IRB and IACUC Review

2. Eliminate Two Layer IRB and IACUC Review of Human and Vertebrate Animal Research - Institutions receiving federal funds for research with human subjects or vertebrate animals are required to maintain a Federal-wide Assurance (FWA) or Animal Welfare Assurance (AWA) with the DHHS Office of Human Research Protections (OHRP) or Office of Laboratory Animal Welfare (OLAW), respectively. Institutions thereby accept the responsibility to form qualified internal committees who operate under the appropriate regulations to review research protections. Despite this fact, some federal sponsors (e.g. DoD, FDA) still require two layers of regulatory approval from 1.) the Awardee’s IRB/IACUC and 2.) the Sponsor’s IRB or IACUC. These dual review requirements are typically not allowed to be conducted in parallel. The secondary review adds additional time and significant administrative burden to investigators, sponsors, and research administration. Elimination of the secondary IRB/IACUC review harmonizes with not only the need for standardized award terms and conditions, but also the recent proposed changes to the Common Rule related to single IRB review.

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Contractors and Grantees
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Reporting compliance requirements shared by prime and subawardees of Federal procurements and grants
Key Participants: contractors, grantees, cooperative agreement holders, and subawardees
- Question: If you could change one thing that would ease your reporting burden associated with your awards, what would it be (e.g. time, cost, resource, other)?
- Question: If you have reporting requirements to the Federal government, how are those met?
- Question: If you could create a central reporting portal into which you could submit all required reports, what capabilities or functions would you include?
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Contractors
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Procurement practices, processes, and reporting
Key Participants: Contractors and subcontractors
- Question: If you could change one thing that would ease your reporting burden associated with your awards, what would it be (e.g. time, cost, resource, other)?
- Question: If you have reporting requirements to the Federal government, how are those met?
- Question: If you could create a central reporting portal into which you could submit all required reports, what capabilities or functions would you include?
- Question: Are there any reporting areas in the FAR that are similar in nature to those in Federal agency supplements?
- Question: What other compliance information are you providing to the Federal government outside of the procurement process that could be used in procurement reporting and reduce duplication?
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Grantees
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Grants practices and processes
Key Participants: grantees, cooperative agreement holders, subgrantees
- Question: If you could change one thing that would ease your reporting burden associated with your grants or subgrants, what would it be (e.g., time, cost, resource burden)?
- Question: If you have reporting requirements to the Federal government, how are those met? (feel free to be specific about what is reported to whom and through what mechanism)
- Question: If you could create a central reporting portal into which you could submit all required reports, what capabilities/functions would you include?
OMB circular A-133:
- Question: If you could make a change to ease your reporting burden for audits under the Single Audit Act (i.e., audits required by OMB Circular A-133 which is being replaced by the Uniform Guidance 2 CFR 200 Subpart F), what one thing would you change about reporting by the auditee?
- Question: If you could make a change to ease your reporting burden for audits under the Single Audit Act (i.e., audits required by OMB Circular A-133 which is being replaced by the Uniform Guidance 2 CFR 200 Subpart F), what one thing would you change about reporting by the auditor?
- Question: If you could make a change to ease your reporting burden for audits under the Single Audit Act (i.e., audits required by OMB Circular A-133 which is being replaced by the Uniform Guidance 2 CFR 200 Subpart F), what one thing would you change about reporting to the Federal Audit Clearinghouse?
Uniform Guidance (2 CFR 200):
- Question: Are there requirements in the new 2 CFR 200 that need additional clarification for improved implementation with reduced administrative burden ?
- Question: What are the perceived burdens associated with the new standards such as the documentation of salaries & wages and time & effort (2 CFR 200.430), subrecipient monitoring (2 CFR 200.331), procurement standards (2 CFR 200.317- 2 CFR 200.324)?
- Question: How can the administrative burden associated with standards compliance be lowered?
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