ORD Common Findings

ORD Common Findings K. Lynn Cates, M.D. Assistant Chief Research & Development Officer Director, PRIDE June 27, 2012

Combined DUA-DTARequired • A combined DUA-DTA is required when data are transferred for research from: • One VA facility to another VA facility • One VA investigator or data owner or administrator (e.g., administrator of a VISN data warehouse, national database, or research data repository) to a VA investigaro for a VA-approved research project

Combined DUA-DTARequired • Preparatory to research when data are transferred from a data repository for review by the investigator or his/her research staff • A VA investigator to a non-VA person or entity who is serving as a contractor or collaborator on the investigator’s approved protocol

Combined DUA-DTANot Required • When data are transferred (disclosed) to a research sponsor in accordance with the VA-approved protocol and signed informed consent documents and HIPAA authorizations • When data are transferred from one VA facility or VA investigator to another VA facility or VA investigator when this transfer is required to conduct a VA-approved protocol, the transfer is described in the protocol, and the protocol is approved by each site’s IRB and the protocol is active at each site

Combined DUA-DTANot Required • When data are disclosed to a non-VA individual or entity for research purposes and: • A signed research informed consent and signed HIPAA authorization have been obtained for each research subject • A written request for the data has been sent to the Privacy Officer and the Privacy Officer has determined that: • The release of the data meets all the requirements • The Privacy Officer has approved the release • All other approvals have been obtained

Data Use Agreements • If data are originally collected for research purposes, future use of the data must be consistent with • The informed consent • The HIPAA authorization • If data are obtained from a national data system, they can only be re-used in accordance with the provisions of the DUA (e.g., if the DUA says the data can be used for protocol x, then they cannot be used for anything else)

Data Use Agreements - Miscellaneous • You do not need a DUA to release data to a sponsor if the language is covered in the CRADA • VA investigators do not need a FOIA request for release of data from a data repository • VHA Handbook 1200.12 does not discriminate between identified and de-identified data

ORD Policies • ORD is responsible for 1200 series handbooks including • 1200.01 (R&D Committee) • 1200.05 (Human Subjects Research) • See FAQ on PRIDE web site at http://www.research.va.gov/resources/policies/FAQs-for-researchers-research-offices.pdf

Advertising

Does VA permit fliers, advertisements, or other recruitment materials for research studies to be posted on VA premises? • Yes • No • It Depends

Advertising • YES for VA studies • NO for non-VA studies

Advertising “Posting” includes • Announcing • Distributing electronically (e.g., email) or in hard copy • Advertising electronically or in hard copy • Tacking up on bulletin boards • Setting out materials in waiting rooms • Putting on web sites

Can VA clinicians discuss non-VA research studies with their patients and refer them to non-VA investigators for more information about these studies? • Yes • No • It Depends

Advertising YES – the clinician • May tell a patient about a non-VA study • May give a patient contact information for a non-VA study However – the clinician • May not recruit patients for a non-VA study • May not obtain informed consent for a non-VA study • May not put out recruitment flyers for a non-VA study

Advertising VA staff can only provide the patient’s protected health information to a non-VA investigator if there is • A signed release form, and • A signed HIPAA authorization, and • He/she adheres to local requirements for release of medical information

If the IRB determines a study is exempt from IRB review, is the study overseen by any committee or subcommittee? • Yes • No • It Depends

Exempt Studies The R&D Committee is the review and approving committee of record. It performs • Initial review • Continuing review • Amendment review • Oversight VHA Handbook 1200.01, subparagraph 10c

Research Protocol An investigator has a project that involves a research intervention in cancer patients who require many medications and interventions. More

Does she have to do anything special in preparing her IRB application? • Yes • No • It Depends

Research Protocol She must clearly differentiate the research activity from the usual care in • The protocol, and • The informed consent form VHA Handbook 1200.05, paragraphs 9, 10, 17

An investigator wants to collect information on the pregnant partner of a research subject. Who is(are) the subject(s) of this study? • The subject • The pregnant partner • Both

Pregnancy The collection of information about the pregnant partner makes her a subject so • She must be included as a subject in the protocol • There must be an informed consent form for her

Does the investigator need a waiver from the Chief Research & Development Officer (CRADO) to collect information about this couple’s baby? • Yes • No • It Depends

Pregnancy YES – collecting information on the baby is considered research involving children and requires a waiver from the CRADO VHA Handbook 1200.05, paragraph 48

