VA ECHCS Recruitment Checklist

COMIRB #:
Study Title:
Name of Principal Investigator:
Name of VA Investigator:
Names and role of all research staff who will be interacting with VA patients and/or accessing their PHI.
Location of subject recruitment (specify clinic or other location).
Name and role of person(s) responsible for recruiting VA patients.
Location of study procedures:
  • Specify institution, e.g. VA, UCD, or name of other institutions where study procedures will occur.
  • Specify the clinic or other location
where study procedure(s) will be
performed.
Please describe your plan to identify potential VA participants.
Reminder: Under VHA Policy, accessing patient records (identifying PHI) for recruitment into a research study requires prior COMIRB and R&D Committee approval of the study, since recruitment is a part of a research protocol. (The VA does not consider recruitment to be an “activity preparatory to research.”) COMIRB must also approve an appropriate Waiver of HIPAA Authorization and Waiver of Informed Consent before PHI may be obtained and used for recruitment. It does not matter if the PI or his/her agent is obtaining information from his/her own patients’ records or not. VHA requirements are stricter in this regard than NIH guidance.
Yes / No / Comments
If you will be recruiting patients by accessing patient records, per the above requirements, have you included a Waiver of HIPAA Authorization and a Waiver of Informed Consent in your submission packet?
Does the person(s) responsible for recruiting VA participants have a treatment relationship with them?
NOTE: COMIRB defines treatment relationship as contact with patients the VA Investigator has had in the past 5 years or the patients of colleagues the VA Investigator has covered for in the past 5 years.
Does the person responsible for recruiting VA participants have a previousresearch relationship with the potential participants within the past 5 years?
Reminder: Even if the researcher has a treatment or research relationship with the potential subjects, the researcher may only contact potential subjects to inform them of the study either in person or by letter (not by telephone or email).
Was a HIPAA VA Authorization B: Enrollment into Research included in your submission packet?
If a HIPAA VA Authorization B: Enrollment into Research is included in your packet, areboth the VA Investigator and the VA ECHCS (Denver VAMC) listed in the first paragraph?
Will you be recruiting VA patients with whom you do nothave a treatment or research relationship? / .
If so, please indicate which of the options below will be used:
If the VA researcher does not have a treatment or research relationship with the potential participants, the researcher cannot contact them, even though the clinic staff may obtain a verbal consent from the patient, unless one of the following first occurs:
a)The treating/clinic physician or his/her clinic staff gives the patient the name & phone number of the researcher either in person or by letter and advises the potential subject to contact the research staff directly for more information about the study if s/her is interested.
b)A member of the research study team is available in the clinic, so clinic staff can introduce the potential participant to the study team, if the potential subject is interested in the study.
c)A letter is sent to the potential subject that originates from the treating/clinical physician (opt in letter; NO opt out letters) telling them about the study.
d)The treating/clinical physician has the interested patient sign a VA HIPAA Authorization A1: Research Recruitment form, authorizing the treating/clinical physician and his/her staff members to share the authorized HIPAA patient identifiers and health information (identified on the form) with the study team.
Yes / No / Comments
If option (d) above will be used, has a HIPAA VA Authorization A1: Research Recruitmentfor the purposes of “ recruitment only” been completed and included with your submission?
NOTE: At the VA, non-veterans may be entered into VA-approved research study only when there are insufficient veterans available to complete the study (in accordance with 38 CFR 17.45 and 38 CFR 17.92).
Yes / No / Comments
Will non-veterans be recruited at the VA for the study?
The recruitment of non-veterans being recruited at the VA due to insufficient veterans available to complete the study should be addressed in the consent form and in the COMIRB Application. Has this been addressed in these documents?
Have you submitted the form titled ‘Recruitment of Non-Veteran Research Subjects’ (including the VA PI signature) with this submission to the VA Research Office?
NOTE: COLD CALLING OF VETERANS IS NOT ALLOWED.
Specific information regarding contacting veterans. This should be addressed in COMIRB’s Application for Protocol Review:
  • During the recruitment process, researchers must make initial contacts with veterans in person or by letter prior to any telephone contact, even if the researcher has a treatment or research relationship with them.
  • Researchers must also restrict telephone and other contacts with veterans to only those procedures and data elements outlined in the protocol. During these contacts, researchers must not request social security numbers.
  • Also, the researcher must provide a telephone number or other means that veterans can use to verify the validity of the study, e.g. or the veteran can contact the VA Research Office at 303-399-8020 ext. 2755. This information should also be included in the consent form.
FYI: After recruitment and during the F/U phase, a researcher should begin calls by referring to previous contacts and the information provided on the informed consent document.
Yes / No / Comments
Will potential subjects contact you in response to advertisements, flyers, etc.?
Have you included these advertisements, flyers, etc. in your submission packet to the VA Research Office and COMIRB?
Have you submitted a VA Consent Form with the required standard statements to the VA Research Office?
Have you completed a Research Impact Statement (RIS) ANDthe RIS Service-Related Attachments, (if indicated)?
COMIRB has determined that all protocols must be flagged in the VHA Health Record (CPRS) unless the study is limited to secondary data or specimen use or the PI has good justification. Do you feel there is a good reason not to flag the subject’s CPRS file? / If yes, please state your justification:
PLEASE NOTE: If the ACOS/R&D agrees with your justification, the ACOS/R&D will provide notification to COMIRB via the VA Clearance Letter. If COMIRB determines that it is appropriate to waive the requirement to flag a subject’s medical record for this specific protocol, this Waiver will be indicated in the COMIRB feedback letter. Only if the COMIRB feedback letter specifically waives the requirement for flagging will the PI be relieved of the flagging responsibilities of that study.

Important Reminders:

You are not allowed to recruit VA patients for your study until you receive approval

from COMIRB, the VA Subcommittee on Research Safety, and the VA R&D Committee.

The VA consent must be stamped with the VA R&D approval stamp as well as the COMIRB

approval.

VA Investigator: ______Date: ______

Revised 01-10-13 Page 1 of 5