Systems approach to assessing and improving local human research Institutional Review Board performance.
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ABSTRACT: Objective
To quantifying the interdependency within the regulatory environment governing human subject research, including Institutional Review Boards (IRBs), federally mandated Medicare coverage analysis and contract negotiations.Methods
Over 8000 IRB, coverage analysis and contract applications initiated between 2013 and 2016 were analyzed using traditional and machine learning analytics for a quality improvement effort to improve the time required to authorize the start of human research studies.Results
Staffing ratios, study characteristics such as the number of arms, source of funding and number and type of ancillary reviews significantly influenced the timelines. Using key variables, a predictive algorithm identified outliers for a workflow distinct from the standard process. Improved communication between regulatory units, integration of common functions, and education outreach improved the regulatory approval process.Conclusions
Understanding and improving the interdependencies between IRB, coverage analysis and contract negotiation offices requires a systems approach and might benefit from predictive analytics.
SUBMITTER: Fontanesi J
PROVIDER: S-EPMC6799096 | biostudies-literature |
REPOSITORIES: biostudies-literature
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Project description:ObjectiveTo describe, qualitatively and quantitatively, the impact of a review by multiple institutional review boards (IRBs) on the conduct of a multisite observational health services research study. DATA SOURCE AND SETTING: Primary data collection during 2002, 2003, and 2004 at 43 United States Department of Veterans Affairs (VA) primary care clinics.DesignExplanatory sequential mixed methods design incorporating qualitative and quantitative elements in sequence. DATA COLLECTION AND ABSTRACTION METHODS: Field notes and documents collected by research staff during a multisite observational health services research study were used in thematic analysis. Themes were quantified descriptively and merged with timeline data.Principal findingsApproximately 4,680 hours of staff time over a 19-month period were devoted solely to the IRB process. Four categories of phenomena impacting research were observed: (1) Recruitment, retention, and communication issues with local site principal investigators (PIs). Local PIs had no real role but were required by IRBs. Twenty-one percent of sites experienced turnover in local PIs, and local PI issues added significant delay to most sites. (2) Wide variation in standards applied to review and approval of IRB applications. The study was designed to be qualified under U.S. government regulations for expedited review. One site exempted it from review (although it did not qualify for exemption), 10 granted expedited review, 31 required full review, and one rejected it as being too risky to be permitted. Twenty-three required inapplicable sections in the consent form and five required HIPAA (Health Insurance Portability and Accountability Act of 1996) consent from physicians although no health information was asked of them. Twelve sites requested, and two insisted upon, provisions that directly increased the risk to participants. (3) Multiple returns for revision of IRB applications, consent documents, and ancillary forms. Seventy-six percent of sites required at least one resubmission, and 15 percent of sites required three or more (up to six) resubmissions. Only 12 percent of sites required any procedural or substantive revision; most resubmissions were editorial changes to the wording of the consent document. (4) Process failures (long turnaround times, lost paperwork, difficulty in obtaining necessary forms, unavailability of key personnel at IRBs). The process required from 52 to 798 (median 286) days to obtain approval at each site.ConclusionsSeveral features of the IRB system as currently configured impose costly burdens of administrative activity and delay on observational health services research studies, and paradoxically decrease protection of human subjects. Central review with local opt-out, cooperative review, or a system of peer review could reduce costs and improve protection of human subjects.
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Project description:One of the most significant changes to the Common Rule is the requirement that institutions use a single Institutional Review Board (IRB) for cooperative research in the United States, unless more than one IRB is required by state, local, or tribal law, or a signatory federal agency decides an exception is warranted. We surveyed Human Research Protection Program (HRPP) officials at the top U.S. research institutions to understand their knowledge and opinion of the mandate, what steps their institutions are taking, and difficulties their institutions are facing. One-hundred seven institutions (56.9%) responded to the survey. While support for the single-IRB mandate was positive overall, most respondents acknowledged that their institution is likely to face some difficulties complying with it. Regulatory agencies can help institutions to comply with the mandate by providing guidance concerning such issues as exceptions to the mandate, local context review, oversight, and implementation of reliance agreements, and development of policies, procedures, and best practices.
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Project description:Most critically ill adults have impaired decision-making capacity and are unable to consent to research. Yet, little is known about how Institutional Review Boards interpret the Common Rule's call for safeguards in research involving incapacitated adults. We aimed to examine Institutional Review Board practices on surrogate consent and other safeguards to protect incapacitated adults in research.A cross-sectional survey of 104 Institutional Review Boards from a random sample of U.S. institutions engaged in adult human subject research (response rate, 68%) in 2007 and 2008.None.Institutional Review Board acceptance of surrogate consent, research risks, and other safeguards in research involving incapacitated adults.Institutional Review Boards reported that, in the previous year, they sometimes (49%), frequently (33%), or very frequently (2%) reviewed studies involving patients in the intensive care unit. Six Institutional Review Boards (6%) do not accept surrogate consent for research from any persons, and 22% of Institutional Review Boards accept only an authorized proxy, spouse, or parent as surrogates, excluding adult children and other family. Institutional Review Boards vary in their limits on research risks in studies involving incapacitated adults: 15% disallow any research regardless of risk in studies without direct benefit, whereas 39% allow only minimal risks. When there was potential benefit, fewer Institutional Review Boards limit the risk at minimal (11%; p < .001). Even in populations at high risk for impaired decision making, many Institutional Review Boards rarely or never required procedures to determine capacity (13%-21%). Institutional Review Boards also varied in their use of independent monitors, research proxies, and advanced research directives.Much variability exists in Institutional Review Board surrogate consent practices and limits on risks in studies involving incapacitated adults. This variability may have adverse consequences for needed research involving incapacitated adults. Clarification of current regulations is needed to provide guidance.
