It is essential that anyone involved in research involving human subjects be familiar with the purpose and role of institutional review boards. Institutional review boards are designed, first and foremost, to protect human research subjects by overseeing the implementation of federal regulations regarding protection of human subjects. The federal government requires institutional review board approval for any human subject research that receives federal funding, and many scholarly journals require proof of institutional review board approval of the research before publication. In this article, the answers to 10 frequently asked questions about the role of institutional review boards highlight the important contributions made by institutional review boards to the conduct of ethically sound research. The aim is to generate a working knowledge of the institutional review board's function that can be used by every researcher contemplating working with human research subjects. This is the first in a series of 3 articles examining common issues in research ethics.

The United Network for Organ Sharing (UNOS) waiting list was designed as a just and equitable system through which the limited number of organs is allocated to the millions of Americans in need of a transplant. People have trusted the system because of the belief that everyone on the list has an equal opportunity to receive an organ and also that allocation is blind to matters of financial standing, celebrity or political power. Recent events have revealed that certain practices and policies have the potential to be exploited. The policies addressed in this paper enable those on the list with the proper resources to gain an advantage over other less fortunate members, creating a system that benefits not the individual most in medical need, but the one with the best resources. These policies are not only unethical but threaten the balance and success of the entire UNOS system. This paper proposes one possible solution, which seeks to balance the concepts of justice and utility.

We obtained data on Institutional Review Boards (IRBs) that review mental health-related applications (MHRAs) in a national survey of institutions with federally assured human research protection programs. Approximately 57% of IRBs review MHRAs, and among these a small percentage may not have mental health experts on their committees (5%). Moreover, mental health experts on IRB committees at high research volume institutions are carrying substantially greater workloads than their lower volume counterparts. In terms of committee demographics, more women (36%) are serving as IRB Chairs on committees that review MHRAs than expected from their representation on medical or university faculties; ethnic minority faculty have lower representation among Chairs than might be expected from their overall faculty representation. Our findings suggest the need for additional studies to (a) examine if the number of mental health experts on IRBs should be increased particularly among IRBs reviewing a high volume of MHRAs,(b) determine if the breadth of expertise among IRB mental health experts corresponds to the range of substantive and methodological approaches represented by the mental health protocols under review, and (c) examine if recruiting IRB scientific expertise from outside an institution, a more common practice among smaller research entities, impacts review quality.

In a national survey of institutions with federally assured human research protection programs, we obtained workload and other relevant data on their Institutional Review Boards (IRBs) and management organizations. The number of IRBs increased substantially from 1995 to 2005/06 (491 to 2,728 IRBs) with a further increase in 2008 to 3,853 IRBs. Nationally, IRBs reviewed over a quarter million research applications in the year prior to our survey, of which 35% were new applications requiring full committee review. Compared to estimates from 1995, current IRBs review more new and full committee review applications, but the relative percentage of new and full committee applications remained about the same. High volume research institutions have IRBs with a substantially larger per person workload, relative to smaller volume IRBs (i.e., members spent nearly seven times more hours reviewing new applications outside formal committee meetings). Virtually all IRBs included community representatives as members (92%); however, a small number may not be compliant with federal regulations. The present findings suggest the need for research to (a) examine workload and its effects on review quality, research costs, and faculty morale,(b) develop methods for determining optimal fit between IRB workload demands and institutional labor and financing requirements,(c) construct benchmarks for judging reasonable workload for individual IRB members, and (d) examine if the need to recruit IRB scientific expertise from outside the institution, particularly true for smaller research institutions, causes delays in IRB review, and if a more effective way of locating and recruiting experts would improve quality and time to completion.

In December 2002, a conference was held in Philadelphia to discuss public concerns about living organ transplantation with the goal of reaching a consensus about new strategies for such transplants. The conference was hosted by the Hospital of the University of Pennsylvania and the Center for Bioethics. A multidisciplinary group of leading experts and stakeholders was called to assess the current status of living donation and suggest productive changes to ensure safer and more ethically sound procedures for both donors and recipients. Prior to the meeting, the research team from the University of Pennsylvania, Center for Bioethics, conducted literature reviews and extensive background research on living organ transplantation. Summary briefs were prepared for all conference participants. Issues were divided into four subcategories; two or three experts led the discussion on each topic. At the conclusion of the conference, the points raised were summarized and discussed, and additional comments were offered before general agreement was reached on each subject. Transcribed minutes and summary statements were reviewed and circulated among participants to allow for additional comments and clarification. All feedback was incorporated into the statement, and a draft of the article was recirculated. Participants who have endorsed the following statements have agreed that these points represent the intent and spirit of the discussion, yet each participant reserves the right to disclaim the document in its entirety. The views represented in the consensus points are held by members of the consensus group and do not necessarily represent the views of the sponsor. A consensus was reached to propose new strategies and make improvements on existing practices and protocols. Specific attention was paid to the widely accepted needs of consistent and responsible communication with the public and press, standardization in donor assessment, a national living donor registry and new research focusing on larger sample numbers and long-term donor follow-up. These consensus points support the work carried out by other advisory transplant organizations and should assist in advocating for living organ donors, the live donor transplant process and the concerns of the public.

