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