VA Ann Arbor Healthcare System Research Services

Frequently Asked Questions

1. How do I know if my project is considered research and requires R&D review?
2. Is my project human subjects research, thus requiring IRB review?
3. My project uses human subjects but can it be exempt from continuing IRB review?
4. How do I add a staff member to a project?
5. What are the training requirements for research staff working with human subjects?
6. What is considered VA Sensitive Information?
7. What does it mean to de-identify a dataset?
8. What is a limited dataset?
9. Who must be listed on R&D and IRB applications?
10. Can I look at records in CPRS or view identifiable information before I have an approved project?
11. If my study is being conducted both at the Ann Arbor VA and the University of Michigan, do I need to provide documentation of UM IRB approval?
12. Does my grant application need to be approved by the R&D Committee before I submit it?
13. What types of adverse events need to be submitted to the IRB and when?
14. Can we communicate with patients using email?
15. How do I transfer a project to a new PI?

How do I know if my project is considered research and requires review?

The AAROW Project Applicaiton form requests information at the start to help determine if a project is research.  There are some situations in which it may not be clear if a project should be considered research. While this FAQ will give you some information, please review these PowerPoint slides and/or contact Elizabeth Koester if you need further clarification.

If a VAAAHS researcher is involved in a research project based at another site, their level of involvement will determine if the AAVAHS Research Service will need to review the project. If they are listed on the grant as a co-investigator, it is likely they will be considered to be “engaged in research”. If, however, they are being paid or donating time to act as a subject area expert and will have no further involvement in the study, the project will not require review by the VAAAHS R&D or IRB.

While both quality improvement and research ask clinically important questions, use patient data, apply complex statistical analyses to those data, retrieve patient information directly from patients and strive to improve patient care, there are differences.

• QI is primarily designed to benefit the participating site and its patients. In research, the benefits are meant to generalize to a population beyond those bearing the risks.
• QI generally uses proven interventions to address health problems while research usually introduces a non-standard element.
• In QI, subjects with a specific condition participate to benefit themselves or their community. Research subjects, however, may be selected randomly so results can be generalized to a larger group.

Remember, research does not have to be the primary objective of a project to require research oversight. Also, a project initially deemed to be QI can become research if the activity is modified to expand the knowledge base of a scientific discipline or scholarly field of study or otherwise contribute to generalizable knowledge.

Is my project human subjects research, thus requiring IRB review?

The RDC Project Application form requests information to help determine if the protocols that are part of the project require IRB review. 

A human subject is defined by 45 CFR 46.102(f)] as a living individual about whom an investigator conducting research obtains either 1) data through intervention or interaction with the individual; or (2) identifiable private information.

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. From Office for Human Research Protections: Guidance on Engagement of Institutions in Human Subjects Research

Thus the AAVAHS is NOT engaged in HS research if we receive coded private information or human biological specimens from another institution and are unable to readily ascertain the identity of the subjects to whom the coded information or specimens belong because the holder of the key has entered into an agreement prohibiting release of the key, and the releasing institution has IRB oversight prohibiting the release of the key. (OHRP Guidance “Engagement in human subjects research”, updated 10/16/2008)

My project uses human subjects but can it be exempt from continuing IRB review?

• In educational settings using common educational practices
• Surveys, interviews or observation with no identifiable data collected
• Use of existing data if publically available and de-identified
• Study of public benefit/service programs
• Consumer taste testing

How do I add a staff member to a project?

New staff members on IRB protocols are added using the IRB Staff/PI Change form in AAROW.  You do not have to notify the RDC of staffing changes unless it includes a change in PI.  Until the IACUC module in AAROW is live, please contact the IACUC Coordinator, Carolyn Slusher, for information. 

What are the training requirements for research staff working with human subjects?

• CITI Training - every 3 years
• Combined VA Privacy and Information Security Awareness and Rules of Behavior - annually
• VHA Privacy and HIPAA Training - annually
• Infection Control: Bloodborne Pathogens & Tuberculosis Training - annually

See the Ann Arbor VA Human Subjects Research Training Policy for details.

What is considered VA Sensitive Information?

