Working with the VA

Important Notice
To the principal investigator performing research at the VAHCS:

Study Approval

While your study has been approved by the MUSC IRB, you may not begin work on your research study at the VAHCS until you have received VAHCS R&D Committee approval. All studies conducted at the VA must receive review and approval by the VA Research & Development Committee.

Informed Consent and HIPAA Forms Reminder.

Only the original stamped consent and HIPAA forms should be used to make copies for study enrollment.  You may not use any consent or HIPAA form that does not have the current IRB stamp of approval date on it.  If you have any questions concerning this procedure please call 843-792-4148.

Recruitment of Research Subjects by Phone

• Proactive calling is not allowed at the VA without VHA Office of Research and Development (ORD) approval.  VHA ORD defines proactive calling as "contacting a potential VA subject by telephone for the purpose of initial research recruitment without prior contact (i.e., letter, email, or clinical encounter) regarding the study."  Investigators are required to ensure appropriate telephone contact with subjects.  ORD states "calling potential VA subjects without first sending a notification in person or through mail or email for the purpose of VA research recruitment is NOT permitted outside of the ORD approval process unless there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research."  Additional information (accessed through the VA intranet) can be found here.  Research team members are prohibited from requesting social security numbers by telephone.
• During the recruitment process, the investigator ensures that the research team makes initial contact with the prospective subject in person or by letter prior to initiating any telephone contact, unless there is written documentation that the subject is willing to be contacted by telephone about the study in question or a specific kind of research (e.g. if the prospective subject has diabetes, the subject may indicate a desire to be notified of any diabetes-related research studies).  The initial contact must provide a telephone number or other means that the prospective subject can use to verify the study constitutes VA research.
• Investigators ensure that, in later contact, the research team begins telephone calls to the subject by referring to previous contacts and, when applicable, the information provided in the consent document, and ensuring that the scope of telephone contacts with the subject is limited to topics outlined in IRB-approved protocols and consent documents.

Charleston VAHCS Research Service

Office of Research and Development (ORD) Policies

For further information contact:

Judy Stine, R&D Program Manager
Judy.Stine@va.gov
843-577-5011 Ext. 201603

or

Jocelyn Reddix, VA/IRB Liaison, HRPP Administrator
Jocelyn.Reddix@va.gov
843-508-4865

or

Qwaneshia Wilson, Administrative Officer for Research
Qwaneshia.Wilson@va.gov
843-415-9931