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Results for “Office for Protection from Research Risks”

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At least 19 recordsLinked to original sources
PubMed1998

Human subject protections in the United States: perspectives from the Office for Protection from Research Risks.

The U.S. Department of Health and Human Services (DHHS) regulations require that all human subjects research supported by DHHS be reviewed and approved by a local institutional review board (IRB). With few exceptions, investigators may not involve human subjects in research without their informed consent, and additional safeguards are required when subjects are likely to be vulnerable to coercion or undue influence. Institutions that receive DHHS funding must enter into an "Assurance" of compliance with the Office for Protection from Research Risks (OPPR), which has the authority for oversight and implementation of the human subjects regulations. As discussed more fully below, Assurances are of a contract nature in that they formally commit the institutions to adherence to the regulations and the ethics standards relevant to research on human subjects. This article addresses the application of human subject protections in biomedical research.

Ethics Committees, Research↗
PubMed2001

IRB/FDA requirements relevant to HIV/AIDS clinical trials in correctional settings.

Federally funded research involving inmates in US correctional facilities requires the approval of the Office for Protection from Research Risks (now called the Office for Human Research Protections [OHRP] and located in the Office of the Secretary of the Department of Health and Human Services). Trials that are carried out by pharmaceutical companies (not federally funded) fall under the jurisdiction of the FDA. This article reviews OHRP and FDA guidelines relevant to the conduct of HIV/AIDS clinical trials in correctional settings.

Acquired Immunodeficiency Syndrome↗
PubMed1995

Informed consent in emergency research. Consensus statement from the Coalition Conference of Acute Resuscitation and Critical Care Researchers.

OBJECTIVE: A coalition conference of acute resuscitation researchers was held to discuss the feasibility of applying current federal research regulations regarding informed consent to the emergency setting. This article presents consensus recommendations for regulatory changes for consent in emergency research. PARTICIPANTS: Representatives from the Society for Academic Emergency Medicine and the American Heart Association identified several professional organizations as stakeholders in this issue, including research, clinical, bioethics, legal, and patient advocacy groups. The Office for Protection From Research Risks (OPRR), the Food And Drug Administration (FDA), and staff from specific legislative offices were also invited to observe. Forty-three participants attended, including representatives from 12 professional organizations, five medical institutions, and the FDA and OPRR. This was a closed meeting. Participants were self-funded or sponsored by their professional organizations. EVIDENCE: Before the meeting, a draft of a position statement was developed by the conference organizers based on the current literature and discussions with experts in the field. This draft, copies of the current federal research regulations, and supporting articles were distributed before the conference. CONSENSUS PROCESS: Participants rotated through moderated discussion sessions to comment on subsections of the draft. Following discussion, a working draft was developed and distributed to each participant and represented organizational board for final review. All comments were considered in the final version of the document. CONCLUSIONS: We believe there are circumstances when it is not feasible to obtain prospective or proxy consent for enrollment into an emergency research protocol. In these circumstances, patients are vulnerable, not only to research risks, but also to being denied potentially beneficial therapy when there is no known effective treatment for their life-threatening condition. We offer recommendations that should be met when the critical nature of the illness or injury or the need to apply an investigational therapy rapidly precludes prospective consent for participation in emergency research.

Consensus↗
PubMed1997

Ethical considerations in neuroclinical trials.

Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. Ethical concepts applicable to Neuroclinical Trials (NCT) are reviewed. The discussion is directed towards ethical concerns that investigators must consider and justify prior to Institutional Review Board (IRB) submission. Risk-benefit analysis, methodology (randomization: placebo; design) and consent (informed; deferred; waived) are reviewed and Office for Protection from Research Risk (OPRR) guidelines are described. Our conclusions: Investigators proposing NCT face increasing ethical scrutiny by IRBs. Attention to ethical issues early in trial planning process is recommended.

Clinical Trials as Topic↗
PubMed1996

Ethical considerations in clinical neuroscience. Current concepts in neuroclinical trials.

BACKGROUND: Ethical decision making in clinical trials has become increasingly emphasized at many levels of the review process. SUMMARY OF REVIEW: Ethical concepts applicable to neuroclinical trials are reviewed. The discussion is directed toward ethical concerns that investigators must consider and justify prior to institutional review board submission. Risk-benefit analysis, methodology (randomization, placebo, design), and consent (informed, deferred, waived) are reviewed and guidelines of the Office for Protection From Research Risk are described. CONCLUSIONS: Investigators proposing neuroclinical trials face increasing ethical scrutiny by institutional review boards. Attention to ethical issues early in the trial planning process is recommended.