Kidney transplantation is a superior treatment strategy than chronic dialysis for end-stage renal disease patients. However, there is a severe shortage of cadaveric kidneys that are available for transplantation. Therefore many patients are turning to living donors. We describe four models of incentives to improve rates of living kidney donation: the market compensation model, the fixed compensation model, no-compensation model and the expense reimbursement model. We discuss the advantages and disadvantages of each of these models. Any incentive to improve rates of living kidney donation must be accompanied by safeguards. These safeguards will prevent living donors from being viewed primarily as a resource for transplants. These safeguards will also prevent vulnerable individuals from being coerced into donation and will monitor long-term outcomes of donors using a donor registry. We recommend the use of the expense reimbursement model along with these safeguards, in order to increase rates of living kidney donation.

VIRTUALLY ALL RESEARCH INVOLVING HUMAN subjects in the United States must be reviewed by an institutional review board, a form of research ethics review board. This article reports the results of qualitative research on how investigators regard this regulatory regime. Interviews were conducted with forty investigators conducting health-related research. Most respondents shared the regulations' goals, but doubted that the regulations, as implemented, promoted these goals efficiently, effectively and fairly. The interviews suggest that efforts to raise researchers' ethical consciousness have been, over time, quite successful, but that implementation of the regulations remains problematic. Research aimed at better defining the problem to be solved b y the r egulatory sy stem, and at a ssessing the effectiveness of the regulatory tools for solving properly defined problems, could guide a more productive debate about human subject protection.

Consent materials often contain complex information, legalese, and other features that render them difficult to comprehend in such a way that consent is truly informed. I propose that researchers adapt cognitive interviewing, normally used for the pretesting of survey questionnaires, to evaluate the understandability of consent materials and the way which subjects use this information to make decisions regarding participation. Cognitive interviewing involves the intensive probing of small samples of volunteer subjects to elucidate thought processes that otherwise remain hidden. Cognitive interviewing can be applied:(a) to further the basic science of informed consent;(b) to pretest materials for a specific study; and (c) as embedded procedure for assessing subject thought processes in the course of obtaining consent.

The concept of informed consent was applied to clinical research in the United States after research abuses were documented in Nazi Germany and this country. The concept is imbedded in the Nuremberg Code, the Declaration of Helsinki, and the Belmont Report. Federal regulations governing clinical research require both the consent of subjects and peer review of research proposals by institutional review boards (IRBs). Subpart A of the Code of Federal Regulations contains basic provisions for the protection of research subjects and requirements for informed consent by subjects or their surrogates; surrogate consent may or may not be allowed under state law. Other subparts contain further protections for subjects with diminished capacity, such as children, that limit the kind of research in which they can participate. Whether these protections should be extended to decisionally impaired adults, including those who are critically ill, remains to be determined. Consent can be deferred or waived for emergency research only rarely in the United States, in contrast to other countries.

This retrospective observational study investigated the frequency of reporting ethical approval and informed consent in recently published oral and maxillofacial surgery (OMS) research involving human subjects. All research involving human subjects published in the International Journal of Oral and Maxillofacial Surgery, Journal of Oral and Maxillofacial Surgery, British Journal of Oral and Maxillofacial Surgery, and Journal of Cranio-Maxillofacial Surgery during January to June 2005-2007 were analysed for disclosure of ethical approval by a local ethical committee and obtaining informed consent from the subjects. 534 articles were identified; ethical approval was documented in 118 (22%) and individual patient consent in 135 (25%). 355 reports (67%) did not include a statement on ethical approval or informed consent and only 74 reports (14%) disclosed statements of both. Ethical documentation in retrospective and observational studies was scant; 12% of randomised controlled trials and 38% of non-random trials did not report both of ethical protections. Most recent OMS publications involving humans failed to mention ethical review or subjects' consent. Authors must adhere to the international research ethics guidelines and journal instructions, while editors should play a gatekeeper role to protect research participants, uphold scientific integrity and maintain public trust in the experimental process and OMS profession.

