VA Form 10-1223: Report of Subcommittee on Human Studies

VA Form 10-1223 is the U.S. Department of Veterans Affairs Report of Subcommittee on Human Studies, listed under VHA on VA's page. It records a subcommittee's review of a research project: the project or program title, the principal investigator, the VA medical center (VAMC) and the review date, then seven yes or no committee findings, comments and a recommendation to approve or disapprove/revise.

The findings cover the informed consent's description of research, how informed consent is obtained, risk to subjects, whether the potential research benefits justify the risk, surrogate consent for incompetent subjects, payment to subjects, and the inclusion of members of minority groups and women. The chairman signs in ink and dates the report. It is a research review form completed by a VA subcommittee, not a form a Veteran or research subject files.

The form is one page. You can fill out the PDF free in your browser on this page and download the result without an account.

Top of page 1 of VA Form 10-1223: Report of Subcommittee on Human Studies, as printed by VA

What's on VA Form 10-1223

Header

Project/Program Title, Principal Investigator, VAMC and Review Date.

Findings 1 and 2: informed consent

Whether the informed consent's description of research is complete, accurate and understandable to a subject or surrogate with standard reading and comprehension skills, and how consent is obtained.

Findings 3 and 4: risk and benefit

Whether every effort has been made to decrease risk to subjects, and whether the potential research benefits justify the risk.

Findings 5 to 7: consent, payment and inclusion

Four conditions, a) to d), for surrogate consent when a subject is incompetent, whether any payment is reasonable and commensurate with the subject's contribution, and whether minority groups and women are included whenever possible and scientifically desirable.

Comments and recommendation

Item 8, Comments, asks to indicate if Expedited Review. The recommendation is Approve or Disapprove/Revise, followed by the chairman's signature and date.

How VA Form 10-1223 is completed

1
Identify the project
Enter the project or program title, the principal investigator, the VAMC and the review date.
2
Answer findings 1 to 7
Check yes or no beside each of the seven committee findings.
3
Add comments
Use Item 8 for comments. The form asks to indicate if the review was an Expedited Review.
4
Record the recommendation
Check Approve or Disapprove/Revise.
5
Chairman signs and dates
The form says the chairman signs in ink, with the date beside the signature.

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Notes and edition

Where it goes

The form prints no mailing address or filing instructions.

Signature

The chairman's signature line says Sign in ink.

Edition

The footer prints DEC 2005, matching the December 2005 revision date on VA's form page. The form is Page 1 of 1.

Who uses VA Form 10-1223?

The Subcommittee on Human Studies
The committee findings section records the subcommittee's yes or no answer to each of seven questions about the research.
The chairman
The report ends with the signature of the chairman, which the form says to sign in ink, and the date.
The principal investigator
The header names the principal investigator. Finding 2 asks whether informed consent is obtained by the principal investigator or a trained and supervised designate under suitable circumstances.
Research subjects and surrogates
The findings concern research subjects and surrogates, for example whether the informed consent is understandable to them. They do not fill in the form.

The form names these people and places.

Official sources and the blank

Official VA form page
The agency’s own page for Form 10-1223.
Blank PDF
The official blank form, to print or fill by hand.

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Questions about Form 10-1223

What is VA Form 10-1223?

It is the VA Report of Subcommittee on Human Studies, listed under VHA on VA's page. It records the subcommittee's findings and recommendation on a research project.

Who signs VA Form 10-1223?

The chairman. The signature line says to sign in ink, with the date beside it.

What findings does the form record?

Seven yes or no findings on the informed consent, how consent is obtained, risk to subjects, benefits against risk, surrogate consent, payment to subjects, and the inclusion of minority groups and women.

What recommendations can the subcommittee give?

The form offers Approve or Disapprove/Revise.

How is an expedited review shown?

Item 8, Comments, asks to indicate if Expedited Review.

Does a research subject fill out VA Form 10-1223?

No. It is a subcommittee report signed by the chairman. Research subjects appear only in the questions the findings ask.

VA Form 10-1223: Report of Subcommittee on Human Studies