**\[Doc. 106\]**

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| **RESEARCH INVESTIGATOR**                                             |
|                                                                       |
| **MANUAL OF POLICIES AND PROCEDURES**                                 |
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| **INCLUDING RESEARCH STAFF, VA EMPLOYEES,\                            |
| MEDICAL STAFF, STUDENTS,\                                             |
| SPONSORS, RESEARCH PARTICIPANTS**                                     |
|                                                                       |
| **IRB MEMBERS AND STAFF**                                             |
|                                                                       |
| **AND THE RESEARCH REVIEW UNIT**                                      |
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| **\                                                                   |
| TO UPHOLD ETHICAL**                                                   |
|                                                                       |
| **STANDARDS AND PRACTICES**                                           |
|                                                                       |
| **IN RESEARCH**                                                       |
|                                                                       |
| **VA ANN ARBOR HEALTHCARE SYSTEM**                                    |
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| **Ann Arbor VA Research Website**                                     |
|                                                                       |
| [**http://www1.va.gov\\aavaresearch**]()                              |
|                                                                       |
| 7-19/2008                                                             |
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**CONTENTS**

Section 1: What is Human Subjects Research? page 3

Section 2: Information The Investigator Provides to the VA IRB page 5

Section 3: Important Ethical Obligations and Expectations for
Investigators page 8\
Research Staff and Sponsors Who Conduct Human Subject Research\
and IRB Members and IRB Staff

Section 4: Obtaining Informed Consent at the VA Ann Arbor Healthcare
System page 10

Section 5: VA IRB Observation of Informed Consent Policies and
Procedures page 14

Section 6: VA AAHS Human Studies Research Education Policy page 16

Section 7: Policy And Procedures for Dealing With Conflicts of Interest
page 17

Section 8: Investigators Must Meet all Government Requirements and
Regulations page 21\
for Conducting Human Subjects Research

Section 9: Policy And Procedures For Dealing With Research Misconduct
page 22

Section 10: VA AAHS Research Noncompliance Management Policy page 38

Section 11: Data Safety Monitoring Policies and Procedures page 42

**1.** **Human Subjects Research Assessment Survey**

-   **The VA ACOS/ Research and/ or the IRB Coordinator will assist
    investigators to determine if their proposed activity must be
    reviewed by the VA IRB.**

-   **The VA IRB maintains the authority to determine when human subject
    research may qualify for exemption from IRB review at the VAAAHS.**

**Quality Improvement (QI) Projects**

Use of a patient's PHI or biological sample for quality improvement
projects is deemed health care operations and does not require IRB
approval or authorization/waiver of authorization. A quality improvement
project, by definition, is a project to look at outcomes or other
assessments of patient care for INTERNAL use only. Thus, the PHI will
not be shared outside of the covered entity, nor published or presented.
If a quality improvement project has the potential to generate
information that may contribute to generalizable knowledge and the
clinician caring for the patient will aspire to publish or present the
information, the activity may be research. Please consult the DHHS and
FDA Check-Lists below.

**Case Reports**

Use of a patient's PHI or biological sample for case reports of 1-2
patients for publication does not require IRB approval or
authorization/waiver of authorization, providing the patient was treated
by the person reporting the case(s) and the information is
de-identified. However, should there be 3 or more cases, the activity
may be research. Please consult the DHHS and FDA Check-Lists below.

**HUMAN SUBJECTS RESEARCH CHECK-LIST**

**[Step 1: Is it Research?]{.underline}\
** \[ \] Yes, \[ \] No Does the activity involve a systematic
investigation designed to develop or contribute to\
generalizable knowledge? **If Yes, go to Step 2.**\
If No, the activity is not research as defined by DHHS. **Go To Step
4!**

**[Step 2: Is it Human Research?]{.underline}**\
\[ \] Yes, \[ \] No Does the research involve collecting information
about living persons?\
**If Yes, go to Step 3.**\
If No, the activity is not human subjects research as defined by DHHS.
**Go To Step 4!**

**[Step 3: Is the activity DHHS-Regulated Research on Human
Subjects?]{.underline}**\
\[ \] Yes, \[ \] No (a) Does the research involve collecting data
through intervention (physical procedures or\
manipulations) or interactions (communications or personal contact) with
the individuals?\
\[ \] Yes, \[ \] No (b) Does the research involve collecting
individually identifiable private information (such as protected\
health information) about living persons)?\
\[ \] Yes \[ \] No (c) Does the activity involves a retrospective chart
review of outcomes of patients on a certain drug or\
device in the course of medical practice?\
\[ \] Yes \[ \] No (d) Does the activity involves a prospective study of
the outcomes of patients who were prescribed a\
drug or device by their personal physicians, or compares the diagnostic
results of scans or tests ordered by their\
personal physicians?

**If you answered Yes to (a) or (b) or (c) or (d), the activity is
"DHHS-Regulated Research on Human Subjects".\
(Continue to Step 4.)**

**[Step 4: Is the activity FDA-Regulated Research on Human
Subjects?]{.underline}**

> \[ \] Yes \[ \] No (a) Does the activity involve the use of a drug,
> other than the use of an approved drug in the course of standard
> medical practice? (Including record/image/chart reviews of patients
> who received FDA regulated products or controls, not in course of
> medical practice.)
>
> [Drugs]{.underline} Including: a substance recognized by an official
> pharmacopoeia or formulary; a substance intended for use in the
> diagnosis, cure, mitigation, treatment, or prevention of disease; a
> substance (other than food) intended to affect the structure or any
> function of the body; a substance intended for use as a component of a
> medicine but not a device or a component, part or accessory of a
> device; a biologic product (any virus, serum, toxin, antitoxin,
> vaccine, blood, blood component or derivative, allergenic product, or
> analogous product) applicable to the prevention, treatment, or cure of
> diseases or injuries. *(A Dietary supplement for which the activity
> involves a disease claim will be treated as a drug.)*
>
> \[ \] Yes \[ \] No (b) Does the activity involve the use of a medical
> device, other than the use of an approved medical device in the course
> of medical practice.
>
> M[edical Devices]{.underline} Including: an instrument, apparatus,
> implement, machine, contrivance, implant, software, in vitro reagent,
> or other similar or related article, including a component part, or
> accessory which is: recognized in the official National Formulary, or
> the United States Pharmacopoeia, or any supplement to them, intended
> for use in the diagnosis of disease or other conditions, or in the
> cure, mitigation, treatment, or prevention of disease, in man or other
> animals, or intended to affect the structure or any function of the
> body of man or other animals, and which does not achieve any of its
> primary intended purposes through chemical action within or on the
> body of man or other animals and which is not dependent upon being
> metabolized for the achievement of any of its primary intended
> purposes.
>
> \[ \] Yes \[ \] No (c) Will the results of the activity be submitted
> to the FDA or held for inspection by the FDA.
>
> \[ \] Yes \[ \] No (d) Will tissue specimens be used to test the
> effectiveness of a medical device and will the information be
> submitted to the FDA for FDA approval of the device (even if
> data/tissue is anonymized).

**If you checked No to (a) and (b) and (c) and (d), the research
activity is not FDA-Regulated. Skip to Step 5**

**IF you checked Yes to (a) or (b) or (c) or (d) then continue below:**

> \[ \] Yes \[ \] No (e) Does the activity involve individual who is or
> becomes a participant in research, either as a recipient of an FDA
> regulated product (approved or experimental) or as a control, as
> directed by a research protocol and not by medical practice?
>
> \[ \] Yes \[ \] No (f) Does the activity involve an individual who
> participates in an investigation, either as an individual on whom or
> on whose specimen an investigational device is used or as a control?

**If you checked Yes to (e) or (f) then the research activity is
"FDA-Regulated Research on Human Subjects"**

*• The consent process must disclose that the FDA may inspect the study
records;*

*• Consent documents must be dated;*

*• Consent cannot be waived except under the planned emergency research
regulations; and*

*• Consent documentation may only be waived if the activity is minimal
risk and documentation of consent is not ordinarily required outside the
research context.*

**[Step 5: Human Subjects Research Engagement Survey - VA Ann Arbor
Healthcare System]{.underline}**

\[ \] **A. VA IRB Review is required for Human Subjects Research
Conducted at Ann Arbor VAMC**

[You must submit a VA Human Studies Research Application\
if **\*ANY\*** of the following research activities will take place at
the Ann Arbor VAMC or other VAMC Sites**^1^**]{.underline}

> \[ \] 1. Human research subjects will be recruited
>
> \[ \] 2. Human research subjects will participate in research (DHHS or
> FDA)
>
> \[ \] 3. Human research samples will be analyzed
>
> \[ \] 4. VA medical records will be accessed for research
>
> \[ \] 5. Human research data (with identifiers) will be managed and
> /or stored
>
> \[ \] 6. VA funds will be used to support the research
>
> \[ \] 7. VERAM will administer the project funds

## Please download the most recent version of the Ann Arbor VA IRB Application at this web-site [**http://www1.va.gov/aavaresearch**](http://www1.va.gov/aavaresearch) You must obtain approval from the Ann Arbor VA Research Service before starting your research. 

\[ \] **B. Exclusion from Human Subjects Research Review**

> [(If you cannot check all boxes 1-7, then please go back to Section
> A.)]{.underline}
>
> \[ \] 1. No human research subjects will be recruited at the Ann Arbor
> VAMC or other VAMC Sites**^(1)^**
>
> \[ \] 2. No human research samples will be tested at the Ann Arbor
> VAMC or other VAMC Sites**^(1)^**
>
> \[ \] 3. No medical records will be accessed for research at the Ann
> Arbor VAMC or other VAMC Sites**^(1)^**
>
> \[ \] 4. No human research data will be managed for stored at the Ann
> Arbor VAMC\
> or other VAMC Sites**^(1)^**
>
> \[ \] 5. No VA funds will be used to support the research
>
> \[ \] 6. No VERAM administration of the project funds
>
> \[ \] 7. The research will not be conducted on VA paid staff time and
> will not use VA resources.
>
> *(1) Other VA Sites = Battle Creek VAMC, Saginaw VAMC, Toledo VAMC,
> Flint VA CBOC,\
> Jackson VA CBOC and Intensive Psychiatric Community Care Clinic (Ann
> Arbor)*

**2. INFORMATION THE INVESTIGATOR PROVIDES TO THE VA IRB.**

**A. Professional qualifications** to do the research (including a
description of necessary support services and facilities).

**B. Study Protocol** which includes/addresses

> 1\) Title of the study and the sponsor of the study
>
> 2\) Purpose of the study (including the expected benefits obtained by
> doing the study).
>
> 3\) Results of previous related research.
>
> 4\) Subject inclusion/exclusion criteria.
>
> 5\) Justification for use of any special/vulnerable subject
> populations
>
> 6\) Study design (including as needed, to support an evaluation of
> sources and mitigators of risk).
>
> 7\) Description of procedures to be performed, extra costs to subjects
> for their participation in the study
>
> 8\) Identification of risks that may result from the research and
> steps taken to minimize risk.
>
> 9\) Information about the probable benefits of the research, including
> the anticipated benefits to subjects and the importance of the
> knowledge that may be reasonably expected to result from the research.
>
> 10\) Information about the reasons for inclusion of vulnerable
> subjects and additional safeguards to protect their rights and welfare
>
> 11\) The circumstances surrounding consent procedure, including
> subject autonomy concerns, language difficulties and vulnerable
> populations.
>
> 13\. Advertisements and/or brochures used for subject recruitment and
> description of recruitment methods
>
> 13\) Payment to subjects for their participation and any compensation
> for injured research subjects.\
> *The VA IRB will not allow excessive payments to research subjects
> that may be a coercive influence on the subject's decision to
> participate in the research study. The nature and amounts of
> compensation must be fully described in the Consent Form.*
>
> 14\) The VA IRB will not allow investigators, physicians, or other
> health care providers to accept personal compensation for recruitment
> of research subjects. *The VA IRB will allow a study sponsor to
> reimburse the medical center for performing the study and/or the
> recruitment of research subjects. This condition must be described in
> the VA Consent Form.*
>
> 15\) Procedures for documentation of informed consent, including any
> procedures for using witnesses, translators and document storage and
> provisions for protection of subject\'s privacy.

**C. Investigator\'s Brochure** (when one exists); relevant Grant
Applications

**D. Texts** of Questionnaires, Survey Instruments, Advertisements and
Recruitment Materials for subject recruitment (if applicable)

**E. The informed consent document**

> A description of VA IRB policies and procedures for informed consent
> are found in the policy document: "How To Prepare a VA Consent Form
> and Obtain Informed Consent at the VA Ann Arbor Healthcare System"
> (part of the VA IRB Application Form)

**F. Plan for Monitoring Safety**

1)  The research plan must make adequate provisions for monitoring the
    data collected to ensure the safety of subjects (38 CFR
    16.111(a)(6)).

2)  The plan may include establishing a Data Safety and Monitoring Board
    (DSMB) or a Data Monitoring Committee (DMC) as required by DHHS or
    FDA policy and a plan for reporting DSMB or DMC findings to the IRB.

3)  The research study team must include a qualified clinician to be
    responsible for all study-related healthcare decisions.

**G. Requests for proposed changes in approved research projects.**

> 1\) Protocol changes in approved research projects may not be
> initiated without review and approval by a meeting of the convened VA
> IRB.
>
> 2\) Investigators of a previously approved project must submit an
> Amendment Request Form to make amendments in various aspects of the
> project. The date of approval of an amendment does not change the date
> by which the next regularly scheduled continuing review of the project
> is to be completed.
>
> 3\) An amendment may be in the content or the form of documentation.
> Types of amendments include the following:
>
> a\) Amendment for a change in the study protocol
>
> b\) Amendment in the investigator\'s brochure describing a test
> article
>
> c\) Amendment in the informed consent document
>
> d\) Amendment in the investigatorship.
>
> 4\) Different types of amendments may be requested individually or in
> combination.

a)  Information that may impact on the risk/benefit ratio should be
    promptly reported to and reviewed by, the IRB to ensure adequate
    protection of the welfare of the subjects.

b)  A change in the study protocol or investigator\'s brochure may
    require a change in the informed consent document. The VA IRB will
    scrutinize the amendment documents to determine the degree to which
    risks to human subjects may have changed, if there is any need to
    revise the consent document and if changes in the consent document
    are adequate. A copy of the current and the revised informed consent
    document shall accompany the amendment application.

**H. Reports of Unanticipated Problems to Research Participants and
Others**

> A complete description of definitions, investigator reporting
> responsibilities, IRB review procedures, possible IRB actions and IRB
> reporting policies and procedures is found in a separate policy
> document**\
> \[VA AAHS Policies and Reporting Form for Unanticipated Problems
> (UPR)\] \[Doc. 110\]**

**I. Progress reports and additional measures to monitor active research
projects.**

1)  Additional monitoring of approved projects will occur in the form of
    data required for Continuing Review and targeted or random reviews.

> a\) Yearly (or more frequent) requests for Progress Reports submitted
> as part of Continuing Review,
>
> b\) Examinations of research records held by the principal
> investigator,
>
> c\) Contacts with former and current research subjects,
>
> d\) Dispatch of observers to the sites, where research involving the
> human subjects is being conducted, or

2)  Verification that no material changes in the study have occurred. In
    targeting research projects to be subjected to these additional
    monitoring activities, the VA IRB will consider:

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a)  the level of risks of harm,

b)  the frequency and nature of adverse events,

c)  the vulnerability of the subjects of research,

d)  information provided by from other sources and

e)  any complaints received from the subjects.

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3)  Such criteria could include some or all of the following:

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a)  Randomly selected projects;

b)  Complex projects involving unusual levels or types of risk to
    subjects;

c)  Projects conducted by investigators who previously have failed to
    comply with the requirements of the HHS regulations or the
    requirements or determinations of the IRB.

