PubMed Health⌕ Search

SEARCH · PubMed Health

Results for “Office for Human Research Protection”

Explore indexed PubMed citations for clinical trials, systematic reviews and public health research. Read source abstracts and follow each citation to its original PubMed record.

Quote a phrase for an exact phrase match. Source license links do not imply unrestricted reuse.

At least 19 recordsLinked to original sources
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↗
PubMed1983

Exemption of certain research and demonstration projects from regulations for protection of human research subjects--Office of the Secretary, HHS. Final rule.

The Department of Health and Human Services (the Department or HHS) is including among the types of research specifically exempt from the application of the regulatory requirements of 45 CFR Part 46 (protection of human research subjects) research and demonstration projects conducted under the Social Security Act and other federal statutory authority and designed to study certain public benefit or service programs, the procedures for obtaining benefits or services under those programs, and possible changes or alternatives to those programs or procedures, including changes in methods or levels of payment. These demonstration and service projects are already subject to procedures which provide for extensive review by high level officials in various program administration offices. Review by an Institutional Review Board (IRB), as required under Part 46, would be duplicative and burdensome to state and local agencies and to other entities participating in demonstration projects. Removal of this unnecessary layer of review will not only reduce the cost of the projects but help to avoid unnecessary delays in project implementation. However, in order to ensure the continued protection of human subjects participating in such research activity, the Department is adding a specific requirement of written, informed consent in any instance, not reviewed by an IRB, in which the Secretary determines that the research activity presents a danger to the physical, mental or emotional well-being of a participant.

Human Experimentation↗
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↗
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↗
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↗
PubMed2002

Regulatory approvals in a large multinational clinical trial: the ESPRIT experience.

While accepted as serving an important function to safeguard human subjects, the process of obtaining regulatory approvals to conduct clinical trials is generally regarded as cumbersome and time-consuming. For large multinational trials, U.S. federally sponsored human subject research abroad involves specific U.S. regulatory requirements, in addition to those of the host country, that act as further hurdles. These requirements may include obtaining an Assurance of Protection for Human Subjects from the Office of Human Research Protection of the U.S. Department of Health and Human Services, maintaining specific Ethics Committee/Institutional Review Board (EC/IRB) composition, and incorporating mandated elements in informed consents, all of which may differ from local policies and guidelines. Specific examples of issues that led to delays in regulatory approvals for sites participating in the multinational clinical trial entitled Evaluation of Subcutaneous Proleukin in a Randomized International Trial (ESPRIT) are presented here. While the goal of these requirements is to protect the rights and welfare of human subjects, they may create substantial delays and engender resentment over the notion of lack of respect for individual country sovereignty. Substudies within ESPRIT have been undertaken to obtain feedback from EC/IRB chairpersons, site personnel responsible for processing the required assurances, ESPRIT investigators, and study participants regarding aspects of current U.S. regulatory requirements related to human subject protection and ethical issues in multinational research. The purpose of these substudies is to compare the attitudes and experiences across countries regarding important ethical issues associated with conducting ESPRIT. One objective of the substudies is to gather additional insight to the impact of U.S. regulatory processes. Another is to help to inform the debate about how to best maximize the rights and welfare of clinical trial participants without delaying the initiation of research, while respecting the importance of national sensitivities.

Clinical Trials as Topic↗
PubMedDate not supplied

Commentary: quality improvement projects: how do we protect patients' rights?

A recent ruling by the Office of Human Research Protection (OHRP) has renewed an ongoing debate over whether Institutional Review Boards (IRBs) should have oversight not only over clinical research but also over quality improvement projects (QIPs). The authors discussed the similarities and differences among clinical practice, QIPs, and clinical research, pointing out issues to consider when identifying the most appropriate method for QIP oversight and accountability. They note that potential solutions must address ethical issues (eg, patient safety, privacy, and self-determination) and weigh the effect of the underlying QIP goal (administrative versus clinical improvement) on an individual patient and patient populations. They conclude that because QIPs are an extension of clinical practice and have elements of clinical research, it too should have an oversight system. Institutional or regional quality improvement boards, operating parallel to current IRBs, are suggested as 1 means of ensuring that QIP participants are offered the same protections as those who take part in clinical research.

Biomedical Research↗
PubMed2001

Adverse events reporting--the tip of an iceberg.

NIH data indicate that annually seven million human subjects are enrolled in research sponsored by NIH alone. In addition, there are sixteen federal agencies and numerous departments outside NIH conducting experiments with human subjects. Moreover, the pharmaceutical industry spends $26 billion on research (compared to $16 billion for NIH), thus, the total number of human subjects enrolled in research for both the public and private sectors can be estimated as high as nineteen million. I present data on the potential magnitude of adverse events in the United States among human subjects enrolled in research that appear to be unreported and unaccounted for. We obtained data from the Office for Human Research Protections (OHRP) through the Freedom of Information Act for the years 1990 to August 2000 regarding all Institutional Incident Reports (IRPTs) and a list of Compliance Oversight Branch Investigations (COBIs) involving Multiple Project Assurances (MPAs). In the ten years of reporting for nearly seventy million human subjects, there were only 878 IRPTs and 41 investigations. From the incident reports to OHRP, 44% involved adverse events. Those projects investigated for Multiple Project Assurances violations (41 such investigations) showed that 51% were suspended or terminated. The number of deaths reported to OHRP in ten years for the seventy million human subjects is merely eight. The anticipated number of deaths among the general population in seventy million (assuming subject's duration in trials is one month) is 51,000. The number of suicides and attempted suicides alone among the seventy million expected research subjects can be anticipated to be about 5,000. Therefore, the number of expected deaths should have been between 5,000 and 51,000. These numbers and percentages represent minimal numbers since they are not a result of random audits or investigations, but a result of self-reporting or an exogenous complaint. Despite the fact that these are conservative estimates, they represent a significant problem. The purpose of this paper is to present the potential boundaries and magnitude of the problem in the current use of human subjects in research. This is a call for responsible institutions to undertake a thorough evaluation of the problem in order to obtain accurate information. For the immediate future, strong actions need to be taken to increase the protection of human subjects enrolled in research. This precautionary policy is prudent in light of recent revelations and data from this investigation.

Clinical Trials as Topic↗