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Re: Subject Fees -Reply -Reply choward@xxxxxx 31 Oct 1997 19:02 EST

Chuck--

One of the problems inherent in this issue is the need to answer to
federal regulations within two spheres, and they aren't always
compatible.

When a PI seeks approval for a project using human subjects, the need
for confidentiality means exactly that.  No records that could be
used to identify the subject can be made public.  The subjects can be
identified by numbers, demographics, or whatever means, but not with
any information that would allow specific identification of a person
or persons.  Identification by the PI for research purposes (second
phase studies, identification of medical problems, etc.) may be
allowed, but the records are not available publicly - by federal
regulations.

Now, to entice or reward subjects, a payment is often offered.  Any
information about the person to be paid (name, social security
number, address, etc.) allows public identification.  And
institutions following good accounting practices need documentation
of expenditures.  Unfortunately, no matter how deeply buried the
information is within the bureucratic system, there is always the
chance of public identification as a research subject and the IRB
rules specifically forbid that.

Thus, we have a conflict in answering to two sets of federal
regulations plus a bunch of internal regulations.

Most places of which I am aware, will designate a pool of money
assigned to the PI that allows him/her to pay subjects in cash - no
names, no social security numbers, no nothing.  Confidentiality is
maintained.  By the way, if confidentiality is not maintained and
the IRB regulations are not followed and documented, the institution
can be in danger of losing their federal funding in all programs.

The PI accounts for this money.  The amount of money that can be used
and the size of payments is usually negotiated within the institution
accounting system and with the IRS.  As I recall when we faced this
at another institution, we were able to ask the IRS about the
limitations and use their opinions in guiding us to set up the PI
accounts..

It is not an unresolvable problem, but it does require some
negotiations among the agencies and some recognition of the conflicts
created by the different agencies.

By the way, I would underscore that our role as research
administrators is that of enhancing research and scholarly
activities at an institution, not just of making sure that all the
rules and regulations are followed.  We often need to be creative
in balancing the needs of the researchers and the regulations that
control their work.  Not always easy, but certainly a challenge.

Chuck Howard
University of Northern Colorado Research Corporation

Date:          Fri, 31 Oct 1997 09:12:30 -0500
Reply-to:      Research Administration Discussion Group
 <xxxxxx@health.state.ny.us>
From:          Chuck Willis <xxxxxx@POBOX.HPRF.ODU.EDU>
From:          Research Administration Discussion Group
 <xxxxxx@health.state.ny.us>
Subject:       Re: Subject Fees -Reply -Reply
X-To:          xxxxxx@albnydh2.health.state.ny.us, xxxxxx@UMDNJ.EDU
To:            Multiple recipients of list RESADM-L
 <xxxxxx@health.state.ny.us>

Barbara,

I don't agree with you, if the payment processing is handled correctly,
but that is why this country is so great.

Anyway, I would adjust to the payment of cash only if the Institutional
policy has the procedure codified in writing,  that policy is accepted
and approved in writing by the awarding agency, and a concurring
approval by legal counsel is in the Foundations files.  These three
conditions would be a prerequisite and should provide adequate
protection to any Institution in a court of law.  Law and ethics are not
always compatible.

I believe that as a Grant/Contracting Administrator, my responsibility
is to ensure the Foundation is operating within generally accepted
accounting principles, governing (Federal & State) rules and regulations
concerning the use of granted funds, and a facilitator to enhance the
research project/program.

These personal principles do not always make me the most popular person
on my P.I's Christmas card list but then I wasn't offered a position at
Stanford.

Creative solutions are available but adequate documentation must be on
file before potential legal problems arise.

Sincerely,

Chuck Willis
Grant & Contract Administrator
ODU Research Foundation
Phone: (757) 683-4293 Ext. 613
Fax: (757) 683-5290
E-mail: xxxxxx@pobox.hprf.odu.edu