ord common questions k. lynn cates, md assistant chief research & development officer director,...

ORD Common Questions

K. Lynn Cates, MDAssistant Chief Research & Development OfficerDirector, PRIDE

December 5, 2012

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ORD Policies

• ORD is responsible for 1200 series handbooks including VHA Handbook 1200.05 (Human Subjects Research)

• See Policies, Guidance & FAQ on PRIDE web site at http://www.research.va.gov/resources/policies/default.cfm

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VA Research

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What is VA Research?*

• VA research is research conducted by VA investigators (serving on compensated, work without compensation (WOC), or Intergovernmental Personnel Agreement (IPA) appointments) while on VA time, utilizing VA resources (e.g. equipment), or on VA property including space leased to, or used by VA. The research may be funded by VA, by other sponsors, or be unfunded.

*VHA Handbook 1200.01, R&D Committee

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Implications of a Study’s Being“VA Research”

• VA R&D Committee approval makes the study “VA Research” &, therefore, VA is responsible for

• The ethical conduct of the research including protecting the rights & welfare of research subjects

• Ensuring the research is carried out in accordance with all VA & other requirements

• Investigators must use VA Form 10-1086 to obtain informed consent if documentation of informed consent is required (DoD exception)

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Implications of a Study’s Being“VA Research”

VA medical facilities must provide necessary medical treatment to a research subject (Veteran or non-Veteran) injured as a result of participation in a research study approved by a VA R&D Committee & conducted under the supervision of one or more VA employees.*

*38 CFR 17.85 & VHA Handbook 1200.05 § 60a

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“Recruitment Only” Studies

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“Recruitment Only” Studies*

Does VA permit its R&D Committees to approve studies in which the VA’s sole involvement is to solicit participation of Veterans in research conducted by non-VA personnel at a non-VA entity?

*See FAQ on ORD web site at http://www.research.va.gov/resources/policies/FAQs-for-researchers-research-offices.pdf

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“Recruitment Only” Studies

• A VA investigator should have a substantive role in any VA Research (not just recruiting Veterans for a non-VA study)

• VA R&D Committee cannot approve a study that is conducted entirely by non-VA investigators

• VA R&D Committee approval makes the study “VA Research” & obligates VA to provide

• Care for research-related injuries

• Oversight of the research

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Advertising

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Advertising*

Does VA permit fliers, advertisements, or other recruitment materials for research studies to be posted on VA premises?

*See FAQ on ORD web site at http://www.research.va.gov/resources/policies/FAQs-for-researchers-research-offices.pdf

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Advertising

• YES for VA studies

• NO for non-VA studies

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Advertising

“Posting” includes

• Announcing (orally or in writing)

• Distributing electronically (e.g., email) or in hard copy

• Advertising electronically or in hard copy

• Placing on bulletin boards

• Setting out materials in waiting rooms

• Putting on web sites

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Clinicians & Non-VA Research

Can VA clinicians discuss non-VA research studies with their patients & refer them to non-VA investigators for more information about these studies?

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Clinicians & Non-VA Research

YES – VA clinicians

• May tell their patients about a non-VA study

• May give their patients contact information for a

non-VA study

However – VA clinicians• 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

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Clinicians & Non-VA Research

Can VA clinicians give non-VA investigators contact information for VA patients if the patients are interested in the non-VA study?

• VA staff can only provide the patient’s protected health information to a non-VA investigator if there is

• A signed release form/HIPAA authorization, and

• They adhere to local requirements for release of medical information including those in VHA Handbook 1605.1

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Clinicians & Non-VA ResearchDual Appointment Investigators

Can an investigator with a dual appointment refer her VA patients to her own non-VA study at the affiliate?

• Conflict of interest issues

• Standards of Conduct from the Office of Government Ethics (OGE)

• A Federal employee cannot use his/her public office for private gain

• Contact OGC Ethics Specialty Team

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VA Human Research Protection Training

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VA Human Research Protection Training*Who has to take it?

• All individuals involved in conducting VA human research

• Research team members (e.g., investigators, study coordinators, research assistants, etc.)

• Trainees (e.g., house officers & students)

• Members of the research office with responsibilities for human research (e.g., ACOS & AO)*ORD only has authority over human research protection training (not other training such as Ethics, Information Security, Privacy, etc.)

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VA Human Research Protection TrainingWho has to take it?