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4)  If the information gained during the monitoring process indicates
    that human subjects of a research project are exposed to unexpected
    serious harm, or the requirements of the VA IRB are not being met,
    the VA IRB may suspend or terminate the research. In such instances,
    the VA IRB will provide the opportunity of rebuttal for the
    investigators, either in writing, or by appearing at a meeting of
    the VA IRB to defend their cases.

**J. Final Report.**

> Investigators of a previously approved project are obligated to notify
> the VA IRB of the completion of the project and to submit a final
> report of human subject enrollment and any unreported adverse events.

**K. Institutional Forms/Reports**

> Investigators of a previously approved project are obligated to
> complete all required institutional forms/reports to maintain
> compliance with local, state and federal regulations.

**L. Reporting Site Visits by Pharmaceutical Co. Monitors**

> 1\. The ACOS/R&D or his/her designee must be notified of all
> monitoring visits by pharmaceutical companies or contract research
> organizations (CROs) as soon as possible. This is the responsibility
> of the research staff person who schedules or confirms the monitoring
> visit. If the monitoring visit is unscheduled, the ACOS/R&D must be
> notified as soon as the study personnel are aware of the visit.
>
> 2\. The CRO or study monitor must sign in as a visitor at the research
> office as required of all visitors to research areas.
>
> 3\. The Principal Investigator or other responsible investigator is to
> meet with the study monitor(s) prior to the monitors\' beginning their
> work. During each visit by a monitor, the role of the monitor should
> be reviewed,.
>
> 4\. Any potential or actual serious findings must be conveyed to the
> investigator and the ACOS/R&D, Administrative Officer for Research
> (AO/R&D) or his/her designee during an exit interview.
>
> 5\. If the monitor records no serious findings or concerns, the study
> investigator or research coordinator must notify the research office
> (in writing) that there were no such findings identified by the
> monitor.

**3. IMPORTANT ETHICAL OBLIGATIONS AND EXPECTATIONS FOR INVESTIGATORS,
RESEARCH STAFF, IRB MEMBERS AND IRB STAFF**

AAHRPP requires the AAHS to establish policies, procedures, and
education programs to help its investigators carry out research studies
ethically. In addition to following applicable federal, state, and local
regulations, investigators follow ethical principles and standards
appropriate for their discipline. In designing and conducting clinical
trials, investigators follow Good Clinical Practice guidelines defined
by the Food and Drug Administration. In designing and conducting
research studies, Investigators have the protection of the rights and
welfare of research participants as their primary concern.

**A. Conflict of Interest Considerations**

1\. Research Investigators and Staff must consider conflicts of interest
that might affect the relationship with the participant or the outcomes
of the research, and with the organization.

2\. Research Investigators and Staff must comply with all AAHS polices
and procedures that require disclosure in the **VAAAHS Conflict of
Interest Management Policy**.

**B. Study Design to Monitor and Report Information to Participants**

1\. Research Investigators must employ sound study design in accordance
with the standards of the discipline.

2\. Research Investigators must implement reporting mechanisms that
provide information relevant to monitoring the rights and welfare of
participants enrolled in the research.

3\. Research Investigators must comply with the reporting requirements
described in the VA IRB policy statement **Information The Investigator
Provides To The VA IRB**.

**C. Evaluation of Less Risky Alternatives and Plans for Detecting
Harm**

1\. Investigators must describe plans to minimize the risk of harm to
their participants.

2\. In research involving greater than minimal risk to participants, the
Investigator must provide the IRB with an evaluation of less risky
alternatives (if any are available).

3\. Investigators must describe plans for detecting harm promptly and
mitigating potential injuries.

4\. Investigators must provide appropriate responses to these concerns
in the **VA IRB Application Form** (the most recent version) and the
**VA IRB Continuation Request Form** (transmitted by automated e-mail).

**D. Fair and Equitable Recruitment of Participants**

1\. Investigators must describe plans to recruit participants in a fair
and equitable manner.

2\. Investigators must, weigh the potential benefits of the research to
the participants against their vulnerability and the risks to them.

3\. Investigators must provide appropriate responses to these concerns
in the **VA IRB Application Form** (the most recent version) and the
**VA IRB Continuation Request Form** (transmitted by automated e-mail).

4\. Compensation for identifying and/or enrolling subjects.

> a\) The VA IRB will not allow direct compensation to investigators,
> physicians and other health care providers for identifying and/or
> enrolling subjects (\"finders fees\").
>
> b\) The VA IRB will not allow payments designed to accelerate
> recruitment that are tied to the rate or timing of enrollment ("bonus
> payments"). (The IRB may grant an exception if the investigator can
> present a compelling reason for the exception.)
>
> c\) When a clinical trial is funded by an industrial sponsor, the
> research subject must be informed. One of these statements should be
> included in the Special Circumstances section:
>
> *i. "The sponsor funds the VA hospital based on the number of research
> subjects enrolled."*
>
> *ii. "The sponsor provides a fixed payment to the VA Hospital for
> performing the study."*

**E. Documentation of Adequate Resources and Facilities**

1\. Investigators conducting a research study involving human
participants must document in the protocol that there are adequate
resources and facilities to carry out the research.

2\. Investigators must provide appropriate responses to these concerns
in the **VA R&D Application Form** (the most recent version).

**F. Importance of Participant Comprehension and Voluntary
Participation**

1\. Investigators must develop an informed consent process and method of
documentation appropriate to the type of research and the study
population.

2\. Investigators must respect the importance of participant
comprehension and voluntary participation.

3\. Investigators understand the concept of legally effective informed
consent.

4\. Investigators must appropriately document informed consent.

5\. Investigators understand the difference between the informed consent
process and the documentation of informed consent.

6\. Investigators must comply with all requirements in the VA IRB policy
statement **Obtaining Informed Consent at the VA Ann Arbor Healthcare
System**

**G. Response to Participants' Complaints or Requests for Information**

1\. The AAHS fosters a culture that encourages all research workers and
research subjects to ask questions and report problems so that
corrective actions can be taken before serious problems occur and formal
actions are required.

2\. Investigators and research staff must respond to participants'
complaints or requests for information.

3\. Investigators must comply with all requirements in the VA IRB policy
statement **AAHS Research Noncompliance Management Policy (Section 10)**

**4. OBTAINING INFORMED CONSENT AT THE VA ANN ARBOR HEALTHCARE SYSTEM**

1.  Investigators will prepare VA Form 10-1086 (Informed Consent
    document) and submit it along with the research proposal protocol to
    the R&D Committee and to the Subcommittee on Human Studies.\
    \[VA Consent Form 10-1086 is required if research subjects will
    participate at the Ann Arbor VA\
    or if the study is VHA-funded.\]

-   The Informed Consent needs to be written in language which the
    subjects can understand (short words and sentences, sixth-grade
    reading level)

-   This document should be as brief as possible but must cover all the
    Basic Elements and any required additional elements

-   Validated translations of consent forms must be available for
    non-English-speaking subjects, if applicable.

2.  The IRB prohibits any informed consent, whether oral or written,
    from including any exculpatory language through which the subject or
    the legally authorized representative is made to waive or appear to
    waive any of the subject\'s legal rights, or releases or appears to
    release the investigator, the sponsor, the institution or its agents
    from liability for negligence.

3.  The informed consent requirements in this policy are not intended to
    preempt any applicable federal, state, or local laws which require
    additional information to be disclosed in order for informed consent
    to be legally effective \[38CFR 16.116(e)\].

4.  Investigators must obtain informed consent prior to entering a
    subject into a study or performing any procedures required by the
    protocol, unless consent is waived by the VA IRB. The Consent Form
    must be the current version approved by the VA IRB.

5.  Informed consent is more than just a signature on a form, it is a
    process of information exchange that may include, in addition to
    reading and signing the informed consent document, subject
    recruitment materials, verbal instructions, question/answer sessions
    and measures of subject understanding. Institutional Review Boards
    (IRBs), clinical investigators, and research sponsors all share
    responsibility for ensuring that the informed consent process is
    adequate. Thus, rather than an endpoint, the consent document should
    be the basis for a meaningful exchange between the investigator and
    the subject.

6.  Informed Consent is the legal way of describing a "meeting of the
    minds" in a contract. In this situation, it means that the subject
    of the experimental procedure clearly understands what the
    experiment is, what the potential risks are, and has freely, and
    without pressure of any kind, elected to participate. The best way
    to ascertain that the consent is informed is to have the subject
    explain back fully to the interviewer his or her understanding of
    the project and what risks are involved. This facilitates
    clarification of any doubts.

7.  In explaining the investigation, the investigator may have to go
    somewhat beyond statements in the informed consent document. There
    must be, however, no addition, deletion, or modification of the
    written information. During the information process, the
    investigator should perform the following:

8.  Investigators must conduct informed consent by these ethical
    standards:

    \*\* Assess the subject's capacity to consent to a research
    protocol, including: an understanding of the nature of the research
    and of his or her participation; an appreciation the consequences of
    the participation, including personal consequences; showing the
    ability to consider alternatives, including the option not to
    participate; and showing the ability to make a reasoned choice.

    \*\*Ensure that information is given to the subject, or their
    legally authorized representative, in a language that is
    understandable to the subject or representative.

    \*\*Provide the prospective subject or the legally authorized
    representative sufficient opportunity to consider whether or not to
    participate.

    \*\*Ensure that subjects give consent without coercion or undue
    influence

    \*\*Investigators may not recruit study team members as subjects in
    this study.

    \*\*Individuals with impaired cognitive judgment but able to
    understand the research must give their assent to participate in the
    study. Individuals with impaired cognitive judgment but able to
    understand the research must give their assent to participate in the
    study. Persons are capable of assent if they \"know what procedures
    will be performed in the research, choose freely to undergo those
    procedures, communicate this choice unambiguously, and \[know that
    they\] may withdraw from participation. The \"mere absence of
    objection\" ought not be interpreted as assent. The consent of a
    potential subject's legal guardian to authorize greater than minimal
    risk research involving non-objecting persons incapable of assent.

    \*\*Individuals with impaired cognitive judgment must have a legally
    authorized representative. The subject's representative must be
    well-informed about the research and their role and obligation to
    protect the vulnerable subject.

    \*\*Informed consent for research may be obtained from: a health
    care agent appointed by the person in a DPAHC or similar document;
    court-appointed guardians of the person, or from next-of-kin in the
    following order of priority, spouse, adult child (18 years or
    older), parent, adult sibling (18 years of age or older),
    grandparent, or adult grandchild (18 years of age or older).

9.  The investigator is not required to personally conduct the consent
    interview. The investigator remains ultimately responsible, even
    when delegating the task of obtaining informed consent to another
    individual knowledgeable about the research. The investigator must
    submit to the IRB the names of all persons who will conduct the
    consent interview.

10. Investigators must always use copies of the current approved version
    of the VA Consent Form (Form 10-1086) that has the VA IRB stamp and
    dates of approval and expiration at the bottom of each page.

11. If the subject is not competent to make his/her own health care
    decisions, the VA-IRB requires the authorized legal representative
    to sign and date the consent document on the designated line on the
    Subject's Rights Page.

12. After fully understanding all the elements in the document, the
    subject (or subject's representative) must put their initials at the
    bottom of each page and then sign and date on the designated line on
    the Subject's Rights Page (last page).

13. Witness for Signed Informed Consent

14. a\) A witness must observe the signature of the research subject and
    sign the\
    Research Consent Form.\
    b) An independent person is required to witness the consent
    interview and the signature of the\
    subject or the subject's representative if the subject is competent
    to make decisions concerning\
    health care [but unable to read the document]{.underline}.

15. The principal investigator **or** designated IRB-approved study team
    member who obtains informed consent must sign and date the Consent
    Form on the bottom line on the Subject's Rights page.

16. The research subject should not begin participation in the study
    until the Consent Form is signed and dated by all the persons
    identified in these instructions and the subject receives a copy of
    the final signed version. A study team member must make at least one
    copy of the signed document.

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a)  The original signed copy must be kept in the investigator's project
    files.

b)  A second copy must be given to the subject.

c)  A scanned image must be placed in the patient's electronic medical
    record.

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```
17. Research Subjects (current, prospective or past) or their designated
    representatives should be told to contact the Research Compliance
    Officer or the IRB Coordinator to discuss any of these topics about
    research studies at the VAAAHS:

    a.  Questions about research.

    b.  Concerns about research.

    c.  Complaints about research.

    d.  Research related injury.

    e.  Questions about your rights as a research participant.

    f.  Discuss concerns when staff members of a research study are not
        available

    g.  Discuss concerns with someone other than a research study staff
        member.

> The Research Compliance Officer (RCO) can be reached at 734-761-7950
>
> The IRB Coordinator (IC) can be reached at 734-761-7951
>
> 18\. VA IRB Observation of Informed Consent\
> (See separate section: "[VA IRB observation of Informed Consent-
> Policies and Procedures]{.underline}".)
>
> a\) The VA IRB has the authority to evaluate the research plan and to
> observe the process to obtain informed consent as a method to provide
> additional safeguards to adequately protect the rights and welfare of
> research participants. The evaluation and/ or observation may include:

a.  Assessing the subject's capacity to consent to a research protocol,
    if applicable.

b.  Ensuring that information is given to the subject, or the subject's
    legally authorized representative, in a language that is
    understandable to the subject or representative.

c.  Providing the prospective subject or the subject's legally
    authorized representative sufficient opportunity to consider whether
    or not to participate.

d.  Ensuring that subjects give consent without coercion or undue
    influence.

> b\) Procedures

1)  The VA IRB will determine when it is appropriate to observe the
    informed consent process for a specific investigator (or authorized
    study team member) and for a research specific study.

2)  Protocols selected for consent observation may represent higher risk
    studies, studies that involve complicated procedures or
    interventions, studies involving potentially vulnerable populations
    or those involving study staff with minimal experience in
    administering consent to potential study participants

3)  The ACOS/ Research or the VA IRB Chair will appoint a trained
    Research Service staff member (Research Compliance Officer or IRB
    Coordinator) to observe the consent process and to submit a written
    report of findings.

> 19\. [Record Retention:]{.underline}
>
> The investigator's research records, must be retained for a minimum of
> 5 years after the completion of the study and in accordance with
> VHA\'s Records Control Schedule (RCS 10-1), applicable FDA and DHHS
> regulations, or as required by outside sponsors.
>
> 20\. COGNITIVE CAPACITY IMPAIRMENT IN THE COURSE OF RESEARCH

**\[see [Alzheimer's Dis. Assoc. Disord. v18, p171-175, July-Sept,
2004](http://www1.va.gov/aavaresearch/docs/research_consent_for_impaired_adults.pdf)\]\
\
**a) [Risk of Loss of Capacity]{.underline}: If at the time of
enrollment a participant who has the capacity to consent is known to be
at risk for loss of that capacity due to cognitive impairment, the
investigator must:\
(1) submit to the IRB a plan for reassessment of cognitive capacity and
capacity to consent if there is a clinically significant change in
cognitive function that could reasonably change the subject's current
status as either capable or not capable;\
(2) offer the participant the opportunity to appoint a proxy to make
ongoing consent decisions regarding the research project should the
participant's capacity to consent become impaired during the course of
the project; and\
(3) when applicable, ask the participant to give guidance to her or his
proxy about the conditions under which she or he would and would not
want to participate in the present and future protocols, in the event of
loss of capacity.\
b) [Apparent Loss of Cognitive Capacity]{.underline}: If a participant
who personally gave consent appears to lose cognitive capacity during
the study, the investigator must:\
(1) formally assess the participant's capacity to consent; and\
(2) if capacity is impaired, obtain permission for further research
participation from a proxy.\
c) [Intermittent Capacity]{.underline}: In cases of intermittent
capacity, periodic reevaluations are indicated. The proxy need not be
called on as long as, in the judgment of the investigator, all decisions
can be safely and appropriately delayed until the participant's
decisional capacity returns.\
d) [Documentation]{.underline}: Proper documentation of the processes
above must be kept in the participant's study records. Reassessment of
consent and assent and associated documentation should occur on a
regular basis during the course of the study, using a time schedule set
by the investigator with the IRB's approval. Documentation is to include
assessment of cognitive capacity, assessment of capacity to consent,
proxy identification and permission (if applicable), and assent.