Pregnancy The investigator has already finished collecting her data on the children of the subjects but forgot to get a CRADO waiver. More

Can she request a CRADO waiver as long as it is before she publishes her results? • Yes • No • Maybe

Pregnancy NO - CRADO waivers cannot be granted retroactively What will happen to the results? See FAQ at http://www.research.va.gov/resources/policies/FAQs-for-researchers-research-offices.pdf

Continuing Review Expiration of IRB Approval An investigator was out of town and missed the deadline for continuing review. All his research activities stopped. More

Does the IRB have to perform a full initial review before the study can be re-started? • Yes • No • It Depends

Continuing Review Expiration of IRB Approval It may require continuing review or initial review depending on • How long the study has been expired (e.g., long enough for something to have changed that would necessitate a new initial IRB review?) • The nature of the study (especially the risks) • Local SOPs VHA Handbook 1200.05, subparagraph 22g

Multi-Site Studies

Local RCOs, Privacy Officers, and ISOs should treat the study at the local site like any other study no matter which of its IRBs of record approved it. • True • False • It Depends

Multi-Site Study Responsibilities RCOs, Privacy Officers, & ISOs • RCOs treat all studies the same • Privacy Officers do not have to review studies reviewed by the VA Central IRB • ISOs may need to work with the VA Central IRB ISO if there are local study-specific information security issues

Multi-Site Studies A VA facility will be one of 6 sites in a multi-site NIH study. Since the IRB of one of the other sites has already approved the study… More

Can the VA facility’s IRB use expedited review? • Yes • No • It Depends

Multi-Site Studies • YES – if the study meets the criteria for expedited review • NO - if it doesn’t

Engagement

Multi-Site Studies* Multi-site studies have more than one site engaged in research involving human subjects *VHA Handbook 1200.05, Paragraph 52

Engagement • VHA Handbook 1200.05, Paragraphs 50-51 • VA follows guidance from the Office for Human Research Protections (OHRP), October 16, 2008 http://www.dhhs.gov/ohrp/policy/engage08.html

Engaged in Human Subjects Research If a VA facility is engaged in human subjects research it must • Hold a Federalwide Assurance (FWA) • Have a local VA PI or Local Site Investigator (LSI) for that study • Have its IRB of record approve the study

Not Engaged in Human Subjects Research* If a VA facility is not engaged in any human research then • It does not need to have an FWA • It does not need to have an IRB • It does not need to have a local investigator • It has no jurisdiction over any human research *VHA Handbook 1200.05, Paragraph 51

Engaged in Human Research How do you make a determination as to whether or not a facility is engaged in human research?

Engaged in Human Subjects Research* In general, a VA facility is “engaged” when someone with a VA appointment obtains for the purposes of the research study • Data about the subjects of the research through intervention or interaction with them • Identifiable private information about the subjects of the research • The informed consent of human subjects for the research *VHA Handbook 1200.05, Paragraph 50

Engaged in Human Subjects Research The facility also is engaged if • It receives an award through a grant, contract, or cooperative agreement for human subjects research even if all activities involving human subjects are carried out elsewhere (e.g., if the grant comes to the nonprofit)

Who decides whether or not a local site is engaged? • The PI’s IRB of record • ORD • ORO • Any of the above

EngagementMulti-Site Studies • For most projects, the PI’s IRB of record should be able to make this determination • If there are any questions, ORD & ORO can provide assistance

When the research will involve a site(s) that is not engaged, the VA PI has to obtain permission from the non-engaged VA facility’s director to perform the research at that site • True • False

Multi-Site Study Responsibilities Principal Investigator (PI)* The VA PI just has to notify the Director of the non-engaged VA facility. He does not have to obtain permission VHA Handbook 1200.05, Paragraph 52a(1)

EngagementDual Appointment Investigators How can you determine if the VA is “engaged”? • Is engaged if he/she uses VA resources (e.g., works on her VA time, uses VA space or equipment) • Is not engaged if he/she does not use VA resources (e.g., works on her university time, in her university office & lab, using her university computer & university research team)

Determining Who is Engaged & Which IRB(s) Review Studies • Who is the sponsor? (e.g., ORD* or not) • Where are PI(s) & other research staff appointments? • What sites will be participating? • Who obtains informed consent? • Who interacts/intervenes? • Who provides private identifiable information? • Who obtains private identifiable information? • Who uses, studies, or analyzes private identifiable information? *ORD sponsored multi-site studies go to VA Central IRB

ORD Common Findings