• VA IRB staff, voting & nonvoting IRB members

• VA representatives to affiliate IRBs

• Voting & nonvoting R&D Committee members

• Members of other research committees or subcommittee with responsibilities for protecting human research subjects*

*Not the Subcommittee on Research Safety (SRS)

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VHA Human Subjects Research TrainingWho does not have to take it?

• Secretarial support staff

• Research office staff whose responsibilities do not involve human research

• Facility Directors - but they are required to complete the required Assurance training (VHA Handbook 1058.03)

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VHA Human Subjects Research TrainingWho does not have to take it?

• Non-VA employees (e.g., phlebotomists, x ray, & laboratory technicians) whose work occurs exclusively outside the VA facility must meet their own institutions’ requirements for training, but the local VA facility is not required to track such training

• Providers of clinical services

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VHA Human Subjects Research TrainingWhen does it have to be taken?

• Every two years

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VHA Human Subjects Research TrainingDoes it have to be CITI?

• No – see PRIDE web site* for approved substitutes for CITI, including

• Some in-person PRIDE training

• Some local VA courses

• Some local affiliate courses

• PRIM&R meetings

*http://www.research.va.gov/pride/training/options.cfm

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Record Retention

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Record RetentionHow long must local VA research records be kept?

• Until the National Archives & Record Administration (NARA) approves the proposed record retention schedule & VHA publishes it

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Record RetentionWhat records must be kept?

The Federal Records Act (FRA) defines “Federal records” as all material, regardless of physical form, made or received by your research program that is connected with transaction of the Agency’s business, (i.e., the conduct of VA’s research programs & VA research) & the materials are preserved or appropriate for preservation because they are evidence of VA’s activities or they have sufficient information value to warrant preservation.

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Examples of Documents Usually Considered to be Federal Records• Policies & procedures documents

• Statistical data

• Reports

• Legal opinions & decisions

• Research data & studies

• Letters & memoranda

• Completed forms

• Photographs, audio & video recordings

• Posters & graphics

• Working files

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What is Usually Not a Federal Record?*

• Technical references

• Informational documents

• Personal papers & files

*There may be some circumstances when these documents are considered to be Federal Records

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Record RetentionHow should Federal records be stored & secured?

• Prevent them from being changed or destroyed

• Ensure they are retrievable

• Ensure they are “readable”

• Secure them from unauthorized access

• Maintain electronic Federal records on the VA server

• Meet all security requirements in VA Handbook 6500

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Changes in

Study Team Members

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Changes in Study Team Members*

When do changes in study team members require IRB review & approval?

• Principal Investigator (PI) or Investigator

• Local Site Investigator (LSI)

• Co-PI or Co-LSI

• If a study team member is listed by name (instead of by title) in the IRB-approved protocol or informed consent form

• If the IRB requires it for a given individual*38 CFR 16.103(b); VHA Handbook 1200.05 § 9(c)

•

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Exempt Studies

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Exempt Studies

If the IRB determines a study is exempt from IRB review, is the study overseen by any committee or subcommittee?• Yes

• No

• It depends

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Exempt Studies

• The R&D Committee is the review & approving committee of record. It performs

• Initial review

• Continuing review

• Amendment review

• Oversight

VHA Handbook 1200.01 § 10c

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Social Media

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Credentialing, Privileging

& Scopes of Practice

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Credentialing & Privileging

• The local VA facility’s Human Resource Management Service (i.e., HR Office) is responsible for credentialing VA facility staff, including research staff. When appropriate, the local facility is responsible for privileging

• The local VA Research Office is responsible for ensuring everyone who conducts human research has the appropriate credentials and, when appropriate, privileges, to perform all their research duties

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Privileging*

Clinical Privileging is the process by which a practitioner, licensed for independent practice, is permitted by law and the facility

• To practice independently, and

• To provide specified medical or other patient care services within the scope of the individual’s license, based on the individual's clinical competence as determined by peer references, professional experience, health status, education, training, and licensure.