**5. VA IRB OBSERVATION OF INFORMED CONSENT - POLICIES AND PROCEDURES**

**A. POLICIES**

> 1\. The VA IRB has the authority to evaluate the research plan and to
> observe the process to obtain informed consent as a method to provide
> additional safeguards to adequately protect the rights and welfare of
> research participants. The evaluation and/ or observation may include

a)  Assessing the subject's capacity to consent to a research protocol,
    if applicable.

b)  Ensuring that information is given to the subject, or the subject's
    legally authorized representative, in a language that is
    understandable to the subject or representative.

c)  Providing the prospective subject or the subject's legally
    authorized representative sufficient opportunity to consider whether
    or not to participate.

d)  Ensuring that subjects give consent without coercion or undue
    influence.

**B. SELECTION PROCEDURES**

> 1\. The VA IRB will determine when it is appropriate to observe the
> informed consent process for a specific investigator (or authorized
> study team member) and for a research specific study.

a)  Protocols selected for consent observation may represent higher risk
    studies, studies that involve complicated procedures or
    interventions, studies involving potentially vulnerable populations
    or those involving study staff with minimal experience in
    administering consent to potential study participants

b)  The ACOS/ Research or the VA IRB Chair will appoint a trained
    Research Service staff member (Research Compliance Officer or IRB
    Coordinator) to observe the consent process and to submit a written
    report of findings.

**C. OBSERVATION PROCEDURES**

> 1\. The Research Compliance Officer (RCO) or the (IRB Coordinator
> (IC)) will contact the study coordinator and/or the study Principal
> Investigator (PI) about observing consenting of study participants.
> Study staff will provide dates and times for the RCO to observe
> consenting in the GCRC.
>
> 2\. Just prior to observing consenting, the RCO will introduce him/
> herself to the potential study subject and explain the reason for his/
> her presence. The RCO will obtain the subject's verbal permission for
> observing consent.
>
> 3\. The RCO will observe and document his/ her observations on the
> Consent Observation Checklist. During consenting, should any issues or
> questions arise that the consenter is unable to address and that the
> RCO is qualified to discuss or answer, the RCO may offer appropriate
> explanations or information.
>
> 4\. After consenting has been completed, the RCO may meet with the
> person who administered consent to discuss the RCO findings about the
> consenting that has just taken place. Often, the consenter does not
> have an opportunity to sit down with the RCO immediately after a
> participant has been consented because the staff member must stay with
> the participant to initiate study screening.
>
> 5\. Written Report: In all cases, the RCO prepares a written report
> which is conveyed electronically to the consenter. If either the RCO
> or the consenter wishes to discuss the findings face-to-face, they
> will arrange an informal meeting. Occasionally, the RCO may schedule a
> second consent observation with the study staff member, to determine
> if some observed "deficiencies" have been corrected. Should serious
> deficiencies be noted by the RCO, these would be brought to the
> attention of the study PI and the IRB.

**D. INFORMED CONSENT OBSERVATION CHECK-LIST**

The RCO considers the following key elements when observing consenting
of a potential study participant (other issues may also be considered by
the RCO):

-   Is the consent form the most recent IRB-approved version?

-   Does the consenter mention that the study involves "research?"

-   If the study involves an unapproved agent (i.e., not FDA approved),
    does the consenter explain this?

-   Does the consenter adequately discuss/summarize the following: study
    purpose, randomization, blinding, study procedures and
    interventions, risks, benefits, alternatives, confidentiality and
    HIPAA authorization, cost and compensation, PI

-   contact information for study related questions or concerns, IRB
    contact information to discuss any concerns about human subject
    rights, voluntary nature of study (right to refuse/withdraw without
    affecting individual's present or future care), research-related
    injury compensation and pregnancy issues (if appropriate).

-   Does the consenter obtain and document in the consent (yes/no check
    box) that the participant grants (or denies) permission to contact
    his/her personal physician?

-   Does the consenter solicit and sufficiently answer questions?

-   Does the consenter avoid using scientific jargon and does he/she
    communicate using understandable language?

-   Is the consent form properly signed and dated?

-   Is a copy of the signed consent form with HIPAA authorization given
    to the participant?

-   Is the consenting "environment" suitable?

-   Did the consenter spend sufficient time obtaining informed consent?

  -----------------------------------------------------------------------
  **6. VAAAHS HUMAN STUDIES RESEARCH EDUCATION POLICY\
  **

  -----------------------------------------------------------------------

All human research study personnel must complete the VA IRB Human
Subjects Research Education requirements prior to engaging in research
projects at the VAAAHS. If you fail to comply with the VA IRB Human
Subjects Education Policy you must cease all work with human subjects in
the research setting.

**COURSE CHOICE #1**

CITI - Good Research Practices for Protection of Human Subjects\"

In collaboration with CITI, VA ORD is now sponsoring a CITI curriculum
group that satisfies the VA annual requirement for training in both
\"Good Clinical Practice\" and \"Ethical Principles of Human Research
Protection\".

1\. [Web-Link]{.underline} =
[**https://www.citiprogram.org/default.asp**](https://www.citiprogram.org/default.asp)

2\. [Select Your Institution]{.underline}: Veterans Affairs -\> Ann
Arbor, MI-506

3\. [Select a Course Group]{.underline}: =\> Question #1 \> Choose one
answer\
**bullet #1 'O**' select this bullet if you completed VA training on the
CITI website in the past year.\
(Hint: Stage 2: Refresher 1 Course = 9 "101 Refresher modules" + 7 "GCP
modules"\
(Hint: Stage 3, Refresher 2 Course = 11 "Required Modules" + 1 "Elective
Module"

> **bullet #2 'O'** select this bullet if you never completed VA
> training on the CITI website.\
> (Hint: Stage 1: Basic Course = 14 modules to complete)

**[COURSE CHOICE #2]{.underline}**

**Appropriate training at the University of Michigan (PEERS)**

(Protection of Human Subjects and Good Research Practice)

> UM PEERRS training is only valid for 365 days to comply with VHA
> policy\
> **(We will accept UM PEERRS training completed within past few
> months)**

To obtain credit for the course, you must submit a dated certificate to
the Ann Arbor VA Research Office\
FAX = 734-845-3241 VA Mail = 11R UM Mail = Zip 2399 US Mail = 2215
Fuller Rd\...

All new Study Team Members must complete The Scope of Practice Survey
Form

<http://www1.va.gov/aavaresearch/docs/scope_of_practice.rtf>

**Ann Arbor VA Research WOC Credentialing Policy**

If you are not a VA employee and you are working in research in any
capacity directly at the Ann Arbor VA site, you must complete the
Without Compensation (WOC) registration and credentialing process at the
VA R&D Office and the VA Human Resources Office. More information is
available at this link:\
<http://www1.va.gov/aavaresearch/page.cfm?pg=8>

7\. POLICY AND PROCEDURES FOR DEALING WITH CONFLICTS OF INTEREST

*The complete version of this policy is found in the policy \"* *VA Ann
Arbor Healthcare System Policy and Procedures for Dealing with Financial
and Outside Management CONFLICTS OF INTEREST\"*

**1. PURPOSE**

VHA employees conducting VA research approved by the Research and
Development Committee must comply with the Federal criminal code and the
Standards of Ethical Conduct for Executive Branch Employees. The
obligation to follow applicable ethics laws and regulations also applies
to without compensation (WOC) employees conducting VA research. Failure
to follow these ethics laws and regulations can have serious
consequences. If criminal ethics statutes are violated, civil fines and
imprisonment can result. Severe administrative disciplinary action can
result from violating ethics regulations, including suspension from
employment, termination of employment, and other administrative
punishment. Further, even seemingly minor violations may impact
perceptions of the research program\'s integrity and credibility.

VA researchers with outside consulting, employment, or royalty payment
opportunities should discuss those potential opportunities with a VA
agency ethics official before entering into any agreements or receiving
any payments. To get help on these matters, employees can contact either
the local Regional Counsel, or ethics officials in the VACO (VA Central
Office) Office of General Counsel (023) VA Central Office 810 Vermont
Avenue, NW Washington, DC 20420

The VA Ann Arbor Healthcare System will exercise care in approving
research projects in which study investigators or professional staff
(or, to their knowledge, their spouses, or dependents) have interests
that create conflicts. Such projects will not be approved if the
conflict:

a\) can be expected with reasonable certainty to compromise the
integrity of those investigations or undermine the employees\'
obligations to the VA, or to the sponsor, and

b\) cannot be satisfactorily managed with appropriate administrative
oversight.

The provisions of this policy apply to all VHA research regardless of
funding source.

**2. BACKGROUND**

The VA is committed to maintaining its basic values of openness,
scientific integrity, and independence, and its tradition and
expectation that its members will conduct their relationships with the
VA with candor and integrity.

VA staff have the right to acquire and retain personal financial
interests (including personal income from the transfer of technology) so
long as those obligations and commitments do not interfere with their
duties or improperly distort the judgments expected of them.

The VA Ann Arbor Healthcare System is required to have a policy for the
disclosure of personal financial information by staff engaged in
sponsored research and procedures for institutional review of the
relevance of such personal outside interests to the integrity of the
proposed research. This policy is required in order to be eligible to
receive federal funds from the Department of Veterans Affairs (VA),
Public Health Service or the National Science Foundation and to be
accredited by the National Committee for Quality Assurance (NCQA).

The policy and the following procedures fulfill these external
obligations while minimizing the personal privacy concerns of
researchers and their families. The disclosure and review process also
protect researchers from misplaced charges of conflict of interest by
providing a mechanism for objective review and approval of personal
outside financial interests.

**3. DEFINITIONS**

a\) A financial conflict or perceived conflict of interest (COI) occurs
when an investigator (or their spouse or minor child) is involved in any
financial arrangement, situation or action that affects or is perceived
to affect an inappropriate influence on the design, review, conduct,
management, treatment of research participants, research quality or
reporting of findings of a research study..

b\) A principal investigator (PI) is the individual who actually
conducts the investigation, i.e., under whose immediate direction
research is conducted or, in the event of an investigation conducted by
a team of individuals, the responsible leader of that team. The PI of a
protocol must ensure that all other investigators and individuals
associated with the protocol have submitted their disclosure forms to
the VA R&D Committee.

**4. DISCLOSURE**

a\) All research proposals submitted to the VA R&D Committee for review
must contain a \"[Financial Conflict of Interest Statement and
Certification]{.underline}\" identifying conflicts of interest for each
principal investigator (PI), co-principal investigator, investigator,
and each collaborator contributing 5 percent or more effort. This
requirement applies to all research activities conducted completely or
partially in VA facilities, conducted in approved off-site locations or
facilities, or conducted by VA investigators while on official VA duty
time, whether funded by VA or by other sources, or unfunded. Further, it
applies to all proposals submitted to a VA medical center for local
initial or continuing review, and to proposals submitted to VHA Central
Office for scientific merit review and funding consideration.

b\) A VA employee with an outside financial interest in a proposed
technology transfer agreement must provide a written description of the
proposed arrangement to the R&D Committee along with a financial
conflict of interest disclosure. The conflict of interest disclosure
asks about management or financial interests held by the employee or
his/her spouse or dependents in the entities involved in the proposed
arrangement. If the outside interests of an individual change so as to
introduce a new, heretofore undisclosed significant financial interest,
the individual must revise the disclosure.

c\) The investigator in designing research protocols whether involving
human subjects, animals, or in other biomedical research not involving
either humans or animals, must consider the potential effect that any
conflict of interest would have on the conduct or outcome of the
research. A discussion of these issues must be included in the proposal
itself or attachments when the effect on the research is actual or
perceived. The discussion must include: the conflict; the type of effect
it would have on the investigator or the research; and steps taken to
manage, reduce, or eliminate the conflict. If the research involves
human subjects, the protocol must contain specific information on how
the conflict would affect the interactions with human subjects
including, but not limited to the consenting process and the written
informed consent.

d\) The disclosure criteria do not vary by funding or regulatory
oversight.

**5. RESPONSIBILITIES OF THE R&D COMMITTEE**

a\) The R&D Committee is responsible for reviewing the COI Forms (in the
R&D Application) from each investigator who is planning to participate
in the facility's research program.

b\) The VA R&D Committee is responsible for:

> \(1\) Determining whether there are actual or perceived COI that could
> affect an investigator's proposed, current, or future research. The
> COI may affect any aspect of the research including the design,
> conduct, or reporting of the research findings.
>
> \(2\) Determining what conditions or restrictions, if any, need to be
> imposed to manage, reduce, or eliminate the conflicts.
>
> \(3\) Reviewing any updates to the financial disclosure forms
> submitted by investigators and making a determination regarding the
> need to modify requirements for management of the COI.
>
> \(4\) Reviewing individual protocols or summaries of protocols and the
> investigator's plan to manage the financial conflict of interest when
> appropriate.
>
> \(5\) Preparing reports of findings and proposed steps to manage the
> COI and submission of the reports to the IRB, the IACUC, and/or the
> Research Safety Committee and to the investigator. NOTE: Significant
> conflicts of interest must be managed with the assistance of VA
> Regional Counsel.
>
> \(6\) Establishing a process to allow the investigator to appeal a
> decision restricting the conduct of research and requiring specific
> steps to manage, reduce or eliminate the COI.
>
> \(7\) Establishing criteria for evaluating an investigator's appeal.
> Criteria may include the nature of the research, the unique experience
> or qualifications required to conduct the research, the number of
> other investigators that may possess these qualifications, the nature
> and magnitude of the financial conflicts of interest, as well as any
> substantial effect of the research on the financial conflicts of
> interest, such as increasing financial gains for the investigator. In
> addition, the magnitude of the risk to the human research subject
> posed by the financial conflicts of interest must be considered.
>
> \(8\) Maintaining written records of its reviews and determinations.
> The minutes of meetings must be sent to the medical center Director
> for final approval.
>
> \(9\) Developing polices and procedures for its recurring processes.

c\) The R&D Committee will determine whether compelling circumstances
exist that would permit the investigator to conduct the research in the
event that an investigator holds significant financial interest that
cannot be adequately managed, reduced, or eliminated Criteria may
include the nature of the research, the unique experience or
qualification required to conduct the research, the number of other
investigators that may possess these qualifications, the nature and
magnitude of the COI, as well as any substantial effect of the research
on the COI, such as increasing financial gains for the investigator. In
addition, the magnitude of the risk to the human research subject posed
by the financial conflicts of interest must be considered, including:

> \(1\) Whether methods used for management of financial interest of
> parties involved in the research adequately protect the rights and
> welfare of human subjects.
>
> \(2\) Whether other actions are necessary to minimize risks to
> subjects.
>
> \(3\) The kind, amount, and level of detail of information to be
> provided to research subjects regarding the source of funding, funding
> arrangements, financial interests of parties involved in the research,
> and any financial interest management techniques applied.

d\) The R&D Committee may determine that significant COI exists that can
not be sufficiently managed, reduced, or eliminated. If this
determination is made, the R&D Committee may disapprove the research or
it may require that those investigators with the conflicts be eliminated
as part of the research team.

e\) For research involving human subjects, the R&D Committee is
responsible for reviewing actions taken by the IRB. The R&D Committee
may approve the IRB's actions, may add other stipulations or changes to
the proposal, but may not disallow any of the IRB\'s stipulations or
required changes to their findings regarding the COI.

f\) For research involving the use of animals, the R&D Committee is
responsible for reviewing actions taken by the IACUC. The R&D Committee
may approve the IACUC's actions, and may add other stipulations or
changes to the proposal, but may not disallow any of the IACUC\'s
stipulations or required changes to their findings regarding the COI.

g\) In its annual review of protocols, the R&D Committee considers any
changes in the conflicts of interest (new, resolved, or changed
conflict), and the impact of these changes on the research and the
research results. During the annual review, for previously identified
COI, the R&D Committee evaluates the effectiveness of the strategies for
management of the conflicts as implemented at the initiation of the
research and, if necessary, alters the previous requirements (adding new
strategies or modifying current strategies). NOTE: If the modification
involves requirements set forth by the e IRB or the IACUC, these
committees must concur with the modifications.

h\) The R&D Coordinator, is responsible for maintenance of records of
all financial disclosures and all actions taken by the medical center
with respect to each conflicting interest for the time period that the
protocol records are maintained; this is a minimum of 5 years after the
protocol is completed or 5 years after the investigator leaves the
facility, which ever is longer NOTE: The investigator must update the
COI Form as changes occur even after a specific protocol is closed.

