ELEMENTS FOR REVIEW OF HUMAN RESEARCH PROPOSALS


	Below is a draft outline of the basic elements that would be
considered in the Research Proposal Review Subcommittee's review 
process.  Note that these elements are intended to be used for our
analysis of the protocols, and not of IRB minutes.

I.	Informed Consent

	A.	Are the proposed procedures for soliciting informed
		consent adequate according to current standards?

	B.	Is the consent form sufficiently comprehensive and 
		accurate.

	C.	How well does the description in the consent form of
		risks and potential benefits conform to that 
		provided in the protocol?

	D.	Is the form intelligible and appropriate for proposed
		subject populations?

	E.	If children or adults of questionable competence are
		involved as research subjects, are procedures for
		obtaining authorization from other parties 
		appropriate according to current standards?

	F.	Does the protocol itself address the process of 
		consent?  If so, does it include such matters as
		subject capacity (e.g., severity of illness as
		affecting patient understanding), surrogate
		consent procedures, who will obtain the informed
		consent, when, exactly how, etc.?  Who has been
		designated to obtain consent from the subjects?

II.	Risk/Benefit

	A.	Is risk/benefit discussed in the informed consent
		form, in the protocol itself, or both?  If so,
		to what extent?

	B.	Do the risk/benefit discussions incude distinctions
		between direct benefits to subjects and benefits to
		others?

	C.	Does the discussion of risks include a cursory, 
		general description of the type of risk, or a more
		sophisticated and specific description of the
		magnitude and probability of risks, unknown risks,
		comparison to know risks, etc.?

	D.	To what extent are humans being exposed to greater
		than minimal risk in these studies?

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	E.	Where risk is greater than minimal, is the risk 
		associated with the study adequately balanced
		against the potential benefit to the research
		subject?

III.	Subject Selection and Recruitment

	A.	Subject Selection

	1.	What criteria were used to select the patient 
		population?

	2.	Is there any indication that certain communities
		or subsets of communities are disproportionately
		"over-represented" or "under-represented" in
		research protocols, and if so, why?

	3.	Is there any indication that disadvantaged 
		populations are disproportionately represented
		in "riskier research" or research without off
		setting benefits?

B.	Subject Recruitment and Compensation

	1.	What was the process of patient recruitment?

	2.	Does the protocol indicate whether incentives
		were used as a recruitment tool?

	3.	Are subjects compensated for their participation
		in the research study?  If so, in what manner?