- Basic law 41/2002 on patient autonomy regulates the rights and obligations of patients, users and professionals, as well as those of public and private health care centers and services. This regulation refers to patient autonomy, the right to information and essential clinical documentation.- This law establishes the minimum requirements for the information the patient should receive and the decision making in which the patient should take part. Diagnostic tests are performed and therapeutic decisions are taken in the ACKD unit in which patient information is an essential and mandatory requirement according to this law.

OBJECTIVES: The objective of this paper is to discuss the importance of obtaining informed consent for conducting epidemiological studies and public health activities, based on the Report of the UNESCO's Working Group on Informed Consent. METHODS: The Report of the UNESCO's Working Group on Informed Consent was reviewed and discussed in connection with the ethical considerations of public health activities and epidemiological research. RESULTS: It was at the Nuremberg Trial for the German war criminals of the Second World War that the principle of 'consent' was first stated as a consequence of the medical abuses carried out during the War. As a result of the Trial, the Nuremberg Code came out in 1947. Since then, various international declarations or ethical principles on 'informed consent' have been developed and published. These ethical principles on 'informed consent' have mostly to do with the clinical research that involves human subjects, and not with epidemiological studies and public health activities. However, UNESCO recently issued a comprehensive Report on Informed Consent based on the Universal Declaration on Bioethics and Human Rights adopted in 2005, and this included detailed guidelines on informed consent in epidemiological studies and public health activities. CONCLUSIONS: Universal Declaration on Bioethics and Human Rights emphasizes the principle of autonomy to protect the human rights of the human subjects involved in any public health activities and epidemiological research. As a practical guideline, obtaining informed consent is strongly recommended.

Clinicians who treat patients with schizophrenia may encounter a variety of ethical issues related to both psychiatric and medical treatment of patients. While informed consent is a crucial aspect of the care of all patients, it may present special challenges for patients with schizophrenia. Schizophrenia is a severe mental illness that is frequently accompanied by neuropsychological deficits. These impairments, as well as psychotic symptoms and lack of insight, can affect patients' abilities to make fully informed decisions about their own care. Ensuring that consent for treatment is informed, voluntary, and competent can thus become a more difficult endeavor. The ethical principles underlying treatment of these patients, however, are the same as those guiding treatment of all patients. Informed consent, as an embodiment of these ethical principles, represents the expression of individual rights in both clinical and research contexts. Attention to the process of informed consent as an ongoing dialogue strengthens the clinician-patient relationship, improves adherence, and helps the patient clarify options, values, and preferences. In the research setting, psychiatric researchers are increasingly concerned with maximizing the abilities of individuals with severe mental illnesses such as schizophrenia to provide meaningful informed consent for protocols. This review addresses decision-making abilities of people with schizophrenia in both treatment and research contexts.

Objectives: To investigate compliance with applicable regulations by Canadian human embryonic stem cell (hESC) researchers and fertility clinics involved in providing embryos for their research, and to ascertain actual consent practices in the hESC research context. Method: Telephone interviews were conducted with all hESC researchers, and email interviews were conducted with fertility clinics that provide embryos to these researchers. Consent forms currently used for donation of embryos to hESC research were reviewed. Separate questionnaires were used for the researchers and clinics. Results: Three of four clinics responded. Of the clinics that responded, each had provided embryos for hESC research to at least one of the researchers. Despite considerable policy attention given to hESC research, very few researchers and clinics are actually involved in the research in Canada. Only cryopreserved embryos are currently being used in hESC research, but one researcher has applied to use fresh embryos. Fertility clinics play a primary role in the consent process, and researchers have no contact with patients/donors. Although representations have been made in academic literature and the popular press suggesting a lack of compliance by Canadian hESC researchers, researchers and clinics report that they are in substantial compliance with applicable regulations. The researchers appear to be very conscious of the ethics of hESC research. In addition, they state that they are willing to follow the rules, but they are frustrated by the lack of regulatory clarity and by delays in the research oversight process. Conclusion: Empirical research on perceptions other stakeholders (donors, research ethics boards etc.) have of the hESC research process appears essential.