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C=P1~ 3 1~ WORE~P Art irIvitationa1 workshop was convened to develop principles arm pro for petit scientific red sibility and ensurir~ quality ~ health sciences r~. Held In Win D.C., In September 1988, the workshop was organized by the IBM ~mnitt~ on the P~nsible Correct of Poseurs arm cosponsored by the CX=nittee on Science, Engineering, and Public Policy (C06EPUP), an entity JO fatly administered by the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The workshop was a productive means for the IOM Sony committee to gather information and perspectives about stand ares and practices that affect the conduct of research in the health sciences. Nore than 100 clinical and academic research scientists, government and university officials, professional society officers, journal editors, an] members of the press attended the workshop. An agenda and list of participants are included as appendixes to this report. After an opening plenary session, the participants met IN SIX panels. Each panel explored a different set of discussion topics designed to elicit perspectives and experiences about (1) laboratory practices and standards, (2) clinical research practices and standards, (3) institutional oversight, (4) education and training for research, (5) academic and career advancement, and (6) authorship, referee, and publication standards. Summaries of the panel discussions were prepared by panel rapp~teurs following the workshop and are irKluded In the appendixes to this report. Before the wor}~h~p, the participants had received discussion papers preE~rGx1 for each parcel. They also ~ aoived two bac3cgr~ nd papers commissioned by the committee, arising Concerns about authorship practices and the relevance of Good laboratory Practices (GLEs) regulations to academic research. me panels formulated more than 60 prcpcsals suggesting various means to improve the quality of academic health sciences research. The workshop panels also identified several key issues for further attention in the fine] plenary session. These iSSUC are described briefly below. KEY ISSUES The Organization of the Research Unit There was general agreement among the workshop participants that current practices and policies of individu~d research centers need 14

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special attention. He sharing and division of investigator are insti~ior~ responsibilities for the Angrily and quality of Card corx~uc~ ~ these awning ~ identified as an issue retrim review Al analysis. For exude, Chid the reach cent; fo~ate their An professional guideline or Chid these be bevels by Be university or Fecal center on a broader ins Lions level? Bald server ~ or mammal oversight of laboratory hers improve qualifier? ~t pro w~lcl improve Her review of senior arx! junior fatty I'- work? To is r~r~s~ble for the work conduct a laboratory or clinical Cam outer? Data Retention and Sharing Any participants affirmed He importer of ensure an= by institutional officers to rearm Eta as He primary means of verifying ff m validity of questioned ~ a ~ ~ suits. & v ~ 1 panels made proposals ~ this area, focusing on the n ~ for institutional policies and procedures regarding Alec to investigator data and minimal time limits for the retention of data. The participants suggested that research institutions need policies to address the Arrests of different parties- the institution, principal investigator, postdoctoral fellows, students, and collar orators--wish respect to the sharing of research data, materials, and methods. Although there was extensive agreement around the principle that institutions had a right to require data retention for Canaan periods of ti~three years was cleanly sagest as a traditions minis that is consistent with NIH guidelines-there was Inch 1~ agreement about the rules under which an institution Chad retire its irwestigators to share ~ data with others;. ~ cation, Training, and ~ntor~hip =dh attention was focus on Anise that wculd improve the truing of yap scientists art students. Scan workshop participants made prc~sals to clarify Be roles of laboratory chiefs arx] dent chairs in developing the caress of young facula anger:;. others pry curricula refortify to require formal train In research scat are practices for all science Serbs. Authorship Practices The participants expressed great interest in recent guidelines and by Harvard Medical School suggesting limits on the n ~ of publications to be considered in appointment and promotion decisions. Many participants suggested that this principle should be incorporat into funding and tenure decisions at other institutions. Others cautioned that setting limits on publications in research evaluation 15

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decisions sight have little effect on authorship practices. m ere was consensus that journals as well as research institutions need to define more clearly the criteria governing allocation of authorship and the responsibilities for publishing retractions of faulty research. Institutional Oversight . .. The workshop panel prepceals supported the need for formal institutional policies and procedures to handle In of alleged m~soonduct in science. They noted the particular difficulties in carrying cat responsible notification and disclosure if investigations are prematurely terminated with the resignation of an accused researcher or if a private settlement is negotiated. A few participants suggested that institutional data aunts could improve the quality of academic research, but most agreed that this approach could be very costly, could lead to an undesirable degree of standardization of research, and could damage the collegiality of the university. Several participants requested greater institutional review of manuscripts submitted for publication to verify the authenticity of the reported results and the contributions of the designated authors. These suggestions: were challenge] by others who believed that such institutional review would impose unnecessary restrictions on investigator a~xtonc~my arm threats academic freecic~m. me Effects; of ~ercialism on the Integrity of Academic ~s~ Several panels void concern that Ann cc~ication of research results and sharing of materials were increasingly inhibited by - ~ial arm competitive interests of academic resealers. mese cor~ns were di~uss~ in a preliminary manna, but He schedule of the workshop did rot allow time for He devel~nt of Pacific proposals in this area. 16