**6. RESPONSIBILITIES OF THE INSTITUTIONAL REVIEW BOARD (IRB)**

a\) The IRB is responsible for identifying, reviewing, and requiring
appropriate changes in protocols affected by actual or perceived
financial conflicts of interest for research involving human subjects to
ensure that the rights and welfare of the subjects are adequately
protected. The IRB may also determine that the research protocol should
not be conducted at the institution. In making their determination, the
IRB must consider the actions and recommendations of the R&D Committee.

b\) Members of the IRB who have a financial and non-financial
conflict(s) of interest must recuse themselves from review of proposals
for which the conflict exists as provided in VHA Handbook 1200.5. NOTE:
VHA Handbook 1200.5 requires reviewers having other types of conflict of
interest to recuse themselves during review of a protocol for which they
are conflicted accept to provide information to the IRB.

c\) The IRB determines if actions in addition to those required by the
R&D Committee need to be taken to manage, reduce or eliminate the
financial conflicts of interest. This decision is to be recorded in the
IRB records (minutes or other records).

d\) The IRB may determine that significant COI exist that compromise the
rights and welfare of human research subjects or the outcome of the
research; and it may determine that the conflicts can not be
sufficiently managed, reduced, or eliminated. If this determination is
made, the IRB may disapprove the research or it may require that those
investigators with the conflicts be eliminated as part of the research
team.

e\) The IRB's findings regarding the financial or other conflicts of
interest are reported to the R&D Committee. This will be done within the
committee meeting minutes.

**7. RESPONSIBILITIES OF THE INSTITUTIONAL ANIMAL CARE AND USE COMMITTEE
(IACUC)**

a\) The IACUC is responsible for identifying, reviewing, and requiring
appropriate changes in protocols affected by actual or perceived
financial conflicts of interest for research involving animal subjects
to ensure that the rights and welfare of the subjects are adequately
protected. The IACUC may also determine that the research protocol
should not be conducted at the institution. In making their
determination, the IACUC must consider the actions and recommendations
of the R&D Committee.

b\) Members of the IACUC who have a financial conflict(s) of interest
must recuse themselves from review of proposals for which the conflict
exists.

c\) The IACUC determines if actions in addition to those required by the
R&D Committee need to be taken to manage, reduce or eliminate the
financial conflicts of interest. This decision is to be recorded in the
IACUC records (minutes or other records).

d\) The IACUC may determine that significant COI exist that compromise
the rights and welfare of human research subjects or the outcome of the
research; and it may determine that the conflicts can not be
sufficiently managed, reduced, or eliminated. If this determination is
made, the IACUC may disapprove the research or it may require that those
investigators with the conflicts be eliminated as part of the research
team.

e\) The IACUC findings regarding the financial or other conflicts of
interest are reported to the R&D Committee. This will be done within the
committee meeting minutes.

**8. INVESTIGATORS MUST MEET ALL GOVERNMENT REQUIREMENTS AND
REGULATIONS\
FOR CONDUCTING HUMAN SUBJECTS RESEARCH**

Investigators must meet all requirements for conducting research with
human participants and comply with all applicable federal, state, and
local regulations and the organization's policies and procedures for
protecting research participants.

**A. Investigator Training and Experience**

1\. The R&D Committee will collect sufficient information to insure that
Investigators and Research Staff are qualified by training and
experience for their research role.

> a\) Investigators must provide appropriate responses to these concerns
> in the **VA R&D Application Form** (the most recent version).

2\. The IRB will provide Investigators and Research Staff information
about applicable federal, state, and local regulations; relevant
professional standards; and the organization's policies and procedures
regarding the protection of research participants.

3\. The Research Compliance Officer or IRB Coordinator will maintain
documentation to certify that Investigators and Research Staff
understand the definition of human research and seek guidance when
appropriate.

> a\) Investigators and Research Staff must comply with all the
> requirements in the VA IRB policy statement **AAHS Human Studies
> Research Education Policy**.

**B. Investigator Assessment and Reporting of Unanticipated Problems**

1\. The AAHS has policies and procedures that describe the events that
investigators are required to report to the IRB as potential
unanticipated problems involving risks to participants or others.

2\. Investigators and research staff must report unanticipated problems
involving risks to participants or others as required by regulations and
organizational policies and procedures.

3\. Investigators and research staff must comply with the **VA IRB
Unanticipated Problem Reporting Policy. \[Doc. 110\]**

**C. Investigator Oversight of Research Protocols**

1\. The Principal Investigator must maintain appropriate oversight of
the following components of the research study:

> a\) The research protocols
>
> b\) The research staff
>
> c\) Selection and recruitment of study participants
>
> d\) Study conduct,
>
> e\) Delegate research responsibilities to research staff.

**D. Data and Safety Monitoring**

1\. The Principal Investigator designs the plans to monitor data for the
safety of participants.

2\. Investigators must provide appropriate responses to these concerns
in the **VA IRB Application Form** (the most recent version)

3\. The VA IRB will review the proposed data monitoring plans during the
approval process for each new study.

4\. Principal investigators comply with the IRB-approved data monitoring
plans.

9\. VA ANN ARBOR HEALTHCARE SYSTEM

POLICY AND PROCEDURES FOR DEALING WITH RESEARCH MISCONDUCT

**1. POLICY STATEMENT**

The VA Ann Arbor Healthcare System is committed to conducting all of its
research activities with utmost integrity, adhering to scientifically
sound practices as well as ethical principles. To that end, VA employees
and any other individuals engaged in VA research are prohibited from
committing research misconduct. The VA Ann Arbor Healthcare System
maintains the right to:

a\. Investigate all allegations of such research misconduct,

b\. Use all legally permitted means for conducting investigations, and

c\. Impose appropriate corrective actions in order to protect its
research funds and the public trust.

**2. BACKGROUND**

a\. The procedures in this Policy are:

\(1\) Intended to protect the public's confidence in the integrity of VA
research by minimizing the incidence of research misconduct and by
providing a fair and timely manner of responding to research misconduct
allegations.

\(2\) Designed to maintain appropriate safeguards for those accused of
research misconduct (Respondents) and those who make allegations of
research misconduct or otherwise cooperate with Inquiries and
Investigations (Informants).

b\. As a public agency, VHA has an ethical obligation to preserve public
trust in the integrity and quality of research carried out by its
investigators, among its patients, and in its facilities. To protect
that trust, VHA has a responsibility to:

\(1\) Ensure that its research is above reproach;

\(2\) Implement mechanisms that enable concerns regarding possible
research misconduct to be brought to the attention of appropriate
institutional officials so that they may address these promptly and
thoroughly; and

\(3\) Ensure that such mechanisms are objective and fair, respecting the
rights and well-being of all individuals who may be involved when
allegations of misconduct are raised.

c\. This Policy has been created for the administrative efficiency of VA
and does not establish rights for any individual. However, individual
rights or obligations that must be observed in the course of
investigations may arise under other policies, regulations, laws, or
governing collective bargaining agreements.

d\. [Research Misconduct is Prohibited]{.underline}. VA is committed to
conducting all of its research activities with utmost integrity,
adhering to scientifically sound practices as well as ethical
principles. To that end, VA employees and any other individuals engaged
in VA research are prohibited from committing research misconduct (see
par. 3). VA maintains the right to:

\(1\) Investigate all allegations of such research misconduct,

\(2\) Use all legally permitted means for conducting investigations, and

\(3\) Impose appropriate corrective actions in order to protect its
research funds and the public trust.

e\. [Federal Policy on Research Misconduct]{.underline}

\(1\) This Policy conforms to the requirements of the Federal Policy on
Research Misconduct at 65 Federal Register (Fed. Reg.) 76260 (December
6, 2000). The Federal policy sets forth the responsibilities of Federal
agencies (which "have ultimate oversight authority for Federally funded
research") and research institutions (which "bear primary responsibility
for prevention and detection of research misconduct and for the Inquiry,
Investigation, and adjudication of research misconduct alleged to have
occurred in association with their own institution" \[see Fed. Reg.
76263\]).

\(2\) For purposes of this Policy, the "research institutions" are the
VA medical centers at which VA research is conducted. The "Federal
agency" is VA which encompasses and oversees the VA medical centers.

**3. DEFINITION OF RESEARCH MISCONDUCT**

a\. Research misconduct is defined as fabrication, falsification, or
plagiarism in proposing, performing, or reviewing research, or in
reporting research results.

\(1\) [Fabrication]{.underline}. Fabrication is making up data or
results and recording or reporting them.

\(2\) [Falsification]{.underline}. Falsification is manipulating
research materials, equipment, or processes, or changing or omitting
data or results such that the research is not accurately represented in
the research record.

\(3\) [Plagiarism]{.underline}. Plagiarism is the appropriation of
another person's ideas, processes, results, or words without giving
appropriate credit.

b\. Research misconduct does not include honest error or differences of
opinion.

c\. To constitute research misconduct, the behavior must:

\(1\) Represent a significant departure from accepted practices of the
relevant research community.

\(2\) Be committed intentionally, knowingly, or with reckless disregard
for the integrity of the research.

d\. To establish a finding of research misconduct, the allegation must
be proven by a preponderance of the evidence; i.e., the allegation is
more likely than not to be true.

**4. SCOPE**

a\. These procedures apply to all VA employees, including "without
compensation" (WOC) employees, contractors, and Intergovernmental
Personnel Agreement (IPA) personnel engaged in or requesting support for
VA research (see subpar. 5t). This includes, but is not limited to:
scientists, trainees, technicians and other staff members, students,
fellows, guest researchers, and collaborators who fall within these
specified categories.

b\. Ethical lapses or other improprieties that do not fall within the
definition of research misconduct in paragraph 3 are not covered by this
Policy. Examples of such improprieties include: conflicts of interest,
misallocation of funds, sexual harassment, discrimination, and breaches
of human subjects protections and animal welfare requirements. These
improprieties are subject to other VA regulations, policies, and
procedures, and in some cases, other laws and regulations. If a matter
involves both research misconduct and non-research misconduct issues, a
single administrative investigation may be convened to review all of the
related issues in order to promote administrative efficiency (see
subpar. 12a and VA Policy 0700). NOTE: If a consolidated administrative
investigation is convened, the investigation procedures must be
consistent with the specifications of this Policy and must contain a
distinct recommendation regarding the research misconduct issue(s).

c\. Misrepresentation of one's qualifications or the misrepresentation
of one's ability to perform the proposed research in merit review
applications or similar submissions falls within the definition of
research misconduct.

d\. Authorship disputes other than plagiarism are not covered by this
Policy.

e\. If oversight of a research protocol falls within another
entity(ies)' jurisdiction in addition to that of VA, primary
responsibility for reviewing a misconduct allegation concerning that
research is to be determined according to subparagraph 12c.

f\. Procedures for determining appropriate corrective actions are set
forth in paragraph 18. Procedures for taking disciplinary or adverse
actions (e.g., admonishment, reprimand, suspension, transfer, reduction
in grade and basic pay, and discharge) are treated separately (see VA
Policy 5021).

g\. Although this Policy does not specifically cover patient safety
issues, it does require that interim actions be taken when harm or
threatened harm to research subjects is discovered during the course of
a research misconduct proceeding (see subpar. 12e\[1\]). NOTE: VHA
policy regarding patient safety is set forth at VHA Policy 1050.1.

**5. DEFINITIONS**

a\. [Allegation]{.underline}. An allegation is a written statement that
research misconduct may have occurred, submitted to the potential
Respondent's supervisor or the Research Integrity Officer.

b\. [Debarment]{.underline}. Debarment is an action taken by the VA
debarring official to exclude a Respondent from participating in the
covered transactions listed at Title 38 Code of Federal Regulations
(CFR) 44, Subpart B. NOTE: For purposes of this Policy, the debarring
official is VA's Under Secretary for Health. A debarment by VA has
government-wide effect, unless a specific exception is granted.

c\. [Fabrication]{.underline}. Fabrication is making up data or results
and recording or reporting them.

d\. [Falsification]{.underline}. Falsification is manipulating research
materials, equipment, or processes, or changing or omitting data or
results such that the research is not accurately represented in the
research record.

e\. [Good Faith and Reasonable Allegation or Cooperation]{.underline}. A
good faith and reasonable allegation of research misconduct is an
allegation which the Informant believes and which a person in the
Informant's position could reasonably make, in light of the readily
available evidence. An allegation is not made in good faith if made with
reckless disregard for or willful ignorance of facts that would negate
the allegation. Good faith cooperation with a research misconduct
Inquiry or Investigation means cooperating honestly and forthrightly
with those conducting the Inquiry or Investigation.

f\. [Informant]{.underline}. An informant is one who makes an allegation
or cooperates with an Inquiry or Investigation of research misconduct.

g\. [Inquiry]{.underline}. An Inquiry is a process in which initial
information is gathered solely to determine whether the readily
available evidence warrants a formal investigation of research
misconduct.

h\. [Investigation]{.underline}. An investigation is a formal process
whereby a properly constituted Investigation Committee evaluates all the
relevant facts, determines whether the evidence supports a finding of
research misconduct, identifies the responsible individual(s), and
assesses the seriousness of the misconduct.

i\. [Plagiarism]{.underline}. Plagiarism is the appropriation of another
person's ideas, processes, results, or words without giving appropriate
credit.

j\. [Research]{.underline}. Research is the term for all basic, applied,
and demonstration research in all fields of science, engineering, and
mathematics. This includes, but is not limited to: research in
economics, education, linguistics, medicine, psychology, social
sciences, statistics, and research involving human subjects or animals.

k\. [Research Impropriety]{.underline}. Research impropriety is any
ethical lapse or other impropriety involving or occurring in connection
with research other than research misconduct as defined in paragraph 3.
Examples of research impropriety include, but are not limited to,
conflicts of interest, misallocation of funds, sexual harassment,
discrimination, and breaches of human subjects protections and animal
welfare requirements.

l\. [Research Integrity Officer (RIO]{.underline}). The RIO is the
appointed official at each VA facility who is responsible for receiving
and coordinating reviews of formal allegations of research misconduct.

m\. [Research Misconduct (or Misconduct).]{.underline} See paragraph 3.

n\. [Research Record]{.underline}. The research record is the record of
data or results that embody the facts resulting from scientific inquiry,
including, but not limited to, research proposals, physical and
electronic laboratory records, progress reports, abstracts, theses, oral
presentations, internal reports, and journal articles.

o\. [Respondent(s]{.underline}). Respondent(s) are the person(s) against
whom an allegation of research misconduct is directed or whose actions
are the subject of an Inquiry or Investigation. Use of this term does
not imply that the person(s) are, or will be, the subject of a
disciplinary proceeding.

p\. [Retaliation]{.underline}. Retaliation is taking or threatening to
take an adverse action within one's authority against an Informant in
response to a good faith and reasonable allegation or cooperation with
an Inquiry or Investigation of research misconduct. An adverse action
may include an intentional failure to take a warranted action.

q\. [Suspension]{.underline}. Suspension is an action taken by the VA
suspending official that immediately prohibits a Respondent from
participating in covered transactions listed at 38 CFR 44, Subpart B for
a temporary period, pending completion of an investigation and ensuing
proceedings. NOTE: For purposes of this Policy, the suspending official
is the Under Secretary for Health.

r\. [VA Medical Center]{.underline}. A VA medical center is a local VA
medical facility or VA Health Care System comprising part of VA's
national health care system.

s\. [VA Medical Center Director]{.underline}. The VA medical center
Director is the Chief Executive of a VA medical center or Health Care
System.

t\. [VA Research]{.underline}. VA research is all research:

\(1\) Funded in whole or in part by VA;

\(2\) Conducted by VA employees within the scope of their VA employment
(whether full-time, part-time, or WOC); and/or

\(3\) Using VA facilities, equipment, personnel, or patients.

u\. [Veterans Integrated Service Network (VISN)]{.underline} Director.
The VISN Director is the head of a designated regional service within
the VA medical system. Each VA medical center belongs to a
geographically-determined VISN and reports to the Director of that
service. NOTE: For purposes of this Policy, "VISN Director" means the
VISN Director, or designee.

