Compliance and Research Oversight Overview
undefined
Research Compliance
Cheryl Kitt, NIH
Alexandra Albinak, JHU
Research Compliance
Reviews existing and new administrative
requirements imposed by federal regulations and
program officers related to but not limited to the
human research participant protections, animal use
and care, conflicts of interest (individual and
institutional), objectivity in research, and export
controls. The emphasis should be on harmonization
of requirements across federal agencies, reduction of
redundancies and identifying good practices.
Conflict of Interest
Co-chairs: Diane Dean, Clint Schmidt
•
Survey of COI procedures and practices
•
Will be sent out late winter or early spring
•
Report on national trends in COI management
•
Compilation of effective practices on managing COI
Data Stewardship
Co-chairs: Melissa Korf, Richard Ikeda
•
Data Transfer and Use Agreement (DTUA) template project
•
First version to be disseminated next month
•
Next version will include terms for sharing identifiable
human data
•
Glossary – Draft released for comment in September 2016
•
Decision Tree and FAQ next steps
•
Data Stewardship Survey
•
Requested that the membership complete a survey in
Sept-Oct 2016 to help us set priorities and determine
future projects
•
Results discussed during Contracts session Tuesday
morning
Animal Care and use
Co-chairs: Susan Silk, Ara Tahmassian
•
Compliance Unit Standard Procedure [CUSP]
sharing site (Animal Care and Use Subcommittee)
•
DEA issues
Human Subjects
Co-chairs: Jane McCutcheon, Debra Murphy, Ann Hardy,
Petrice Brown-Longenecker
•
Exempt Wizard
•
In data analysis phase and results expected late winter
or early spring
•
Upcoming HS policies
•
Single IRB requirement including uniform reliance
agreements
•
Clinical trials reporting – to be discussed later today
•
Proposed changes to Common Rule
Lab Safety
Co-chairs: Robert Nobles, Alice Young
•
APLU lab safety report (
http://www.aplu.org/projects-and-
initiatives/research-science-and-technology/task-force-
laboratory-safety/
)
•
Review possible grant requirements regarding safety
•
Changes to journal policies. (e.g. the American Chemical
Society, first announced here:
http://pubs.acs.org/doi/abs/10.1021/acscentsci.6b00341
This document provides insights into various compliance initiatives, including research participant protections, animal care, conflict of interest, and data stewardship. It highlights the importance of harmonization, reducing redundancies, and identifying best practices to meet federal regulations effectively. The information covers key areas such as human subjects, lab safety, and COI management trends.
Download Presentation
Please find below an Image/Link to download the presentation.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.If you encounter any issues during the download, it is possible that the publisher has removed the file from their server.
You are allowed to download the files provided on this website for personal or commercial use, subject to the condition that they are used lawfully. All files are the property of their respective owners.
The content on the website is provided AS IS for your information and personal use only. It may not be sold, licensed, or shared on other websites without obtaining consent from the author.
E N D
Presentation Transcript
Research Compliance Cheryl Kitt, NIH Alexandra Albinak, JHU
Research Compliance Reviews existing and new administrative requirements imposed by federal regulations and program officers related to but not limited to the human research participant protections, animal use and care, conflicts of interest (individual and institutional), objectivity in research, and export controls. The emphasis should be on harmonization of requirements across federal agencies, reduction of redundancies and identifying good practices.
Conflict of Interest Co-chairs: Diane Dean, Clint Schmidt Survey of COI procedures and practices Will be sent out late winter or early spring Report on national trends in COI management Compilation of effective practices on managing COI
Data Stewardship Co-chairs: Melissa Korf, Richard Ikeda Data Transfer and Use Agreement (DTUA) template project First version to be disseminated next month Next version will include terms for sharing identifiable human data Glossary Draft released for comment in September 2016 Decision Tree and FAQ next steps Data Stewardship Survey Requested that the membership complete a survey in Sept-Oct 2016 to help us set priorities and determine future projects Results discussed during Contracts session Tuesday morning
Animal Care and use Co-chairs: Susan Silk, Ara Tahmassian Compliance Unit Standard Procedure [CUSP] sharing site (Animal Care and Use Subcommittee) DEA issues
Human Subjects Co-chairs: Jane McCutcheon, Debra Murphy, Ann Hardy, Petrice Brown-Longenecker Exempt Wizard In data analysis phase and results expected late winter or early spring Upcoming HS policies Single IRB requirement including uniform reliance agreements Clinical trials reporting to be discussed later today Proposed changes to Common Rule
Lab Safety Co-chairs: Robert Nobles, Alice Young APLU lab safety report (http://www.aplu.org/projects-and- initiatives/research-science-and-technology/task-force- laboratory-safety/) Review possible grant requirements regarding safety Changes to journal policies. (e.g. the American Chemical Society, first announced here: http://pubs.acs.org/doi/abs/10.1021/acscentsci.6b00341
