Responsible Research A Systems Approach to Protecting Research Participants (2003) / Chapter Skim
Currently Skimming:
6 Improving Human Research Participant Protection Program Performance and Clarifying Roles
6 Improving Human Research Participant Protection Program Performance and Clarifying Roles
Pages 162-196
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 162... ...
Previous chapters have stressed the need to promote the incorporation of ethical principles in the design and conduct of studies, ensure that independent scientific review occurs as well as considerations of financial conflicts of interest and that mechanisms are in place for continuing review and monitoring of protocols, particularly those that pose more than minimal risk. This chapter further argues for the need to "purify" the role of the Research Ethics Review Boardi (Research ERB)
|
From page 163... ...
Formal, systematic QI methods are widely used in the health care system and are at the heart of health care accreditation. One of the promises of accrediting protection programs previously highlighted by this committee is the much greater visibility of and attention to QI in participant protection efforts.
|
From page 164... ...
Information Tracking at the Federal Level Recommendation 6.1: The Department of Health and Human Services should commission studies to gather baseline data on the current system of protections for participants in the research that it oversees and to assess whether the system is improving over time. In recognition of the continuing need for information collection on the national human research protection system, the committee repeats this recommendation from its earlier report, Preserving Public Trust: Accreditation and Human Research Participant Protection Programs (IOM, 2001a, p.90~.
|
From page 165... ...
For example, a study of research injury or harm cannot proceed without the prior development of a taxonomy that encompasses the spectrum of types of injury and harm and the contexts in which they occur. Research injury or harm is not limited to physical injury, and it does not always occur at the level of the individual.
|
From page 166... ...
QI goes beyond QA's focus on identifying and correcting errors (Box 6.2~; QI is a methodology and set of statistical and qualitative analysis tools that programs use to ascertain the most common underlying causes of shortfalls in, for example, Research ERB work processes and procedures, and develop improvements that would eliminate them. OHRP indicates that it will phase in a QI assessment too!
|
From page 167... ...
In the unlikely event that serious systemic noncompliance or a serious problem(s) that had resulted in or may pose a threat to the safety and well-being of research subjects is discovered during a QI consultation, institutional officials will be appropriately notified and will be expected to take immediate action to remedy the situation, including filing an appropriate corrective action plan with OHRP.
|
From page 168... ...
There is an extensive literature available in both scientific and professional journals about CQI in health care generally, addressing both the results of CQI efforts as well as methods, approaches, statistical metrics, and other aspects of the CQI process itself.5 Yet, with the exception perhaps of studies involving ways to conduct informed consent, there is a notable lack of published CQI literature on the elements of human research participant protection, much of which paradoxically takes place in the same settings in which CQI evolved and currently flourishes. The CQI field can accelerate QI if programs and their protection functions are made the focus of sound scientific research.
|
From page 169... ...
Another important research area is QI methodologies devised and/or adapted for use in the unique health settings of protection programs, as there is little experience to draw upon that is explicit to participant protection efforts. Dedicated research funding would help move this objective forward.
|
From page 170... ...
There are often unforeseen uses for the types of information gathered in the conduct of human research, and a central database, with appropriate archiving and security measures to ensure confidentiality, assures that this information is available for self-assessment, policy development, research purposes, and QA support. Although QA is not QI, it provides programs with data about the conduct of human research, and it provides investigators an opportunity to learn through external evaluation.
|
From page 171... ...
Examples explicitly identifying QI requirements in the NCQA standards include the following: (NCQA, 2001~. databases and information systems that provide QI data; compliance in drug/device studies, correction of deficiencies; adequacy and effectiveness of Research ERB processes; and appropriate investigator conduct of informed consent process Accreditation site visits provide a mechanism for identifying performance deficiencies, as well as for finding and commending strengths and excellent program performance.
|
From page 172... ...
National Committee on Quality Assurance NCQA is in the second year of a five-year contract with VA to develop and implement an accreditation program, which will apply to more than 120 VA medical centers that conduct research involving human participants. On November 15, 2001, NCQA released its final VA Human Research Protection Accreditation Program Accreditation Standards,7 to remain in effect until July 1, 2004 (NCQA, 2001~.
|
From page 173... ...
. The accreditation process involves rigorous self-assessment, followed by a site visit from AAHRPP accreditors who are experts in practicing, teaching, and promoting human research protections.
|
From page 175... ...
Recommendation 6.3: Human Research Participant Protection Program accreditation programs should include a standard directed at establishing and identifying accountability for specific protection funct~ons. ~ lAAHRPP's accreditation standards are available online at www.aahrpp.org/ standards.htm.
|
From page 176... ...
· Consider accreditation not only of the research organization, but also of organizations established to carry out only one of the functions of a program, such as protocol review (e.g., independent Research ERBs)
|
From page 177... ...
ROLE DIFFERENTIATION WITHIN THE HRPPP As described in Chapter 3, Research ERBs should be reshaped to perform the role that they were originally intended to serve ensuring participant protection through the careful ethical review of protocols. Although they are the cornerstone of a system in which other entities also have participant protection obligations, Research ERBs should not be expected to assume all of the responsibilities of a protection program, and they should be properly constituted to carry out their duties (Recommendation 3.5~.
|
From page 178... ...
Organizational Compliance When encountering risk issues, Research ERBs in particular and protection programs more generally should also consider the parent organiza13Examples of these lawsuits include Gelsinger v. University of Pennsylvania; Wright v.
|
From page 179... ...
