Clinical And Translational Science Awards Institutions Research Articles

A national unmet needs assessment for CTSA-affiliated electronic health record data networks: A customer discovery approach.

The expansion of electronic health record (EHR) data networks over the last two decades has significantly improved the accessibility and processes around data sharing. However, there lies a gap in meeting the needs of Clinical and Translational Science Award (CTSA) hubs, particularly related to real-world data (RWD) and real-world evidence (RWE). We adopted a mixed-methods approach to construct a comprehensive needs assessment that included: (1) A Landscape Context analysis to understand the competitive environment; and (2) Customer Discovery to identify stakeholders and the value proposition related to EHR data networks. Methods included surveys, interviews, and a focus group. Thirty-two CTSA institutions contributed data for analysis. Fifty-four interviews and one focus group were conducted. The synthesis of our findings pivots around five emergent themes: (1) CTSA segmentation needs vary according to resources; (2) Team science is key for success; (3) Quality of data generates trust in the network; (4) Capacity building is defined differently by researcher career stage and CTSA existing resources; and (5) Researchers' unmet needs. Based on the results, EHR data networks like ENACT that would like to meet the expectations of academic research centers within the CTSA consortium need to consider filling the gaps identified by our study: foster team science, improve workforce capacity, achieve data governance trust and efficiency of operation, and aid Learning Health Systems with validating, applying, and scaling the evidence to support quality improvement and high-value care. These findings align with the NIH NCATS Strategic Plan for Data Science.

Engaging community in the translational process: Environmental scan of adaptive capacity and preparedness of Clinical and Translational Science Award Program hubs.

This paper is part of the Environmental Scan of Adaptive Capacity and Preparedness of Clinical and Translational Science Award (CTSA) hubs, illuminating challenges, practices, and lessons learned related to CTSA hubs' efforts of engaging community partners to reduce the spread of the virus, address barriers to COVID-19 testing, identify treatments to improve health outcomes, and advance community participation in research. CTSA researchers, staff, and community partners collaborated to develop evidence-based, inclusive, accessible, and culturally appropriate strategies and resources helping community members stay healthy, informed, and connected during the pandemic. CTSA institutions have used various mechanisms to advance co-learning and co-sharing of knowledge, resources, tools, and experiences between academic professionals, patients, community partners, and other stakeholders. Forward-looking and adaptive decision-making structures are those that prioritize sustained relationships, mutual trust and commitment, ongoing communication, proactive identification of community concerns and needs, shared goals and decision making, as well as ample appreciation of community members and their contributions to translational research. There is a strong need for further community-engaged research and workforce training on how to build our collective and individual adaptive capacity to sustain and improve processes and outcomes of engagement with and by communities-in all aspects of translational science.

Dissemination and implementation science resources, training, and scientific activities provided through CTSA programs nationally: Opportunities to advance D&I research and training capacity.

Clinical and Translational Science Award (CTSA) Program hubs are well-positioned to advance dissemination and implementation (D&I) research and training capacity nationally, though little is known about what D&I research support and services CTSAs provide. To address this gap, the CTSA Dissemination, Implementation, and Knowledge Transfer Working Group conducted an environmental scan of CTSAs (2017-2018). Of 67 CTSA institutions, we contacted 43 that previously reported delivering D&I research services. D&I experts from these institutions were emailed a survey assessing D&I resources, services, training, and scientific projects. Responses were categorized and double-coded by study authors using a content analysis approach. Thirty-five of the 43 D&I experts (81.4%) responded. Challenges to CTSAs in developing and supporting D&I science activities were related to inadequate D&I science workforce (45.7%) and lack of understanding of D&I science (25.7%). Services provided included consultation/mentoring programs (68%), pilot funding/grants (50%), and workshops/seminars/conferences (46%). Training and workforce development in D&I were frequently identified as future priorities. Recommendations included increase training to meet demand (68.6%), accessible D&I tools/resources (34.3%), greater visibility/awareness of D&I methods (34.3%), consultation services (22.9%), and expand D&I science workforce (22.9%). CTSAs have tremendous potential to support the advancement and impact of D&I science across the translational continuum. Despite the growing presence of D&I science in CTSAs, continued commitment and prioritization are needed from CTSA and institutional leadership to raise awareness of D&I science and its value, meet training demands, and develop necessary infrastructure for conducting D&I science.

