[DYSPHAGIA] FEES: consents for patients/normals?

[helen-sharp@uiowa.edu (helen-sharp@uiowa.edu)]

I don't have experience with this particular issue, but it seems from your 
description that the "normals" are recruited volunteers brought in for 
training purposes only with no potential clinical benefit to 
themselves.  Although your goal is not "research" and is clinical training, 
it seems that you could (or should) use the same process already in place 
for research - in which your protocol and formal written and verbal consent 
processes undergo a review process.

Most institutions have an Institutional Review Board (IRB) or an affiliate 
institution with an IRB.  The IRB should review  the protocol and consider 
issues of potential coercion (including large amounts of money paid for 
participation), review the consent forms with an eye to clarity, 
voluntariness of participation, and ensure that the volunteers understand 
that they can stop volunteering anywhere along the way without negative 
effects (e.g., they still get paid).  Part of the consent form should 
specify that you do not anticipate any benefit to the volunteer, but hope 
that the experience you gain will benefit others in the future.  It should 
spell out the potential risks and the extent to which your institution will 
provide care (usually some) and/or financial compensation (often none) 
should an adverse effect take place.  The IRB also requires forms to be 
submitted each time an adverse effect occurs.  They have the right to stop 
a protocol in the event of too many adverse effects.

The IRB review process would be quite protective to you and your 
institution.  The forms themselves are sort of protective.  They are really 
designed to ensure that you have a clear, informative discussion with your 
volunteers, that they have a chance to ask questions, and a clear 
opportunity to refuse once they understand the protocol.  Since there are 
risks associated with this procedure, the IRB review process could be a 
significant benefit to all concerned.  At a minimum, you should include all 
the "stuff" just described in a conversation with your volunteers and then 
document that you had that conversation and who was present (one witness 
strongly advised).

Best wishes,
Helen

At 02:55 PM 11/1/01 -0800, you wrote:
>I work in an acute care hospital and our SLP
>department is in the process completing our FEES
>competencies by passing the scope on 25 "normals."
>Last week we had a "normal" go into a vasovagal
>reaction/seizure.  We are now considering having our
>"normals'" sign a consent form prior to volunteering.
>
>My question(s): are other facilities using consent
>forms with normals and/or patients?  Have you
>encountered any adverse reactions with
>patients/normals, such as laryngospasm or vasovagal?
>Is a MD present when you pass the scope on
>patients/normals?
>
>Any information and feedback would be appreciated.
>Please email:
>andreahirsch@yahoo.com
>
>Thank you.
>
>Andrea S. Hirsch, MA, CCC-SLP
>
>
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