**6. THE OFFICE OF RESEARCH OVERSIGHT (ORO) (10R)**

ORO (10R) serves as the primary VHA office that advises the Under
Secretary for Health on all compliance matters related to the protection
of human research subjects, research misconduct, laboratory animal
welfare, and research safety. ORO Central Office oversees VHA's research
misconduct program in general and reviews all misconduct cases
adjudicated by the VISN Directors. An ORO ad hoc committee may conduct
investigations in exceptional cases (see subpars. 12d(2) and 17b\[2\]).
If at any time in its oversight of a research misconduct case ORO
determines that an allegation does not fall within the scope of this
Policy (see par. 4) or fails to meet the required threshold (see subpar.
13e), it may dismiss the case.

**7. RESEARCH INTEGRITY OFFICERS (RIOs)**

The Director of each VA medical center with research involvement must
designate a permanent RIO position responsible for overseeing misconduct
allegations at that facility. The VA medical center Director delegates
responsibility to the RIO for overseeing all aspects of research
misconduct Inquiries and Investigations except as otherwise provided
herein.

a\. At the Ann Arbor VA, the position of RIO is assigned to the
Associate Chief of Staff (ACOS) for Research.

b\. The RIO is responsible for:

\(1\) Receiving formal allegations of research misconduct, determining
whether the alleged misconduct falls within the scope and meets the
required threshold of these procedures, overseeing all Inquiries and
Investigations, maintaining files of all documents and evidence,
ensuring the confidentiality and security of those files, forwarding all
information to the appropriate offices or persons as required by these
procedures, and otherwise acting as a liaison between the VA facility
and ORO.

\(2\) Coordinating and monitoring the necessary steps for maintaining
appropriate safeguards for Respondents and Informants.

\(3\) Receiving initial and continuing education and training in the
handling of research misconduct allegations according to the information
in this Policy, and transmitting the information obtained in such
training to members of Inquiry and Investigation Committees.

\(4\) Keeping the scientific and administrative staff of the VA medical
center informed of the policies and procedures in this Policy and for
overseeing the VA medical center's compliance with the Policy's
provisions.

\(5\) Demonstrating objectivity, both apparent and actual, in carrying
out RIO duties.

c\. [Conflict of Interest.]{.underline} If the RIO has a conflict of
interest, or apparent conflict of interest, in a particular case because
of a significant relationship with the Respondent, the Informant, or the
underlying research project or its investigator(s), the RIO must not
participate in the oversight of that particular misconduct case. The VA
medical center Director must appoint an acting RIO to oversee such
cases.

**8. INFORMANTS**

a\. VA employees have a responsibility to report suspicions of
misconduct in VA research if, after a careful assessment of the readily
available facts, they honestly and reasonably believe there is credible
evidence of misconduct.

b\. VA employees also have a responsibility to cooperate in good faith
with research misconduct reviews whether led by a VA medical center or
an agency/entity with joint jurisdiction (see VA Policy 0700, and 38 CFR
Sec. 0.735-12\[b\]).

c\. VA medical center authorities must make diligent efforts within the
scope of their authority to protect from retaliation Informants who make
good faith and reasonable allegations of research misconduct or who
cooperate with an Inquiry or Investigation in good faith.

d\. VA employees, former VA employees, and applicants for VA employment
who make allegations of research misconduct or cooperate with an Inquiry
or Investigation consistent with the Whistleblower Protection Act of
1989, may seek redress for retaliation as provided under that Act (see
Title 5 of the United States Code \[U.S.C.\] Section 1201 Notes, et
seq.).

e\. Informants' requests to protect their identities are to be honored
as far as possible. In order to complete most Investigations, however,
an Informant's identity and testimony may ultimately be required.

f\. Informants may consult privately with the RIO before making a
formal, written allegation. The RIO must:

\(1\) Indicate any deficiencies in the potential allegation, and

\(2\) Explain to the Informants the procedures for making an allegation
and their responsibilities and safeguards under these procedures.

g\. Informants who make good faith and reasonable allegations of
research misconduct must be given an opportunity to provide testimony
during the Inquiry and Investigation phases, to review portions of the
Investigation Report pertinent to their own testimony, and to be
informed of the general outcome of the Inquiry and Investigation as it
relates to their allegations.

h\. VA employees whose research misconduct allegation or cooperation
with an Inquiry or Investigation is not in good faith may be subject to
disciplinary measures.

**9. RESPONDENTS**

a\. Respondents must be given timely, written notification of the
allegations made against them, a description of all such allegations,
and reasonable access to the data and other evidence supporting the
allegations.

b\. Respondents will be given the opportunity to respond to allegations
of research misconduct, the supporting evidence, proposed findings of
research misconduct, and proposed corrective actions, if any. They must
be promptly notified of final findings and actions.

c\. Respondents must have the opportunity to be interviewed and present
evidence during the Inquiry and Investigation and to provide comments on
the Investigation report. Respondents are required to cooperate in good
faith with any Inquiry or Investigation conducted pursuant to this
Policy. Inquiries and Investigations proceed regardless of Respondents'
cooperation, and misconduct determinations are based on the available
evidence.

d\. Respondents may obtain the advice of legal counsel or a personal
advisor who is not otherwise involved with the case. The counsel or
advisor may be present at interviews with the Respondent, but may not
speak for, or on behalf of, the Respondent during the Inquiry or
Investigation.

e\. Respondents are prohibited from retaliating against Informants who
make good faith and reasonable allegations of research misconduct, even
if such allegations are ultimately not substantiated. To the extent that
allegations of research misconduct constitute disclosures under the
Whistleblower Protection Act of 1989, individuals making such
disclosures are covered by the protections of that Act, including
protection from retaliation.

f\. Respondents against whom a finding of research misconduct is made
under these procedures must be afforded an opportunity to appeal that
finding and proposed corrective actions according.

g\. If another agency or entity has joint jurisdiction over a misconduct
case, additional sanctions within the authority of that agency or entity
may also apply.

h\. Respondents who are not found guilty of committing research
misconduct will be afforded reasonable assistance in restoring their
reputations to the extent that the VA medical center management deems
appropriate, and within the scope of the VA medical center's authority.
For example, the VA medical center might publicize the outcome in forums
in which the allegation was previously publicized (if any) and/or
expunge references to the misconduct allegation from the Respondent's
personnel file.

**10. PRIVACY AND CONFIDENTIALITY**

The privacy of all participants and the confidentiality of information
gathered in a research misconduct proceeding will be preserved by all
persons to the extent possible consistent with a fair and thorough
investigation and as allowed by law (see VA Policy 0700).

a\. Only those individuals who are specifically authorized to review a
misconduct allegation will be provided with nonpublic information in
connection with the misconduct proceeding. Any person who receives such
information as part of a misconduct proceeding is obligated to keep that
information confidential until otherwise made public or as required by
law.

b\. Records maintained by the VA, its local facilities and their
affiliates, in connection with and during the course of a research
misconduct proceeding will be protected to the extent permitted by law
from public disclosure under the Freedom of Information Act (FOIA) (5
U.S.C. 552) and the Privacy Act (5 U.S.C. 552a).

c\. Individual case files are not to be listed or retrievable by
individual name or any other information that could easily identify the
Respondent or Informant. Case files must be stored in a secure location.
Copies of file documents may be made on a limited basis for the purpose
of review by authorized individuals.

**11. RECORD RETENTION AND ACCESS**

All documents and evidence obtained or generated for a research
misconduct investigation must be carefully secured and itemized. The
requirements for obtaining, maintaining, and making accessible these
documents and/or evidence (the record) are:

a\. The local RIO, the Inquiry and Investigation Committees, and ORO
have the right to inspect and sequester all research records related to
a misconduct allegation without notice.

b\. Reasonable, supervised access to, or copies of, the original data
may be provided to Respondents so that they can continue their research
prior to completion of a misconduct proceeding.

c\. After a research misconduct case is closed, the RIO's office must
securely retain all research misconduct allegations and Inquiry and
Investigation Reports with the underlying evidence, or copies, as
appropriate, regardless of merit or outcome, until expiration of their
authorized retention period. A research misconduct case is considered
closed for purposes of this paragraph if and when:

\(1\) ORO dismisses the case (see par. 6);

\(2\) The case is terminated after an Inquiry (see subpar. 14g);

\(3\) The VISN Director does not find research misconduct, and ORO
reviews and provides notification of that outcome (see subpar.
17c\[1\]);

\(4\) The VISN Director finds research misconduct, and the Respondent
does not file a written appeal within 30 days of receiving the notice of
research misconduct finding (see par. 19b); or

\(5\) The Respondent appeals a finding of research misconduct, and the
Under Secretary for Health makes a final decision (including any
reconsideration of a debarment decision) in writing (see par. 19e).

d\. Upon request, ORO must be given immediate access to any and all
materials retained by a VA medical center in connection with a research
misconduct proceeding.

**12. GENERAL PROCEDURES**

a\. [VA Policy 0700, Administrative Investigations.]{.underline}
Inquiries and Investigations of research misconduct under this Policy
constitute specialized Administrative Investigations (AIs) as described
by VA Directive and accompanying Policy 0700.

\(1\) The requirements set forth in VA Policy 0700 must be observed in
all research misconduct Inquiries and Investigations except to the
extent that any provision of this Policy contradicts a provision of VA
Policy 0700. In all research misconduct Inquiries and Investigations,
the provisions of this Policy take precedence over any contrary
provision of VA Policy 0700.

\(2\) Consistent with this Policy, the following points must be
observed:

\(a\) For purposes of research misconduct Inquiries and Investigations,
the "Convening Authority" (see VA Policy 0700) is the VA medical center
Director, or Chief Executive of the VA facility. Once an Inquiry or
Investigation has been convened, the RIO is delegated the administrative
authority over the Inquiry and Investigation.

\(b\) Evidence must be collected according to the provisions in VA
Policy 0700.

b\. [Administrative Discretion.]{.underline} Particular circumstances in
individual cases of alleged research misconduct may dictate variation
from the procedures in this Policy when deemed in the best interests of
VA. Any significant change from normal procedures must be pre-approved
by ORO Central Office and must ensure fair treatment of the Respondent.
The Respondent should be notified of any such significant changes.

c\. [Joint Jurisdiction.]{.underline} Other non-VA agencies or entities
(e.g., academic affiliates of the VA) may have concurrent jurisdiction
over the same research project, or parts thereof that is the subject of
a VA research misconduct Inquiry and Investigation. In such cases, VA
must coordinate its response to allegations of research misconduct with
the relevant non-VA agencies and/or entities, in order to maximize
procedural uniformity and minimize duplication while recognizing
institutional autonomy. VHA, in a good faith effort to effectuate a
coordinated response, must adhere to the following guidelines:

\(1\) For every research misconduct allegation received, the VA medical
center RIO must determine whether and what other non-VA agencies or
entities have joint jurisdiction over the underlying research. Joint
jurisdiction may be exerted by agencies or entities that co-sponsor or
otherwise support the research, employ or provide academic privileges to
the principal investigator(s) or support staff, or provide regulatory
oversight. Examples include, but are not limited to: the VA medical
center's academic affiliate, the Public Health Service (PHS) of the
Department of Health and Human Services (HHS), the Food and Drug
Administration (FDA), and other sponsors and regulators.

\(2\) The VA medical center RIO must notify all non-VA agencies or
entities that have joint jurisdiction over a research project of any
misconduct allegation regarding such research. This notice needs to be
directed to the office(s) that provide oversight of research misconduct;
e.g., the Office of Research Integrity (ORI) for the PHS.

\(3\) Wherever possible, the VA medical center and the non-VA agencies
or entities with concurrent jurisdiction are encouraged to perform a
[joint]{.underline} Inquiry, and if warranted, a [joint]{.underline}
Investigation. Each agency or entity with jurisdiction must designate at
least one representative to participate in the Inquiry and
Investigation. The qualifications of such representative are to be
determined by each agency'sor entity's own policies and procedures.

\(4\) Through informal negotiation between the VA medical center and the
non-VA agencies or entities with concurrent jurisdiction, a mutual
determination must be made as to which agency or entity will take the
lead in conducting the joint Inquiry and Investigation. Factors to
consider in making this determination include, but are not limited to,
which agency or entity:

\(a\) Is the primary sponsor or funder of the underlying research;

\(b\) Approved the underlying research;

\(c\) Is the primary employer of the Respondent;

\(d\) Operates the facilities that were used to conduct the underlying
research; and

\(e\) Has the resources and personnel best suited to conducting a timely
and thorough Inquiry and Investigation.

\(5\) The applicable procedures for conducting an Inquiry and
Investigation are those of the agency or entity that takes the lead, as
determined by subparagraph12c(4). The VA medical center and other non-VA
agencies or entities are encouraged to make, to the extent possible,
their respective research misconduct procedures compatible in carrying
out the joint Inquiry and Investigation.

\(6\) If a non-VA agency or entity is given primary responsibility for
conducting the joint Inquiry and Investigation as determined by
subparagraph 12c(4), at least one VA employee with research experience
and at least 5/8^th^ status must be included as a full participant in
the Inquiry and Investigation.

\(7\) Each Inquiry and Investigation must result in a single set of
recommendations, although a minority opinion may be produced if the lead
agency's or entity's procedures so specify.

\(8\) Each agency or entity with concurrent jurisdiction must follow its
own procedures for adjudicating and appealing research misconduct cases.
No agency or entity is bound by another's adjudication or appeal
decision. Each agency or entity may implement administrative actions in
accordance with its own laws, regulations, policies, or contractual
procedures, although non-procurement debarments and suspensions are
applied across the Federal government pursuant to Executive Order 12549.

\(9\) Each agency or entity is to give timely notice to the other
agencies or entities with concurrent jurisdiction of the final outcome
of its adjudication and appeal, if applicable.

d\. [Sequence of Review.]{.underline} In cases in which VA takes the
lead, as determined by subparagraph 12c(4), review of formal allegations
of research misconduct must follow the sequence of steps outlined in
subparagraphs 12d(1) through 12d(5). Any significant departure from this
sequence of review must first be approved by ORO Central Office, must be
in the interests of VA and the integrity of its research, and must
ensure appropriate safeguards for Respondents and Informants, including
timely notice of such changes.

