Financial ''risk-sharing'' or refund programs in assisted reproduction: an Ethics Committee opinion.

Financial "risk-sharing" fee structures in assisted reproduction programs charge patients a higher initial fee that includes multiple cycles but offers a partial or complete refund if treatment fails. This opinion of the American Society for Reproductive Medicine Ethics Committee analyzes the ethical issues raised by these fee structures, including patient selection criteria, conflicts of interest, success rate transparency, and patient-informed consent. This document replaces the document of the same name, last published in 2016.

The untimely death of the UK Donation Ethics Committee.

This brief report describes the contribution of the UK Donation Ethics Committee to organ donation and transplantation in the UK, and explains why the committee has met an early demise.

Impact of recent regulatory notifications on an institutional ethics committee.

The Government of India came out with a slew of notifications to streamline clinical research in the beginning of 2013 in response to the Supreme Court's orders and a Parliamentary Standing Committee's report. The notifications greatly influenced the structure, review process, outcomes and administration of ethics committees across India. In this study, we attempted to objectively evaluate the impact of these notifications on our institutional ethics committee's (IEC) structure, review process, outcomes and administration. The results revealed that though the number of regulatory studies reviewed by our IEC remained the same, the number of studies actually approved decreased with an increase in the turnover time. The number of serious adverse events (SAEs) reported also fell, although the number of meetings held to discuss these SAEs increased significantly. The administrative workload rose with increased documentation. Though the annual income of the IEC fell marginally, the expenses shot up. We believe that the notifications definitely had an impact on the structure, review process, outcomes and administration of our IEC, although it remains to be seen whether they had a real impact on the research participants' safety and well-being.

Burdens on research imposed by institutional review boards: the state of the evidence and its implications for regulatory reform.

CONTEXT: Federal regulations mandate independent review and approval by an "institutional review board" (IRB) before studies that involve human research subjects may begin. Although many researchers strongly support the need for IRB review, they also contend that it is burdensome when it imposes costs that do not add to the protections afforded to research participants and that this burden threatens the viability of research. The U.S. Department of Health and Human Services recently announced its intention to reform the regulations governing IRB review. METHODS: We used a search of the PubMed database, supplemented by a bibliographic review, to identify all existing primary data on the costs of IRB review. "Costs" were broadly defined to include both expenditures of time or money and constraints imposed on the scope of the research. Burdensome costs were limited to those that did not contribute to greater protections for the participants. FINDINGS: Evidence from a total of fifty-two studies shows that IRBs operate at different levels of efficiency; that waiting to obtain IRB approval has, in some instances, delayed project initiation; that IRBs presented with identical protocols sometimes asked for different and even competing revisions; and that some decisions made (and positions held) by IRBs are not in accord with federal policy guidance. CONCLUSIONS: While the evidence is sufficient to conclude that there is burden associated with IRB review, it is too limited to allow for valid estimates of its magnitude or to serve as the basis for formulating policies on IRB reform. The single exception is multicenter research, for which we found that review by several local IRBs is likely to be burdensome. No mechanism currently exists at the national level to gather systematic evidence on the intersection between research and IRB review. This gap is of concern in light of the changing nature of research and the increasingly important role that research is envisioned to play in improving the overall quality of health care.

Capacity mapping of national ethics committees in the Eastern Mediterranean Region.

BACKGROUND: Ethics issues in the areas of science, technology and medicine have emerged during the last few decades. Many countries have responded by establishing ethics committees at the national level. Identification of National Ethics Committees (NECs) in the Eastern Mediterranean (EM) region and the extent of their functions and capacity would be helpful in developing capacity building programs that address the needs of these committees. Accordingly, we conducted a survey to determine the characteristics of existing NECs in the EM region. METHODS: We developed a questionnaire to collect information on different aspects of NECs. The questionnaire was sent to the WHO country office in each of the 22 Member States in the EM region. We used descriptive statistics to analyze the data. RESULTS: We obtained responses from 77% (17/22) of the EM countries; 88% (15/17) of the countries stated they had NECs. Of these NECs, 40% (6/15) were involved in the ethics of science and technology, 73% (11/15) in medical ethics, and 93% (14/15) in medical research ethics; 10 NECs stated they reviewed research protocols. Of the respondent NECs, 25% (4/15) met at least on a monthly basis. Regarding training, 21% of the members from all of the NECs had received formal training in ethics; 53% (8/15) of the NECs had none of their members with formal training in ethics. Regarding support, 33% (5/15) received financial support and 60% (9/15) had administrative support. CONCLUSION: While many countries in the EM region report the existence of NECs, many meet infrequently, many have members without formal training in ethics, and many lack important financial and administrative resources. Further efforts should be directed towards capacity building programs that include ethics training and provision of important infrastructure resources for these committees.

