of the IRB protocol file, or the R&D protocol file if not reviewed by the IRB.
Why fill Form 10-250 on indox
You get the real form, filled in a browser tab, with nothing standing between you and the finished PDF.
- Fill the form right in your browser, no software to install
- Free to fill and free to download, with no account
- The official blank straight from the VA, not a copy someone retyped
- Works on a phone, tablet or computer
Where it goes and other details
Who receives it
The study information is sent to the Privacy Officer. The form does not print a mailing address.
Protocol file
The checklist should become part of the IRB protocol file in accordance with VHA Directive 1200.05, paragraph 13, or the R&D protocol file in accordance with VHA Directive 1200.01, paragraphs 11 and 12.
Forms it names
VA Form 10-0493, Authorization for Use & Release of Individually Identifiable Health Information for VHA Research, and VA Form 10-0483, Acknowledgement of the Notice of Privacy Practices.
Edition
The PDF is dated AUG 2019, matching the August 2019 revision date on VA's form page.
Related forms
Who uses VA Form 10-250?
The form names who completes each part.
Official sources and the blank
Do it all with indox
No tool matches that search.
Questions about Form 10-250
What is VA Form 10-250?
The VHA Research Protocol Privacy Review Checklist. A Privacy Officer uses it to review a human subject research study for privacy and confidentiality requirements.
Who completes VA Form 10-250?
The Principal Investigator or other research study personnel complete the study information. The Privacy Officer completes and signs the preliminary and final reviews.
When is a privacy review not required?
The form says that if PHI/IIHI is not accessed, collected or disclosed, a privacy review is not required, and to notify the Privacy Officer.
What is the difference between the preliminary and final review?
The preliminary review is done before submission to the IRB, or R&D if not reviewed by an IRB. The final review is done after IRB or R&D Committee approval, even if the study is IRB Exempt.
When does the form point to VA Form 10-0493?
The form says a combined Research Informed Consent with Research HIPAA Authorization is not permitted if the study includes tissue or data banking for future use, or an optional component needing separate consent, and that VA Form 10-0493 must be used.