Role Of Institutional Review Boards Research Articles

Are institutional review boards effective in safeguarding patients in intensive care units?

Institutional Review Boards have been recently audited in the US, and a great deal of concerns and criticisms appeared in the medical literature and the lay press. Globally, these comments questioned the efficiency of Institutional Review Boards in fulfilling their basic mission, the protection of patients subjected to biomedical research. Vulnerable populations, such as psychiatric and incompetent patients, were particularly identified. In intensive care units, conducting research in critically ill patients unable to give informed consent themselves remains a hot issue. Several possibilities have been proposed and assessed in the recent past: pre-emptive (global) consent, proxy consent from a surrogate, deferred consent, and, more recently, waiver of consent for emergency research. Obviously, the inability to deal with this major obstacle (i.e. obtaining consent from incompetent patients) would lead to the cessation of any research in intensive care units, which is hardly acceptable and certainly unethical. Recent published studies have reported over-mortality in treatment groups, posing new questions: who should be informed of those failures, and when? What is the role of Institutional Review Boards in preventing such an issue? What type of indemnity should be proposed to the family of deceased patients during a trial?

My Year as 1999 ASHG President

Upon our request, the Society has been admitted to full membership in FASEB (the Federation of American Societies of Experimental Biology), the nation's largest association of biomedical scientists. Made up of 19 societies, with a combined total of 63,000 members, FASEB has a strong voice on matters of legislative and public interest and has campaigned successfully for increased biomedical research funding. We have appointed ASHG representatives to the FASEB Board of Directors and to seven different committees dealing with research funding, public affairs, and science policy.In national debates about guidelines and regulations, many issues have come to the forefront and will continue to be addressed by the Society, its committees, and its members. These include the overhaul of the NIH peer-review system, the establishment of PubMed Central, the derivation and use of human pluripotent stem cells in research, the use of archived human tissues for research, federal oversight of genetic testing, and patenting of human genes and of genetic diagnostic tests. The protection of human subjects from research risks—including the protection of the privacy of genetic information collected as part of family studies—and issues of informed consent procedures for mentally disabled persons have caught public attention. With the formation of the Office of Human Research Protection (OHRP) under the Secretary of HHS—replacing the Office of Protection from Research Risks (OPRR) under the NIH Director—there will be increased scrutiny of informed-consent procedures and of the role of Institutional Review Boards. These developments are likely to have considerable impact on researchers in human genetics.Under John Carey, an Ad Hoc Committee on Consumer Issues has been formed of researchers and leaders of advocacy groups. With the support of ASHG, a workshop was held to address consumer issues surrounding participation in clinical genetic research. The combined voice of researchers and consumer advocates will be needed to ensure that the progress of research will not be impeded by—and will be conducted within the framework of—existing federal regulations. The ASHG Social Issues Committee, under Mark Rothstein, has developed a statement on Genetic Testing in Adoption that will soon be released. As Social Issue Committees of other genetics organizations (ACMG, NSGC, and ISONG) are dealing with similar topics, the Board strongly encouraged joint sessions and activities of the ASHG committee with these committees.To improve communication between the ASHG officers, the membership, and the public, a Communications Committee has been established by the Board to redesign our Web site, making it more visible, informative, and interactive. This effort should enable ASHG members to be informed of critical issues in a timely fashion and to act in influencing public policy. Active participation of the ASHG membership will be essential for some of these complex issues.With increasing globalization, the communication between human genetics societies around the world is facilitated by the formation of the International Federation of Human Genetics Societies (IFHGS). The Federation currently has three full members—the regional societies ASHG, ESHG (European Society of Human Genetics), and HGSA (Human Genetics Society of Australasia)—and over 30 national societies as corresponding members. As I am beginning a three-year term as President of the IFHGS, I look forward to expanding the activities of this global organization in the information age. The new IFHGS web site is http://www.faseb.org/genetics/ifhgs/index.html. Elaine Strass, the ASHG Executive Director, deserves recognition for her expert management of the Society's office in Bethesda and special gratitude for serving as IFHGS Executive Secretary as well.

Institutional Review Board Issues Related to Special Populations

The present article begins with an introduction to the role of Institutional Review Boards (IRBs) in research activities in general and proceeds to issues IRBs face with relation to special populations, including children and terminally ill individuals, as well as developmentally disabled and cognitively impaired persons. A historical overview of research with these special populations is included, and the report concludes with a real-world example of how IRB-related issues with developmentally disabled and cognitively impaired individuals are discussed and resolved.

Nurses as members of institutional review boards

NCREASINGLY, nurses serve as members of institutional review boards (IRBs), committees whose charge is to review whether the benefits of proposed institutional research outweigh the risks and to ensure that investigators have explained the protocol sufficiently to allow subjects to give informed consent. Understanding the roles of the nurse as a member of a hospital's IRB can provide valuable insight for nurses who are appointed to serve on this committee, for directors of nursing who need to quantify the nursing resources used to support the research mission of the hospital, and for nurse investigators seeking IRB approval. The nurse IRB member may represent the hospital's nursing department, a school of nursing affiliated with the hospital, or a hospital department other than nursing. For the purpose of this report, the roles of the nurse who represents the nursing department will be explored. The authors, who are nursing department representatives on the IRBs of two academic medical centers, will provide a brief review of the literature concerning the role of IRBs and nurses who serve on these committees. The responsibilities of the nurse as an IRB member and as a representative of a nursing department will be discussed.

Ethical and legal issues of clinical research involving the cognitively impaired: the role of institutional review boards in the U.S.

In this paper we briefly review the history of human clinical research in the United States, and describe the role that Institutional Review Boards (IRBs) have played. In particular, we describe the role of the IRB in clinical research involving the cognitively impaired. We emphasize the importance of further empirical research to elucidate the process of informed consent, surrogate decision-making, advance directives, and the role of the IRB, and suggest directions for future investigation.

Ethical issues in reporting and referring in research with low-income minority children.

Ethical research with children requires a special concern for their well-being as individuals. Researchers are therefore expected to report problems children experience and to refer children for assistance. This article addresses difficultites that can arise as researchers attempt to meet this obligation in research with low-income ethnic minority children. Potential difficulties include both failure to report and overreporting suspected problems. The role of institutional review boards in researchers' reporting and referring behavior is also discussed.

Hospice research: the importance of program participation.

Hospice research is needed in order to understand the complex phenomena of holistic care for terminally ill persons and their families. Hospice program participation is key to future hospice research efforts. The purpose of this article is to encourage hospice programs to participate in hospice research. The discussion includes why research is done, who undertakes a research project, the role of institutional review boards in assuring rights of human subjects and potential strategies for recruitment of research subjects. The authors use their experiences with conducting hospice research to illustrate potential recruitment strategies.

The Role of Institutional Review Boards in Facilitating Research, Marketing of Drugs and Devices, and Protecting Human Subjects

Concern for outside review of medical research involving human subjects has been documented as far back as the early Nineteenth Century. It was not until 1966, however, when applicants for Public Health Service grant funding were subjected to such a requirement, that researchers were required to undergo review. Institutional Review Boards (IRB) are the bodies charged with performing the mandated screening functions by the Department of Health and Human Services (HHS) for federally funded projects and by the Food and Drug Administration (FDA) in the drug and device approval process.This paper explores an IRB's responsibilities under the HHS and FDA regulations generally, and emphasizes several critical attendant issues including: the manufacturer's IRB; IRB members' individual liability; compensation for research injuries; civil rights protections afforded subjects; impact upon academic and health practitioner research; and effect upon drug and device approvals.