The MRC spine stabilization trial: surgical methods, outcomes, costs, and complications of surgical stabilization.

STUDY DESIGN: A review of the surgical costs and results in a group of patients randomly allocated to surgery as part of a large prospective randomized trial of patients with chronic back pain. OBJECTIVE: To report the observational data from the surgical arm of a randomized trial comparing surgery with intensive rehabilitation for chronic low back pain. Clinical and economic data are reported. SUMMARY OF BACKGROUND DATA: Surgery for chronic low back pain is a well established but unproven intervention. The most cost-effective technique for spinal stabilization is still not established. METHODS: One hundred six patients with chronic low back pain were randomized to the surgical group of a randomized trial comparing spinal fusion of the lumbar with a 3 week intensive rehabilitation program. The primary outcomes were the Oswestry Disability Index (ODI) and the Shuttle Walking Test measured at baseline and 2 years postrandomization. Patients were stratified by preoperative diagnosis, smoking habit, and litigation. Complications were assessed and costs analyzed. RESULTS: Of the 176 surgical patients, 56 underwent postero-lateral fusion, 57 underwent interbody fusion, and 24 underwent flexible stabilization of the spine. The mean ODI for all patients in the surgical arm of the trial improved from a baseline of 46.5 (SD 14.6) to 34.2 (SD 21) at 2 years. Health care costs were higher ( 3109 pounds difference) for more complex procedures, and nearly 6 times as many early complications occurred with the more complex procedures. Smoking and unemployment were associated with worse results whereas litigation did not adversely affect the outcome. CONCLUSION: These observational changes in the ODI after surgery are similar to those reported from other studies of spinal fusion. More complex surgery is more expensive with more complications than postero-lateral fusion.

Research Ethics Committee: getting started

Unanticipated questions arose when starting an institutional research ethics committee in Grenada. Research ethics committees are charged with the ethical review of research protocols. They serve to protect people who volunteer as research subjects from harm or wrong that may result from participating in research. The Caribbean has a rich history of medical research involving human subjects. There is a growing will in the region to establish effective and sustainable research ethics committees that adhere to international standards. This paper examines uncertainties and questions that arose in starting a research ethics committee in Grenada, and describes how uncertainties were resolved. The questions centre on which guidelines to follow, who to appoint as members, what procedures to follow, and how to train members. An additional question relates to the role of a Ministry of Health in founding a research ethics committee. Resolution of these uncertainties shows that ethical review of research can be both effective and sustainable in the Caribbean. (AU)

Costs of seeking ethics approval before and after the introduction of multicentre research ethics committees.

With the advent of multicentre research ethics committees in the UK, local research ethics committees (LRECs) are required to advise only on issues relating to the local acceptability of a project. We looked at the handling of two commercially sponsored studies, one initiated before the change and one after, confining the analysis to 21 LRECs approached in both. As judged by the amount of paper per application, the new system for LRECs is simpler and should be less costly. However, there was an increasing tendency for LRECs to charge for their services (30% study 1, 47% study 2) and these charges varied by more than 400%. If such fees must be levied, a common scale is desirable.

Evaluating ethics committees: a view from the outside.

More than 60 percent of hospitals have ethics committees. The wide-scale, voluntary adoption of these committees by hospitals is surprising, given the lack of data on their effectiveness. Little effort has been made to evaluate such committees, in part because of the lack of consensus on their purpose. The argument presented here is that, from a policy perspective, the committees' purpose must be to safe-guard patients' interests; a framework for evaluating committees based on that objective is outlined. The criteria for evaluation include access, quality, and cost effectiveness. Existing data used to assess ethics committees, using these criteria. Based on available data, it is questionable whether ethics committees are performing any better or worse than alternative mechanisms to achieve the same goal.