Survey
NSF Efforts to Reduce Admin Burden
The document presents initiatives undertaken by the National Science Foundation (NSF), as discussed by representatives from the Council on Governmental Relations and NSF leadership, to address and reduce the administrative burden associated with research proposal preparation and submission. Key efforts are informed by extensive survey data collected from principal investigators (PIs) and sponsored
Overview of the Common Rule Comments
The document provides an initial analysis of public comments received in response to proposed revisions to the Common Rule, focusing on a review presented at the Council on Governmental Relations Meeting in February 2016. Out of approximately 2,190 comments, the majority came from individual patients, the general public, and representatives or associations, with significant contributions also from
Advocacy Summary
The document presents preliminary findings from COGR and APLU’s analysis of advocacy group responses to the Notice of Proposed Rulemaking (NPRM) on changes to the Common Rule for human subjects research. Sixty responses from a broad range of organizations—including disease-specific advocacy groups, patient and privacy advocates—were reviewed, focusing on proposals concerning biospecimens, IRB revi
Biorepositories
The preliminary findings from COGR and APLU synthesize responses provided by biorepositories, affiliated organizations, and consultants to the proposed revisions of the Common Rule as they pertain to biospecimen research. The reviewed respondents, primarily large biobanking networks and groups supporting biospecimen research, expressed significant concern about the proposed expansion of the defini
Disease Registries
The preliminary review by COGR and APLU of the Disease Registries’ responses to the Common Rule NPRM highlights significant opposition among disease registry stakeholders to several proposed regulatory changes, particularly those involving biospecimens. The majority of responding registries—large national databases and professional organizations—expressed concern about expanding the definition of
Health Departments
The preliminary findings from COGR and APLU provide an overview of 17 responses from state and city health departments, public health labs, CDC staff, and related associations regarding proposed changes to the Common Rule as outlined in the Notice of Proposed Rulemaking (NPRM). The review focused on major issues such as the definition and research use of biospecimens, mandated use of a single inst
Independent IRBS
The preliminary findings from COGR and APLU's review of responses to the Common Rule NPRM reveal a range of perspectives from twelve submissions, including those from independent institutional review boards (IRBs). The areas evaluated primarily concern biospecimens, the use of a single IRB for multisite studies, broader application of the Common Rule, data security, and the public posting of
Industry
The preliminary findings from COGR and APLU’s review of industry, pharmaceutical, and trade group responses to the Common Rule NPRM reveal significant opposition to several key proposed regulatory changes, particularly those affecting biospecimens and informed consent procedures. All respondents who addressed the proposal to expand the definition of "human subject" to include non-identif
Patients
The document provides a detailed analysis of 245 responses from patients and patient representatives—primarily individuals affected by rare diseases such as Desmoid Tumors and Leiomyosarcoma—regarding proposed changes to the federal Common Rule, specifically relating to biospecimens. The overwhelming majority of respondents (97%) opposed proposals to expand the definition of "human subject&qu
Tribal Governments
The document reviews and summarizes preliminary responses from Tribal Nations regarding proposed changes to the Common Rule, particularly those affecting biospecimens and the use of a single Institutional Review Board (IRB) for multisite research. Thirteen responses were analyzed, with a strong emphasis on protecting tribal sovereignty, cultural values, and ethical considerations in research invol