We all know that any research subject’s Protected Health Information (PHI) and Personally Identifiable Information (PII) must have a number of specific protections outlined in 1605.1, Privacy and Release of Information and VHA Handbook 1200.05, Requirements for the Protection of Human Subjects in Research. In addition to this, you will see the acronym VASI used. This is VA Sensitive Information/Data. While it includes all PHI and PII, it is more broadly defined as “All Department Information and/or data on any storage media or in any form or format, which requires protection due to the risk of harm that could result from inadvertent or deliberate disclosure, alteration, or destruction of the information. The term includes information whose improper use or disclosure could adversely affect the ability of an agency to accomplish its mission, proprietary information, and records about individuals requiring protection under applicable confidentiality provisions." SOURCE: 38. USC § 5727

What does it mean to de-identify a dataset?

1605.1 4 (l) De-identified Information. De-identified information is health information that does not identify an individual and with respect to which there is no reasonable basis to believe that the information can be used to identify an individual.

What is a limited data set?

1605.1 4 (ff).Limited Data Set. A Limited Data Set is protected health information from which certain specified direct identifiers of the individuals and their relatives, household members, and employers have been removed. These identifiers include name, address (other than town or city, state, or zip code), phone number, fax number, e-mail address, Social Security Number (SSN), medical record number, health plan number, account number, certificate and/or license numbers, vehicle identification, device identifiers, web universal resource locators (URL), internet protocol (IP) address numbers, biometric identifiers, and full-face photographic images. A limited data set is not de-identified information or data. A limited data set may be used for research, health care operations, and public health purposes. VHA may disclose a limited data set for research, health care operations, and public health purposes pursuant to a data use agreement. Return to top

Who must be listed on R&D and IRB applications?

All co-investigators and staff at Ann Arbor VA and anyone off-site who will view identifiable data. The latter must have a VA appointment at another site or become a WOC at Ann Arbor. Off-site investigators may also be required by their site to obtain local R&D/IRB approval.

Can I look at records in CPRS or view identifiable information before I have an approved project?

VA investigators may use individually-identifiable health information to prepare a research protocol prior to submission of the protocol to the IRB for approval. However, the data cannot be used for any other purpose, cannot leave the VA and can only be recorded in aggregate. In addition, this data cannot be used for recruitment. Please see this excerpt of VHA Directive 1200.05 for details.

If my study is being conducted both at the Ann Arbor VA and the University of Michigan, do I need to provide documentation of UM IRB approval?

Yes, please include the UM IRB approval if available at the time of submission. If not, please submit when it is complete.

Does my grant application need to be approved by the R&D Committee before I submit it?

This pertains only to VA funding. Every VA grant that’s submitted must be approved by the Associate Chief of Staff for Research, Dr. William Weitzel in Ann Arbor.

If you work at CCMR, you will need to complete the “Clinical Impacts” form and the CCMR administrative staff will get the required sign offs from the Research Office.

If your research is not being submitted through CCMR, the study staff must complete an R&D application and submit it, along with the proposal, the month prior to the final grant submission date. For example, if a grant were due on September 15th, you could submit the application by August 17th for review on September 2nd.

What types of adverse events need to be submitted to the IRB and when?

If the death of a research subject is unanticipated and related to research, must be verbally reported to the IRB Coordinator within 24 hours. Leaving a voice mail is acceptable. The death must then be reported in writing within 5 business days. Other unanticipated and related SAEs, including, but not limited to, life-threatening experience, inpatient hospitalization, prolongation of hospitalization or persistent/significant disability OR the need for an intervention to prevent any of these, should be reported to the IRB within 5 business days.

Dealing with adverse events is a complex issue and it is strongly suggested that investigators and project managers contact IRB Coordinator with any questions.

Can we communicate with patients using email?

The short answer is no.  However, VA employees are allowed to communicate with patients using MyHealtheVet.  Please click here for details. 

How do I transfer a project/protocol to a new PI?

This change must be for both the project and the protocol.  For the project, use the RDC Project Amendment form in AAROW.  For an IRB protocol, use the IRB Staff/PI Change form in AAROW.  Until the IACUC module in AAROW is live, please contact the IACUC Coordinator, Carolyn Slusher, for information. 

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