Scholarly Productivity Evaluation of KL2 Scholars Using Bibliometrics and Federal Follow-on Funding: Cross-Institution Study.

BackgroundEvaluating outcomes of the clinical and translational research (CTR) training of a Clinical and Translational Science Award (CTSA) hub (eg, the KL2 program) requires the selection of reliable, accessible, and standardized measures. As measures of scholarly success usually focus on publication output and extramural funding, CTSA hubs have started to use bibliometrics to evaluate the impact of their supported scholarly activities. However, the evaluation of KL2 programs across CTSAs is limited, and the use of bibliometrics and follow-on funding is minimal.ObjectiveThis study seeks to evaluate scholarly productivity, impact, and collaboration using bibliometrics and federal follow-on funding of KL2 scholars from 3 CTSA hubs and to define and assess CTR training success indicators.MethodsThe sample included KL2 scholars from 3 CTSA institutions (A-C). Bibliometric data for each scholar in the sample were collected from both SciVal and iCite, including scholarly productivity, citation impact, and research collaboration. Three federal follow-on funding measures (at the 5-year, 8-year, and overall time points) were collected internally and confirmed by examining a federal funding database. Both descriptive and inferential statistical analyses were computed using SPSS to assess the bibliometric and federal follow-on funding results.ResultsA total of 143 KL2 scholars were included in the sample with relatively equal groups across the 3 CTSA institutions. The included KL2 scholars produced more publications and citation counts per year on average at the 8-year time point (3.75 publications and 26.44 citation counts) than the 5-year time point (3.4 publications vs 26.16 citation counts). Overall, the KL2 publications from all 3 institutions were cited twice as much as others in their fields based on the relative citation ratio. KL2 scholars published work with researchers from other US institutions over 2 times (5-year time point) or 3.5 times (8-year time point) more than others in their research fields. Within 5 years and 8 years postmatriculation, 44.1% (63/143) and 51.7% (74/143) of KL2 scholars achieved federal funding, respectively. The KL2-scholars of Institution C had a significantly higher citation rate per publication than the other institutions (P<.001). Institution A had a significantly lower rate of nationally field-weighted collaboration than did the other institutions (P<.001). Institution B scholars were more likely to have received federal funding than scholars at Institution A or C (P<.001).ConclusionsMulti-institutional data showed a high level of scholarly productivity, impact, collaboration, and federal follow-on funding achieved by KL2 scholars. This study provides insights on the use of bibliometric and federal follow-on funding data to evaluate CTR training success across institutions. CTSA KL2 programs and other CTR career training programs can benefit from these findings in terms of understanding metrics of career success and using that knowledge to develop highly targeted strategies to support early-stage career development of CTR investigators.

Recognizing Cross-Institutional Fiscal and Administrative Barriers and Facilitators to Conducting Community-Engaged Clinical and Translational Research.

