**[Office of Research Compliance and Assurance (10R)]{.underline}**

Bi-Monthly Teleconference

Tuesday, April 15, 2002, Noon to 12:50 P.M. EST

[ORCA Staff participating:]{.smallcaps}

+-----------------------+----------------------------------------------+
| ####                  | [ORCA Regional Offices]{.underline}          |
| ## ORCA Headquarters  |                                              |
+-----------------------+----------------------------------------------+
| Dr. John Mather       | Southern (Atlanta) -Dr. David Miller         |
|                       |                                              |
| Dr. Joan Porter       | Midwestern (Chicago) -- David Semlow for Dr. |
|                       | Karen Smith                                  |
| Peter Poon            |                                              |
|                       | Mid-Atlantic (Washington, D.C.) -- Dr. MinFu |
|                       | Tsan                                         |
+-----------------------+----------------------------------------------+
| Shannon McCormack     | Western (Loma Linda) -- Dr. Paul Hammond     |
+-----------------------+----------------------------------------------+
| Paula Squire Waterman |                                              |
+-----------------------+----------------------------------------------+

[Introductions and Agenda]{.underline}: Dr. Mather introduced the call,
asking participants to use the mute button while listening, and to speak
loudly, identifying themselves when they spoke. He also noted that
today's ORCA Teleconference was limited to 50 minutes, so there might
not be a lot of time for questions and answers about the issues
discussed. He then stated that the June ORCA teleconference would be
back to the usual time of one hour plus an optional 50-minute Q&A period
at the end. Dr. John H. Mather then noted the agenda has been divided
into 1) Information items that were thought to be important, 2) ORCA's
perspective on the accreditation process and some other related items,
and 3) Clarification on the process of continuing review for research
protocols.

**[ORCA Information]{.underline}:**

-   [ORCA HQ Project updates and staff reports]{.underline}:

> [Dr. David Weber]{.underline} -- ORCA SES Seminars and SAEs. Dr. David
> Weber was unavailable for the teleconference because he's
> participating in VA leadership training, so Dr. Mather commented on
> his topics. 1) SES Seminars are all complete except for 3 VISNs that
> ORCA hopes to complete within the next month. It is hoped to
> accomplish the seminars by the end of May because there are already
> intimations that people in the field would like a second set of
> seminars to drill down even further on human research protection
> activities. 2) ORCA has had a working group for several months dealing
> with the issue of AEs and SAEs, being done in conjunction with some
> other work under way in the Office of Human Research Protections
> (OHRP) and the Food and Drug Administration (FDA). ORCA hopes to get
> some of that work completed within the next week or so. ORCA is well
> aware of the difficulty people are having in discerning which items
> need to be reported, and where. ORCA hopes to get this clarified very
> quickly so that it is not an ongoing area of ambiguity.
>
> [Dr. Karen Smith]{.underline} -- CQI (Continuous Quality Improvement)
> Working Group. Dr. Smith was traveling to visit one of the facilities
> in her region and was not able to participate in the teleconference.
> Paula Squire Waterman of ORCA CO, who is also on the CQI Working
> Group, gave a brief overview of what that group is doing. The Working
> Group is putting together a "CQI Toolkit," that the Working Group
> hopes will help institutions figure out how to develop a CQI program
> that 1) meets the NCQA accreditation and 2) (even more important)
> enables the institution to have a functioning, viable and good human
> research protection program. The working group hopes to have the
> Toolkit out fairly soon, by the end of May/beginning of June. It will
> be coming out on a CD, as well as being posted on the ORCA website.
>
> [Priscilla Craig]{.underline} -- FWA & MOU update. Priscilla was not
> available, so Dr. Mather summarized her update. 1) All VA MPA
> contracts have been converted to the new FWAs with the exception of
> some 20 VAMCs that are delayed because of their affiliates; the VA has
> a joint IRB with the affiliate, and the affiliate has not yet filed
> its FWA. He urged any VA in this group to work closely with its
> affiliate to get them to file their FWA. OHRP is about to issue the
> final guidance on the FWA, so the affiliates should be moving ahead
> anyway. 2) ORCA has seen a wide variety of MOUs (Memoranda of
> Understanding), particularly MOUs for VAMCs to have with their
> affiliates, if using the affiliate's IRB. He asked that any VAMC using
> an affiliate's IRB to spend time getting the MOUs completed and copies
> into ORCA CO. Finally, ORCA sent out (a week or so ago) information on
> completing a licensing agreement so the VAMC can be sent a CD ROM
> useful for educating the IRB and all researchers at the site (under
> the VAMC's FWA). Once the licensing agreement is signed, then, each
> individual VAMC can make as many copies as they want. VAMCs should
> have received both electronic and hard copies, and he urged all
> listening to get the licensing agreements into ORCA CO. **Q.** ORCA CO
> has already had questions on whether the CD ROMS can be used for the
> affiliates. **A.** NO. The CD ROMS are limited to each VA FWA
> facility. VAMC staff less than 8/8s time can also receive copies of
> the CDs.
>
> [Dr. Joan Porter]{.underline} -- TED Activities and Brochure. There
> are two activities Dr. Porter wanted to highlight under the Training,
> Education and Development (TED) Focus Group. 1) The brochure is for
> veterans who are research subjects and patients. The title is, "I am a
> Veteran. Should I Participate in Research?" It is scheduled to be
> printed by May 15^th^ and will be distributed widely. Copies will be
> given to the ACOS for R&D, VISN Directors, Medical Center Directors,
> and to many others at VAMCs. Dr. Porter felt the VAMCs would find it a
> very good brochure to help those enrolled in research, as well as
> potential research subjects, understand their responsibilities and
> something about VA research. The brochure was unveiled by Dr. Roswell,
> USH, for the VSOs last week and was well received. 2) Currently, the
> TED Focus Group is actively considering the possibility of having and
> formulating plans for regional meetings for Research Compliance
> Officers (RCOs) and Research Assurance and Compliance Officers (RACOs)
> in sometime in September.
>
> Dr. Mather noted that the ORCA Field Advisory Committee (FAC) has
> formed a subcommittee so ORCA can take more leadership on the issue of
> RCOs/RACOs. Ron Norby has agreed to serve as Chair of that
> subcommittee, with a number of members from different parts of the VHA
> research community and Dr. Mather hopes the work will move ahead
> quickly, including submitting a report to the FAC this coming July.
>
> [Paula Squire Waterman]{.underline} -- VA Day at PRIM&R, 2002. Ms.
> Waterman noted that a Flyer on the 2002 VA Day at PRIM&R was attached
> to the Agenda. She said planning for the next VA Day at PRIM&R was
> just beginning. The next VA Day at PRIM&R will be given on November
> 16^th^, and it will be an all day meeting and, again, will be free.
> Ms. Waterman reminded any VA staff who want to go to either (or both)
> PRIM&R and ARENA (as well as VA Day at PRIM&R) that PRIM&R especially
> fills up very quickly once announced, and those hoping to attend
> should register early (August at the latest, with registration usually
> starting in June/July) and be prepared to pay for the November
> conference with FY 2002 funds. If you wait to register and pay for
> PRIM&R after October 1, you will not be able to -- the conference
> registration will have been closed for a long time, although you
> [may]{.underline} be able to still register (and pay) for ARENA
> (scheduled to be the day after VA Day at PRIM&R), and this cannot be
> guaranteed. Ms Waterman said that if any had ideas of topics for VA
> Day at PRIM&R to please feel free e-mail any ideas to her at
> <paula.waterman@hq.med.va.gov> or call her at (202) 565/6188, and she
> will pass it on to the planning group. Information on VA Day at PRIM&R
> (both past and future) is on the ORCA website. The URL is
> <http://www.va.gov/orca>.

Dr. Mather noted that ORCA has worked to collaborate with both OHRP and
the FDA, and that Dr. Joan Porter was going to introduce the discussion
of one such collaboration -- the OHRP/FDA/VA Regional Conferences on
Human Subject Protection.

