Human Research Protection Program Research Articles

The Development and Acceptance of a Simple Tool to Aid IRB Compliance

The United States' Food and Drug Administration (FDA) has had an increase of warning letters issue' to institutional review boards (IRBs). These have been issued to IRBs of all experience levels, from the seemingly most inexperienced IRBs to IRBs accredited by the Association for Accreditation of Human Research Protection Programs. This exemplifies the fact that IRBs, no matter their size and experience, need compliance tools to assure that their activities and decisions are made within the confines of the regulations. A simple compliance tool was created for IRBs to improve their discussions and criteria-based decision making during convened meetings. The tool is a presentation of 14 slides consisting of the federal criteria for most major IRB decisions printed on 11-inch by 17-inch paper and then laminated to be used as placemats during convened IRB meetings. Recommendations for use were provided with this tool, but each IRB was free to use as desired. A survey was issued after 8 months of distribution to determine acceptance, methodology, and the perceived effect of the tool. While some IRBs did not utilize the tool, 80% of the responding IRB members and staff felt that it either somewhat or greatly enhanced their discussions and criteria-based decision making. The greatest satisfaction and perceived effect was when the tool was used in the recommended format. This results in a very inexpensive, customizable, and well-received compliance assurance tool that any IRB can easily adopt.

Accreditation of human research protection program: An Indian perspective

With the increasing number of clinical trials being placed in India, it is the collective responsibility of the Investigator sites, Government, Ethics Committees, and Sponsors to ensure that the trial subjects are protected from risks these studies can have, that subjects are duly compensated, and credible data generated. Most importantly, each institution/hospital should have a strong Human Research Protection Program to safe guard the trial subjects. In order to look at research with a comprehensive objective approach, there is a need for a formal auditing and review system by a recognized body. As of now, only the sponsors are monitoring/auditing their respective trials; however, there is an increasing need to perform a more detailed review and assessment of processes of the institution and the Ethics Committee. This challenge can be addressed by going for accreditation by a reputed association that encompasses-the institutions, the ethics committees, and researcher/research staff. Starting their journey for the accreditation process in late 2010, Kasturba Medical College and Hospital [KMC], Manipal, and Manipal Hospital Bangalore [MHB] received full Association for the Accreditation of Human Research Protection Programs (AAHRPP) accreditation in Dec 2011—a first in India. This article delves into the steps involved in applying for AAHRPP accreditation from an Indian Perspective, the challenges, advantages, and testimonials from the two hospitals on the application experience and how the accreditation has improved the Human Research Protection Program at these hospitals.

Diagnostic Accuracy of Ultrasonography for Midline Neck Masses in Children

To evaluate the diagnostic accuracy and to assess the utility of preoperative ultrasonography in the pediatric patient with a midline neck mass. Diagnostic test study. Tertiary care university hospital. An institutional review board (UCLA Office of the Human Research Protection Program)-approved retrospective review of pediatric patients undergoing excision of a midline neck mass between 1999 and 2010 at a tertiary care institution was performed. The preoperative imaging modality, imaging diagnosis, and pathologic results were evaluated. Forty patients were included in this review. This study failed to demonstrate an association between preoperative ultrasound-based diagnoses and postoperative pathologic results (P > .99). Ultrasonography is commonly used in the workup of a midline neck mass in the pediatric population. Despite the utility of preoperative ultrasonography, the diagnostic accuracy of this imaging modality may have significant limitations.

C-A2-01: IRB Review in the Era of ARRA: Streamlining Without Sacrifice

Background and Aims: In the era of ARRA, we are routinely confronted with compressed timelines and an accelerated pace of research. Concurrently, discussions have intensified over recent months about the HMORN’s capacity to conduct comparative effectiveness research on topics of national interest. Building on these unique challenges and opportunities, this interactive session will serve as a forum for conference attendees to discuss recent HMORN efforts to make multi-site IRB review as agile as possible. In particular, we will showcase the HMORN facilitated review process and discuss how it might be further improved or expanded. Methods: In early 2008, the HMORN ratified its first Standard Operating Procedure (SOP), which outlines procedures for inter-institutional IRB review of data-only studies. This SOP helped clarify what steps to take and who to contact, both in order to pursue ceding, and when multiple IRBs need to review the same study. This process has now been used in a majority of HMORN member institutions. As its use has increased, researchers and IRB administrators have become more familiar with the process. In September 2009, the HMORN Governing Board identified continuing such work to ensure IRB agility as a key 2010 priority for the HMORN. Results: In this session, we will review how to use the facilitated IRB review process outlined in the SOP and learn from attendees how we can further facilitate multi-site IRB review, along with attendant concerns such as HIPAA. In addition, we will give a snapshot of recent and upcoming developments across the Network sites, including human research protection program accreditation efforts and migration to electronic IRB systems. Conclusions: This session will enable research investigators, IRB administrators and HMORN leadership to engage in a constructive dialogue about the residual barriers to using the facilitated IRB process for data-only studies, and identify pathways to institutionalize this process in our Network’s routine research processes. This session will also introduce how the demands of IRB accreditation and the implementation of new electronic IRB systems may facilitate or impede our progress in this area.

