DISCLAIMER

The following is a staff memorandum or other working document 
prepared for the members of the Advisory Committee on Human
Radiation Experiments.  It should not be construed as representing
the final conclusions of fact or interpretation of the issues. 
All staff memoranda are subject to revision based on further 
information and analysis.  For conclusions and recommendations of
the Advisory Committee, readers are advised to consult the Final
Report to be published in 1995.


TAB E

               þþþDRAFTþFOR DISCUSSION PURPOSESþþþ

MEMORANDUM

TO:       Members of the Advisory Committee on Human Radiation
	  Experiments

FROM:     Research Proposal Review Subcommittee

DATE:     September 28, 1994

RE:       Status Report of Subcommittee Activities



EXECUTIVE SUMMARY

     The Office of Management and Budget (OMB) granted clearance to 
the Research Proposal Review Project under the provisions of the 
Paperwork Reduction Act of 1980, which enables the Research Proposal 
Review Subcommittee and staff to commence sampling and reviewing of 
proposals.  The Subcommittee decided to devote all available resources 
to the review of FY 1993 research and not to additionally pursue a 
review of post-1974 published reports of human radiation research.  A 
plan for sampling FY 1993 human subjects research proposals has been 
devised, in which the entire universe of research projects involving 
ionizing radiation exposure to human subjects and a sample of 
non-radiation research will be drawn for review.  Based on the 
capacity of the Advisory Committee and staff and on the number of 
research proposals anticipated, a tentative time frame for carrying 
our the various stages of the project has been developed.


I.   SAMPLING PLAN AND REVIEW OF PROPOSALS

     The Subcommittee devised a plan for sampling human research 
proposals that were approved and funded in FY 1993:

     Research Involving Ionizing Radiation:  Request IRB materials 
     from universities for all FY 1993 research projects involving the 
     exposure of human subjects to research applications of ionizing 
     radiation (including tissue studies , if the tissue was collected 
     after subject's exposure to ionizing radiation), Nþ250.  Expect 
     50% return rate within our time frame, or ~125 projects to 
     review.

     Research not Involving Ionizing Radiation:  Draw a random sample 
     of 100 non-radiation FY 1993 human studies.  Divide the 100 
     proportionately over HHS, DOE, DoD, VA, and NASA to correspond
     to agency proportion overall.  Expect a 50% hit rate, or Nþ5 to 
     review.

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     The sample of non-radiation FY 1993 human studies will be drawn 
to parallel the universe of FY 1993 studies involving ionizing 
radiation according to the following stratification criteria:

          Funding agency
          Intramural or extramural
          Single site or multi-center site (possible criterion)
          Cancer studies or non-cancer studies
          Randomized clinical trial or not

     Staff has received abstracts of all FY 1993 human radiation 
research projects from HHS, DOE, DoD, VA, and NASA, in addition to 
lists of all non-radiation research from this period.  Staff is 
currently assessing the number of projects constituting the universe 
of human research involving ionizing radiation.  Table E.1 illustrates 
the breakdown of studies involving ionizing radiation (by agency) 
according to experimental category.  This information will enable 
staff to send out highly specific requests to universities for IRB 
materials.  A master list of all human radiation research abstracts, 
set up as a computer database, will serve to track the status of 
requests to universities as well as a means to select the parallel 
sample of non-radiation studies as a comparison group.  

     Our requests to universities and other research institutions will 
include the following:  IRB applications, including project proposals; 
consent form as approved by the IRB; and the final disposition letter.


 
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TABLE E.1  [Shaded cells are currently being determined]
BREAKDOWN BY AGENCY OF HUMAN RESEARCH INVOLVING IONIZING RADIATION 
APPROVED AND FUNDED IN FY 1993 

			{FOR REFERENCE SEE 7bb001}


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II.  TIME FRAME, RESOURCES, AND CAPACITY

     The following time frame has been proposed for the various stages 
of the Research Proposal Review Project:

TABLE E.2
TENTATIVE TIME FRAME FOR RESEARCH PROPOSAL REVIEW PROJECT



                           T A S K                                                              
D E A D L I N E 

1.     Design and execute sampling frame  11/15
            Obtain lists and abstracts from agencies     9/20
            Staff review of abstracts                    9/29
            Finalize sampling                            10/5
            Request letters sent to universities         10/10

2.     Finalize evaluation criteria       11/15
            Consultant review                            10/31

3.     Train "reviewers"                  11/15

4.     Conduct reviews                    11/15 - 2/15

5.     Analyze and interpret findings3/15
            Interim results                              2/15
                                              (prior to Feb. mtg)



     Maximum capacity is estimated at approximately 200 research 
projects to be reviewed between November 15, 1994 and February 15, 
1995.  Each project will have two independent reviews and a third 
review to resolve any discordance; an estimated total of 500 reviews 
will be conducted.  Twelve weeks have been set aside to conduct the 
reviews.  The "review load" will be lighter in month 1 than in months 
2 and 3.  A core review group of staff and Committee members will 
conduct the reviews; staff will conduct approximately 350 reviews, and 
Committee members will conduct approximately 150 reviews.  Advisory 
Committee members also will serve as "consultant reviewers," 
particularly with respect to evaluation of medical risks and prospect 
for medical benefit.

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