-   [ORCA Participation in OHRP/FDA/VA Regional
    Conferences]{.underline}: Dr. Joan Porter said OHRP and FDA had
    collaborated on these regional workshops for many years. For the
    last 2 years VA (ORCA) has been participating as a partner in both
    teleconference-type regional conferences and in convened
    conferences. As part of the TED program, ORCA is working to put
    VA-specific information in these regional conferences. A list of
    upcoming OHRP/FDA/VA Workshops was attached to the Agenda for this
    call and is posted on the ORCA website. The OHRP website is
    <http://ohrp.osophs.dhhs.gov/wrkshp.htm> scroll down until you get
    to the workshop list. You may also contact your ORCA Regional Office
    for information on OHRP/FDA/VA conferences in their region. Each
    ORCA Regional Office Director gave some information on upcoming
    Regional Conferences in their region.

> [Southern Region - Dr. David Miller]{.underline}: September 18-20,
> 2002 in Oklahoma City, OK, hosted by the University of Oklahoma Health
> Sciences Center. The title is, "Current Research Issues & Solutions:
> Human Subject Protections." Dr. Miller is talking to the Oklahoma VP
> for Research. One of the possible topics they are discussing to look
> at both of the accrediting organizations (NCQA and AAHRPP), trying
> them to both send representatives to discuss commonality and how they
> can work together.
>
> [Northeastern Region - Dr. David Weber (Acting Director)]{.underline}:
> Paula Squire Waterman spoke for Dr. Weber. There are two upcoming
> conferences in this region. 1) July 10-12, 2002 in Long Island, NY,
> hosted by North Shore Long Island Jewish Health System. The title is
> "Protecting Human Research Subjects: Whose Responsibility Is It
> Anyway?" 2) The second conference is a Town Meeting Federal
> Interactive Teleconference, and the date has not been confirmed yet.
> It is currently planned to be in Albany, NY in October-November of the
> next fiscal year, hosted by the Research Foundation of State
> University of New York, SUNY Network. The current title is, "New
> Insights, Issues and Solutions." Please check the ORCA or OHRP
> websites to get the final date of this conference.
>
> [Midwestern - Dr. Karen Smith]{.underline}: David Semlow spoke for Dr.
> Smith. The conference is May 13-14, 2002, in Minneapolis, MN, hosted
> by the University of Minnesota. The title is, "Innovation,
> Inclusiveness & Informed Consent: Current Challenges for Institutional
> Review Boards and Researchers." The Midwestern Regional Office is
> still working on this conference and is in the process of putting the
> program together. This one is rescheduled from last September. There
> is also a University of Minnesota website.
> <http://www.research.umn.edu/subjects/conference/>
>
> [Western -- Dr. Paul Hammond]{.underline}: August 15-16, 2002, in
> Seattle, WA, hosted by the Fred Hutchinson Cancer Research Center. The
> title is, "Protecting Human Subjects: Safety, Welfare, & Privacy." Dr.
> Hammond strongly encouraged VAMCs in the Western Region to send
> representatives to this conference. There will be many workshops,
> including some on accreditation, QA/QI, documenting consent, radiation
> safety and the protection of human subjects, and many contributions
> from the VA perspective.

**[ORCA Perspective on NCQA Accreditation and Other Issues (Dr. John
Mather)]{.underline}:** Although the Office for Research and Development
is on lead for the accreditation effort, Dr. Mather thought there were
some issues worth discussing from ORCA's perspective. Questions on the
accreditation process should be addressed to Bill Judy in ORD at (202)
565-7830 or Sandy Sanford in NCQA at (202) 955-3588. Dr. Mather stated
he would talk about what ORCA can and will do, to give the VAMCs some
sense of document preparation for a NCQA site survey, and the ongoing
tracking of the process. Dr. Mather said he was dealing with the last
two subjects because at each of ORCA's SES seminars, there has been
mounting interest in the question of "what do we need to do to get
ready?"

Current status of accreditation actions is that there have been 4 pilots
and 20 site surveys (one site had two locations). Of these 20 (or 21) 9
have received a final accreditation status decision, with 7 accredited
with conditions and 2 not accredited. (NOTE: Attachment #1 is a list of
the sites that have received either a pilot or a regular NCQA site
survey as of the date of this teleconference.)

