Date:         Wed, 12 Apr 1995 09:29:38 -0400
Sender: SJU Madness List <MADNESS@SJUVM.STJOHNS.EDU>
From: Vera Hassner Sharav <VHasSharav@AOL.COM>
 
Because we have come to recognize that safeguards for patients who
participate in experimental research are weak, and full disclosure of risks
are not universally implemented,   AMI suggests that the
following 14 QUESTIONS be asked by EVERYONE thinking about participating in
research, their involved families, or significant others, before signing
consent  to research forms:
 
1.  Is there an independent monitor (who is not connected with the research
team) assigned to  ensure that patient safeguards are followed?    What
authority does that individual have?
   How will this person ensure the patient-subject's continued consent?
 
2.  Who is authorized and available during off hours (ie. week-ends,
evenings, holidays) for patients to contact in the event they wish to
withdraw from a protocol?
 
3. Is there a patient advocate / representative on staff ?
 
4.  During participation in a research protocol, what services and activities
are available to the patient?    Are these services part of the institution's
normal rehabilitation and treatment program or are they available only to
research subjects?
 
5.  Are drug wash-outs required?  For how long?  Is this a placebo control
study?
 
6.  If symptoms return and I am uncomfortable, will I be given therapeutic
medications immediately?
   Who is authorized to prescribe therapeutic medications upon my (or my
family's) request ?
 
7.  Are non-FDA approved, investigational medications given in this protocol?
 
    Is this study being funded  the phamaceutical company?     If yes, ask to
meet with a member of the IRB, not one of the research team,  to discuss the
known and potential risks involved.
 
8.  If non investigational drugs are involved, are these drugs approved (by
the FDA) for my condition?   Ask for a photocopy of the PDR reference
discussing the risks and side effects of this medication, and ask whether you
will be given the standard recommended dose?
 
9.  If the drugs used in the study prove to be beneficial to me,  am I
assured that I will continue to be treated with the medications after
completing the study?
 
10.  Are there procedures that involve radiation in this study?
   If yes, ask to speak to the chairman of the IRB to discuss the limitation
of risks.
 
11.  Will this experiment involve any procedures that are painful or
uncomfortable?
   (e.g., injections or I-V, spinal taps, long periods of immobilization,
sleep deprivation, dietary restrictions, bed / unit restrictions)
 
12.   Does the consent form cover more than one study?   Is this an
"umbrella" consent that will allow several procedures to be performed
concomitantly or successively?
 
13.   If there are any therapeutic benefits learned from the protocol, will I
and my family be informed of this in writing?
   Will my patient record indicate these beneficial findings for the purpose
of follow-up care?
 
14.   What follow-up care is offered to patients who complete a study?  To
those who drop out?
 
Vera Hassner Sharav
Legal Action & Quality of Treatment Chair
AMI-NYS