Results
of the medical schools responded, 76% of these institutions indicated that they had never used a central IRB and 24% of these institutions had. Most of the institutional respondents expressed no interest in using a central IRB in the future because they believe that their institutional IRB is working efficiently, and they are concerned about issues of institutional liability and the loss of local representation in the review process. Of the institutions that had used a central IRB, most were pleased with the performance of the central IRB and would continue to utilize a central IRB in the future. Of interest, most of these respondents did not agree that a central IRB had helped them to attract industry-sponsored research.

Conclusions
In spite of much discussion about the advantages of central IRBs in expediting overview of human subjects research, especially in multi-center trials, the majority of medical schools surveyed have never used a central IRB and express no interest in doing so.

¹ Loh, E.D. and Meyer, R.E., 2004. Medical Schools' Attitudes and Perceptions Towards Using a Central Institutional Review Board, Acad. Med. 79:644-651.
² Korn D. Central IRB information brief. AAMC Information Brief. 2002 January;23:1-3.

Results
We are making this learning program available globally to all healthcare providers at the following website: www.Cure4Kids.org. This educational development program was funded by the Office of Research Integrity, Department of Health & Human Resource and the American Lebanese Syrian Associated Charities.

Please Note
Presentation of project results is part of the project dissemination plan. A similar abstract has been submitted to the Association of Clinical Research Professionals.

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Results
IRB websites generally provide basic information about pediatric research, including the special federal regulations governing pediatric research and the categories of permitted research. However, there are missed opportunities to help investigators understand the regulatory and ethical requirements for pediatric research. Moreover, some IRB advice may be problematic. More detailed IRB guidance may help protect children in clinical research. Examples of ways to achieve this include checklists and "points to consider," concrete examples to illustrate regulatory requirements, and highlighting areas of controversy.

Conclusions
Few IRBs present the kind of detailed guidance that investigators need to apply ethical principles to specific protocols. IRBs should take advantage of the opportunity to help investigators browsing the IRB website to think through ethical issues that arise in their research. In addition, IRBs should work cooperatively with pediatric professional societies to address controversial issues in pediatric research and develop more consistent guidelines.

Results
Readability results for child assent forms were as follows: Fog 8.9, SD ± 1.3; Smog 8.6, SD ± 1.1; FRE 74.0, SD ± 6.3. Readability results for parental consent forms were as follows: Fog 14.1 SD ± 0.8; Smog 12.9 SD ± 0.6; FRE 47.6, SD ± 4.1. Each of the six consent form sections were written at the college reading level. Results were unchanged when stratified by protocol sponsorship or IRB protocol review type. Increasing page length was correlated with more difficult readability in assent forms (r=0.4, p=0.0002) but not consent forms (r=0.0, p=0.93).

Objectives
The main objective of the programme was to promote the ethical conduct of health research in Zimbabwe through the enhancement of the human subject protection system and practices. The programme was made up of various components (activities) and each component was related to a particular specific objective. The specific objectives included the following:

• To conduct a situational analysis of the current human subject protection system and practices in Zimbabwe.
• To update the MRCZ review and monitoring systems and procedures.
• To develop a comprehensive set of guidelines on the operations of IRBs.
• To conduct a workshop in order to sensitize researchers and IRB members on the ethical conduct of research and to apprise them about the new systems and procedures in place to ensure the protection of human subjects.
• To sensitize members of the community who are often the subjects of research on the difference between research and routine care and on their rights as subjects of research:
• To train and educate researchers and IRB members in the ethical conduct of research

Results/Observations
The committees were similar in all major variables explored including membership, number of new submissions reviewed (A=242, B=241), and rate of proposals initially approved (A=52.9%, B=53.9%). There was a robust statistical difference between the percentage of "trainee submissions" initially approved (39.6%) and those that did not identify a trainee (58.7%) (?2(1)=13.56, p<.0003). Of those proposals that were initially not approved (either deferred pending clarification ("tabled") or disapproved ("rejected")), 29.6% of those including a trainee were outright rejected in contrast to only 11.1% without a trainee (?2(1)=10.93, p<.001).