This qualitative study examined fiscal and administrative (i.e., pre- and post-award grants process) barriers and facilitators to community-engaged research among stakeholders across 4 Clinical and Translational Science Awards (CTSA) institutions. A purposive sample of 24 key informants from 3 stakeholder groups-community partners, academic researchers, and research administrators-from the CTSA institutions at the University of North Carolina at Chapel Hill, Medical University of South Carolina, Vanderbilt University Medical Center, and Yale University participated. Semistructured interviews were conducted in March-July 2018, including questions about perceived challenges and best practices in fiscal and administrative processes in community-engaged research. Transcribed interviews were independently reviewed and analyzed using the Rapid Assessment Process to facilitate key theme and quote identification. Community partners were predominantly Black, academic researchers and research administrators were predominantly White, and women made up two-thirds of the overall sample. Five key themes were identified: level of partnership equity, partnership collaboration and communication, institutional policies and procedures, level of familiarity with varying fiscal and administrative processes, and financial management expectations. No stakeholders reported best practices for the institutional policies and procedures theme. Cross-cutting challenges included communication gaps between stakeholder groups; lack of or limits in supporting community partners' fiscal capacity; and lack of collective awareness of each stakeholder group's processes, procedures, and needs. Cross-cutting best practices centered on shared decision making and early and timely communication between all stakeholder groups in both pre- and post-award processes. Findings highlight the importance of equitable processes, triangulated communication, transparency, and recognizing and respecting different financial management cultures within community-engaged research. This work can be a springboard used by CTSA institutions to build on available resources that facilitate co-learning and discussions between community partners, academic researchers, and research administrators on fiscal readiness and administrative processes for improved community-engaged research partnerships.

Challenges and lessons learned for institutional review board procedures during the COVID-19 pandemic.

The COVID-19 pandemic changed the clinical research landscape in America. The most urgent challenge has been to rapidly review protocols submitted by investigators that were designed to learn more about or intervene in COVID-19. International Review Board (IRB) offices developed plans to rapidly review protocols related to the COVID-19 pandemic. An online survey was conducted with the IRB Directors at Clinical and Translational Science Awards (CTSA) institutions as well as two focus groups. Across the CTSA institutions, 66% reviewed COVID-19 protocols across all their IRB committees, 22% assigned protocols to just one committee, and 10% created a new committee for COVID-19 protocols. Fifty-two percent reported COVID-19 protocols were reviewed much faster, 41% somewhat faster, and 7% at the same speed as other protocols. Three percent reported that the COVID-19 protocols were reviewed with much better quality, 32% reported slightly better quality, and 65% reported the reviews were of the same quality as similar protocols before the COVID-19 pandemic. IRBs were able to respond to the emergent demand for reviewing COVID-19 protocols. Most of the increased review capacity was due to extra effort by IRB staff and members and not changes that will be easily implemented across all research going forward.

4436 A Content Analysis of CTSA Websites: The Identification and Evaluation of CTSA Program Hub Website Content Standards for Knowledge Management of NCATS CTSA Program Goals and Initiatives

OBJECTIVES/GOALS: Introduction: Between 2014 and 2019 the National Institute of Health (NIH) through the National Center for the Advancement of Translational Science (NCATS) has awarded about $2.7 billion to U.S. Academic Medical Centers to build a national network of clinical and translational science program hubs that serve to meet their key goals and initiatives. Today there are about 60 Clinical and Translational Science Award (CTSA) program hubs. Each CTSA program hub has a corresponding website highlighting its clinical and translational science centered programs and activities. These websites are a critical communication gateway to promote NCATS goals and initiatives. Objective: The objective of this research is to evaluate the NIH funded Clinical and Translational Science Award (CTSA) program hub websites for NCATS goals and initiative content alignment, navigability, and interactivity. METHODS/STUDY POPULATION: Methods: Each CTSA program hub website was systematically evaluated for information or tools that align with the five NCATS / CTSA Goals and eight CTSA nationally identified program initiatives. Each NCATS goal and CTSA initiative was subsequently ranked by information diversity level (text, tool, interactivity) and navigation level (click distance from the home page). RESULTS/ANTICIPATED RESULTS: Results: Four of the five NCATS goals are thoroughly and consistently represented among the CTSA Consortium with workforce development, patient and community engagement, and quality and efficiency of research being the top three. Informatics is thoroughly and consistently represented, but not always clearly identified on the home page. The most underrepresented goal is integration of special and underserved populations which was identified on only 60% of CTSA program hub websites. The most common focus of the eight CTSA program initiatives is the Trial Innovation Network in CTSA program hub websites. The Smart IRB comes in a distant second. The remaining six initiatives are severely underrepresented. DISCUSSION/SIGNIFICANCE OF IMPACT: Discussion: The identification of these gaps among the CTSA program hubs presents an understanding of content management and website functionality among the consortium from 3 principal approaches. First it creates an understanding of CTSA program hub content alignment with its funding source goals and initiatives. Such an understanding presents an opportunity to promote ways to create a better aligned consortium with improved collaboration pathways by the funding source through program hub website content standards. Second, it creates an opportunity for program hubs to understand and respond to the messaging their websites are presenting as it relates to the funding source. Third, it provides an opportunity to identify specific program initiatives and goals the CTSA institutions independently chose to highlight which can open a dialog to the better understanding the value of the program initiatives as they relate to the needs of CTSA program hubs. Ultimately, CTSA websites through content alignment should lead to an improved user experience.