*VHA Handbook 1100.19 § 3e &

VHA Handbook 1200.05 § 3hhh

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Privileging

• Clinical privileges must be facility-specific and provider-specific

• If the local VA facility where the research is to be performed requires privileges to perform a given duty (e.g., a procedure such as a muscle biopsy) in the clinical setting, the individual must have clinical privileges to perform that duty at that facility before he/she can perform that duty in the research setting

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Scope of Practice/Functional Statement

• Research Scope of Practice or Functional Statement must be consistent with the position to which the individual is appointed and it must define the responsibilities, duties, actions, and processes that are permitted for an individual

• Purpose is to ensure the individual and his/her supervisor both understand what the individual can and cannot do

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Research Scope of Practice

• Must be consistent with the occupational category under which the individual was hired

• Must not include any duties for which the individual is not qualified

• Must define the duties the person is allowed to perform for research purposes

• Must be approved by the individual’s immediate supervisor and the ACOS/R&D

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Research Scope of Practice*

• Each member of the research team must have a research scope of practice statement or functional statement unless the employees’ clinical privileges, clinical scope of practice statement, or clinical functional statement includes all of the duties necessary for a specific research study

• A research scope of practice or functional statement must be developed for all research personnel who are not privileged for all the duties the person is allowed to perform for research purposes

*VHA Handbook 1200.05 § 62

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Scope of Practice

• If research personnel are involved in more than one study, the research scope of practice statement or functional statement may be written to cover multiple studies

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CRADO Waivers

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VA Research Involving Children*

When do you need a waiver from Chief Research & Development Officer (CRADO)?

• Any VA research involving children – including research involving biological specimens** or data** obtained from children

• If the whole study does not involve children, the CRADO waiver is not needed to initiate the study, but it is needed before children, or their specimens and/or data are involved

*VHA Handbook 1200.05 § 48

**Identified, de-identified, or coded

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International Research*

When do you need a CRADO waiver?• For VA-approved research

• Conducted at international sites (i.e., not within the U.S., its territories, or Commonwealths)

• Using human biological specimens** and/or human data** originating from international sites

• Entailing human biological specimens** and/or human data** sent out of the U.S.

*VHA Handbook 1200.05 § 56

**Identified, de-identified, or coded

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International Research*

When do you need a CRADO waiver for multi-site international studies?• VA is a sponsor or coordinating center

• VA subcontracts to a foreign site

• The principal investigator for the total study is a VA investigator, or

• The VA investigator is collaborating with an international investigator and is sending and/or receiving data or specimens

* VHA Handbook 1200.05 § 56

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International Research*

A CRADO wavier is not needed

• If VA is only one of the participating sites in a multi-site international study and the study does not meet the criteria on prior slide for multi-site international studies

• If the research is conducted at U.S. military bases, ships, or embassies

* VHA Handbook 1200.05 § 56

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CRADO Waivers

The investigator has already finished collecting her international data but forgot to get a CRADO waiver. Can she request a CRADO waiver as long as it is before she publishes her results?

• Yes

• No

• Maybe

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CRADO Waivers

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

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HIPAA

Privacy Officers & ISOs

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HIPAA Authorization*

• HIPAA Authorization must be a standalone document

• Privacy Officer reviews HIPAA Authorization to verify it meets requirements but does not “approve” it

• IRB does not have authority to approve a HIPAA Authorization, but it can approve a waiver of HIPAA Authorization

* VHA Handbook 1200.05 § 37

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Waiver of HIPAA Authorization*

• IRB or Privacy Board can approve waiver of HIPAA Authorization

• IRB must document its approval of the waiver

• IRB must document its determinations as specifically required by the HIPAA regulations

• IRB can use VA Form 10-0521 (waiver of HIPAA authorization form)

* VHA Handbook 1200.05 § 37

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Privacy Officer & ISO Responsibilities*

• Providing a summary report to the IRB of findings in a timeframe that does not delay the approval process (not necessarily same as final report)• Convened IRB - Prior to or at the meeting (can

be presented orally at the meeting instead of in writing)

• Expedited Review - Prior to IRB approval

• Exempt Studies - To ACOS/R&D

• Make recommendations to investigators

• Follow up with investigators

* VHA Handbook 1200.05 § 38

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VA Central IRB

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RCO, Privacy Officer & ISOVA Central IRB Studies

• 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

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SAVE THE DATEWebinar for Local Liaisons to VA Central IRB

Purpose: Information on VA Central IRB operations

Date: Monday, December 17, 2012

Time: 3 p.m. EST

Target Audience: Local Liaisons to the VA Central IRB & others who have interactions with the VA Central IRB

Live Meeting & VANTS: To Follow

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Accreditation

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VA Human Research Protection ProgramAccreditation Update

• Alion is working on standards & procedures

• Training will be provided before the process starts

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