Considering all 483 submissions, those that identified external funding were more likely to be initially approved (64.9%) (?2(1)=93.12, p<.0001). Funding also seemed to influence the trainee and initial approval interaction. Approval rates for funded proposals were similar with trainees (63.5%) and without (65.2%). However, for proposals without funding the rate of initial approval with trainees (24.4%) was less than without trainees (37.8%, ?2(1)=2.85, p<.10). Of proposals that identified funding and listed no trainees, 7.5% were rejected. Of those without funding and with trainees 17.6% were rejected.

* Poster Selected for Presentation
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Results
Of 250 individuals that received the survey, 135 (54%) returned completed questionnaires, and 89 (66%) of these respondents were involved in obtaining informed consent and make up the study group. Most respondents (54%) spend 30 minutes or less in the informed consent process, and only 47% check the understanding of the patient. A majority of respondents encourage questions (95%), encourage patients to take home the consent form (67%), and encourage discussion with family or friends (84%), but only 27% felt that the primary purpose of clinical research was to benefit future patients, and 36% would encourage subjects to enter a clinical trial. Respondents with training in the informed consent process and those having spent 12 or more years in research spent more time on average than those respondents who had no training or who spent less time in clinical research (p = 0.01; p = .003). Clinical research coordinators were more likely than clinician investigators to encourage patients to take home the informed consent form (p = 0.044) and to leave the decision to enter the trial up to the patient (p = 0.022).

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Results
Among the 1191 intervention research protocols reviewed by WIRB in 2003, about 22% used a data and/or safety monitoring committee by the name of DSMB or other similar denominations. Biotechnology research used DSMBs more frequently than studies with drugs and devices. Pulmonology and cardiology research used DSMBs more frequently than other specialties. In the areas of oncology, CNS research, and infectology, the use of placebo or sham devices was more frequently associated to the use of a DSMB. About 59% of the DSMBs were independent; 11% were not independent and the rest did not specify. The average number of members among the studies which mentioned this variable (n=144) was 3.5, ranging from 2 to 7. The frequency of meetings was often flexible depending on the achievement of recruitment or safety targets. Among 210 drug studies, 88 DSMBs (42%) reviewed efficacy interim analysis and included clearly defined stopping rules. Among 47 device studies, 7 (14%) DSMBs reviewed efficacy interim analysis and 12 (25.5%) had stopping rules. Many protocols did not include enough information about the DSMB, and in many cases, a DSMB seemed to be in place but was not mentioned.

1. The use of DSMBs in Clinical Research has increased in recent years.
2. Following FDA and NIH guidance, DSMBs are established for studies on high-risk interventions, usually comparative but not necessarily blinded.
3. More than a half of the DSMBs for drug studies and most DSMBs for device studies are established for safety purposes only.
4. IRBs require information about the characteristics and objectives of DSMBs.

The e-packet has proven to be easy to build, read, use during meetings, and transport; economical to produce, ship and use; palatable for all users; culturally compatible; and expandable for future uses. Many of the necessary items for conversion from paper-based review materials into electronic media already existed within the organization's infrastructure.

Board member and staff training were completed within a two-month time frame. Most e-packet users converted from paper packets to electronic packets by their second meeting. By the end of the second month, all 70 board members and approximately 40 WIRB employees were using e-packet exclusively.

Beyond the cost savings in raw materials, printing, labor, shipping, and document security issues, e-packet has provided for other operational processes to be developed which further enhanced customer and board support.

Capital investment for the project was approximately $1200 per board member. It is estimated that the project will have paid for itself by the second quarter of implementation. This savings does not reflect the increased revenue which is indirectly a result of e-packet, such as improved operational performance, enabling board meetings which include participants from remote sites, and facilitating communication with consultants. The growth of a business is not just seen in the number of employees, but also in how an organization handles information. Choosing to update information strategies is critical in the current business climate. Fortunately, the computer era has generated many options for today's businesses.