A crucial issue is documentation and document tracking -- much of the
NCQA accreditation process is related to the documents you have
available, might have available, should have available, and the
documents a VAMC would use for any comment/response to a NCQA draft
report or for an appeal of an accreditation decision, whether
"Accredited with Conditions," or "Not Accredited." ORCA has provided the
field with some assistance over the past year, including the two CD ROMs
with all the regulations and internal hyperlinks relevant to the NCQA
accreditation standards and a best practices IRB SOP, ORCA Information
Letter #46 that transmitted the most recent best practices document
coming out of OHRP. ORCA Regional Offices have been conducting courtesy
site visits since the beginning of the fiscal year, during which the
ORCA Multi-Assessment Program (MAP) self-assessment process is
presented, as well as a 'delta document' or a list of the nine NCQA
standards that go beyond the regulatory "de minimus," and (finally)
instructed how you might conduct your own self-assessment. ORCA will
soon be preparing a document on how to do a self-assessment to
specifically prepare for a NCQA accreditation site survey, essentially
combining the human subject protection sections of the MAP, integrating
those nine additional standards, and reformatting the document to make
it easier to prepare for the NCQA surveyor site visit.

Dr. Mather then talked about the careful preparation of documents. He
urged to sites to "share, share, share." Talk to the sites that have
already had a site survey, or those that are due to have one soon, to
find out how they prepared or are preparing documents. Ideally, a site
might want to start 6 months' ahead of time. So any VAMC that doesn't
know when they are scheduled for an NCQA site survey, call NCQA to find
out. In any case, as soon as you know your schedule, or even earlier,
identify all the documents that are in the standards that are required
and annotate them according to the standards. When you submit documents
to NCQA make sure you keep a copy of your annotated set so you know
exactly what has been submitted. Also, when the surveyors are there on
site, keep a record of the protocols reviewed, and after the surveyors
have left, re-review and annotate them yourselves.

Dr. Mather then drew attention to 2 particular items at the exit
briefing he thought they should be aware of. Some of the surveyors while
on site have a list of documents they have been asked by NCQA to
identify and find. Sometimes at the end of the visit, the surveyors may
not have been able to find all the documents. He urged the VAMCs to ask
for that list or any list the surveyors may have compiled during the
course of the site survey to see what documents might be missing so the
VAMC can supply them before the surveyor leaves, as opposed to having to
try to respond to what is intimated as a missing document in a draft
report.

Also at the exit interview or briefing, urge that the surveyors give you
a full briefing -- not just the positive, but also the negatives. The
surveyors are at a bit of a disadvantage because they are at the site to
collect information, to fill out the data collection forms and do
interviews. They do not have the full database at their disposal, as it
is back at NCQA headquarters. Still, it is possible to ask the surveyors
about specific areas where the surveyor believes the site is not
performing as well as it might.

After receiving the draft report (1-2 months after the surveyors'
visit), do review it very carefully and prepare detailed annotated
comments. Your comments are limited to a certain number of pages, but
you can attach appendices of examples of missed documents. Currently the
limit of such a response is 20 pages, and it is difficult to follow that
limit when it is clear that there are documents that need to be shown as
evidence to 'rebut' what NCQA on the draft appears not to have or
believe exists. This is a contentious issue, and keeping the response to
20 pages with the identification of the documents is the goal, but you
should not feel you're absolutely limited to 20 pages for appendices on
documentation, but the actual comments are limited to 20 pages.

It has become clear in the last week or so that there are some 12
critical standards upon which NCQA will be basing the accreditation
decision. We also know that if an institution gets a "0" score on 6 or
more of these 12 standards, it is strongly likely that the institution
will not be accredited. There is an additional 12 (or, perhaps 11)
important standards, so that there is a list of some 23 or 24 pivotal
standards that the accrediting committee uses in its decision-making on
accreditation status. After the NCQA accreditation committee makes its
final decision, the site receives a letter giving the accreditation
status (for most that will be accredited with conditions or not
accredited.) Dr. Mather feels it is unlikely that any institution will
receive full accreditation during this cycle because of the 12-month
look-back period and the standards that go beyond the regulations. Dr.
Mather urges any site that received "Accredited with Conditions" to
check to see if their comments on the draft findings were dealt with,
and possibly think about appealing those on which you don't think you
got a fair shake, because with the 'Accredited with Conditions' status
comes a list of conditions and a list of recommendations. The site will
be expected to supply NCQA with correction action plans (CAPs) on a
schedule, and the site needs to be very careful about meeting those
'due' dates.

