Overview
Title
Agency Information Collection Request. 60-Day Public Comment Request
Agencies
ELI5 AI
The Department of Health and Human Services wants people to tell them what they think about a new plan for collecting important forms that help keep people safe in studies. They want to make sure they're doing it right and want feedback by March 16, 2021.
Summary AI
The Department of Health and Human Services (HHS) published a notice inviting public comments on a proposed information collection under the Paperwork Reduction Act of 1995. The collection is related to the "Incident Report Form" for human subjects protection, aiming to streamline reporting and compliance with federal regulations. HHS is seeking comments on various aspects of this collection, including its necessity and accuracy. Comments are to be submitted by March 16, 2021.
Abstract
In compliance with the requirement of the Paperwork Reduction Act of 1995, the Office of the Secretary (OS), Department of Health and Human Services, is publishing the following summary of a proposed collection for public comment.
Keywords AI
Sources
AnalysisAI
The document from the Department of Health and Human Services (HHS) invites public comments on a proposed information collection related to the "Incident Report Form" for the protection of human subjects. This initiative aligns with the Paperwork Reduction Act of 1995, which aims to minimize the paperwork burden on citizens when interacting with the federal government. By streamlining reporting and ensuring compliance with federal regulations, HHS is seeking feedback from the public on this collection.
General Summary
HHS has introduced a notice in the Federal Register to gather public input on a specific form used to report incidents in research involving human subjects. This form aids organizations and institutions in swiftly reporting incidents to comply with existing federal regulations. HHS is requesting a three-year extension for this reporting process, which ensures that all research involving human subjects is conducted ethically and safely.
Significant Issues and Concerns
The document contains bureaucratic language and technical terms such as "IRB Certification/Declaration of Exemption Form" and "OMB No. 0990-0263." Such language can be challenging for the general public to understand, possibly limiting the comprehensibility and accessibility of the notice. Additionally, the document does not adequately explain the purpose and utility of the information collection in straightforward terms, which might deter public participation or lead to misunderstandings.
Another potential issue is the connotation of the term "incident report," which might imply something negative or urgent. Individuals not familiar with the procedural nature of federal documentation may misinterpret the intent and use of the form.
Impact on the Public
For the broader public, this document offers a chance to engage with federal processes and voice their opinions on how information is collected in research involving human subjects. By seeking public comment, HHS demonstrates openness to feedback, which can enhance transparency and accountability. However, without clearer language and detailed context, public engagement might remain limited.
Impact on Specific Stakeholders
The proposed information collection primarily affects institutions conducting human subjects research, particularly those relying on federal support. These institutions must accurately comply with regulatory requirements, and the standardized form aims to simplify this process. While the initiative could potentially reduce administrative burdens for these institutions, misunderstandings or lack of clarity in the document might complicate adherence to regulatory requirements. Furthermore, other federal departments and agencies that adopt the Common Rule also rely on this information, potentially broadening the impact across various government sectors.
In summary, while the notice reflects an important step in regulatory compliance and public engagement, clearer communication and simplification of technical language could greatly enhance its effectiveness and accessibility for both the general public and specific stakeholders.
Issues
• The document uses a lot of bureaucratic and technical language that may be difficult for the general public to understand, such as 'Assurance Identification/IRB Certification/Declaration of Exemption Form', 'OMB No. 0990-0263', and 'Federal Policy for the Protection of Human Subjects (Common Rule)'.
• The purpose of the information collection and how it is used by the agency is not thoroughly explained in layman's terms, which might be confusing for people unfamiliar with the process.
• Contact information is provided, but additional context on what specific comments or feedback are being solicited could enhance public participation.
• The term 'incident report form' could imply something negative or urgent, which might not be entirely accurate and could lead to misunderstanding.