Overview
Title
Agency Information Collection Request. 30-Day Public Comment Request
Agencies
ELI5 AI
The Department of Health and Human Services wants to make it easier for people to tell them about problems or accidents that happen in research with people. They're asking if anyone has ideas or thoughts about their new Incident Report Form by February 18, 2021, to help keep everyone safe during research.
Summary AI
The Office of the Secretary at the Department of Health and Human Services has announced a proposal involving a new information collection called the Incident Report Form. This form is intended to help organizations report incidents related to human subject protection more easily, using a simplified and standardized format. Public comments on this initiative are invited until February 18, 2021. The collection aims to ensure the safety of human research subjects and compliance with regulations in HHS-conducted or supported research.
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
In the Federal Register document from the Office of the Secretary of the Department of Health and Human Services, a proposal is announced regarding the introduction of a new information collection tool known as the Incident Report Form. This tool is intended to streamline how organizations report incidents related to human subject protection. The goal is to make this process more standardized and straightforward to ensure the safety and compliance of research involving human subjects. Public input on this proposal is welcomed until February 18, 2021.
General Summary
The proposal is part of a compliance effort with the Paperwork Reduction Act of 1995. The Incident Report Form is meant to help organizations that conduct or oversee research involving human subjects. The form aims to simplify the process of reporting any incidents that may occur during such research, allowing for easier analysis and corrective measures.
Significant Issues or Concerns
One of the primary concerns with this document is its lack of clarity for the general public. Terms such as "non-exempt," "OHRP," and "45 CFR part 46" are used without explanation, making it difficult for those unfamiliar with legal or technical jargon to understand the document. Additionally, there is no financial analysis or cost implications discussed, leaving questions about potential expenses or savings unaddressed.
Impact on the Public
For the general public, the introduction of this form could mean enhanced safety and ethical standards for human subject research. However, the comprehension of this document could be challenging due to its reliance on specialized knowledge. Enhancing public understanding could foster greater trust and transparency in research practices.
Impact on Specific Stakeholders
For institutions or organizations that conduct human subjects research, the form represents a significant development. It could potentially reduce the complexity of incident reporting, allowing these stakeholders to focus more on research while maintaining high ethical standards. On the flip side, the requirement for standardized reporting might involve adapting new procedures, which could initially introduce additional administrative burdens.
In summary, while the document outlines a potentially beneficial initiative for simplifying the research reporting process, it could be made more accessible through the inclusion of explanatory details and financial considerations. Such improvements could foster broader understanding and support from both the public and specific research entities.
Issues
• The document lacks detailed financial implications or cost analysis related to the proposed information collection, making it difficult to assess potential wasteful spending.
• There is no specific mention of particular organizations or individuals that might be favored. However, the type of respondents (institutions or organizations conducting certain research) might indirectly indicate certain beneficiaries.
• The term 'non-exempt HHS-conducted or -supported research' could be unclear to those unfamiliar with exemption criteria in human subjects research.
• The document uses terms like 'non-exempt,' 'OHRP,' and '45 CFR part 46' without explanation, which could be challenging for lay readers not versed in regulatory or research ethics terminology.
• The Supplementary Information section is concise but relies heavily on specialized knowledge, which may not be accessible to a broad audience.