**[Office of Research Oversight (ORO)]{.underline}**

Bi-Monthly Teleconference Minutes

Wednesday, May 12, 2004, 12 Noon to 12:50 P.M. EST

[ORO Staff participating:]{.smallcaps}

+-------------------------------+--------------------------------------+
| > [ORO Central                | [ORO Regional Offices]{.underline}   |
| > Office]{.underline}         |                                      |
+-------------------------------+--------------------------------------+
| > Dr. David Weber             | Northeastern (Boston) -- Richard     |
|                               | D'Augusta                            |
+-------------------------------+--------------------------------------+
| > Priscilla Craig             | Southern (Atlanta) -- Dr. David      |
|                               | Miller                               |
+-------------------------------+--------------------------------------+
| > Dr. Joan Porter             | Midwestern (Chicago) -- Dr. Karen    |
|                               | Smith                                |
+-------------------------------+--------------------------------------+
| > Lisa Franklin               | Mid-Atlantic (Washington, D.C.) --   |
|                               | Dr. Min-Fu Tsan                      |
+-------------------------------+--------------------------------------+
| > Paula Squire Waterman       | Western (Loma Linda) -- Dr. Paul     |
|                               | Hammond                              |
+-------------------------------+--------------------------------------+
| > Shannon Williams            |                                      |
+-------------------------------+--------------------------------------+
| > Peter Poon                  |                                      |
+-------------------------------+--------------------------------------+

[Introduction (Dr. David Weber)]{.underline}

In his introduction, Dr. Weber welcomed everyone to the bimonthly ORO
teleconference call. Dr. Weber noted that a handout related to the topic
had been sent e-mail before the teleconference to assist listeners in
following the discussion, and suggested that those who had not yet
printed off a copy might want to do so. Dr. Weber then introduced the
speaker, Paula Squire Waterman, MS, CIP, Program Analyst in ORO Central
Office. Ms. Waterman's topic was "What the regulations and policy
require in recording human subject protection activities/determinations
-- Where there is latitude and where there is none." To assist those
participating in the teleconference, Ms. Waterman developed a table
outlining the activities and required documentation found in VHA policy
and the human federal human subject protection regulations that was
e-mailed before the teleconference to those receiving the ORO
Teleconference announcements and Agendas.

Regulatory and policy requirements in recording human subject protection
activities/determinations (Paula Squire Waterman, MS, CIP)

Ms. Waterman noted that a large part of compliance lay in understanding
the applicable regulations and policy. For this reason, she reviewed the
federal regulations and VHA policy underlying a human research
protection program (HRPP), focusing on those regulations/policies that
most directly set out required human subject protection activities. In
her talk, Ms. Waterman followed the handout sent before the
teleconference, consisting of a table listing applicable
regulations/policies, summarizing what each required be done, describing
the various documentation/records that might provide evidence the
activity took place, and noting who/what group was required to perform
the action. Ms. Waterman noted that some regulations/policies don't
specify (for example) which group/person performs a specific activity
and/or how it is actually to be done. Thus, an institutional HRPP might
have some flexibility on how it functions, and still be in compliance
with applicable requirements. To help further compliance, the table also
notes especially were VHA policy exceeds the federal regulations,
especially in requiring additional actions, or more explicit
documentation of the activity. The table has been further reviewed,
refined and edited, and is posted, along with the minutes, on the ORO
website as part of the record of the May 12, 2004 teleconference at
<http://www1.va.gov/oro/page.cfm?pg=30#Past_ORO_Teleconference_Minutes>.

This table is a "work in progress;" Those with suggestions for
corrections, changes, updates, clarifications, etc. are urged to contact
Paula Squire Waterman at <paula.waterman@hq.med.va.gov> or (202)
565-6188. If you have questions on compliance issues related to
regulations/policy, please contact your ORO Regional Office or the ORO
Central Office. Information on contacting ORO Central Office is on the
website home page \[<http://www1.va.gov/oro>\] and information on the
ORO Regional Offices is at <http://www1.va.gov/oro/page.cfm?pg=00>.

COMPLIANCE SUMMARY

See the Table "[Activities/Determinations Found in VHA
Policy]{.smallcaps} (Handbook 1200.5) [and Human Subject Protection
Regulations \[38 CFR 16, 45 CFR 46, 21 CFR 50 & 56]{.smallcaps}\]"posted
on the ORO website at
<http://www1.va.gov/oro/page.cfm?pg=30#Past_ORO_Teleconference_Minutes>.

FINAL NOTE: Dr. Weber asked those listening to send any recommendations
they might have for either topics and/or speakers on future
teleconferences, so the teleconferences can cover materials that are
both relevant and of interest to those in the field.

*[Next Teleconference]{.underline}: The next teleconference will take
place Wednesday, July 14, 2004 from 12 noon to 12:50 P.M. EST. (Note:
2^nd^ Wednesday in July) The call-in number will be (800) 767-1750,
Access code 24088#.*