CTSA recruitment resources: An inventory of what CTSA hubs are currently offering.

In order to tackle the challenge of efficiently meeting clinical research accrual goals, many Clinical and Translational Science Award (CTSA) recipients have developed recruitment support mechanisms and resources to help investigators successfully recruit study participants. Disseminating recruitment best practices and developing collaborations between institutions can help strengthen recruitment capabilities and methodologies currently utilized by researchers. To discover what recruitment resources and mechanisms CTSAs are using, the CTSA Recruitment and Retention working group developed an electronic survey, which was distributed to CTSAs between May and July 2019. The survey contained over 50 multiple choice and short answer questions, with 40 of the 64 CTSA institutions completing the survey. Institutions reported on registries, feasibility assessment tools, clinical trial listings, experience recruiting special populations, program operations and evaluation, workforce education, social media use, and other recruitment resources. All respondents currently utilize some form of a volunteer registry; over 80% of the CTSAs provide investigators with recruitment consultations, feasibility assessments, study listings, and electronic health record (EHR) utilization; 73% assist with study materials; 47% offer social media assistance. Many institutions reported success in recruiting patients and healthy volunteers, but difficulty in recruiting special populations such as non-English-speaking persons and rural populations. Additional recruitment tools included use of the EHR to facilitate recruitment, use of registries, and use of social media to engage participants. Areas of opportunity or growth include the development of innovative solutions in the areas of social media advertising, identification of participants from special populations, and research volunteer engagement.

Collaboration and Context in the Design of Community-Engaged Research Training.

Collaboration between academic researchers and community members, clinicians, and organizations is valued at all levels of the program development process in community-engaged health research (CEnR). This descriptive study examined a convenience sample of 30 projects addressing training in CEnR methods and strategies within the Clinical and Translational Science Awards (CTSA) consortium. Projects were selected from among posters presented at an annual community engagement conference over a 3-year period. Study goals were to learn more about how community participation in the design process affected selection of training topics, how distinct community settings influenced the selection of training formats, and the role of evaluation in preparing training participants to pursue future health research programming. Results indicated (1) a modest increase in training topics that reflected community health priorities as a result of community (as well as academic) participation at the program design stage, (2) a wide range of community-based settings for CEnR training programs, and (3) the majority of respondents conducted evaluations, which led in turn to revisions in the curricula for future training sessions. Practice and research implications are that the collaboration displayed by academic community teams around CEnR training should be traced to see if this participatory practice transfers to the design of health promotion programs. Second, collaborative training design tenets, community formats and settings, and evaluation strategies should be disseminated throughout the CTSA network and beyond. Third, common evaluative metrics and indicators of success for CEnR training programs should be identified across CTSA institutions.

KL2 mentored career development programs at clinical and translational science award hubs: Practices and outcomes.

