Guide to Services

Assurances and Regulations

The principal investigator (PI), USU, HJF Regulatory Affairs Department and the three research administrative offices at HJF (Office of Sponsored Programs, Clinical Trials Department and Contracts Department) are all responsible for ensuring that the application/proposal complies with applicable federal laws and regulations, sponsor policies and regulations, site requirements, HJF policies and the terms of the award document.

Note:
USU must approve all protocols involving human and animal use for all USU faculty and researchers. As the official recipient of the award, HJF is required to collect additional documentation (please see the HJF Regulatory Affairs Checklist).

The time to address many of the compliance issues is at the proposal development stage with HJF and/or the USU Office of Research Administration (REA). Some federal sponsors require assurances as part of the proposal submission process, while other sponsors require documentation at the time of award.

An award cannot be set up in the HJF accounting system until all necessary regulatory compliance documents have been received.

For questions or assistance, contact the Regulatory Affairs Department.

Guidelines for Use of Human and Animal Subjects

Generally, all sites where research is conducted require approval. For research involving humans, Institutional Review Board (IRB) approval is required. An Institutional Animal Care and Use Committee (IACUC) approves research involving animals. For research conducted at USU, the USU Office of Research must approve all protocols involving human and animal use for all USU faculty and researchers.

Refer to HJF's Regulatory Affairs Checklist for guidance on the use of human and animal subjects.

International Compilation of Human Research Standards

The 2019 edition of the International Compilation of Human Research Standards has been released and is now available online by clicking here. The Compilation features listings of over 1,000 laws, regulations and guidelines on human subject protections in 131 countries, as well as standards issued by a number of international and regional organizations. 

The updated edition includes hundreds of updates from the previous year. One new country is included in the 2019 edition: El Salvador. 

The listings are organized into nine categories:

1.         General Research
2.         Drugs and Devices 
3.         Clinical Trial Registries 
4.         Research Injury
5.         Social-Behavioral Research
6.         Privacy/Data Protection 
7.         Human Biological Materials
8.         Genetic Research
9.         Embryos, Stem Cells, and Cloning 

Many of the listings include a hyperlink that allows the user to directly access the law, regulation or guideline of interest. 

Prepared by the Office for Human Research Protections of the U.S. Department of Health and Human Services, the Compilation is designed for use by IRBs, researchers, sponsors and others involved in human subjects research around the world. The Compilation was first published in 2005 and is updated annually. 

Changes to the Common Rule

The U.S. Department of Health and Human Services (DHHS) and 15 other Federal Departments and Agencies have issued final revisions (the Final Rule) to the Federal Policy for the Protection of Human Subjects (the Common Rule). The effective date for full implementation is Jan. 21, 2019, for any ongoing or new studies initiated on or after this date. More information can be found at:

DHHS Policy: https://www.hhs.gov/ohrp/regulations-and-policy/regulations/finalized-revisions-common-rule/index.html

Federal Register - Final Rule: https://www.federalregister.gov/documents/2017/01/19/2017-01058/federal-policy-for-the-protection-of-human-subjects

There are four main changes to the Final Rule to better protect human research subjects and to reduce administrative burden:

  • Exemptions—There are new and revised categories when determining if a protocol falls under exempt from IRB review.
  • Continuing Review for Minimal Risk Studies—Continuing review may not be required for some minimal risk research.
  • Consent Forms—New requirements regarding the information that must be given to prospective research subjects as part of the informed consent process. 
  • Other/Miscellaneous—Thesingle IRB of record change in the Common Rule will take effect in January 2020.  

Please note the Final Rule requires a copy of the IRB-approved informed consent form (ICF)to be posted on a publicly available federal website no later than 60 days after the last study visit of any subject, without any signatures, for each clinical trial conducted or supported by a Common Rule department or agency. The Office for Human Research Protections (OHRP) has identified two publicly available federal websites that will satisfy the consent form posting requirement:

  1. http://ClinicalTrials.gov 
  2. a docket folder on http://Regulations.gov.

HJF’s Office of Regulatory Affairs and Research Compliance will create an account for you on clinicaltrials.gov so you can post the informed consent.

Please work with the Office of Regulatory Affairs & Research Compliance (240-694-4026 or regulatoryaffairs@hjf.org) to determine whether your research will be subject to the new requirements and learn about the specifics of these new rules.

Updating Your Protocol for New Common Rule

FROM WRNMMC: Beginning in early 2019, changes will be made in the Common Rule, which governs the ethics of human subjects research. Studies approved by the Institutional Review Board before Jan. 21, 2019 can use the 1991 version, but those approved for the first time after Jan. 20, 2019 must follow the new Common Rule.             

The accompanying release notes spell out related updates to the Electronic Institutional Review Board. Be sure to review all three pages. Meanwhile, here are some highlights:

  • New Privacy Forms and Checklists, which reflect Common Rule changes, are located in the Resource Center.
  • A revised Informed Consent document is located in the Resource Center and the Protocol Manager.
  • The Protocol Application is changed in four sections: 10.2, 10.4, 10.7 and 13.5.
  • The Continuing Review form is updated in three sections: Current Project, Study Status and Consent Upload.
  • The Modification form is changed in sections 2.2 and 2.4.
  • Researchers with new studies (unapproved as of Jan. 21) must check their entire form for accuracy.

Please see the release notes for details. 
NOTE: If you are unable to open the embedded files in the release notes, please contact the WRNMMC IRB.