Guide to Services
- Research Administration
- Clinical Trials
- Initiate a Clinical Trial
- Prepare a Protocol
- Protocol Approval
- Track Patient Visits
- Close a Clinical Trial
- Clinical Trials FAQs
- Subcontract and Vendor Contract Services
- Subaward Services
- Consulting Agreements
- Lease & Renovation Services
- Regulatory Affairs
- Human Resources
- Occupational Safety and Health
- Purchasing & Reimbursements
- Financial Reports
- Graphics & Communications
- Information Technology
- Technology Transfer & Commercialization
Research Management & Clinical Trials
A clinical trial is an investigator- or sponsor-initiated study using a study drug or study device on a human subject. All clinical trials involve human use, but not all human use studies are clinical trials. HJF has extensive experience managing clinical trials in the military medical community, including Phase I-IV, single- and multi-site trials. Our responsive and focused infrastructure enables you to accomplish your research goals quickly and cost effectively.
As an HJF customer, you have access to our extensive research support services. Our Research Management Office and Clinical Trials Department provides personal assistance to help minimize administrative burdens.
This section will guide you through the pre- and post-award activities associated with clinical trials.
Because of the unique nature of clinical trials and their funding, all hiring, purchasing and travel requests should go through the Research Management Office or to the Clinical Trials Department. Please contact the department directly for further information.
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:
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:
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 firstname.lastname@example.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.
Registering a Clinical Trial
PIs of government-funded clinical studies are encouraged to register their studies with the service ClinicalTrials.gov. In September 2004, the members of the International Committee of Medical Journal Editors (ICMJE) implemented a requirement that PIs or other responsible parties register their clinical trials with this NIH system as a prerequisite for publication of research findings.
The goal of the registry is to foster a comprehensive, publicly available database of clinical trials. The registry also provides a mechanism to thank clinical trial participants and to let them know that the information that accrues from these studies is part of the public record, where it is available to guide decisions about patient care.
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.