For a site that receives a status of "Not Accredited," if the site
intends to appeal the decision, Dr. Mather urges them to send an
immediate letter of intent to appeal to put NCQA on notice that they
will be receiving, within the 30-day time frame, a full package
appealing the decision. Make sure you meet the deadlines imposed by
NCQA. When CO (both ORCA and ORD) hears that a site has received a "Not
Accredited" notification; this is a matter of great concern.

ORCA will immediately do a couple of things:

1.  First ORCA puts together a 1 or 2-person team for a "Focus Review"
    to be on site within a few days to A. work with the site to make
    sure there is no possibility that a subject at the site in one of
    the research protocols has been medically harmed (key issue -- not
    accredited is one thing, but has anybody been harmed) and (b) see if
    there is any serious/egregious noncompliance with regulations,
    meaning "dignity" harm. This is the beginning of obtaining some
    contemporaneous data, as it may be several months since the NCQA
    site survey occurred.

2.  A week after the site has filed its appeal (not before the appeal
    goes in, unless there were serious/egregious problems found during
    the Focus Review), ORCA will be doing a Systematic
    Post-Accreditation Review (SP-AR) to look at the full scope of the
    findings, drilling down to look at significant matters. The intent
    of this SP-AR is to develop a more-contemporaneous set of
    information to make a decision of what else might need to be done,
    especially at those sites where NCQA confirms the finding of Not
    Accredited. It is especially important that sites understand that
    the NCQA decision is based on materials/information/data gathered
    when the surveyors were on site, not on any progress a site may have
    made since the accreditation site survey. This is why it's so
    important to develop contemporaneous data, which is what ORCA will
    be doing during the Systematic Post-Accreditation Reviews (SP-AR).
    At that point, ORCA feels they will be in a good position to figure
    out what needs to be done for those sites whose 'Not Accredited'
    status has been confirmed.

In conclusion, Dr. Mather emphasized that accreditation was very much a
question of documentation, a document-driven process. Many VAMCs had
found this document-driven process very frustrating; however, Dr. Mather
suggests accepting the situation and working with it to the best of your
advantage.

There was some time available for questions, so Dr. Mather opened the
line for questions/comments. **Q.** We'd like more information about
NCQA's critical standards. **A.** Dr. Mather said he would make a list
of the 12 critical NCQA standards to send out to the VAMCs, and attach
them to these minutes. **Q.** One site wanted to hear more from the
sites that already have been audited, so they can get information on the
process directly from those who have already undergone a site survey.
**A.** Dr. Mather said a list of those facilities that have already
received a surveyor site visit would be appended to the minutes. **Q.**
Who do we contact at NCQA to find out the date of our site survey?
**A.** NCQA is Sandy Sanford, phone \# (202) 955-3588 or (if necessary)
Bill Judy in ORD at (202) 565-7830. **Q.** How can I get on the ORCA
mailing list? **A.** Use Outlook to e-mail Shannon McCormack, the
management Analyst in ORCA central office, who will put you on the list.

In summary, Dr. Mather noted that the NCQA accreditation process is a
very intense activity. ORD is clearly receiving many comments and
concerns that they are actively looking into. ORD has further commented
that it is a matter of some chagrin that there are a few sites that are
not accredited, but this is not unexpected. The ORCA staff feels very
strongly that they need to do whatever they can to be of some assistance
to the field. If you don't hear the kind of assistance you're looking
for during this call, please contact ORCA for further information, in
particular your ORCA Regional Office.

**[ORCA Special Topic: Continuing review of research protocols (Dr. Joan
Porter)]{.underline}:** Dr. Porter wanted to highlight this topic
because, when visiting/working with facilities, quite often a serious,
systemic flaw is identified in which the dates of continuing review are
late because a site depends on the PROMISE system. The bottom line is --
DO NOT depend on the PROMISE system in and of itself to calculate for
you the date of continuing review of research protocols for the IRB. It
is not suited for that purpose. PROMISE uses the date of the R&D
Committee Meeting, but the date for continuing review is based on the
date of a convened IRB meeting.

