The roles and experiences of nonaffiliated and non-scientist members of institutional review boards.

PURPOSE: Little is known about the roles and experiences of non-scientist and nonaffiliated institutional review board (IRB) members (also known as lay members), and what contributions they are making to IRBs. This study investigated the experiences of IRB lay members from leading academic medical institutions in the United States and presents their recommendations for future education and training. METHOD: In 2000, the authors randomly selected and contacted 20 IRBs. From the 11 IRBs that agreed to participate, a total of 32 lay members participated in telephone interviews in which they were asked open-ended questions about the types of initial and ongoing education they had received, their interactions with scientific members, their contributions, the problems they experienced on the IRB, and recommendations for future education and training. RESULTS: Participants believed their role was to represent the community of human subjects, and 94% reported that their main contribution was simplifying the consent forms. Although 94% of participants had positive experiences working with scientist IRB members, 88% occasionally had been intimidated and felt disrespected by them. Forty-seven percent of participants identified lack of education and training as a problem, and 78% wanted more intensive education and training for future non-scientist/nonaffiliated members. CONCLUSION: IRB reform should include better training for non-scientist and nonaffiliated members so that they can take on more active roles. In addition, measures are needed to strengthen the relationships between scientist and non-scientist and nonaffiliated members.     

The cost of operating institutional review boards (IRBs).

PURPOSE: Recent reports have claimed that institutional review boards (IRBs) are underfunded, yet little is known about the costs of operating IRBs. This study estimated the costs for operating high-volume and low-volume IRBs. METHOD: IRB costs were calculated from published summary data. Costs were standardized to reflect 2001 dollars. RESULTS: Total estimated costs for operating high-volume and low-volume IRBs were $770,674 and $76,626, respectively. The average cost per action, a measure of economic efficiency, was lower for high-volume IRBs ($277 per action) than it was for low-volume IRBs ($799 per action). CONCLUSIONS: Although high-volume IRBs are more expensive than are low-volume IRBs in absolute terms, they are more economically efficient. Policy debates should consider the potential savings from large IRBs, perhaps by encouraging small IRBs to merge, although this may result in less local review, control, and oversight.     

Collaboration and peer review in medical schools' strategic planning.

The management of medical schools has never been so difficult, but can be facilitated by using a well-developed, broadly accepted strategic plan. While the concept of strategic planning has been reasonably well accepted by both faculty and leaders at most medical schools, using the strategic plan to allocate resources has proved to be a challenge. Achieving "buy-in" by all parties involved can help meet this challenge and can be critical to the success of strategic planning and management. The authors describe the collaborative planning process that the University of Wisconsin Medical School used to develop its 1998-2000 strategic plan. This unique effort culminated in using a peer-review process--similar to that used by the National Institutes of Health (NIH)--and developing criteria to select a limited number of program priorities. This selection occurred after a school-wide process to solicit strategic program proposals had taken place. Over 130 faculty from most departments throughout the school helped develop and revise the strategic plan. There was frequent communication and engagement with faculty at all levels, which was important in gaining the faculty's acceptance and, indeed, endorsement of the process and its outcomes. Because the process was effective in achieving consensus about the school's strategic priorities, it enabled the school to reach a firmer end-point and implementation plan than had been possible with the previous strategic plan. It also identified important weaknesses in some areas of the medical school; the resulting attention to those areas will help strengthen the school. Finally, the process moved much more swiftly than the previous effort. The authors recommend that such an approach be used by other medical schools, and be carried out before a school implements mission-aligned budgeting and management of its fiscal resources.     

Characteristics of medical school faculty members serving on institutional review boards: results of a national survey.

PURPOSE: To understand the characteristics of medical school faculty members who serve on institutional review boards (IRBs) in U.S. academic health centers. METHOD: Between October 2001 and March 2002, a questionnaire was mailed to a stratified random sample of 4,694 faculty members in 121 four-year medical schools in the United States (excluding Puerto Rico). The sample was drawn from the Association of American Medical College's faculty roster database for 1999. The primary independent variable was service on an IRB. Data were analyzed using standard statistical procedures. RESULTS: A total of 2,989 faculty members responded (66.5%). Eleven percent of respondents reported they had served on an IRB in the three years before the study. Of these, 73% were male, 81% were white (non-Hispanic). Virtually all faculty IRB members (94%) conducted some research in the three years before the study, and, among these, 71% reported conducting clinical research, and 47% served as industrial consultants to industry. Underrepresented minority faculty members were 3.2 times more likely than white faculty members to serve on the IRB. Clinical researchers were 1.64 times more likely to be on an IRB than were faculty members who conducted nonclinical research. No significant difference was found in the average number of articles published in the three years before the study comparing IRB faculty to non-IRB faculty. CONCLUSIONS: The faculty members who serve on IRBs tend to have research experience and knowledge that may be used to inform their IRB-related activities. However, the fact that almost half of all faculty IRB members serve as consultants to industry raises potential conflicts of interest.     