Getting from A to IRB: Developing an Institutional Review Board at a Historically Black University

Shaw University, the oldest historically black college or university in the southern USA, recently partnered with the University of North Carolina at Chapel Hill, a major research institution in North Carolina, to further develop Shaw's research infrastructure. One aim of the partnership involved establishing a human research ethics committee and an accompanying administrative structure and research ethics education program. This paper describes the process of developing an entire human research protection program de novo through collaboration with and mentoring by the members of the human research protection program at a nearby major research institution. This paper provides a detailed description of the aims, procedures, accomplishments, and challenges involved in such a project, which may serve as a useful model for other primarily teaching institutions wishing to develop research infrastructure and ethical capacity.

Abstract ED06-02: Effective resources for recruitment for cancer prevention research

Abstract ED06-02: Effective resources for recruitment for cancer prevention research

Hybrid notes: incisionless intragastric stapled cystgastrostomy of a pancreatic pseudocyst

Purpose We present a case report of a novel hybrid natural orifice transluminal endoscopic surgery (NOTES). The operation performed was a transgastric cystgastrostomy with endoscopic guidance for a pancreatic pseudocyst. This operation was completed entirely through an existing gastrostomy site with no incisions, thus avoiding the peritoneal cavity. Methods This is a case of a 7-year-old boy with neurologic impairment from congenital herpes simplex virus encephalitis who is tube fed. He had acute pancreatitis and developed a 9 cm pancreatic pseudocyst. The pseudocyst failed to resolve after 6 weeks and developed a mature wall. Due to a history of multiple abdominal surgeries and known abdominal adhesions, a minimally invasive approach that would avoid entering the peritoneal cavity was the desired approach. The technique involved a trans-oral endoscope for visualization and the use of the gastrostomy as access to the gastric lumen and pseudocyst. The pancreatic pseudocyst was stabilized with two T-fasteners and confirmed with needle aspiration under endoscopic visualization. The pseudocyst was then opened with the LigaSure (Valleylab, Boulder, CO). The cystgastrostomy anastomosis was completed with an Endopath ETS-Flex Articulating Linear Stapler/Cutter (Ethicon Endo-Surgery, Inc, Cincinnati, OH). The operation took less than 2 hours and was completed without an incision. Under the policies of the Human Research Protection Program, review of a single case is outside the scope of the definition of human subjects research and does not require institutional review board review and approval. Results The patient did well postoperatively and had a dramatic reduction in size of the pancreatic pseudocyst to 3.5 cm by 2 weeks. Conclusions Hybrid NOTES cystgastrostomy performed through an existing gastrocutaneous fistula is an excellent approach for minimally invasive drainage of pancreatic pseudocysts.

Survey of U.S. Boards That Review Mental Health-Related Research

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.

Survey of U.S. Human Research Protection Organizations: Workload and Membership

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.

Establishing a Human Research Protection Program in a Combatant Command

Extensive United States combat operations commenced for the first time in over decade in 2003. Early in 2004 there was no human research protection regulatory review and approval mechanism based in a deployed military combatant command. The absence of such a system presented a critical impediment to implementation of the time-honored tradition of a robust combat casualty care research effort. A coalition of concerned military medical personnel from the US Army proposed a novel mechanism to meet Department of Defense (DOD) requirements for the human research protection oversight of studies conducted in the combat theater of operations. In 2005, the Commander of Task Force 44 Medical Command (44th MEDCOM), who was serving as the Multi-National Corps Iraq (MNC-I) Surgeon, was charged with negotiating a DOD Assurance and implementing a new system of research review and protections. He deployed an Army Medical Department Medical Corps officer to assist in this endeavor and operationalize the plan. On March 19, 2005, the Multi-National Corps Iraq Commander signed a historic agreement with the US Army Surgeon General who developed a regulatory support and oversight mechanism to conduct research in theater. This innovative system not only honored the Army's commitment to human research protections, but also provided much needed support in the form of scientific and ethical review and compliance oversight to those deployed medical personnel with the vision to conduct healthcare studies in the combat environment. On July 20, 2005, the first DOD Assurance of Compliance for the Protection of Human Research Subjects was approved for MNC-I. This assurance allows the conduct of human subjects research in full compliance with all Federal, DOD, and Army regulatory requirements. This article describes that unique process.