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1. Process Issues
   
   Environmental Assessment: Make a compelling case for the changes you are anticipating with every substantive stakeholder.
   Visioning: Bring together some of the stakeholders - faculty and staff - and conduct a highly focused session surrounding an "idealized state."
   Prioritization: Armed with a good sense of the stakeholders and feedback from the visioning session, priorities should be set.
   Readiness Assessment: Conduct a readiness assessment to describe the state of readiness along with several major attributes and what you will do to address areas of concern.
   Technical Assessment: Only after you have clearly identified the real issues of concern should you begin to address the technical issues. Your technical vision should be driven by the important issues that bring real and immediate benefit.
   Communications Strategy: Develop a means of telling your constituents what it is you are doing and why. You should help set expectations and constantly invite feedback.
   
   
2. How the System Works
   
   Screening of unanticipated problems: This instrument helps the PI determine what needs to be reported.
   Routing of unanticipated problems: Once reported, the system archives the event or routes it a reviewer.
   Resolution: Contingencies are communicated to the PI and may be resolved electronically increasing efficiency.
   Record keeping: The system maintains a cumulative report.

Conclusions/Applications
Using the process above, an electronic submission system of unanticipated problems was developed that has improved the accuracy of reporting and reduced the burden of ambiguity for the reviewers.

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Overview of the Project
In recruiting and retaining its 250 members, the HSC has developed strategies for targeting and recruiting its membership. The purpose of this poster is to provide institutions with guidance regarding strategies that can be used by any committee when recruiting new members, developing a balance between reviewers, and increasing retention. A special emphasis will be placed on recruiting and retaining unaffiliated members, as IRBs are exploring the possibility of increasing their "lay membership" to 25% or more.

Recruitment strategies include:

• Presentations at Mini-Med School and community organizations such as Oasis
• Contacting the Rabbinical Association, Catholic Diocese, and other religious organizations
• Efforts to reach minority communities
• Use of research databases
• Letter from the Dean, School of Medicine encouraging new members to join
• Identifying number of protocols submitted from a given area and requesting members from that area in proportion to number of submissions
• Educational events
• Word of mouth

• Annual recognition dinner
• Offering a variety of on-going education for members
• Letter from Dean, School of Medicine thanking IRB members for serving

Conclusions/Applications
Feedback has been positive from IRB members and HSC staff concerning the recruitment and retention of IRB members. Developing and maintaining a balance between physician scientists, other scientists, and unaffiliated members so that the committee has enough expertise to review the protocols and also enough representation to ensure that a research participant's perspective is considered a continual process.

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Overview of the Project

1. Evolution and History of Human Subject Research
   Objectives: Explore the history of research ethics and emerging ethical considerations as new fields emerge. Learn what lead to the formation of current regulations governing human subject research, their implications, and how research is governed.
   
2. The Research Process
   Objective: Provide an overview of the research process from study origination through data collection an analysis.
   
3. Overview of Good Clinical Practice
   Objective: Understand and be able to apply the elements and principles of Good Clinical Practice
   
4. Institutional and Investigator Responsibilities
   Objectives: Explain responsibilities from study initiation through closure.
   
5. Current Issues and Future Considerations
   Objective: Discuss current topics.

Overview
Ethical considerations are important in any biomedical research, but especially so in research involving human subjects. Roche has established a framework for discussing and resolving potential ethical issues that may arise during the course of clinical research. This encourages ethical issues to be addressed in a proactive manner, which facilitates consensus decisions and promotes a shared understanding of the company's corporate values and ethical standards. The preferred model consists of a three step process, through which even the most difficult ethical issues can be resolved.