Clinical Trials as Topic↗
PubMed1996

The controversy over emergency research. A review of the issues and suggestions for a resolution.

Emergency research that occurs upon critically ill subjects in circumstances that do not allow the subjects or their legally authorized representatives to grant an informed consent is currently the subject of great controversy. This Clinical Commentary reviews three issues that dominate the debate: research risk assessment, the concept of a particular kind of risk called minimal risk, and the regulations governing research on human subjects. The theses of this article are that Institutional Review Boards (IRBs) are not violating Office of Protection from Research Risks (OPRR) regulations, that Food and Drug Administration (FDA) regulations do not adequately address research design, and that emergency research fits within the ethical standards of justice, respect for autonomy, and beneficence. To defend these claims, the following points are argued: risk assessment is a moral or transscientific exercise, minimal risk refers to the increment of risk that the subject of the research faces, and that when equipoise exists between experimental and standard therapies, this state of uncertainty contributes to a study's justifications. In order to resolve the emergency research controversy, certain regulations will need to be rewritten and others reinterpreted, and a national board created to review a proposed study's clinical relevance and whether the current state of knowledge justifies a trial.

Critical Illness↗
PubMed2003

The role of the data coordinating center in the IRB review and approval process: the DIG trial experience.

Before any clinical trial can begin to recruit patients, participating clinical centers must obtain approval from their institutional review board (IRB). When studies are federally funded, such as by the U.S. Department of Health and Human Services (DHHS), centers must also have or obtain a federal compliance agreement from the Office of Human Research Protections (formerly the Office for Protection from Research Risks [OPRR]). The Digitalis Investigation Group trial was a large, international, double-blind, DHHS-funded randomized trial on the effect of digoxin on mortality in heart failure. Due to the anticipated number of centers (>200), the study's data coordinating center (DCC) was requested to assume additional responsibilities that included: (1) acting as a liaison between the OPRR and all study centers; (2) reviewing and correcting all assurance statements before submission to the OPRR; (3) reviewing and approving all centers' informed consent forms; and (4) helping the many research-inexperienced centers to establish IRBs or to locate an IRB in their region that would accept IRB responsibility for them. Although a heavy burden was placed on the DCC, the IRB and OPRR approval process was probably shortened by many weeks at those centers not already possessing a federal compliance agreement. This enabled the study to be completed on schedule and within budget.

Canada↗
PubMedDate not supplied

Informed consent for research on stored blood and tissue samples: a survey of institutional review board practices.

Numerous position papers have outlined informed consent recommendations for the collection, storage, and future use of biological samples; however, there currently is no consensus regarding what kinds of information should be included in consent forms. This study aimed to determine whether institutional review boards (IRBs) vary in their informed consent requirements for research on stored biological samples, and whether any variation observed could be correlated to factors such as volume of work, IRB members' familiarity with ethical issues in genetic research, and IRBs' use of either of two policy guidelines as resources. A brief survey was mailed to all IRB chairpersons on a mailing list obtained from the Office for Human Research Protections. Survey questions included whether consent forms for the collection of biological samples for future use address each of six provisions recommended in current guidelines and position statements, and whether IRBs used the Office for Protection from Research Risks' 1993 Protecting Human Research Subjects: Institutional Review Board Guidebook, chapter 5 (hereinafter IRB Guidebook) or the National Bioethics Advisory Commission's 1999 Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Volume I (hereinafter Report) in their deliberations. Despite a low response rate (22%, 427 respondents), results indicate that IRB practices vary substantially. The degree to which the provisions were included in consent forms was found to correlate positively with IRBs that review a greater volume of protocols annually, those that use the National Bioethics Advisory Commission Report in their deliberations, and those that draw on both the Report and the IRB Guidebook.

Biomedical Research↗
PubMedDate not supplied

Research involving persons with cognitive impairments: results of a survey of Alzheimer disease research centers in the United States.

Research involving persons with cognitive impairments presents ethical and practical challenges, including how to obtain valid informed consent. We asked the directors of the 29 U.S. research centers funded by the National Institute on Aging as "Alzheimer Disease Centers" to provide us with policies or guidelines used in their centers or associated institutions with regard to research involving cognitively impaired subjects. Twenty-four of the 29 centers (83%) responded. Five institutions (21%) had authored their own institutional policies, seven (29%) used guidelines issued by the Department of Health and Human Service's Office for Protection from Research Risks, and 12 (50%) had no policy or guidelines. The five institutional policies addressed a variety of issues, including obtaining consent from cognitively impaired subjects or their authorized representatives, subjects' assent to research participation, and guidance concerning determination of subjects' intellectual capacity. A well-written policy on the protection of cognitively impaired research subjects is one way a research institution demonstrates that it gives serious attention to the rights and welfare of these vulnerable persons. We recommend that all institutions conducting such research author written policies articulating appropriate safeguards for these vulnerable subjects. To promote the protection of cognitively impaired subjects, federal agencies and other funding groups may want to consider requiring written institutional policies as one condition of receiving funds to conduct such research.