In addition, the Human Subjects Research Subcommittee (HSRS) of the
National Council on Science and Technology has worked on a policy to
clarify dates of continuing review. This policy will be posted on the
OHRP website, it is hoped, this week. Once posted, ORCA will get out an
Information Letter that summarizes the guidance about continuing review.

There is nothing new in this guidance, but many people misunderstand the
date of continuing review that the IRB has, based on the date of the
convened meeting of the IRB at the institution. The Common Rule requires
an IRB conduct continuing review of research at intervals appropriate to
the degree of risk, but not less often than once per year. The FDA
regulations include an identical requirement. The IRB should decide the
frequency of continuing review for each study protocol necessary to
insure the continued protection of the rights and welfare of research
subjects. Dr. Porter went on to describe several scenarios, giving the
rationale behind the particular continuing review date used for research
considered at a convened meeting. Dr. Porter also reminded people that
review of a protocol change does not alter the date of continuing
review, because continuing review is review of the full protocol (and
all that has happened since approval), not simply a change in it.

**Q.** One site was under the impression that a continuing review date
can be adjusted to the last date of IRB approval, if it is within 30
days before the IRB approval expires. **A.** That is correct and is
discussed in the Guidance on Continuing Review that's about to be
published.

Dr. Mather noted that ORCA has developed a Frequently Asked Questions
section for the ORCA website, and, after specific items are cleared
through ORD, ORCA hopes that will be activated soon. Also, ORCA will
continue to flag OHRP guidance updates, such as the one sent out in ORCA
Information Letter #46, describing what needs to be in an IRB SOP. The
FDA is also actively looking at updating their Information Sheets,
although that may be delayed by the effort to make sure there is
harmonization between the signatories of the Common Rule and also what
comes out of OHRP and the FDA. Such harmonization is especially
difficult because the FDA also has to reference or reconcile everything
to the Good Clinical Practice Guidance.

Dr. Mather then asked if anyone had questions on any of the previous
topics or on any new topics. **Q.** Could you quickly outline which are
the 12 NCQA pivotal standards (critical elements)? **A.** Yes. He list
them will be attached to the minutes (see Attachment #2). He commented
that ORCA has noted there seems to be very little difference in scores
between draft and final reports, so he reiterated the importance of
responding to the NCQA draft and being very meticulous and provide the
documentation that supports your claim to get better than 0%, 50% or
75%, if that was your score for that element. Spend time getting
documentation straight as to why you think you deserve better than 0%.
**Q.** Did you say that there was very little change from the draft to
final report or that it can be changed? **A.** It can be changed with
suitable documentation, as you look at the draft and you provide the
documentation to NCQA so that when they receive it, they can make
appropriate adjustments when they come to make the final judgment and
the final documents are presented to the NCQA accreditation committee.

Dr. Mather closed by reminding the listeners to call Bill Judy at ORD or
Sandy Sanford at NCQA if they had questions about the accreditation
process.

**The regularly scheduled post-teleconference optional time for
questions and answers did not occur this time. It will occur next
teleconference (see below).**

*[Next Teleconference]{.underline}: Monday, June 17, 2002 (3^rd^ Monday
in June) from 12 Noon to 1:00 P.M. EDST. An additional 50 minutes
(optional) will be available at the end of the teleconference for
questions and answers. The call-in number is (800) 767-1750, Access code
24088.*

