Flagging of VHA Flagging of VHA Health RecordHealth Record

IRB Determination for VA IRB Determination for VA StudiesStudies

The IRB may determine that the The IRB may determine that the patient health record must be patient health record must be flagged to protect the subject’s flagged to protect the subject’s safety by indicating the subject’s safety by indicating the subject’s participation in the study.participation in the study.

Mandatory FlaggingMandatory Flagging(1) The patient record MUST be flagged if the (1) The patient record MUST be flagged if the

subject’s participation in the study involves:subject’s participation in the study involves:(a)(a) Any invasive research procedure;Any invasive research procedure;(b)(b) Interventions that will be used in the medical care Interventions that will be used in the medical care

of the subject, or that could interfere with other of the subject, or that could interfere with other care the subject is receiving or may receive;care the subject is receiving or may receive;

(c)(c) Clinical services that will be used in the medical Clinical services that will be used in the medical care of the subjects;care of the subjects;

(d)(d) The use of a survey or questionnaire that may The use of a survey or questionnaire that may provoke undue stress or anxiety unless the IRB provoke undue stress or anxiety unless the IRB determines that mandatory flagging is not in the determines that mandatory flagging is not in the best interests of the subject (e.g., an interview best interests of the subject (e.g., an interview study of victims of sexual assault).study of victims of sexual assault).

Mandatory Flagging Mandatory Flagging (cont.)(cont.)

(2) In other situations, the IRB (2) In other situations, the IRB determines if flagging is necessary.determines if flagging is necessary.

AAHRRP ElementAAHRRP ElementII.5.BII.5.B

The IRB or EC documents discussions and decisions relevant to a research protocol or plan in accordance with legal and regulatory requirements, Sponsor requirements, if any, and organizational policies and procedures.

eIRB SmartformseIRB Smartforms Revised eIRB smartforms to provide Revised eIRB smartforms to provide

VA investigators with: VA investigators with: an easy way to request waiver.an easy way to request waiver. education on when medical records education on when medical records

must be flagged.must be flagged. examples of circumstances when examples of circumstances when

flagging may be waived.flagging may be waived.

Document the DecisionDocument the Decision The IRB’s determination of whether The IRB’s determination of whether

medical records need to be flagged medical records need to be flagged or whether to waive the requirement or whether to waive the requirement must be documented in the IRB must be documented in the IRB minutes.minutes.

Questions?Questions?

Stacey Goretzka Stacey Goretzka IRB Program Manager IRB Program Manager

goretzka@musc.edu843-792-6527843-792-6527