Aged↗
PubMed2001

Protection of research subjects with emphasis on protocols involving radiation.

Approval by an institutional review board (IRB) or human studies committee must be obtained prior to conducting human subject research. Historically this was not the case, and human subjects were injured as a result. Because there has been and still remains an inevitable conflict of interest for researchers, instititions that perform human research must follow regulations designed to protect human subjects contained in the Code of Federal Regulations, if the research is federally funded. Two federal agencies provide oversight for IRB activities: the Food and Drug Administration (FDA) and a National Institutes of Health Office for Human Research Protection (OHRP), formerly the Office for Protection from Research Risks (OPRR). These agencies are charged with the implementation of rules related to ethical and legal obligations of researchers and their institutions. The institution's role, by means of an IRB, is to adhere to principles of the Belmont Report and to set forth ethical principles, policies, and procedures for protecting the rights and welfare of human subjects. The researchers' role is to conduct their research ethically while maximizing benefits and minimizing harm. Studies involving radiation exposure of human subjects add another level of risk that must be evaluated by an IRB with assistance of a radiation expert or radiation safety committee (RSC). This paper will look at regulatory aspects of human research, IRB responsibilities overall and as they relate to radiation exposure of subjects, and the role of the RSC.

Child↗
PubMed1995

Cloning without prior approval: a response to recent disclosures of noncompliance.

In September 1994, the Kennedy Institute of Ethics Journal published a special issue on the ethics of embryo splitting or "cloning," which included papers originally prepared for a workshop on embryo splitting sponsored by the National Advisory Board on Ethics in Reproduction (NABER) and NABER's report, Human Cloning through Embryo Splitting. The impetus for the project was embryo-splitting research conducted by Drs. Jerry L. Hall, Robert J. Stillman, and others, at George Washington University and presented in October 1993 at a joint meeting of the American Fertility Society and the Canadian Fertility and Andrology Society. Media coverage at the time reported that the research had been approved by the university's formal review committees. However, it came to light in December 1994 that the researchers had not obtained approval from the university's institutional review board prior to conducting the research. Following a university investigation, the researchers were disciplined and instructed to destroy their data. The university also voluntarily forwarded the records of the incident to the Office for Protection from Research Risks at the National Institutes of Health. Dr. Hall resigned from George Washington University in September 1994. In the following postscript to her article on the ethics of embryo splitting (KIEJ, September 1994), Ruth Macklin discusses these events. The letters and memoranda that she cites were obtained from NIH through the Freedom of Information Act.

Clone Cells↗
PubMed2002

National practices regarding payment to research subjects for participating in pediatric research.

OBJECTIVE: Payment to subjects for participation in research is reportedly common, but no published data documents the nature of this practice. Institutional review boards (IRBs) are responsible for ensuring both the safety and voluntary participation of research subjects, yet guidance from federal and expert pediatric sources regarding appropriate payment approaches is conflicting. Ethical issues of payment for participation of adult versus pediatric research subjects may differ. This empirical study sought to examine current payment practices for participation in pediatric research as reported by IRBs. DESIGN: An 18-question survey regarding payment practices for participation in pediatric research was sent to IRB chairs at member institutions of the National Association of Children's Hospitals and Related Institutions, and to a systematic random sample of IRB chairs listed with the Office for Protection From Research Risks. Descriptive, nonparametric, and qualitative analyses were used to describe institution types, payment practices, and correlations among responses. RESULTS: Data from 128 institutions that conduct pediatric research revealed that payment for participation in pediatric research was allowed by 66% of responding institutions, and practices varied widely among institutions. Most responding IRBs that allowed payment required disclosure of payment before enrollment (during the consent process), following federal guidelines more closely than American Academy of Pediatrics guidelines. An IRB's perception of potential benefits or harms of a study correlated with the amount of payment approved. CONCLUSIONS: IRBs must balance the need to recruit pediatric research subjects against the risk of undue influence during the recruitment process. Federal guidelines and expert pediatric opinion differ in recommendations regarding payment; responding IRBs appeared to follow federal guidelines more closely than guidelines proposed by the American Academy of Pediatrics.

Child↗