Current status of the institutional review boards in Korea: constitution,operation, and policy for protection of human research participants

The institutional review board is crucial to ensure the scientific and ethical quality of human participant research. This paper analyzes a survey on the current constitution and operation of institutional review boards (IRBs) in Korea, conducted by the Korean Association of Institutional Review Boards in April 2002. Out of 74 IRBs, 63 responded to the survey (85.1% response rate). IRB membership has a male-to-female ratio of approximately 80:20, a predominance of male clinicians (60%) and an underrepresentation of community people unaffiliated to the institutions (less than 10%). Most IRBs (around 80%) confine the scope of their reviews to the clinical evaluation of drugs or devices, leaving the remaining areas of research involving human participants untouched. As their role is limited, the majority of IRBs do not operate actively: 72% of responding IRBs reviewed less than one protocol per month in 2001. Sixty two percent of institutions have never discussed the need for insuring research participants' risks or making indemnity arrangements. This survey reveals many shortcomings and points for improvement by the institutional support bodies, including the need to establish regular education programs for IRB members and investigators.     

Mothers'' use of and attitudes to BabyCheck.

A copy of BabyCheck was sent to 497 mothers shortly after the birth of their baby. Six months later they were sent a questionnaire asking about their use of and attitudes to, BabyCheck. Questionnaires were returned by 323 (65%) mothers; 215 (67%) of them reported reading BabyCheck, the majority found it easy to understand (74%) and agreed with the advice (67%). Eighty-four (26%) of the mothers who returned the questionnaires reported using BabyCheck when their baby was ill; of these, 71% agreed with the advice and 65% trusted the advice. None of the mothers had used the complete range of tests. This lead to our conclusion that BabyCheck is well accepted among mothers but is not used routinely as part of mothers' response to illness in their babies. BabyCheck requires introductory education to ensure that parents score all the tests and that the predictive power of BabyCheck is not compromised. Further evaluation of BabyCheck is needed to find its ideal role in the assessment and monitoring of infant illness.     

Parental attitudes regarding newborn screening of PKU and DMD

The ability to perform predictive genetic testing of children raises ethical concerns. Current guidelines support the screening of newborns for conditions in which early treatment reduces morbidity and mortality, and oppose most other predictive genetic screening and testing in childhood. Little is known, however, about parental attitudes. We conducted focus groups to gain information on the attitudes, beliefs, and concerns of parents about newborn screening and testing for both treatable and untreatable conditions that present in childhood. Respondents across racial groups support mandatory newborn screening for treatable conditions like phenylketonuria (PKU), citing lack of parental knowledge, and concerns about immature parental decision-makers. Parents do, however, want more information. Citing a variety of psychosocial concerns, respondents believe that parents should have access to predictive genetic testing for childhood onset conditions, even when there are no proven treatments. Respondents want this information to make reproductive and non-reproductive plans and decisions. Although respondents varied in their personal interest in testing, overwhelmingly they believed that the decisions belong to the parents. Professional guidelines that proscribe predictive testing for untreatable childhood onset conditions should be re-examined in light of consumer attitudes.     

Patients' attitudes and comfort levels regarding medical students' involvement in obstetrics-gynecology outpatient clinics.

PURPOSE: To identify patients' attitudes toward the role of medical students, their preferences regarding medical student involvement, and their comfort level with a medical student's presence during common clinical situations in obstetrics-gynecology. METHOD: A self-administered questionnaire was distributed to patients waiting for an office visit with the obstetricians or gynecologists who served as preceptors for both male and female medical students. The questionnaire asked patients about their comfort levels with having medical students present during commonly encountered clinical situations. A random subsample of these patients were also asked whether they would allow a medical student to be present during future visits, and why or why not. RESULTS: A total of 229 patients completed the survey and 124 responded to the supplemental survey. Sixteen respondents were excluded due to missing data or a lack of an adequate comparison group. A majority responded they would feel comfortable having a medical student present during most clinical situations. Almost half of the patients preferred to see the doctor and medical student together, while less than a quarter wanted to see just the physician. Patients with more experience with medical students were more likely to favor medical student involvement and would feel more comfortable having a medical student present during obstetrics or gynecology clinical situations. CONCLUSION: Patients are willing to involve and feel comfortable with medical students in the obstetrics-gynecology clinic. However, physicians and clinics need to take steps to ensure that patient willingness and comfort are maintained by asking patients about their comfort with medical student involvement, clearly outlining the roles and responsibilities of participating medical students, and gradually increasing medical students' responsibilities as patients gain more experience with them.