FR 2021-01205

Overview

Title

Human Studies Review Board; Notification of Public Meetings

Agencies

ELI5 AI

The Environmental Protection Agency (EPA) is having online meetings this year to talk about how they make sure that research on people is done safely and fairly. They are telling people about these meetings at the last minute and you can talk or write to them if you have something to say, but there are some rules and limits.

Summary AI

The Environmental Protection Agency (EPA) has announced the dates for the 2021 virtual public meetings of the Human Studies Review Board (HSRB). These meetings are intended to provide advice on the ethical and scientific review of research involving human subjects. Four three-day meetings will occur from January to October, and they are accessible to the public online. Individuals interested in participating can pre-register for oral comments or submit written comments to be considered by the Board. Meeting minutes and final reports will be available online 90 days after each meeting.

Abstract

The Environmental Protection Agency (EPA), Office of Research and Development announces the 2021 public meetings dates of the Human Studies Review Board (HSRB) to advise the Agency on the ethical and scientific review of research involving human subjects. Due to unforeseen circumstances, EPA is announcing this meeting with less than 15 calendar days' notice.

Type: Notice
Citation: 86 FR 6325
Document #: 2021-01205
Date:
Volume: 86
Pages: 6325-6326

AnalysisAI

The Environmental Protection Agency (EPA) has announced the dates and details for the 2021 public meetings conducted by the Human Studies Review Board (HSRB). These meetings, set to be held virtually, are designed to provide advice on the ethical and scientific review of research involving human subjects. Four three-day meetings will take place between January and October, with additional teleconference meetings planned to finalize reports. Public engagement is encouraged, offering opportunities for oral comments and written submissions.

General Summary

The document outlines the schedule for the 2021 meetings of the Human Studies Review Board (HSRB), a body that assists the EPA by reviewing research involving human subjects. The inclusion of both ethical and scientific perspectives highlights the dual focus of these discussions. Held virtually due to current circumstances, these meetings are open for public participation, which includes pre-registration for oral comments and submission of written comments. The availability of meeting minutes and reports ensures transparency and accountability in the Board's deliberations.

Significant Issues and Concerns

Several concerns are notable in this announcement. First, the notice for the first meeting was provided with less than 15 days' notice, citing 'unforeseen circumstances.' Such short notice can impact transparency and limit accessibility for interested parties. Furthermore, by offering information primarily via the website, individuals without internet access may face challenges in participating fully. The procedures for providing oral and written comments—requiring contact with a specific Designated Federal Official—may also seem cumbersome to potential participants, as more streamlined options could facilitate broader engagement. Additionally, the limitation of five minutes for oral comments could restrict the depth of input on complex issues.

Impacts on the Public and Stakeholders

For the general public, these meetings represent an opportunity to gain insight into how research involving human subjects is managed and evaluated ethically and scientifically. By making the meetings accessible online, the EPA ensures that information and participation are within reach for many, although this does not completely alleviate accessibility issues for those who are less tech-savvy or without internet access.

Specific stakeholders, such as researchers, advocacy groups, and individuals directly involved in studies, could be significantly impacted by the outcomes of these meetings. The procedures and guidelines discussed and recommended by the HSRB may influence the regulatory environment surrounding human subjects research. While the opportunity for input is positive, the limitations and potential barriers to effective participation could skew the breadth of perspectives considered.

Conclusion

Overall, while the EPA’s continuation of these important meetings through virtual means during challenging times is commendable, the approach to public notice and participation presents areas for improvement. By addressing these issues, the EPA could enhance the inclusivity and effectiveness of the HSRB's work, ensuring that a broader range of voices and concerns are adequately heard and considered in its deliberations.

Issues

  • • The notice of the meeting is given with less than 15 calendar days' notice due to 'unforeseen circumstances,' which might raise concerns about the transparency and accessibility of the meeting to the public.

  • • Information on how to access the meeting and related materials is only available on the HSRB website. This might disadvantage people without internet access or those who are not proficient in navigating online resources.

  • • The requirement to contact the DFO, Thomas O'Farrell, for oral and written comments might be a barrier to participation for some members of the public, as opposed to having more streamlined and multiple channels for communication.

  • • The provision for oral comments during meetings being limited to five minutes per individual or organization may be restrictive, especially for complex or significant issues that require more time to address.

  • • Written comments submitted after the deadline will still be provided to the HSRB members but may not be adequately considered before discussion, suggesting a potential issue with timing and comprehensive input consideration.

Statistics

Size

Pages: 2
Words: 940
Sentences: 42
Entities: 86

Language

Nouns: 300
Verbs: 68
Adjectives: 51
Adverbs: 13
Numbers: 56

Complexity

Average Token Length:
5.24
Average Sentence Length:
22.38
Token Entropy:
5.16
Readability (ARI):
17.96

Reading Time

about 3 minutes