NIH Clinical and Translational Science Awards (CTSAs) include KL2 mentored career development awards for faculty commencing clinical and translational research. A survey of KL2 leaders revealed program practices, curricular elements and compelling data about scholar characteristics and outcomes. We conducted a literature review, framed the survey construct, and obtained input from across the CTSA consortium. A REDCap survey was emailed in fall 2016 to 61 active programs. Fifty-five programs (90.2%) responded. Respondents had been funded from 3 to 11 years, including 22 "mature" hubs funded for ≥8 years. Program cohort sizes were 56% "small", 22% "medium", and 22% "large." Hubs offer extensive competency-aligned training opportunities relevant to clinical and translational research, including graduate degrees, mentorship, and grant-writing. Seventy-two percent of hubs report parallel "KL2-equivalent" career development programs. All hubs share their training and facilitate intermingling with other early stage investigators. A total of 1,517 KL2 scholars were funded. KL2 awardees are diverse in their disciplines, research projects, and representation; 54% are female and 12% self-identified as underrepresented in biomedical research. Eighty-seven percent of scholars have 2-3 mentors and are currently supported for 2-3 years. Seventy-eight percent of alumni remain at CTSA institutions in translational science. The most common form of NIH support following scholars' KL2 award is an individual career development award. The KL2 is a unique career development award, shaped by competency-aligned training opportunities and interdisciplinary mentorship that inform translational research pathways. Tracking both traditional and novel outcomes of KL2 scholars is essential to capture their career trajectories and impact on health.

Promotion and tenure policies for team science at colleges/schools of medicine.

Advancing understanding of human health promotion and disease prevention and treatment often requires teamwork. To evaluate academic medical institutions' support for team science in the context of researchers' career development, we measured the value placed on team science and specificity of guidance provided for documenting team science contributions in the promotion and tenure (P&T) documents of Colleges/Schools of Medicine (CoMs) in the National Center for Advancing Translational Sciences' Clinical and Translational Science Award (CTSA) program. We reviewed complete P&T documents from 57 of 63 CTSA CoMs to identify career paths defined by three dimensions: academic rank (associate versus full professor), tenure eligibility (tenure track versus not), and role (research, clinical, education, and administrative), and we rated team science value and documentation guidance for each path. Multilevel models were estimated to compare team science value and documentation guidance as a function of the three career path dimensions while accounting for the clustered data (N = 357 career paths within 57 CoMs). Team science value was greater for associate than full professors, non-tenure-eligible versus tenure-eligible positions, and roles prioritizing clinical, education, and administrative responsibilities versus those prioritizing research. Guidance for documenting team science achievements was more explicit for roles that prioritized research. Although P&T policies at most CTSA institutions express value for team science, inconsistent within-institutional patterns of recognition and reward across career paths may have implications for researchers' involvement in team science. We discuss the implications of our findings for research and for P&T policies that promote team science.

3355 The CTSA Institutional website: A higher purpose - Researcher use of institutional Clinical and Translational Science Award (CTSA) website content to assess or promote NCATS CTSA Program Goals.

3355 The CTSA Institutional website: A higher purpose - Researcher use of institutional Clinical and Translational Science Award (CTSA) website content to assess or promote NCATS CTSA Program Goals.

A collaborative, academic approach to optimizing the national clinical research infrastructure: The first year of the Trial Innovation Network.

Inefficiencies in the national clinical research infrastructure have been apparent for decades. The National Center for Advancing Translational Science (NCATS) -sponsored CTSA program is able to address such inefficiencies. The Trial Innovation Network (TIN) is a collaborative initiative with the CTSA Program and other NIH Institutes and Centers (ICs) that addresses critical roadblocks to accelerate the translation of novel interventions to clinical practice. The TIN's mission is to execute high quality trials in a quick, cost-efficient manner. The TIN awardees are composed of: three Trial Innovation Centers (TICs), the Recruitment Innovation Center (RIC), and the individual CTSA institutions that have identified TIN Liaison units. The TIN has launched a national scale single (central) IRB system, master contracting agreements, quality-by-design approaches, novel recruitment support methods, and applies evidence-based strategies to recruitment and patient engagement. The TIN has received 113 submissions from 39 different CTSA institutions and 8 non-CTSA Institutions, with projects associated with 12 different NIH ICs across a wide range of clinical/disease areas. Already more than 150 unique health systems/organizations are involved as sites in TIN related multisite studies. The TIN will begin to capture data and metrics that quantify increased efficiency and quality improvement during operations.