A Roche employee who feels he is facing an ethical dilemma or who has an ethics question can get in touch with the Global Ethics Liaison. This individual serves as a central contact for uniform advice on ethical issues in clinical research, and is independent from the clinical development teams. Thus, the Global Ethics Liaison is able to help the clinical development teams to find an appropriate answer through open discussion and fact finding. If this is not sufficient, the Global Ethics Liaison will escalate the issue to the Head of Pharma Development and his advisors. If need be, advice can also be sought from an independent external advisory group consisting of bioethicists and other experts from academia and the patient community. Membership of this advisory group is global in character, with current members coming from Asia, Europe, and North America. The main role of this external ethics advisory group is to participate in periodic ethics discussions, serving as a sounding board, and to ensure that Roche is made aware of current external ethical issues in an ongoing manner.

To promote awareness of the process, and to reinforce the company's corporate values and ethical standards, ethics education is offered to employees. During training sessions the benefit of open dialogue regarding potential ethical issues is stressed, and the concept of ethics and what it means to Roche employees in their daily work is explored.

Abstract/Publication Plan

1. Process/Framework (2004-2005)
2. External Ethics Committee Concept - CREAG
3. Ethics Education Concept; (a) Awareness, (b) Culture Change, Problem Solving
4. Update(s) on 1-3 as appropriate through time

Supplemental Reviews
Human subjects research protocols are also reviewed by the Departments of Pharmacy, Nursing, Biostatistics, Diagnostic Imaging, Biosafety and Radiation Safety, and Cardiology. In addition, a compliance officer reviews all protocols for any issues that may concern a study that involves an Investigational New Drug and/or an Investigational Device.

Conclusions
All critique-related documentation is provided to the IRB committee members for review prior to and during the scheduled presentation of the protocol on the IRB meeting date. The scientific review process allows for a seamless and intense analysis of the human subjects research conducted at M.D. Anderson Cancer Center, making for a well-documented review.

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Singapore inherited a health system and a legal system based on the British model, but has in recent years been increasingly influenced by US-style medical/patient attitudes on their rights over their tissues. In view of the Alder Hey publicity, it was decided to implement a consent form for all leftover tissue in our hospital in April 2002.

In the consent form, the patient is asked if he/she would agree to allow the remainder of any tissue not required for diagnosis to be used for medical research, education and study purposes. The patient is also informed that only excess tissue that remains after all necessary medical tests are completed will be used, and no extra tissue will be removed. An explanation, in the form of a Patient Information Sheet, is given to the patient that in the course of many procedures, tissue may be removed as part of the surgical procedure, and these tissues would otherwise be discarded if not required for diagnostic purposes.

With the introduction of this consent form, we discovered that first it was necessary to have a tracking system to link the consent or non-consent with the individual tissue specimen in order to follow the patients' wishes. This was achieved by the addition of an electronic `tag' to the patient's identification number at the hospital, which is linked to all the patient's investigations results. With this in place, we had a quiet launch in March 2002.

The graph shows the level of positive consent over the last 6 months. There was initial resistance and this was discovered to be at the level of the junior doctors, who had not been adequately briefed and were not enthused with having to request (yet) another consent form to be filled by the patient. After a few meetings, the hospital staff (junior and senior) could see the importance of this new development for the purposes of medical research and education. As the graph shows, the level of positive responses then climbed steadily and has now reached a plateau of 80%.

We feel that this is a good result within 6 months, and other hospitals in Singapore will be implementing this consent request in the near future. Other hospitals in Singapore were persuaded that if this is possible for a tertiary hospital like National University Hospital, the other general and community hospitals might also be able to seek consent from patients for use of their tissues.

Patient Consent for donating leftover tissue - 8 Apr 2002 to 4 Jul 2004

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Departmental/Divisional Research QI Activities
Clinical research is discussed within the framework of Departmental/Divisional QI Committees. These Committees will be required to share trends and issues with the CQI program and other departments.

1. Decrease the time from new submission of a protocol to the IRB review;
2. Decrease the time from initial IRB review to first correspondence to the investigator; and
3. Increase investigator and study coordinator satisfaction with the IRB process.