**VAMCs that have had a NCQA Pilot or regular Site Survey to date:**

+-----------------------------+------------------+--------------------+
| **Site**                    | **IRB Status**   | **Date of Survey** |
+=============================+==================+====================+
| PILOTS                      |                  |                    |
+-----------------------------+------------------+--------------------+
| Madison, WI                 | University       | 4/23-25/01         |
+-----------------------------+------------------+--------------------+
| Birmingham, AL              | Independent      | 5/1-3/01           |
+-----------------------------+------------------+--------------------+
| St. Louis, ML               | Independent      | 5/14-15/01         |
+-----------------------------+------------------+--------------------+
| Durham, NC                  | Independent      | 5/21-22/01         |
+-----------------------------+------------------+--------------------+
| SITE SURVEYS                |                  |                    |
+-----------------------------+------------------+--------------------+
| Bedford, MA                 | Independent      | 9/24-25/01         |
+-----------------------------+------------------+--------------------+
| Long Beach, CA              | Independent      | 10/1-2/01          |
+-----------------------------+------------------+--------------------+
| Richmond, VA                | Independent      | 10/9-10/01         |
+-----------------------------+------------------+--------------------+
| Pittsburgh (HD), PA         | Independent (2   | 10/15-16/01        |
|                             | locations)       |                    |
| Pittsburgh (UD), PA         |                  |                    |
+-----------------------------+------------------+--------------------+
| Manchester, NH              | Independent      | 10/22/01           |
+-----------------------------+------------------+--------------------+
| Syracuse, NY                | Independent      | 11/5-6/01          |
|                             |                  |                    |
| Canandaigua, NY             |                  |                    |
+-----------------------------+------------------+--------------------+
| Martinez, CA                | Independent      | 11/13-14/01        |
+-----------------------------+------------------+--------------------+
| Mountain Home, NT           | Joint            | 11/19-20/01        |
+-----------------------------+------------------+--------------------+
| Minneapolis, MN             | Independent      | 11/27-28/01        |
+-----------------------------+------------------+--------------------+
| Shreveport, LA              | University       | 12/5-6/01          |
+-----------------------------+------------------+--------------------+
| Philadelphia, PA            | Independent      | 12/17-18/01        |
+-----------------------------+------------------+--------------------+
| Providence, RI              | Independent      | 1/24-25/02         |
+-----------------------------+------------------+--------------------+
| West Haven, CT              | Independent      | 1/31-2/1/02        |
+-----------------------------+------------------+--------------------+
| Phoenix, AZ                 | Independent      | 2/7-8/02           |
+-----------------------------+------------------+--------------------+
| Omaha, NE                   | Independent      | 2/14-15/02         |
|                             |                  |                    |
| Lincoln, NE                 |                  |                    |
|                             |                  |                    |
| Grand Island, NE            |                  |                    |
+-----------------------------+------------------+--------------------+
| West LA, CA                 | Independent      | 2/20-22/02         |
+-----------------------------+------------------+--------------------+
| Northampton, MA             | Independent      | 2/28/02            |
+-----------------------------+------------------+--------------------+
| Hampton, VA                 | Independent      | 3/28/02            |
+-----------------------------+------------------+--------------------+
| Salem, VA                   | Independent      | 3/28-29/02         |
+-----------------------------+------------------+--------------------+
| Charleston, SC              | Joint            | 4/3-5/02           |
+-----------------------------+------------------+--------------------+

# NCQA Critical Elements

# 

# INR1D: Federal-Wide Assurance/MPA:

The institution maintains and supports a current and approved
Federal-Wide Assurance (FWA) and/or an assurance in accordance with
current VA regulations that includes its principles and guidelines for
protecting research subjects. The institution demonstrates its
maintenance and support of its assurance by the following:

1.  The institution is operating under a current approved assurance.

2.  The institution identifies the responsible official for the
    assurance (Note: In VA facilities, the Medical Center Director/CEO
    is the responsible official).

3.  If the assurance is an FWA, it is approved by the VA Office of
    Research Compliance and Assurance (ORCA).

**[INR2C]{.underline}: [Protocol Tracking]{.underline}:**

The institution must be able to ascertain the following for each active
research proposal:

1.  Date originally approved and if applicable, date of most recent
    approval.

2.  Date of expiration of approval.

**[INR5A]{.underline}: [Policy and Procedures --
Noncompliance]{.underline}:**

The institution has policies and procedures for responding to complaints
and allegations of noncompliance with institutional policies. The system
includes the following factors:

1.  Ensuring a response to each question, concern or complaint.

2.  Investigating complaints and allegations.

3.  Taking remedial action for, and consequences of findings of,
    noncompliance with HRPP and IRB policies.

4.  Identifying individuals who have responsibility for responding to
    questions, concerns or complaints regarding an individual's rights
    as a research subject.