Defining and Measuring Community Engagement and Community-Engaged Research: Clinical and Translational Science Institutional Practices.

The institutions that comprise the Clinical and Translational Science Award (CTSA) consortium and the National Center for Advancing Translational Sciences continue to explore and develop community-engaged research strategies and to study the role of community academic partnerships in advancing the science of community engagement. To explore CTSA institutions in relation to an Institute of Medicine recommendation that community engagement occur in all stages of translational research and be defined and evaluated consistently. A sequential multimethods study starting with an online pilot survey followed by survey respondents and site informant interviews. A revised survey was sent to the community engagement and evaluation leads at each CTSA institution, requesting a single institutional response about the definitions, indicators, and metrics of community engagement and community-engaged research. A plurality of CTSA institutions selected the definition of community engagement from the Principles of Community Engagement. Although claiming unique institutional priorities create barriers to developing shared metrics, responses indicate an overall lack of attention to the development and deployment of metrics to assess community engagement in and contributions to research. Although definitions of community engagement differ among CTSAs, there seem to be more similarities than differences in the indicators and measures tracked and reported on across all definitions, perhaps owing to commonalities among program infrastructures and goals. Metrics will likely need to be specific to translational research stages. The assessment of community engagement within translational science will require increased institutional commitment.

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OBJECTIVES/SPECIFIC AIMS: This study describes the design, operation, and evaluation of a community-based research (CBR) consult service within the setting of a Clinical and Translational Science Award (CTSA) institution. To our knowledge, there are no published evaluations of a CBR consult service at a CTSA hub. METHODS/STUDY POPULATION: A CBR consult service was created to support faculty, healthcare providers/research coordinators, trainees, community-based organizations, and community members. A framework was developed to assess the stages of client engagement and to foster clear articulation of client needs and challenges. A developmental evaluation system was integrated with the framework to track progress, store documents, continuously improve the consult service, and assess research outcomes. RESULTS/ANTICIPATED RESULTS: This framework provides information on client numbers, types, services used, and successful outreach methods. Tracking progress reveals reasons that prevent clients from completing projects and facilitates learning outcomes relevant to clients and funding agencies. Clients benefit from the expert knowledge, community connections, and project guidance provided by the consult service team, increasing the likelihood of study completion and achieving research outcomes. DISCUSSION/SIGNIFICANCE OF IMPACT: Our evaluation suggests that clients benefit by (1) gaining the collective knowledge of the experts comprising the team, (2) learning the process of doing CBR, including the required steps to reach completion, and (3) gaining a project management mentality promoting translational research outcomes. This study offers a framework by which CTSA institutions can expand their capacity to conduct and evaluate CBR while addressing challenges that inhibit community engagement.

CTSA Institution Responses to Proposed Common Rule Changes: Did They Get What They Wanted?

In 2015, the U.S. Department of Health and Human Services (HHS) and 15 other federal departments and agencies proposed revisions to the Federal Policy for the Protection of Human Subjects. In this Notice of Proposed Rulemaking (NPRM), the departments sought to strengthen, modernize, and make more effective human subjects regulations while reducing administrative burden, delay, and ambiguity. We reviewed public comments from National Institutes of Health (NIH)-funded Clinical and Translational Science Awards (CTSA) institutions on key provisions of the NPRM to understand how the proposed changed were received at research-intensive institutions. CTSA institutions responding to the proposed rule were predominantly opposed to the major proposals, including proposed changes to the treatment of de-identified biospecimens, demonstrating a lack of support from academic medical centers. In January 2017, a Final Rule was issued. We compare the Final Rule to what was proposed.