Results
The average number of days from new protocol submission to the formal IRB review decreased from 24 days to 17 days (p value 0.17). The average number of days from the IRB meeting to initial correspondence to the investigator decreased from 22 days to 5 days (p value .001). Principal investigators and study coordinators reported increased satisfaction with the new IRB procedures.

Results
The two biomedical IRBs were similar in all major variables explored. These included membership, number of "new" submissions reviewed (A=242, B=241), and rate of proposals initially approved (A=52.9%, B=53.1%). The rate of approval by department was highly variable. When departments that submitted fewer than eight protocols are excluded, the initial approval rate by department ranged from 5.9% to 88.9%.

Understandably, most "new" proposals had a primary reviewer assigned from the same clinical department as the principal investigator (64.9%). Protocols with a primary reviewer from the same department were more likely to be initially approved (58.0%) than protocols where the primary reviewer was from a different department (44.4%) (p<.005). Proposals with a primary reviewer from a different department (23.6%) were more likely to be disapproved ("rejected") than those for whom the primary reviewer was from the same department (13.6%). This comparison just missed statistical significance (p<.06). Interestingly, protocols that identified external funding were significantly more likely to be assigned a reviewer from the same department (73.5%) than were protocols that did not identify external funding (47.8%) (p<.001).

Results
An overall 90% response rate was achieved. Respondents unanimously indicated they had enough time and information to make an informed choice, had their questions answered satisfactorily, felt they were given the choice of whether to participate or not and understood what the research was about. Almost all respondents were given a copy of their consent, did not feel forced to participate, knew they could decline and still receive usual care, understood what was being asked of them, and knew what to do and whom to call in case of a problem. The majority indicated that words were explained to their satisfaction, while the remainder noted their were no words that they needed explained. Most indicated they knew of the risks (21) and the remainder indicated there were no risks (6). Comments were positive about participation in the study. Some negative comments indicated desire for follow-up information about the results, and not receiving reimbursement for parking.

Conclusions
This is a pilot study of 30 subjects, so definite conclusions are not made. Results of the pilot suggest that a mailed survey is an effective tool (90% response) to ascertain the comprehension and voluntariness of informed consent. Results also suggest that subjects felt adequately informed and freely consented to be in the MS treatment related studies. Further research is warranted on a larger sample to make more than preliminary conclusions. The risk item needs further attention, as "risk" had been addressed in the consent document yet 25% indicated "no risks."

* Poster Selected for Presentation
** Authors unavailable to present

Methods
Vignettes were developed that represented one of two levels of disease severity (high/low) for four illness types, two representing psychiatric (depression, schizophrenia) and two representing medical (cancer, diabetes) diagnoses in a 2 x 2 x 2(N) experimental design. IRB members were mailed one vignette (determined randomly) that described a clinical trial scenario relevant to one of the eight experimental conditions. After reading the vignette, IRB members rated the hypothetical subject on a range of variables, including measures of vulnerability and competence to provide consent.

Results
Preliminary analyses based on data provided by 113 IRB members (data collection is ongoing) supported the main hypotheses. Patients with psychiatric diagnoses were rated as significantly more vulnerable to coercion (P < 0.001) and less capable of providing autonomous, informed consent (P < 0.001). Patients with diabetes, even those with severe neuropathic pain were viewed as much less vulnerable than other patient groups (P < 0.001). In terms of informed consent, patients with schizophrenia were viewed as the least capable (P < 0.001). Interestingly, all (100%) patients with diabetes were viewed as competent, and patients with cancer, including those with life expectancies less than 6 months, were viewed as more competent than those with psychiatric diagnoses (P < 0.05).

Results
We fulfilled the goal of this pilot project: to develop a draft evaluation instrument and use it to evaluate IRB review of protocols by several of NIH's 14 IRBs. Based on our experience, the draft instrument captures expert evaluators' objective and subjective observations of a convened IRB's performance in fulfilling minimal regulatory requirements for the protection of human research subjects.