| S-EPMC3939835 | biostudies-literature
Project description:BackgroundInstitutional Review Boards (IRBs) have been criticized for inconsistency, delay, and bias, suggesting an opportunity for quality improvement. To aid such quality improvement, this study aimed at determining IRB members' and investigators' priorities regarding IRB review at 10 Veterans Affairs (VA) IRBs.Methods680 anonymous internet surveys were sent to 252 IRB members and staff, and 428 principal investigators and project coordinators at 9 VA Medical Centers and the VA Central IRB. Surveys included 27 statements adapted from Koocher and Kieth-Spiegel's IRB-RAT describing IRB activities or functions (e.g., "An IRB that is open to reversing its earlier decisions"). Respondents indicated how each statement described both their "ideal" and "actual" IRBs. The difference between the ratings of the actual and ideal IRBs was calculated for each item along with estimated 95% confidence intervals. Ratings outside those intervals indicated activities or functions with relatively good or poor performance compared to the ideal IRB.Results390 (57.4%) responses from 165 IRB members and staff (65.5%) and 225 investigators and project coordinators (52.6%) demonstrated that these IRBs were closest to the ideal when protecting human subjects, treating investigators with respect, and taking appropriate action for alleged scientific misconduct. The IRBs were furthest from the ideal regarding duplicative forms, timeliness of review, and provision of complete rationales for decisions. Although IRB members reported near-ideal willingness to reverse earlier decisions, investigators rated this capacity far from ideal. Investigators rated IRB members' knowledge about procedures and policy as nearly ideal, but IRB members themselves rated this aspect far from ideal. Noteworthy site-level differences in the ratings of IRB functions and activities were also identified.ConclusionsAlthough these VA IRBs perform well in some areas, these data support the need for ongoing quality improvement. The described method of administering and analyzing the IRB-RAT may help identify and monitor site- and activity- specific initiatives for quality improvement.
| S-EPMC7409436 | biostudies-literature
Project description:The aim of this study was to evaluate the process of accreditation resulting in improvement of the Institutional Review Board (IRB) functioning.Randomly selected projects from years 2007 (before accreditation), 2010 (after accreditation), and 2013 (after reaccreditation) were evaluated to assess parameters, namely, submission of good clinical practices (GCPs), completeness of IRB submission form, fulfillment of quorum, documentation of the declaration of conflict of interests, and submission of the status reports. Compliance to these parameters was compared over a period of 3 years.A total of seventy projects were evaluated retrospectively. Compliance of the principal investigators regarding submission of GCP certificates increased substantially from 5% to 53.1%. Completeness of IRB forms was 80% in 2007 while it became 100% in 2010 and continued even in 2013. Fulfillment of quorum increased significantly from 35% in 2007 to 100% in 2010 and 2013 after the accreditation procedures. Out of the selected twenty projects (2007), nonfinancial conflict of interest was not declared in all three applicable projects, while of 18 projects (2010), nonfinancial conflict of interest was declared in all three applicable cases. Of 32 projects (2013), nonfinancial conflict of interest was declared in seven out of eight applicable cases. Timely submission of status reports increased from 10% in 2007 to 38.9% in 2010 and 37.5% in 2013.Accreditation plays a vital role in the improvement of IRB. The policies and procedures formulated and implemented during the process of accreditation resulted in improvement of IRB performance. Continuing training of the IRB and researchers is required to maintain the accreditation.
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Project description:Institutional Review Boards (IRBs) have been increasingly criticized for how they review protocols, but how IRBs perceive, and make decisions about, the quality of the science of protocols has not been examined.To explore how and when IRBs view and make decisions about the quality of the science of studies they review.I contacted the leadership of 60 IRBs (every fourth one in the list of the top 240 institutions by National Institutes of Health (NIH) funding) and interviewed IRB chairs, co-chairs, administrators, and a director from 34 IRBs (response rate = 55%), and an additional 7 members.Interviewees faced several ambiguities and questions concerning the quality of the science of protocols. IRBs are often not sure how and to what extent to evaluate the science of protocols, whether the science should be 'good enough' (and if so, what that means) versus as good as possible. Federal regulations state that IRBs should ensure that risks are minimized, and commensurate with benefits. Thus, at times IRBs feel that changing the science is ethically necessary. But IRBs also then struggle with whether to adopt a higher threshold (1) that social and thus scientific benefits be maximized and (2) that scientific efforts and resources should not be wasted. Committees face dilemmas - for example, if a 'perfect' study is not feasible. For protocols already approved elsewhere (e.g., by the NIH), IRBs vary in how much they feel they can request alterations, and sometimes make changes nonetheless. Larger institutional contexts and biases can shape these issues, and IRBs differ in how much they are 'pro-research', and have sufficient expertise. IRBs at times also approve studies despite reservations about the science.This study includes interviews with IRBs, but not observations of IRB meetings.IRBs often face ambiguities and conflicting goals in assessing scientific quality. Many IRBs try to improve the science beyond what the regulations mandate. These data have important implications for improving practice, education, research, and policy.
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