It has direct access to the leadership of the institution and thus can call the attention of leadership to research compliance problems; · it carries on a standard-setting and education function within the institution that could incorporate research concerns; · it could establish a hotline for participants, as well as provide protection for whistleblowers; · in many institutions, the compliance office will be relatively well resourced, and can thus take pressure off Research ERBs and protection programs; and · it should already be identified within the institution with the authority of the law and thus has the advantage of having its concerns treated .
|
From page 181... ...
Both positions will support and work with Kaiser Permanente's eight region-based research programs and Research ERBs, with each region contributing a portion of the cost.l6 Separating the Consent Process from Institutional Legal Matters One expression of how sponsor and institutional interests have become entangled in the effort to conduct the Research ERB's participant protection mission is the current informed consent document.l7 In clinical trials, these documents can run to 8, 12, or even 20 single-spaced pages. It strains credulity to suppose that this amount of text supports the ethical purpose of such documents, which is to appropriately inform a potential participant's decision to enroll in a study.
|
From page 182... ...
, but as noted in Chapter 3, it is imperative that explicit mechanisms be in place for this body to feed information about financial conflicts of interest into the Research ERB's comprehensive ethical review of protocols. An organization might wish to have a liaison from the conflict of interest committee to the Research ERB.
|
From page 185... ...
As academic institutions have increasingly entered into financial and collaborative research arrangements with private industry, as encouraged by the Bayh-Dole Act of 1980,19 institutional conflicts of interest have become a topic of growing concern and increasing public scrutiny (AAU, 2001; DHHS, 2001a; Emanuel and Steiner, 1995; Gillis, 2002; Moses and Martin, 2001~. Currently, no federal regulations or final guidance address institutional financial or nonfinancial conflicts of interest, although the DHHS draft interim guidance does address institutional conflicts of interest, as does proposed federal legislation.20 Federal agencies and appropriate interest groups should continue to develop guidelines for evaluating, and if appropriate, managing institutional conflicts of interest with the same rigor that is on-going to the pursuit of professional norms and standards regarding individual financial conflicts of interest.
|
From page 186... ...
If the external conflict of interest committee or the Research ERB, in consultation with the conflict of interest body, determined that the research could proceed, it could require that the institution divest questionable holdings; conduct the research in question only as part of a multicenter trial; or identify an independent entity to monitor participant recruitment, the informed consent process, participant enrollment, data monitoring, and other aspects of the trial that could be adversely affected (or appear to be adversely affected) by the conflict.
|
From page 187... ...
The evolving accreditation process should incorporate attention to nonfinancial conflicts in its assessments of human research protection programs, and the groups pursuing conflict of interest policies should work to develop guidelines that are as rigorous as those directed at individual financial conflicts. At the institutional level, structural relationships could threaten the independent activities of individuals or committee operations.
|
From page 188... ...
Research participants injured as a result of a product defect or malfeasance or incompetence in the design and execution of the study can resort to the tort system for compensation, but those injured through no fault of their own or of anyone else have no legal recourse. It is the committee's impression that many research organizations conducting clinical trials agree to provide short-term medical care (during the course of the study)
|
From page 190... ...
The claims to date relate to inadequacy of consent, departure from the protocol, or other negligent activities. Inevitably, these cases invite the courts to expand the legal grounds of recovery, and in an uncertain legal environment cases can be inconsistently resolved.22 A no22This occurred in the case of vaccine injuries prior to enactment of the National Childhood Vaccine Injury Act of 1986 (P.L.
|
From page 191... ...
It has been argued that a participant relinquishes his or her right to compensation when giving informed consent, but in the committee's view, a right to compensation for research-related injury should not be subject to waiver. The DHEW Task Force declared in its report that "The fact that a person has volunteered does not eliminate that person's right to be compensated in the event of injury, whether or not the injury was foreseeable....
|
From page 192... ...
The DHEW report and the more recent University of Washington examples appear to provide the most relevant information about the number and cost of injuries, but, obviously, this information is both sketchy and inconsistent. However, based on the media attention given to adverse research events in recent years,25 the increased attention given by regulatory agencies to institutional noncompliance and financial conflicts of interest, and the growing pressures on the research system, the potential for diminished public trust in the research community is real (Marwick, 2002~.
|
From page 193... ...
Making such determinations will require supplemental studies, and the committee recommends that these studies be commissioned as soon as possible in order to guide public policy decisions and accreditation standard development in this area. Recommendation 6.8: Organizations conducting research should compensate any research participant who is injured as a direct result of participating in research, without regard to fault.
|
From page 194... ...
PERSONAL LIABILITY OF RESEARCH ERB MEMBERS As noted, litigation over research injury appears to be increasing (Blumenstyk, 2002; Washburn, 2001~. Research organizations with effective protection programs, including effective Research ERBs, should be better protected from legal losses than those that employ less robust efforts.
|
From page 195... ...
Organizations should indemnify both internal and external board members to prevent them from being unduly influenced by the personal risks of potential litigation, a protection that should be extended to individuals of other boards, such as DSMB/DMCs, Scientific Review Boards, and ethics and research expert consultants used by Research ERBs and other review bodies. SUMMARY An effective protection program should have QA and QI measures in place in order to continuously assess its strengths and weaknesses and to redress those weaknesses.
|
From page 196... ...
Therefore, these issues should be referred to the research organization's management for resolution or delegation.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.