Sustaining Public Trust: Falling Short in the Protection of Human Research Participants

Sustaining Public Trust: Falling Short in the Protection of Human Research Participants Anna C. Mastroianni (bio) An aura of complacency surrounds the protection of human research participants in the United States. From investigators to policy-makers, many involved in research are exhibiting bureaucratic resignation, allowing paperwork compliance and checkboxes to protect the rights and interests of participants. The routinizing of ethics gives some tangible assurance that a system is in place, but it also undermines deliberate attention to ethical issues. Meanwhile, there is a disconnect between oversight practices and public perceptions. In a March 2008 survey conducted jointly by USA Today, the Kaiser Family Foundation, and the Harvard School of Public Health, 28 percent of respondents believed that most pharmaceutical companies acted unethically when testing new drugs on people.1 Since the line between public and private sector research has blurred, this perception could readily affect attitudes toward public sector drug development as well. Maintaining public trust is absolutely crucial to the research enterprise. Without trust, volunteers will be impossible to recruit, and the public will be unwilling to fund research. Here I venture some preliminary thoughts on some of the central marks of public trust in the research enterprise: creating accountability in research, instilling confidence in the integrity of process, ensuring fairness and transparency in the research enterprise, and affirming a commitment to the protection of human participants by all involved in research. To create accountability, the public needs to be assured that processes are in place to protect research participants. We have those systems in the form of regulations and oversight bodies, such as institutional review boards, the Office of Human Research Protections, the Food and Drug Administration, and Congress. Although the system has been subject to legitimate criticism, some level of standardization (and bureaucracy) is required to ensure a common approach to research protections. In the USA Today survey, 44 percent said that government regulation was insufficient to ensure that prescription drugs are safe.2 Perhaps the movement toward voluntary accreditation of human research protection programs through the Association for the Accreditation of Human Research Protection Programs offers a way to certify public accountability by establishing performance standards above federal and state requirements. Accreditation may become more desirable in an increasingly competitive research environment. Indeed, public, private, and international entities are paying attention, and nearly one hundred and twenty institutions have received accreditation to date.3 The public also needs to be confident that the system is working as intended and is being maintained. Are we falling short in instilling public confidence in research? Although infrastructure deficiencies in research approval and oversight have been heavily scrutinized in the scholarly literature, they rarely attract public attention until something goes wrong. A surge in litigation for research injuries and declining confidence in the FDA show that the public is indeed paying attention—and that its confidence is shaken. Over the years, the volume of research has grown tremendously, and research has come to involve more complex and invasive technologies. Given the litigious climate in health care, it is no surprise that litigation for research injuries is on the rise.4 Every death and injury (preventable or not) can have a negative impact on the public’s perception of the research enterprise. Participants surely expect that if they are injured while providing benefit to society, they will receive prompt treatment and be reimbursed at least for the real costs imposed on them (such as medical expenses and loss of work), if not also for “pain and suffering.” Yet the regulations require only that participants be informed about whether compensation and medical treatment for research injury is available, not that researchers or sponsors actually provide compensation or treatment. More than twenty-five years after the President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research articulated ethical justifications for no-fault compensation for research injuries (reinforced by similar recommendations by a number of blue ribbon committees5), only a relatively few research institutions have policies in place to compensate injured research participants, and these pay only for medical expenses.6 No wonder litigation looks attractive. In the medical malpractice context, there is some evidence that...

Educational Advantage

The december issue of JERHRE features four themes: Empirical approaches to improving Human Research Protection Programs (HRPPs) and their research ethics committees or Institutional Review Boards (IRBs). Models for considering how much, how, or whether to pay research participants. Approaches to making consent information understandable to subjects or their legally authorized representatives. Constraints that ethical or regulatory requirements place on research. The curriculum materials presented here are deliberately general so that the instructor can adapt them to any students, be they freshmen, ethics committee members, or senior investigators. Drawing on the concepts and methods presented in the eight articles that explore these four topics, some useful skills of ethical problem solving can be developed.