\(1\) Inquiry and Investigation by a Local VA Medical Center. In most
instances, the local VA medical center that receives a research
misconduct allegation is responsible for conducting an Inquiry and, if
warranted, a further Investigation. The Investigation Committee's
findings and recommendations for corrective actions, if applicable, are
set forth in an Investigation Report. The VA medical center Director
forwards this Investigation Report with additional recommendations, if
any, to the appropriate VISN Director for adjudication.

\(2\) Substitute Investigation by ORO Ad Hoc Committee. In
[exceptional]{.underline} cases as determined by ORO Central Office
within its discretion, an ORO Ad Hoc Committee consisting of ORO staff
(VA Central Office and Regional Offices) and outside experts, as needed,
may investigate a misconduct allegation in lieu of the local VA medical
center. Such cases may include, but are not limited to, instances in
which the local VA medical center is not prepared to handle the
allegation in a manner consistent with these procedures, or cannot
complete an investigation for any reason, or when ORO involvement is
needed to protect the public interest, including the interests of
veterans and of human research participants. The ORO Investigation
Committee may use ad hoc procedures in conducting research misconduct
investigations, but all of the responsibilities and safeguards set forth
in paragraphs 8 through 11 must be observed. The ORO Investigation
Committee forwards its Investigation Report with recommendations for
corrective actions, if applicable, to the appropriate VISN Director for
adjudication, with a copy to the VA medical center Director.

\(3\) Adjudication by VISN Director. The appropriate VISN Director
reviews the final Investigation Report and renders a decision regarding
the findings and recommendations for corrective actions. The VISN
Director transmits this final determination and the Investigation Report
to ORO Central Office.

\(4\) Departmental Review. ORO Central Office reviews the case file for
procedural sufficiency, consulting with the Office of Research and
Development (ORD) on matters that concern VA funding. If ORO determines
that the Inquiry or Investigation failed to comply with the procedures
in this Policy so as to materially affect the outcome of the case, ORO
may direct the VA medical center to reopen the Investigation or convene
its own Investigation.

\(5\) Appeal to the Under Secretary for Health. The Respondent may
appeal a finding of research misconduct and proposed corrective actions
(including debarment, if applicable) to the Under Secretary for Health
in accordance with paragraph 19. The Under Secretary for Health makes a
ruling on the Respondent's appeal which constitutes VA's final agency
action.

e\. [Interim Actions.]{.underline} Between the time that a research
misconduct allegation is filed and when it is fully resolved, VA may
take interim action(s) as necessary.

\(1\) The VA medical center must immediately notify ORO Central Office
of the following, if present: harm or threatened harm to research
subjects, serious violations of animal welfare requirements, research
safety compromises, harm or threatened harm to those involved in the
investigation, risks to public health or safety, loss or destruction of
VA funds or property, or possible violations of civil or criminal law
associated with the alleged research misconduct. All interim
administrative actions taken to minimize damage must be reported to ORO
Central Office.

\(2\) When Government-wide suspension is determined to be appropriate,
the procedures set forth at 38 CFR 44, Subpart G, must be followed.

\(3\) If evidence of criminal activity is discovered in connection with
a research misconduct proceeding, the provisions at 38 CFR §§ 1.200 --
1.205 for reporting criminal matters must be followed. If there is
reasonable indication of a possible criminal violation, the VA medical
center must promptly refer the matter to the VA Inspector General, or
other appropriate investigative body.

\(4\) Nothing in this Policy is to be construed as limiting the VA
medical center's duty to cooperate with any concurrent VA or non-VA
administrative or investigative proceeding authorized by law, including
the sharing of information and investigative materials to the extent
permitted by law and VA policy.

f\. [Admissions.]{.underline} Prior to the completion of a case, the
Respondent might admit to having committed misconduct. Such admission by
itself is not grounds for termination of the case. Any admissions must
be placed in writing and signed by the Respondent and a witness.
Additional investigation may be necessary to discover the full extent of
the Respondent's misconduct or the roles of other potential Respondents.
All of the elements of a finding of research misconduct (see par. 3), if
not evident in the admission, must be established by a full
Investigation.

g\. [Respondent's Employment Status.]{.underline} Termination of a
Respondent's VA employment, by resignation or otherwise, does not
preclude the initiation or continuation of an investigation of
misconduct alleged to have occurred during the Respondent's VA
employment. If a former VA employee chooses not to cooperate with an
investigation, all other available testimony and evidence is reviewed.

h\. [Federal Tort Claims Act (FTCA).]{.underline} As VA employees acting
within the scope of their employment, the RIO, members of the Inquiry
and Investigation Committees, and other VA support staff are protected
from personal liability in accordance with the FTCA. Agencies or
entities with joint jurisdiction in particular cases (see subpar. 12c)
are responsible for providing liability coverage for their employees who
participate in a research misconduct proceeding. Non-VA consultants who
are asked to provide advice in an investigation need to be formally
designated as WOC employees, unless they are contractors.

**13. ALLEGATIONS**

a\. [Referrals.]{.underline} All formal allegations of research
misconduct must be referred to the RIO of the relevant VA medical
center. If ORO or any other VA office receives a misconduct allegation
concerning VA research, that office must forward the allegation, with
the Informant's knowledge and permission, to the RIO of the relevant VA
medical center.

b\. [Good Faith and Reasonable.]{.underline} Allegations of research
misconduct must be made in good faith and must be reasonable. A
misconduct allegation not made in good faith may result in the waiver of
any and all protection privileges listed in subparagraph 8d. A "good
faith and reasonable allegation" consists of the following:

\(1\) The Informant must believe in the substance of the allegation, and
the allegation must be one which a person in the Informant's situation
could reasonably make.

\(2\) The Informant needs to have made a reasonable inquiry into the
matter before formally alleging research misconduct. Such inquiry might
include raising the concerns with the suspected individual(s) or the
individual(s)' colleagues and supervisor. The Informant, however, need
not place the Informant's own interests in jeopardy in inquiring about
the matter.

\(3\) An allegation is not made in good faith nor reasonable if made
with reckless disregard for or willful ignorance of facts that would
negate the allegation.

c\. [Formal Allegation]{.underline}

\(1\) If possible, allegations of research misconduct must be made in
writing.

\(2\) The written allegation normally is given to the potential
Respondent's supervisor who must then forward the allegation immediately
to the RIO. If the Informant prefers, however, the Informant may submit
the allegation directly to the RIO. The allegation needs to include all
relevant information in detail, including the names of involved
individuals and research projects, sources of funding if known,
important dates, and any documentation that bears upon the allegation.

\(3\) The RIO must promptly notify the VA medical center Director of all
research misconduct allegations received.

d\. [Anonymity.]{.underline} Anonymous allegations of research
misconduct may be evaluated under these procedures. However, a complete
investigation and adjudication of a misconduct allegation often requires
the participation of an identified Informant. An anonymous allegation
that does not meet the required threshold set forth in subparagraph 13e
will [not]{.underline} be pursued.

e\. [Required Threshold.]{.underline} Upon receipt of a research
misconduct allegation, the RIO must determine whether the allegation
contains all of the threshold requirements for opening an Inquiry.
Before an Inquiry is opened, the RIO must determine that the allegation
meets [all]{.underline} of the following requirements:

\(1\) The allegation involves VA research as defined in subparagraph 5t.

\(2\) The allegation is of research misconduct as defined in paragraph
3.

\(3\) The allegation [on its face]{.underline} contains the elements of
a finding of research misconduct as defined in paragraph 3. The
misconduct [as alleged]{.underline} must represent a significant
departure from accepted practices of the relevant research community and
must be committed intentionally, knowingly, or with reckless disregard
for the integrity of the research. An allegation that is clearly
frivolous and without any basis in fact or reason fails to meet the
required threshold for opening an Inquiry.

f\. [Deficient Allegations.]{.underline} If the allegation fails to meet
one or more of the threshold requirements in the preceding subparagraph
13e, the VA medical center Director must notify the Informant, in
writing, that a research misconduct case will not be opened.

\(1\) The notification must set forth the particular threshold
requirement(s) that the allegation fails to meet.

\(2\) A copy of this notification is to be forwarded to the appropriate
VISN Director and retained in a secure file for a minimum of 3 years.

\(3\) If appropriate, the RIO may process the allegation under
appropriate other procedures or direct the Informant to another office
that may have jurisdiction over the allegation.

\(4\) If the Informant amends and resubmits the allegation, the RIO must
reassess whether the amended allegation meets the threshold requirements
found in subparagraph 13e.

g\. [Other Information Sources.]{.underline} Information about potential
research misconduct from sources other than an Informant (e.g., media,
other agencies) may also lead to the opening of an Inquiry if the
threshold requirements in subparagraph 13e are met. The procedures in
this Policy apply in such cases.

**14. INQUIRY**

a\. [Applicability.]{.underline} The procedures outlined in this
paragraph apply whenever a VA medical center takes the lead in
conducting an Inquiry, as determined by subparagraph 12c(4). If a non-VA
agency or entity with joint jurisdiction takes the lead in conducting
the Inquiry, that agency or entity's misconduct Inquiry procedures
apply, consistent with subparagraph 12c(5).

b\. [Purpose.]{.underline} If a research misconduct allegation meets the
threshold requirements of these procedures (see subpar. 13e), an Inquiry
must be initiated for the sole purpose of determining whether sufficient
evidence exists to open a formal Investigation (see par. 15).

c\. [Initiation of Inquiry]{.underline}

\(1\) The VA medical center Director must convene an Inquiry within 5
working days after a research misconduct allegation is received if the
allegation meets the threshold requirements of subparagraph 13e, and it
has been determined that the VA medical center will take lead
responsibility for the Inquiry according to subparagraph 12c(4).

\(2\) The following persons must be provided written notification of the
misconduct allegation and the opening of an Inquiry:

\(a\) The named Respondent(s);

\(b\) The Informant;

\(c\) The appropriate VISN Director;

\(d\) ORO Central Office; and

\(e\) The research misconduct oversight office for the agency or entity
with joint jurisdiction, if any.

\(3\) The notification specified in subparagraph 14c(2) must include the
name of the Respondent(s), the nature of and basis for the allegation,
and the research funding involved.

d\. [Sequestration of Physical Evidence.]{.underline} As soon as
possible, the RIO must sequester all physical materials that might serve
as evidence in determining the merits of the research misconduct
allegation (see VA Policy 0700). In most cases, sequestration must take
place prior to, or at the time of, notification to the Respondent.

e\. [Inquiry Review.]{.underline} An Inquiry consists of a review of the
research misconduct allegation, sequestered and submitted materials, and
any other readily available evidence, followed by a decision as to
whether sufficient evidence exists to open an Investigation. The review
must adhere to the following requirements:

\(1\) The Inquiry Review (including final Inquiry Report) must normally
be completed within 30 days from the initiation of the Inquiry (see
subpar. 14c). If an extension is required, the VA medical center
Director shall submit a timely request to ORO Central Office which may
grant such request at its discretion.

\(2\) Inquiries may be conducted by either the RIO or an Inquiry
Committee appointed by the VA medical center Director. If review of the
allegation would involve complex scientific or procedural matters, it is
encouraged that an Inquiry Committee be formed to review the allegation.
The VA medical center Director must charge the Committee in accordance
with the purpose set forth in subparagraph 14b. The procedures in this
Policy are to be carefully reviewed at the first Inquiry Committee
meeting and the scope of the Committee's Inquiry needs to be clearly
understood.

\(3\) Any agency(s) or entity(s) with concurrent jurisdiction over a
research misconduct allegation must designate one representative to
participate in the Inquiry, either in conjunction with the RIO or as a
member of an Inquiry Committee.

\(4\) If the RIO or any member of the Inquiry Committee, has an actual
or apparent conflict of interest that cannot be resolved with respect to
a particular case, such individual must be replaced by another eligible
individual. A conflict of interest may include, but is not limited to, a
close familial, personal, or professional relationship with the
Respondent or Informant, the nature of which creates a strong potential
for biasing the individual's decision-making.

\(5\) Both the Respondent and the Informant must be interviewed, if
available. Additional individuals who can provide relevant information
may also be interviewed. Written transcripts of these interviews must be
prepared, provided to the respective interviewees for correction, and
included in the record (see VA Policy 0700).

\(6\) Subject-matter experts from within or outside VA may be consulted
to aid in the analysis of the evidence. Regional Counsel may also be
consulted on legal matters. Persons other than the RIO, or Inquiry
Committee members, may not participate in the substantive
decision-making and must maintain strict confidentiality in accordance
with paragraph 10.

\(7\) After the evidence is reviewed, a decision must be made whether an
Investigation is to be opened. Evidence that would raise a significant
suspicion of research misconduct to a reasonable person is sufficient to
justify opening a formal Investigation.

f\. [Inquiry Report.]{.underline} For every case in which an Inquiry is
initiated, the RIO, or Inquiry Committee if applicable, must produce an
Inquiry Report that summarizes the research misconduct allegation, the
evidence reviewed, and how the evidence supports the recommendation to
open or not open an Investigation. The Inquiry Report may be presented
in summary format (see VA Policy 0700).

g\. [Termination of VA Case]{.underline}

\(1\) If the RIO, or Inquiry Committee, finds that the available
evidence is insufficient to justify opening an Investigation, and the VA
medical center Director concurs, the VA case will be terminated;
however, the case file must be retained until expiration of the
authorized retention period (see subpar. 11c).

\(2\) Written notice of the VA case closure must be provided to the
individuals listed in subparagraph 14c(2). The RIO must forward the
Inquiry Report to the appropriate VISN Director, ORO Central Office, and
the research misconduct oversight office for the agency or entity with
joint jurisdiction, if any.

\(3\) The Informant may file a subsequent allegation of research
misconduct, but an Inquiry should not be reopened unless substantially
new allegations are made or new evidence is provided.

h\. [Decision to Open an Investigation.]{.underline} If the RIO, or
Inquiry Committee, finds that the available evidence is sufficient to
justify opening an Investigation, or if the VA medical center Director
disagrees with a recommendation to terminate the case, an Investigation
must be opened. In the latter case, the VA medical center Director must
include in the notification letter specified in subparagraph 15c, the
Director's reason for opening an Investigation despite a recommendation
to terminate the case.

**15. INVESTIGATION**

a\. [Applicability.]{.underline} The procedures outlined in this
paragraph apply whenever a VA medical center takes the lead in
conducting an Investigation, as determined by subparagraph 12c(4). If a
non-VA agency or entity with joint jurisdiction takes the lead in
conducting the Investigation, that agency's or entity's misconduct
Investigation procedures will apply, consistent with subparagraph
12c(5).

b\. [Purpose.]{.underline} If the Inquiry results in a recommendation to
open an Investigation (see subpar. 14h), an Investigation must be
initiated for the purpose of determining whether and to what extent
research misconduct has occurred, who is responsible, and what
corrective actions are appropriate.

c\. [Initiation of Investigation.]{.underline} The VA medical center
Director must convene an Investigation, including the selection of an
Investigation Committee, within 10 working days of a recommendation to
open an Investigation. A Charge Letter must be issued according to VA
Policy 0700. Written notification of the Investigation must be made to
the persons listed in subparagraph 14c(2). Such notice must include the
name of the Respondent(s), the nature of and basis for the allegation,
any additional areas of potential investigation, and the research
funding involved.

d\. [Sequestration of Physical Evidence.]{.underline} As soon as
possible and to the extent not done so during the Inquiry, the RIO must
sequester all physical materials that might serve as evidence in
determining the merits of the research misconduct allegation (see VA
Policy 0700).

e\. [Composition of the Investigation Committee.]{.underline} Each
Investigation must be conducted by an Investigation Committee composed
of three to five individuals. The membership requirements of this
Investigation Committee are as follows:

\(1\) The Investigation Committee must be constituted within 10 working
days of the Inquiry's recommendation to open an Investigation.