A Consult Service to Support and Promote Community-Based Research: Tracking and Evaluating a Community-based Research Consult Service.

This study describes the design, operation and evaluation of a community-based research (CBR) consult service within the setting of a Clinical and Translational Science Award (CTSA) institution. To our knowledge, there are no published evaluations of a CBR consult service at a CTSA hub. A community-based research Consult Service was created to support faculty, health care providers/research coordinators, trainees, community-based organizations and community members. A framework was developed to assess the stages of client engagement and to foster clear articulation of client needs and challenges. A developmental evaluation system was integrated with the framework to track progress, store documents, continuously improve the consult service and assess research outcomes. This framework provides information on client numbers, types, services used and successful outreach methods. Tracking progress reveals reasons that prevent clients from completing projects and facilitates learning outcomes relevant to clients and funding agencies. Clients benefit from the expert knowledge, community connections and project guidance provided by the Consult Service team, increasing the likelihood of study completion and achieving research outcomes. This study offers a framework by which CTSA institutions can expand their capacity to conduct and evaluate community-based research while addressing challenges that inhibit community engagement.

NIH Career Development Awards in Clinical and Translational Science Award institutions: distinguishing characteristics of top performing sites.

To identify and disseminate the organizational characteristics of "top performing" National Institute of Health (NIH) Clinical and Translational Science Awards (CTSA) institutions in regards to career development, using the number of new K awards received per year to rank institutions and comparing these with non-CTSA institutions. The authors analyzed the organizational characteristics of all 61 CTSA institutions from 2006 to 2013 using the American Association of Medical Colleges Organizational Characteristics Database and K Award funding details using NIH RePORT. Five of the "top 10 performing" institutions are in the western region, and six out of the ten are public schools. Three of the "top 10 performing" institutions receive most of their K awards through two funding mechanisms-the K08 (mentored clinical scientist research award) and K23 (mentored patient-oriented research career development awards). Notably, these three institutions lack a KL2 program. The CTSA network of institutions is committed to developing the next generation of physician scientists in order to meet the pressing health needs of society. Educators and evaluators within this network may need to provide training to junior investigators beyond the traditional KL2 programs in order to advance their career development as physician scientists and clinical translational researchers.

Recommendations From the Investigational New Drug/Investigational Device Exemption Task Force of the Clinical and Translational Science Award Consortium

ObjectiveThe objective of this study was to provide recommendations for provision of training for sponsor and investigators at Academic Health Centers.BackgroundA subgroup of the Investigational New Drug/Investigational Device Exemption (IND/IDE)...

Proposed regulations for research with biospecimens: Responses from stakeholders at CTSA consortium institutions

Secondary research with biospecimens acquired through clinical care and through research is often conducted without the informed consent of individuals from whom the specimens were acquired. While such uses are consistent with the current federal regulations, surveys of the general public suggest that many individuals would prefer more information and choice regarding research use of biospecimens. The federal government issued an Advance Notice of Proposed Rulemaking (ANPRM) in 2011 that proposed a number of potential changes in the regulations governing human subjects. These proposed regulations are particularly pertinent to institutions committed to research involving human subjects-including institutions in the NIH-funded Clinical and Translational Science Awards (CTSA) consortium. In this study, we reviewed public responses by CTSA-funded institutions and CTSA-affiliated organizations and groups regarding the proposed changes in the ANPRM with respect to research with biospecimens. Our results indicate that the majority of responses to the ANPRM from CTSA institutions were not supportive of the proposed changes. While many responses acknowledge a need to change current research practices regarding biospecimens, the proposed changes in the ANPRM received only limited support from this subgroup of academic research institutions.