Research Compliance News and Updates (January 2024)

By Deepika Bhatia, Associate Vice President, RCRA

Research Compliance News and Updates from Your Research Compliance & Regulatory Affairs Team

For ongoing updates on new policies and research regulatory topics, join us on the third Thursday of every month to Ask RCRA!

Here’s our quarterly newsletter with news you can use –  https://rcra.emory.edu/_includes/documents/newsletter-docs/october-2023-rcra-newsletter.pdf

We are here 24/7 to provide support, assistance and be compliant – rcra.emory.edu

NEW! Regulations in Effect

Federal Interim Rule Implements TikTok Ban on Devices Used in the Performance of Federal Contracts

A new Federal Acquisition Regulation (FAR 52.204-27) clause prohibits federal contractors and subcontractors from “having or using” the social networking service TikTok or any “successor application” developed by ByteDance, a Chinese internet technology company headquartered in Beijing, on any information technology system used or provided by the contractor in the performance of a government contract.
This ban affects not only institutionally owned and managed devices used for the conduct of federal research, but potentially personally owned devices of personnel involved in federally funded research, when those devices are used to conduct Emory business. As a federal contractor and subcontractor on various grants/contracts Emory is required to comply with the FAR statement above

See more information on Emory’s compliance efforts with the ban and responses to frequently asked questions on this topic – https://rcra.emory.edu/research-security/tik-tok.html

NIH Final Policy on Foreign Subawards (issued September 2023)

The NIH earlier this year announced policy guidance that would require foreign subrecipients of NIH-funded grants to provide copies of lab notebooks, data, and documentation supporting research outcomes to the prime recipient. This guidance was originally effective Oct. 1, 2023.

NIH has issued a final updated guidance and the key changes are as follows:
The new effective date is January 1, 2024. NIH expects recipients to update existing subaward agreements to address this requirement within 60 days of the effective date.
NIH is modifying the requirement for the required documentation from every quarter to “no less than once per year, in alignment with the timing requirements for Research Performance Progress Report submission.”
NIH will change the language from requiring foreign subrecipients to “provide copies” of lab notebooks, data, and documentation to “provide access to copies” and notes that this access may be entirely electronic.

Here is more information from our Research Security team – https://rcra.emory.edu/research-security/nih-foreign-subawards.html

REMINDER!  NIH Workplace Conduct Requirements

NIH supports safe and respectful work environments that are free from harassment, including sexual harassment, discrimination, or other forms of inappropriate conduct that can result in a hostile work environment. Learn who to contact with questions or concerns, and what NIH’s expectations are for institutions and the individuals supported on NIH-funded awards.

In accordance with NIH Notice NOT-OD-22-129, NIH requires institutions to notify NIH when a Program Director/Principal Investigator (PD/PI) or other Senior/Key personnel on an NIH grant or cooperative agreement notice of award is removed or otherwise disciplined due to concerns about harassment, bullying, retaliation, or hostile working conditions.

Emory is committed to NIH’s expectation that all NIH-funded research occurs in a harassment-free environment.

Emory has effective measures in place to address concerns and to safeguard the research environment. Allegations of harassment and bullying are investigated by the university when reported. Moreover, concerns about harassment and bullying can be reported through numerous means including, but not limited to, Human Resources, the Department of Equity and Inclusion, and through the Trust Line.

The Trust Line is run by an independent third-party and is designed for reporting potential ethical, legal, and/or business conduct violations or concerns at Emory in a confidential manner.

Concerns received via the Trust Line are then triaged to the appropriate office at Emory for review. The Trust Line is available by telephone and through an online reporting tool.

Information on the Trust Line is available here:

In addition, Emory also maintains numerous institutional policies to help foster a safe environment including the following:

Have questions on this regulation or need to report a concern? Contact researchcompliance@emory.edu 

ORCiD IDs @ Emory

ORCID iDs–or Open Researcher and Contributor Identifiers–are unique identifiers that you can use to ensure you are always correctly associated with and connected to your academic work. The iDs help Emory staff, funders, publishers, scholarly societies, and other researchers quickly find and distinguish your work from materials created by other researchers with similar names. ORCID iDs are being used increasingly by publishers such as the Royal Society, PLOS, the American Geophysical Union, BMJ, Wiley, and dozens more.

ORCID iDs are already required for all NSF, NIH, AHRQ, and CDC grant submissions, and all other federal agencies are expected to follow suit in the near future as called out in the August 22, 2022 White House Office of Science & Technology Policy Public Access Policy memo stating that no later than by the end of 2025 all federal funders will require grantees to obtain a unique digital persistent identifier (DPI) that meets the standards of a digital persistent identifier as defined in the  NSPM-33 Implementation Guidance—which ORCID iDs do.

Benefits of ORCID include:

  • Differentiate yourself from other researchers with the same or similar names
  • Collect works published under different versions of your name
  • Provide your ORCID iD to funders and publishers when required, and to colleagues who wish to view your works
  • Create an online research CV
  • ORCID iDs are increasingly being used by publishers, funders and other organizations to confirm identity and improve their workflows.

To get started with ORCID, follow these three steps:

  1. Get an ORCID iD for freeNavigate to https://orcid.emory.edu/ and click on “Create and Connect an ORCID iD” to register for an iD and connect it to Emory.
  2. Add your scholarly works: Once you’ve created your ORCID iD, you can add works to your record, set up automatic updates, or delegate management of your account to someone else.
  3. Use your ORCID iD: Include your ORCID iD on your webpage, when you submit publications, on grant applications, and in other research workflows to ensure that you get credit for your work.

IMPORTANT! When registering, make sure to click on “EVERYONE” in the “Visibility Settings” portion of the form. Doing so will make your research more visible and discoverable, and you will reap all the benefits of having an ORCID iD. Note: your email address(es) are always kept private.

For more information:

ORCID.org Support

ORCID at Emory

ResearchSecurity@Emory.edu

COMING UP! HHS Office of Research Integrity (ORI) Notice of Proposed Rule Making (NPRM)

In this Notice of Proposed Rulemaking (NPRM) released in October 2023, the Department of Health and Human Services (HHS), Office of the Secretary, Office of the Assistant Secretary for Health (OASH), Office of Research Integrity (ORI) proposed to revise the Public Health Service (PHS) Policies on Research Misconduct. The proposed revisions are based on the experience ORI and institutions have gained with the regulation since it was released in 2005.

Research Misconduct allegations are managed in accordance with Emory Research Misconduct Policy 7.8.

Emory’s Research Integrity team submitted comments to voice our opinions on the NPRM. We will keep the Emory research community updated as we receive more information on the new ORI regulations.

Know your Emory Research Integrity Team

DECIDING OFFICIAL (DO)

Robert Nobles, DrPH, MPH, CIP

RESEARCH INTEGRITY OFFICER (RIO)

Deepika Bhatia, MSBME, CCRP, CHRC, CHPC, CCEP

DEPUTY RIO

Maria Davila, MD, MA (Bioethics), CCRC, CIP

RESEARCH INTEGRITY MANAGER

Danisha Biossat, BA

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