**[INR6E]{.underline}: [Investigational Drug Dispensing]{.underline}:**

The Pharmacy Service ensures that investigational drugs are not
dispensed without the following on file:

1.  Approved protocol.

2.  Signed informed consent form.

3.  VA Form 10-9012 (Investigational Drug Information Record)

**[INR8A]{.underline}: [Policy and Procedures - Education and
Training]{.underline}:**

The institution ensures that research investigators, research staff, IRB
members and other individuals with responsibility for human subject
protection have completed required training in human subject protection.
Policies and procedures regarding education and training address the
following:

1.  Type and scope of human subject protection education and training
    that meets VA and Federal requirements.

2.  Identification of the individuals for whom training is required in
    compliance with VA and Federal requirements.

3.  Methods for confirming that individuals required to have training by
    VA and Federal requirements have met training requirements.

**[IRB1B]{.underline}: [IRB Membership Requirements]{.underline}:**

The IRB has proper composition and the IRB has information about each
IRB member:

1.  Name.

2.  Earned degree.

3.  Representative capacity (e.g., physician, non-scientist, ethicist,
    community member, etc.).

4.  Indications of experience, such as board certifications, licensures,
    certifications.

5.  For community members, confirmation that no part of the community
    member's immediate family is affiliated with the VA or its academic
    affiliates.

6.  For community members, confirmation that no part of the community
    member's immediate family is affiliated with the VA or its academic
    affiliates.

7.  Documentation of the voting status of each member.

8.  Documentation of alternate status.

**[IRB6B]{.underline}: [IRB Actions for Changes in Risk]{.underline}:**

Whenever the IRB determines that the risks to subjects have changed
after reviewing documentation obtained during the period for which the
research is authorized, the IRB takes one of the following actions:

The IRB decides that the research:

1.  May continue.

2.  May continue with modifications.

3.  Must be suspended.

4.  Must be terminated.

**[IRB9B]{.underline}: [Determination of Exempt]{.underline}:**

The institution or IRB makes determination of exempt status in
accordance with VA policy and Federal regulations.

**[CRB2A]{.underline}: [Evaluation of Proposal Risk]{.underline}:**

The IRB's evaluation of research proposal risk includes consideration of
the following:

1.  Study design.

2.  Scientific rationale.

3.  Procedures to minimize risk.

4.  Process for monitoring and reporting adverse events.

5.  Presence of a Data Safety Monitoring Board (DSMB), if applicable.

6.  Scientific training and qualifications of investigators and research
    staff.

7.  Human subject protection training of investigators and research
    staff.

**[CRB2C]{.underline}: [Consideration of Inclusion of Vulnerable
Subjects]{.underline}:**

The IRB considers the inclusion of vulnerable subjects in research,
where applicable. Consideration includes the following:

1.  Category of vulnerability of the proposed study population.

2.  Additional safeguards planned to protect the rights and welfare of
    potentially vulnerable subjects.

**[CRB2I]{.underline}: [Determination of Continuing
Review]{.underline}:**

The IRB determines the interval for continuing review appropriate to the
degree of risk (at least once per year) for each protocol reviewed.

**[ICS3A]{.underline}** **: [Consent Form Content -- Basic
Elements]{.underline}:**

The IRB approved consent forms include all the basic elements of
information as set forth in VA and other Federal regulations.

1.  A statement that the study involves research, an explanation of the
    purposes of the research and the expected duration of the subject's
    participation, a description of the procedures to be followed, and
    identification of any procedures which are experimental.

2.  A description of any reasonably foreseeable risks or discomforts to
    the subject.

3.  A description of any benefits to the subjects or to others which may
    reasonably be expected from the research.

4.  A disclosure of appropriate alternative procedures or courses of
    treatment, if any that might be advantageous to the subject.

5.  A statement describing the extent, if any, to which confidentiality
    of records identifying the subject will be maintained and notes (if
    applicable) the possibility that the FDA may inspect the records.

6.  For research involving more than minimal risk, an explanation as to
    whether any compensation, and an explanation as to whether any
    medical treatments are available, if injury occurs and, if so, what
    they consist of, or where further information may be obtained.

7.  An explanation of whom to contact for answers to pertinent questions
    about the research and research subjects' rights, and whom to
    contact in the event of a research-related injury to the subject.

8.  A statement that participation is voluntary, refusal to participate
    will involve no penalty or loss of benefits to which the subject is
    otherwise entitled, and the subject may discontinue participation at
    any time without penalty or loss of benefits, to which the subject
    is otherwise entitled.