\(2\) The Investigation Committee may be either a standing committee
which conducts all research misconduct Investigations for the VA medical
center or an ad hoc committee reconstituted for each new misconduct
allegation.

\(3\) Members of the Inquiry Committee, if any, may serve on the
Investigation Committee.

\(4\) Except as specified in subparagraph 15e(6), Investigation
Committee members need to be employees of the VA medical center,
preferably with relevant research experience. The VA medical center
Director is responsible for selecting these Committee members.

\(5\) Each Investigation Committee must be directed by a Chair who is a
VA medical center employee with 5/8^ths^ or greater appointment and is
actively involved with VA research either as an investigator or as an
administrator.

\(6\) Any agency or entity with concurrent jurisdiction over the matter
(see subpar. 12c) must designate one representative to be a member of
the Investigation Committee. The qualifications of that individual are
to be determined by the agency's or entity's own policies and
procedures. If the other agency or entity does not or cannot designate
an individual, the Investigation Committee may be composed entirely of
employees of the VA medical center.

\(7\) An Investigation Committee member who has an actual or apparent
conflict of interest that cannot be resolved with respect to a
particular case must be replaced by another eligible individual. A
conflict of interest may include, but is not limited to, a close
familial, personal, or professional relationship with the Respondent or
Informant the nature of which creates a strong potential for biasing the
Committee member's decision-making.

\(8\) The RIO must notify the Respondent and Informant of the
Committee's membership upon selection. Within 5 days of receiving such
notification, the Respondent and the Informant may each submit written
objections to the selection on the basis of conflict of interest. Any
objections must be documented in the case record. The final decision to
retain or replace Committee members belongs to the VA medical center
Director.

f\. [Investigation Review.]{.underline} The Investigation Committee is
to conduct a thorough review of the research misconduct allegation; any
other potential instances of related, research misconduct not specified
in the allegation; the Inquiry Report; sequestered and submitted
materials; and any other relevant evidence that can be obtained. The
Committee must reach a decision as to whether and to what extent
research misconduct has occurred, who is responsible, and what
corrective actions are appropriate (see par. 18). This review must
adhere to the following guidelines:

\(1\) The Investigation Review (including final Investigation Report)
normally must be completed within 90 days from the initiation of the
Investigation. If an extension is required, the VA medical center
Director must notify ORO Central Office at least 5 working days prior to
the end of the initial review period. ORO may grant an extension at its
discretion.

\(2\) The VA medical center Director is to charge the Investigation
Committee according to the purpose stated in subparagraph 15b. The
procedures in this Policy and VA Policy 0700 are to be carefully
reviewed at the first Investigation Committee meeting, and the scope of
the Committee's investigation must be clearly understood.

\(3\) If additional Respondents or substantively new allegations are
added in the course of the Investigation, notification of these
additions must be given in accordance with subparagraph 15c.

\(4\) The Investigation Committee must interview both the Respondent and
the Informant if available. If possible, additional individuals who can
provide relevant information must be interviewed. Written transcripts of
the interviews are to be prepared, provided to the respective
interviewees for correction, and included in the record (see VA Policy
0700).

\(5\) Subject-matter experts from within or outside VA may be consulted
to aid in the analysis of the evidence. Regional Counsel may also be
consulted on legal matters. Persons who are not members of the
Investigation Committee may not participate in the Committee's
substantive decision-making and must maintain strict confidentiality in
accordance with paragraph 10.

\(6\) After reviewing the evidence, the Investigation Committee must
decide by consensus whether research misconduct occurred and, if so, the
type and extent of misconduct, who is responsible, and appropriate
corrective actions (see par. 18). If a consensus cannot be reached on
one or more of these questions, the Investigation Report must note the
area(s) of disagreement, the arguments supporting and opposing the
various viewpoints, and the majority opinion, if any.

g\. [Investigation Report]{.underline}

\(1\) The Investigation Committee is to produce an Investigation Report
that summarizes the research misconduct allegation, the evidence
reviewed, and the Committee's recommendation about whether research
misconduct occurred and, if so, the type and extent of misconduct, who
is responsible, and appropriate corrective actions (see VA Policy 0700).

\(2\) The Investigation Report must be provided to the Respondent, and
the portions of the Investigation Report related to the initial
Informant's role and testimony must be provided to the Informant, for
their responses. Written comments must be submitted to the Committee
within 7 days. The Investigation Committee makes any necessary revisions
to the report and attaches the Respondent and Informant comments, if
any, to the final Investigation Report.

h\. [Certification and Transmittal.]{.underline} Within 7 days of
receiving the final report from the Investigation Committee, the VA
medical center Director must certify completion of the Investigation
according to VA Policy 0700, and transmit the final Investigation Report
with all supporting documents to the VISN Director to which the VA
medical center reports.

\(1\) Along with the Investigation Report, the VA medical center
Director may append the Director's own recommendations. The Director's
recommendations may concur with, or differ from, the recommendations of
the Investigation Committee. The rationale for any recommendation that
differs from that of the Investigation Committee must be provided.

\(2\) The VA medical center Director must notify the VISN Director of
any proposed disciplinary action(s) that the VA medical center Director
intends to take (see subpar. 4f).

\(3\) Copies of the final Investigation Report and the VA medical center
Director's recommendations are to be provided to the Respondent, ORO
Central Office, and the head of the agency or entity that has joint
jurisdiction, if any.

**16. ADJUDICATION**

a\. [Applicability.]{.underline} The procedures outlined in this
paragraph apply only to the VA's adjudication of research misconduct
cases. VA adjudicates every research misconduct case over which it has
jurisdiction (i.e., allegations involving VA research as defined in
subpar. 5t), whether the Investigation was led by VA or by a non-VA
agency or entity with concurrent jurisdiction. Non-VA agencies or
entities with joint jurisdiction, if any, follow their own adjudication
procedures with respect to the findings and recommendations of the
Investigation Committee. VA is not bound by another agency's or entity's
adjudication (see subpar. 12c\[8\]).

b\. [Purpose.]{.underline} The purpose of an Adjudication under this
Policy is to make a VA determination, based on the recommendations from
the Investigation, as to whether research misconduct occurred and, if
so, the type and extent of misconduct, who is responsible, and
appropriate corrective actions.

c\. [Receipt of Case.]{.underline} In keeping with subparagraph 15h, the
appropriate VISN Director is to receive a research misconduct case from
the VA medical center once its Investigation Report is completed. Prior
to receipt of the case, the VISN Director should not be consulted or
otherwise involved in the Inquiry or Investigation of the misconduct
allegation, except to the extent that significant and extraordinary
conditions require the immediate attention of the VISN Director's
office.

d\. [Review.]{.underline} The VISN Director reviews the Investigation
Report and all supporting documents before making a final adjudication
of the matter.

\(1\) The VISN Director may request additional information from the RIO
and request the Investigation Committee to examine additional issues and
evidence. The VISN Director may also consult with ORO Central Office,
ORD, and the Office of the General Counsel (OGC) in reviewing the case.

\(2\) If the VISN Director has an actual or apparent conflict of
interest that cannot be resolved in adjudicating a case, another VA
official must be appointed by ORO Central Office as an alternate
Adjudicator. A conflict of interest may include, but is not limited to,
a close familial, personal, or professional relationship with the
Respondent or Informant the nature of which creates a strong potential
for biasing the Adjudicator's decision-making.

e\. [Final Decision.]{.underline} After fully reviewing the case, the
VISN Director makes a decision about whether research misconduct
occurred, and if so, who is responsible, the type of misconduct involved
(fabrication, falsification, and/or plagiarism), the extent or
seriousness of the misconduct, and appropriate corrective actions.

\(1\) The final decision must be consistent with the definition and
elements of a finding of research misconduct, as specified in paragraph
3.

\(2\) The VISN Director reviews the VA medical center Director's
recommendation for disciplinary action(s), if any, and makes any
appropriate modifications.

\(3\) The VISN Director's decision may adopt all, some, or none of the
investigative findings and recommendations. Any decision contrary to the
recommendations of the Investigation Committee and/or VA medical center
Director must be noted, and specific reasons for that decision must be
set forth in writing and made part of the case file.

\(4\) The review and final decision is to be completed within 30 days of
the VISN Director's receipt of the Investigation Report.

f\. [Transmittal.]{.underline} When the VISN Director has made a final
decision on the merits of a research misconduct case, that decision is
to be transmitted to ORO Central Office along with the Investigation
Report.

**17. DEPARTMENTAL REVIEW**

a\. [Administrative Review.]{.underline} ORO Central Office reviews the
VISN Director's final determination along with the Investigation Report
and any supporting evidence that ORO may request.

\(1\) The case is reviewed for conformance with the procedures set forth
in this Policy including, but not limited to: timeliness; objectivity;
preservation of safeguards; thoroughness; and competence.

\(2\) If it determines that the allegation falls outside the scope or
does not meet the threshold requirements of this Policy, ORO will
dismiss the case (see par. 6).

\(3\) ORO Central Office consults with ORD on all matters that concern
or might affect VA funding.

\(4\) ORO Central Office may request further information from the VISN
Director, the VA medical center RIO, the Investigation Committee, or
other parties with relevant information.

b\. [Disposition.]{.underline} ORO disposes of the case as follows:

\(1\) If ORO determines that the Inquiry and Investigation and
adjudication substantially adhered to the procedures set forth in this
Policy, the VISN Director's decision will be upheld.

\(2\) If ORO determines that the Inquiry or Investigation did not
substantially adhere to the procedures set forth in this Policy so as to
materially affect the outcome of the case, ORO will either request the
VA medical center to reopen the Investigation using the same or
different Committee or assemble an ad hoc ORO Investigation Committee
(see par. 6) to conduct a new Investigation. The Investigation's
findings and recommendations will be submitted to the VISN Director for
a de novo adjudication according to paragraph 16.

c\. [Notification.]{.underline} ORO Central Office provides written
notification of the outcome to the Under Secretary for Health; the VISN
Director; the VA medical center Director; the head of the agency or
entity that has joint jurisdiction, if any; the Informant; and the
Respondent.

\(1\) If the final outcome does not result in a finding of research
misconduct, the VA medical center Director will be directed to provide
reasonable assistance in restoring the Respondent's reputation,
according to subparagraph 9h.

\(2\) If the final outcome involves a finding of research misconduct,
ORO Central Office notifies the Respondent of the Respondent's
opportunity to appeal the finding and proposed corrective actions
according to paragraph 19.

\(3\) If the final outcome involves a debarment recommendation, ORO
Central Office issues a notice of proposed debarment to the Respondent
on behalf of the Under Secretary for Health. Such a notice is prepared
according to the requirements of 38 CFR sec. 44.805, and specifies the
length and terms of the proposed debarment. A copy of 38 CFR Part 44
(Government-wide Debarment and Suspension \[Non-procurement\]) is to be
included with the notification.

**18. CORRECTIVE ACTIONS**

a\. [Considerations.]{.underline} When a finding of research misconduct
is made, corrective actions must be proposed and implemented as
appropriate to the circumstances surrounding the misconduct. The VISN
Director has wide discretion in proposing corrective actions. The
following criteria may be considered in making that determination:

\(1\) The extent of the research misconduct (amount, duration, scope);

\(2\) The degree to which the misconduct was knowing, intentional, or
reckless;

\(3\) The presence or absence of a pattern of misconduct;

\(4\) The consequences or possible consequences of the research
misconduct (injury to research subjects, skewing of related research
results, waste of VA funds, misleading funding reviewers, etc.)

\(5\) The Respondent's position and responsibility for the research
project;

\(6\) The cooperation of the Respondent during the Inquiry and
Investigation;

\(7\) The likelihood of rehabilitation;

\(8\) The type of corrective actions imposed in past research misconduct
cases with similar features, if any; and

\(9\) Any other extenuating or aggravating circumstances.

b\. [Examples of Possible Corrective Actions.]{.underline} The following
is a [non-exhaustive]{.underline} list of corrective actions that may be
taken in response to a finding of research misconduct. The
implementation of these actions may require further procedures, as
specified in other VA rules, regulations, or policies. *).*

\(1\) Government-wide debarment.

\(2\) Removal from a particular project, or suspension or termination of
an active award.

\(3\) Restitution of funds or civil penalties.

\(4\) Prohibition from receiving VA research funds for a period of time.

\(5\) Correction or retraction of published article.

\(6\) Monitoring or supervision of future work.

\(7\) Required certification of data.

\(8\) Required certification of sources (references and contributors).

\(9\) Remedial education and/or mentoring.

**19. APPEALS**

a\. [Applicability]{.underline}

\(1\) All final VA research misconduct findings and proposed corrective
actions (including debarment, if applicable), except those based upon a
conviction or civil judgment, may be appealed to the Under Secretary for
Health according to paragraph 19. Appeals of other related actions may
be combined with the research misconduct appeal in a single proceeding
at the discretion of the Under Secretary for Health.

\(2\) Only named Respondents may appeal a finding of research misconduct
under paragraph 19. Neither the Informant nor any other party has a
right to appeal an agency finding or non-finding of research misconduct.

b\. [Filing Period.]{.underline} In order to preserve the opportunity to
appeal under these procedures, the Respondent must file a written appeal
of the research misconduct finding or proposed corrective actions
(including debarment, if applicable) within 30 days of receiving the
notice of research misconduct finding (see subpar. 17c).

c\. [Submission.]{.underline} The appeal is to be sent directly to the
Under Secretary for Health's office, with a copy to ORO Central Office.
The Respondent's submission must include the notice of research
misconduct finding, the final Investigation Report, the precise findings
or proposed corrective actions that are being appealed, a statement of
the grounds for the appeal, and any additional evidence that supports
the grounds for appeal.

d\. [Review.]{.underline} The Under Secretary for Health reviews all
appeals that are timely and complete.

\(1\) The appeal is reviewed and decided based on the documents
submitted by the Respondent and ORO, and any other relevant information.

\(2\) The Office of the General Counsel (OGC) and other Departmental
resources may be consulted for advice.

\(3\) All hearings in which a proposed debarment is being contested must
adhere to the requirements of 38 CFR 44, Subpart H.

e\. [Final Decision.]{.underline} The Under Secretary for Health makes a
final decision on the issues appealed by the Respondent, based on the
Under Secretary for Health's review (see subpar. 19d).

\(1\) The Under Secretary for Health makes a final decision in writing.
The written decision must include a justification for upholding,
reversing, or modifying the VISN Director's decision. The decision must
be consistent with the definition and elements of a finding of research
misconduct, as specified in paragraph 3.

\(2\) The Under Secretary for Health's final written decision must be
made within 45 days after all final submissions, information, and
findings of fact have been received, unless a good cause for extension
exists.

\(3\) ORO Central Office forwards the Under Secretary for Health's final
written decision to the Respondent, the VISN Director, the VA medical
center Director, and the head of the agency or entity that has joint
jurisdiction, if any.

\(4\) If the Under Secretary for Health reverses the finding of research
misconduct, the VA medical center Director will be directed to provide
reasonable assistance in restoring the Respondent's reputation to the
extent deemed appropriate and within the VA medical center's authority,
according to subparagraph 9h.

\(5\) If the final decision includes the imposition of a debarment, the
notice to the Respondent must adhere to the requirements of 38 CFR
Section 44.870.