Human Research Accreditation Relevant to Anthropology

Anthropology NewsVolume 45, Issue 6 p. 27-27 Human Research Accreditation Relevant to Anthropology Marjorie A Speers, Marjorie A Speers AAHRPP Marjorie Speers is Executive Director of the Association for the Accreditation of Human Research Protection Programs. She served as acting Executive Director of the National Bioethics Advisory Commission, where she oversaw the development of Ethical and Policy Issues in Research Involving Human Participants, a comprehensive report on the oversight system of protection: Previously, Speers was Deputy Associate Director for science at the Centers for Disease Control and Prevention, where she oversaw all domestic and international research. She has also held faculty positions at the University of Texas Medical Branch at Galveston and the University of Connecticut.Search for more papers by this author Marjorie A Speers, Marjorie A Speers AAHRPP Marjorie Speers is Executive Director of the Association for the Accreditation of Human Research Protection Programs. She served as acting Executive Director of the National Bioethics Advisory Commission, where she oversaw the development of Ethical and Policy Issues in Research Involving Human Participants, a comprehensive report on the oversight system of protection: Previously, Speers was Deputy Associate Director for science at the Centers for Disease Control and Prevention, where she oversaw all domestic and international research. She has also held faculty positions at the University of Texas Medical Branch at Galveston and the University of Connecticut.Search for more papers by this author First published: 07 July 2009 https://doi.org/10.1111/an.2004.45.6.27 AboutPDF ToolsExport citationAdd to favoritesTrack citation ShareShare Give accessShare full text accessShare full-text accessPlease review our Terms and Conditions of Use and check box below to share full-text version of article.I have read and accept the Wiley Online Library Terms and Conditions of UseShareable LinkUse the link below to share a full-text version of this article with your friends and colleagues. Learn more.Copy URL Share a linkShare onFacebookTwitterLinked InRedditWechat No abstract is available for this article. Volume45, Issue6September 2004Pages 27-27 RelatedInformation

Association for the Accreditation of Human Research Protection Programs Elects Bierer President

Association for the Accreditation of Human Research Protection Programs Elects Bierer President

Association for the Accreditation of Human Research Protection Programs Elects Bierer President

Association for the Accreditation of Human Research Protection Programs Elects Bierer President

Association for the Accreditation of Human Research Protection Programs Elects Bierer President

Association for the Accreditation of Human Research Protection Programs Elects Bierer President

ABOUT THE AUTHORS

ABOUT THE AUTHORS

Clinical trial safety

Current concerns about the protection of humans participating in clinical trials has led to the formation of the Association for the Accreditation of Human Research Protection Programs, conveniently shortened to AAHRPP. Founded by the Association of American Medical Colleges (AAMC), Association of American Universities, Consortium of Social Science Associations, Federation of American Societies for Experimental Biology, National Associations of State Universities and Land-Grant Colleges, National Health Council and Public Responsibility in Medicine and Research, this non-profit organization will accredit institutions. The plan will be to visit sites and construct an educational programme to encourage improvement of human research protection programmes. This should be fully operational by January 2002. KP

Rotations and translations in infancy

Global efforts to increase births at health-care facilities might not reduce maternal or newborn mortality if quality of care is insufficient. However, little systematic evidence exists for the quality at health facilities caring for women and newborn babies in low-income countries. We analysed the quality of basic maternal care functions and its association with volume of deliveries and surgical capacity in health-care facilities in five sub-Saharan African countries.In this analysis, we combined nationally representative health system surveys (Service Provision Assessments by the Demographic and Health Survery Programme) with data for volume of deliveries and quality of delivery care from Kenya, Namibia, Rwanda, Tanzania, and Uganda. We measured the quality of basic maternal care functions in delivery facilities using an index of 12 indicators of structure and processes of care, including infrastructure and use of evidence-based routine and emergency care interventions. We regressed the quality index on volume of births and confounders (public or privately managed, availability of antiretroviral therapy services, availability of skilled staffing, and country) stratified by facility type: primary (no caesarean capacity) or secondary (has caesarean capacity) care facilities. The Harvard University Human Research Protection Program approved this analysis as exempt from human subjects review.The national surveys were completed between April, 2006, and May, 2010. Our sample consisted of 1715 (93%) of 1842 health-care facilities that provided normal delivery service, after exclusion of facilities with missing (n=126) or invalid (n=1) data. 1511 (88%) study facilities (site of 276 965 [44%] of 622 864 facility births) did not have caesarean section capacity (primary care facilities). Quality of basic maternal care functions was substantially lower in primary (index score 0·38) than secondary care facilities (0·77). Low delivery volume was consistently associated with poor quality, with differences in quality between the lowest versus highest volume facilities of −0·22 (95% CI −0·26 to −0·19) in primary care facilities and −0·17 (−0·21 to −0·11) in secondary care facilities.More than 40% of facility deliveries in these five African countries occurred in primary care facilities, which scored poorly on basic measures of maternal care quality. Facilities with caesarean section capacity, particularly those with birth volumes higher than 500 per year, had higher scores for maternal care quality. Low-income and middle-income countries should systematically assess and improve the quality of delivery care in health facilities to accelerate reduction of maternal and newborn deaths.None.