\(6\) The Under Secretary for Health's decision constitutes VA's final
agency action, except with respect to a debarment decision. At the Under
Secretary for Health's discretion, the Under Secretary for Health may
reconsider a debarment decision according to 38 CFR Sections 44.875 and
44.880. No other appeals are available within VA.

**10. VA AAHS RESEARCH NONCOMPLIANCE MANAGEMENT POLICY**

**1. Response to Complaints and Allegations of Noncompliance with
Institutional Policies**

a\. The AAHS fosters a culture that encourages all research workers and
research subjects to ask questions, express concerns, make suggestions
and report problems so that corrective actions can be taken before
serious problems occur and formal actions are required.

b\. Investigators and research staff are responsible for reporting
issues of non-compliance to the Research Compliance Officer or the IRB
Coordinator.

c\. The Research Compliance Officer or the IRB Coordinator will have
responsibility for responding to questions, suggestions, concerns or
complaints regarding noncompliance with institutional policies. All
complaints and allegations will be investigated and a preliminary
response will be made to the individual making the complaint within 24
hours (or the next regular work day). All noncompliance issues will be
communicated to the ACOS/ Research.

d\. The VA Research Compliance Officer or the IRB Coordinator will
report the names of staff members with expired GCP training (\>30 days)
to the ACOS/ Research.

e\. The ACOS/ Research will report unresolved issues of noncompliance to
the R&D Committee and/ or IRB Committee (in the case of human subjects
research) for further review.

**2. Definitions**

a\. Non-compliance occurs when investigators fail to follow or disregard
federal regulations, state laws, institutional policies and procedures,
IRB determinations and requirements, the ethical principles of the
Belmont Report, or the requirements of VHA Handbook 1200.5 when
conducting human subject research.

b\. Serious non-compliance affects the rights and welfare of research
subjects and is determined by the R&D or IRB to be a flagrant violation
of regulations, or the requirements or determinations of the R&D or IRB.

c\. Non-serious non-compliance does not affect the rights and welfare of
research subjects and is determined by the R&D or IRB not to be a
flagrant violation of regulations, or the requirements or determinations
of the R&D or IRB. Non-serious non-compliance may be relatively minor
such as reporting an event to the IRB a few days after the due date or
it may be a one-time event.

d\. Continuing non-compliance is a problem that persists (i.e. there has
not been compliance with the corrective action plan) after the R&D or
IRB has identified it as a problem, completed an analysis and provided
written notification of corrective action.

**3. Investigation of concerns, complaints, and allegations of
non-compliance or misconduct**:

a.  When non-compliance or misconduct issues are identified, every
    effort will be taken to correct these issues at the administrative
    level. If an issue involves human subject protection and safety the
    IRB will be immediately notified and affiliate policies and
    procedures will be followed pending the outcome of formal inquiry.

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a.  All reports will be directed to the RCO. The RCO or designee will
    conduct an initial inquiry of fact finding, as appropriate to the
    nature of the concern, complaint, or allegation of non-compliance
    issue. With issues of non-compliance the RCO will and will initiate
    the inquiry process at the direction of, and through, the Associate
    Chief of Staff (ACOS) for Research and Development or the
    Administrative Officer (AO) for Research and Development. The
    purpose of this fact finding inquiry is to determine whether there
    is non-compliance in fact and whether the non-compliance is serious
    or continuing.

b.  The Associate Chief of Staff (ACOS) for Research and Development
    will be notified of all non-compliance or misconduct issues and
    whenever an inquiry has begun.

c.  The Associate Chief of Staff (ACOS) for Research and Development
    will determine if concerns, complaints, or allegations of
    non-compliance involve non-compliance in fact. If there is no
    non-compliance or no misconduct, no further action needs to be taken
    under this policy. If there is non-compliance the "Investigation of
    Non-compliance" is followed.

e\. **If the ACOS determines that the report meets the definitions of
Serious Non-Compliance or Continuing Non-Compliance, the report will be
forwarded to VA R&D and VA IRB (in each case of human subjects
research).**

f\. The ACOS, AO, RCO may take additional actions.

g\. If evidence of Research Misconduct (i.e. fabrication, falsification,
or plagiarism) is discovered, a written allegation will be submitted to
the Research Integrity Officer (RIO) for further action.

> h\. If the ACOS determines that the non-compliance is neither serious
> nor continuing:
>
> \(1\) The investigator will be asked to take corrective actions within
> a specified time frame
>
> \(2\) When appropriate, the investigator will be asked to submit a
> plan to prevent reoccurrence
>
> \(3\) Based on the event, the ACOS may require that the investigator
> take additional training in human research protections
>
> \(4\) Notification will be sent to the Principal Investigator,
> Co-investigator, and the IRB of the determinations of the ACOS and any
> sanctions that are levied as a result. At the discretion of the ACOS
> the Principal Investigator's department chair or Service Chief may
> also be notified.

**4. Investigation of Non-Compliance: Committee Review Process and
Considerations**

a\. The VA R&D and the VA IRB (in [each]{.underline} case of human
subjects research) will use a Primary Reviewer system of review:

(1) Documents distributed to the Primary Reviewer and the Committee
    Chair:\
    R&D Application, Scientific Protocol, Investigator Brochure, IRB
    Application

(2) Documents distributed to all Committee Members:\
    Reports of Misconduct and Non-Compliance; relevant support documents

b\. Elements of Concern

(1) What caused the problem?

(2) Is the Non-compliance Serious or Continuing?

(3) Did it or could it result in serious harm to subjects?

(4) Did it or could it significantly impact subject safety?

(5) Did it or could it significantly impact the research record or data
    integrity?

(6) Was it an isolated event, first occurrence or part of a pattern?

(7) Was it reported by the investigator or by a third party?

(8) Was it intentional?

(9) Was it reckless?

(10) Were laws, regulations or policies violated?

**5. Research Committee Determinations**

a\. The convened R&D [(and in each case of human subjects research, the
VA IRB)]{.underline} will make a determination if serious
**[or]{.underline}** continuing non-compliance exists. That
determination will be recorded in the Committee minutes and appropriate
notifications to institutional officials and regulatory agencies will be
sent. Corrective actions will be commensurate with the level of
non-compliance.

b\. The R&D (and in [each]{.underline} case of human subjects research,
the VA IRB) may need additional information in order to adequately
evaluate non-compliance and may request the Research Compliance Officer
(and the IRB Coordinator), sponsor or other independent reviewers to
conduct a review and report findings. Investigations of non-compliance
will be conducted under due process and the rights of all individuals
involved will be respected.

c\. The Committee findings are documented in the R&D (and the IRB)
minutes.

[d. Notification of committee findings of non-compliance or continuing
non-compliance are sent to the appropriate research investigators,
institutional officials and regulatory agencies. (See Section 10
below.)]{.underline}

**6. Action Plan for Non-Serious or Non-Continuing Non-Compliance**

· a. The R&D committee [(and in each case of human subjects research,
the VA IRB)]{.underline} will evaluate the seriousness of the problems
and determine if actions are required to protect subjects, staff and
others and to validate data integrity.

· b. Require a corrective action plan.

· c. Require additional training (e.g. GCP, ACRP training, or individual
training by the Research Compliance Officer or IRB Coordinator).

· d. Require the investigator attend an IRB/R&D meeting to discuss
non-compliance and plans for improvement.

· e. Require additional monitoring.

· f. Place restrictions on this or other studies. (e.g. stop enrollment,
not allow initiation of new studies, HRPP official observe informed
consent process or study procedures)

· [g. Request the VA IRB to consider increasing the frequency of
Continuing Review.]{.underline}

· h. Require additional research staff and or research resources.

**7. VA IRB Action Plan for Findings of Serious or Continuing Non-
Compliance**

a\. The IRB evaluates the seriousness of the problems and determines if
the rights and welfare of subjects are adversely affected. The IRB takes
actions in order to protect subjects, staff and others and to validate
data integrity.

b\. The IRB conducts a risk-benefit assessment in order to

> \(1\) determine if the research should continue,
>
> \(2\) if modifications are needed prior to continuation of the
> research or
>
> \(3\) if the research should be discontinued. The IRB assures that
> appropriate plans are in place that maximize subject safety (e.g.
> continuation of research participation, subject withdrawal or
> transition to standard of care).

· c. Require a corrective action plan. If a problem persists (i.e. there
has not been compliance with the corrective action) after the IRB has
identified it as a problem, completed an analysis and provided written
notification of corrective action, then the non-compliance will be
considered to be continuing non-compliance and will be reported to
institutional officials, regulatory agencies and sponsors if applicable.

· d. Suspend or terminate the study in question (or other studies, if
applicable) and notify institutional, regulatory and sponsor officials.

· e. Place restrictions on this or other studies. (e.g. stop enrollment,
not allow initiation of new studies, Research Compliance Officer or IRB
Coordinator observe informed consent process, monitor other aspects of
the research ).

· f. Determine if modification of the research and/or re-training of
study staff is a condition of re-approval.

· g. If the IRB determines that additional training will not resolve the
problem and the problem cannot be resolved privileges to conduct
research at AAHS may be revoked.

· h. Determine if subjects (current and past if warranted) should be
notified, when subjects should be notified, how subjects should be
notified, what information should be provided to the subjects, and who
should provide subjects with such information. The IRB makes these
determinations based upon what it judges to be in the subject's best
interest and understands that the information and the manner in which it
is conveyed to subjects could influence a subject's decision to continue
participation in the research.

· i. Determine if a new investigator needs to assume responsibility for
the study and determine if other research staff changes are necessary.

· j. Determine if the consent form needs revision, if subjects should be
re-consented or if the consent process should be changed.

k\. • More than minor modifications to previously approved research
taken in response to non-compliance are reviewed by the convened IRB.

· l. Assign an outside monitor to supervise the continuation and/or
withdrawal process.

· m. Determine an appropriate Continuing Review timetable.

· n. As warranted, coordinate actions with other services in the medical
center (lab, pharmacy, nursing service, medical service, surgical
service etc.).

· o. For studies that are terminated assure that subject withdrawal
plans and/or transition to standard of care are in place and do not
compromise subject safety.

p\. The Committee findings are documented in the Minutes.

[q. Notification of committee findings of non-compliance or continuing
non-compliance are sent to the appropriate research investigators,
institutional officials and regulatory agencies. (See Section 10
below.)]{.mark}

**8. IRB Suspension or Termination of Approval of Research Study**

a\. The IRB may suspend or terminate approval of the research study
*[(or permanent closing of a part of the research study)]{.underline}*
at any time if it determines that research activities are not being
conducted in accordance with federal regulations or that the research
has been associated with unexpected serious harm to subjects \[21 CFR
56.113\]. The concerns of the IRB will be conveyed to the Principal
Investigator in writing and will include a statement of the reasons for
the IRB's action and procedures to be followed. A written response
addressing IRB concerns may be required from the Principal Investigator.

b\. For suspended research, enrollment for new subjects cannot occur;
continuation of research interventions or interactions in already
enrolled subjects should only continue when the IRB or IRB Chairperson
finds that it is in the best interest of individual subjects to do so.
Once suspended, IRB review and re-approval must occur prior to
re-initiation of the research.

**9. Sharing Findings of Investigator Misconduct with other
Institutions**

Reports of established findings of investigator misconduct will be
shared with all professional institutions that employ the research
investigator. The Associate Chief of Staff for Research at the Ann Arbor
VAMC will assume the responsibility of reporting established findings of
misconduct to the other professional institutions.

**10. Prompt reporting of All Suspensions and Terminations of IRB
Approval, Serious or Continuing Non-Compliance, and Unanticipated
Problems involving Risks to participants or Others to institutional
officials, and regulatory agencies**

Whenever the R&D Committee, the IRB or any official in the organization
suspends or terminates IRB approval, the IRB chair or IRB determine that
non-compliance is serious or continuing non-compliance, or when the IRB
or IRB chair determine that a problem is an unanticipated problem
involving risks to participants or others, the ACOS/ Research will
prepare a report and submit the report within [15 calendar
days]{.underline} to:

a.  The VA IRB and the VA R&D

b.  Principal investigator.

c.  Signatory of the Federalwide assurance

d.  OHRP in all cases.

    e.  FDA, if the study is subject to FDA regulations.

    f.  The Regional VA Office of Research Oversight (VA ORO)

    g.  The Office of Research and Development (VA ORD)

    h.  Any "Common Rule" Federal Agency that is supporting the
        research.

e.  The Privacy Officer of a covered entity, if the report involves
    unauthorized use, loss, or disclosure of individually identifiable
    patient information from that covered entity.

f.  The Information Security Officer of an organization if the report
    involves violations of information security requirements of that
    organization.

g.  The IRB staff can provide copies to others as deemed appropriate by
    the Institutional Official.

> **11. DATA SAFETY MONITORING POLICIES AND PROCEDURES**
>
> **1. POLICIES**
>
> a\) The VA IRB requires data and safety monitoring for all types of
> clinical trials, including physiologic, toxicity, and dose-finding
> studies (Phase I); efficacy studies (Phase II); efficacy,
> effectiveness and comparative trials (Phase III); etc. It includes all
> types of intervention studies, whether medication or non-medication
> (e.g., behavioral, prevention, diagnostic) trials. Monitoring should
> be commensurate with the study risks.
>
> b\) The VA IRB requires investigators to establish a Data Safety and
> Monitoring Board (DSMB) or a Data Monitoring Committee (DMC) for all
> Clinical Trials that are Phase III, or Multicenter, or recruiting
> subjects at risk (blinded, high-risk interventions, or vulnerable
> populations), as required by DHHS or FDA policy.
>
> c\) The VA IRB requires investigators to establish a plan for
> reporting DSMB or DMC findings to the IRB.
>
> **2. DATA SAFETY MONITORING PLAN**

a)  The plan must make adequate provisions for monitoring the data
    collected to ensure the safety of participants.

b)  The plan may vary depending on the potential risks, complexity and
    nature of the study The plan might include the information
    evaluated, harm and benefit to be monitored, study endpoints, timing
    of monitoring, and decisions to be made by the monitoring process.

c)  Monitoring might occur at specific points in time, after a specific
    number of participants have been enrolled, or upon recognition of
    harm. Monitoring might be conducted by the investigator, the sponsor
    (e.g., medical monitor, safety monitoring committee), or by an
    independent monitoring board. The monitoring person might compare
    the character, incidence and severity of actual harm to that
    expected, comparing the magnitude and probability of benefits to
    that expected, or to determine the causality of unexpected harm..

d)  A data and safety monitoring board or data monitoring committee
    needs to be part of the monitoring plan when required by NIH or FDA.

e)  The use of a data and safety monitoring board or data monitoring
    committee needs to be considered if there are multiple clinical
    sites, the study is blinded, interventions are particularly
    high-risk, or vulnerable populations are included.

f)  In addition, for studies that do not have or are not required to
    have a data and safety monitoring board or data monitoring committee
    and are blinded, have multiple sites, enter vulnerable populations,
    or employ high-risk interventions, the IRB needs to carefully review
    the data and safety-monitoring plan.

> **3. DATA SAFETY MONITORING BOARD or DATA MONITORING COMMITTEE**

a)  If a data and safety monitoring board or data monitoring committee
    is used, all events must be reported to the data and safety
    monitoring board or data monitoring committee and a summary of the
    data and safety monitoring board or data monitoring committee
    findings must be reported to the IRB and other entities as required.
    \[VHA Handbook 1200.5 10.f\]

> **4. PLAN FOR REPORTING FINDINGS TO THE IRB**

a)  Adverse events, as defined by the monitoring plan in the protocol,
    must be reported in accordance with the monitoring plan approved by
    the IRB and as defined in FDA regulations, or other applicable
    Federal regulations. \[VHA Handbook 1200.5 10.f\]