Regulatory, Ethics, Knowledge and Support

  1. What's It All About?
  2. Who is Responsible?
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  4. Resources
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For Investigators:

For application forms for IRB Review, please go to your sponsor institution IRB site.

We also do provide assistance with study design and ethical consultations. Please contact the program director for more information. For application forms for IRB Review, please go to your sponsor institution IRB site.

The Georgetown Clinical Research Network (CRN) Seminar Series is co-sponsored by GHUCCTS and the Clinical Trials Office, and is open to all individuals interested in clinical research at Georgetown University. Seminars take place on the 4th Thursday of each month at 12:30PM in the Warwick Evans Conference Room in Building D.  The seminar schedule is available here.

The Research Team Training series is designed for new research professionals who, manage and oversee one or more aspects of research studies involving human subjects. This is in addition to any CITI research training requirements your organization has. Target audience that may benefit from the workshop include Clinical Research Coordinators, Clinical Research Nurses, Clinical Research Staff and Research Investigators as well as Research Administrators and Assistants.


Online Resources & Training


GHUCCTS


Good Clinical Practice (GCP)

As you are aware, as of January 1, 2017, NIH requires all PIs and clinical research team members who are supported in whole or in part by NIH funds, to complete GCP training. Investigators and others are expected to refresh their training every three years. The resources linked below are available to the Georgetown research community to satisfy these requirements.  When the courses are completed, each researcher should print and maintain the certificate of completion that is provided. You will be required to produce proof of completion to the IRB in order to obtain IRB approval of clinical research!

For biomedical researchers: CITI training module instructions and access
For social and behavioral researchers: Society of Behavioral Medicine GCP eLearning Course 

Training materials were developed by the Clinical and Translational Science Awards Program, funded by the NIH National Center for Advancing Translational Science. SBM is hosting the training at the request of the NIH Office of Behavioral and Social Sciences Research.

Good Laboratory Practices (GLP) 

GLP training modules also are now available for faculty, students, and staff as part of the Georgetown University suite of training modules from CITI.

Additional Training:

Research Misconduct Resources from the Office of Research Integrity

ClinicalTrials.gov Training Materials

Trial Reporting in ClinicalTrials.gov - The Final Rule by D. Zarin, T. Tse, R. Williams, and S. Carr.

Institutional Conflict of Interest: A First Look Webinar


Clinical Trial Registration and Results Reporting


ClinicalTrials.gov Background
ClinicalTrials.gov Results Database


Food and Drug Administration (FDA)


Dietary Supplements - FDA

Apr 13, 2018 - FDA regulates both finished dietary supplement products and dietary ingredients. FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Dietary Supplements Guidance | ‎Information for Industry | ‎New Dietary Ingredients

Botanical Drug Development Guidance for Industry - FDA

FDA: For Scientists and Researchers

FDA Basics Document for Investigators

The FDA published draft guidance calling for the “judicious inclusion of pregnant women in clinical trials,” with “careful attention to potential fetal risk,” according to an article in Regulatory Focus. Read More

FDA Doubles Down on Efforts to Develop Guidance for Clinical Trial Stakeholders
The U.S. Food and Drug Administration (FDA) has updated its information sheet on payments to clinical trial subjects, including travel reimbursements. The National Law Review, February 8, 2018



The NIH single IRB [sIRB] requirement for multi-site research is effective as of January 25, 2018. 

Applicants will be expected to include a plan for the use of a sIRB in the grant applications and contract proposals they submit to the NIH (for due dates on or after January 25, 2018).

It is likely that GU will use an external, commercial IRB for NIH funded studies that include more than 2 or 3 sites.  The cost for services of the commercial IRB should be included as a Direct Cost in the study budget.  These are permissible Direct Costs because commercial IRB costs are not included in the F&A negotiated rate.  

Before submitting grant applications to NIH for human research that will involve multi sites, please contact the GU IRB to determine whether a commercial IRB will be used. We will help obtain documentation for you to use to justify the IRB budget. We have a commitment from Western IRB to provide a letter with an IRB budget for the life of the study that you can use in support of the Direct Cost budget item.

Additional NIH information and other examples (though less relevant to our specific institution) are available at https://grants.nih.gov/grants/guide/notice-files/NOT-OD-16-109.html.

Reliance on an External IRB

Whenever the Institution relies upon an IRB operated by another institution or organization for review of research to which the FWA applies, the Institution must ensure that this arrangement is documented by a written agreement between the Institution and the other institution or organization operating the IRB that outlines their relationship and includes a commitment that the IRB will adhere to the requirements of the Institution’s FWA. OHRP’s sample IRB Authorization Agreement may be used for such purpose, or the parties involved may develop their own agreement. This agreement must be kept on file at both institutions/organizations and made available upon request to OHRP or any U.S. federal department or agency conducting or supporting research to which the FWA applies.

Investigational New Drug (IND) Development Process
FDA: Investigational New Drug (IND) Application


Research Ethics


HHS - Office for Human Research Protections (OHRP)

Federal Policy for the Protection of Human Subject ('Common Rule') 45 CFR part 46

Clinical Trial Informed Consent (45 CFR 46.116): The revised Common Rule requires that for any clinical trial conducted or supported by a Common Rule department or agency, one consent form be posted on a publicly available federal website within a specific time frame. 

Federalwide Assurance (FWA) for the Protection of Human Subjects

The Bioethics Research Library at Georgetown University

National Center for Professional & Research Ethics (NCPRE)


Regulations, Policies and Guidance


NIH Definition of a Clinical Trial:
(This is significant in determining what needs to be registered on clinicaltrials.gov and when results are required to be reported)

A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.   

See FAQs and Case Studies on the NIH webpage to determine if your research is considered a clinical trial. 

* This is relevant to funding opportunities, obligations of registration and results reporting via ClinicalTrials.gov, and to sIRB requirements.

NIH - Research and Training Resources

NIH Research Methods Resources

The NIH is launching a series of initiatives in 2017–2018 to enhance the accountability and transparency of clinical research. These initiatives target key points along the entire clinical trial lifecycle, from concept to results reporting.

The Research Methods Resources website provides investigators with important research methods resources to help them satisfy these new requirements. While the website currently only addresses methodological issues inherent in trials that randomize groups or deliver interventions to groups, new methods-related topics and resources will be added in the future. For a guided tour of this website, please refer to a recent Mind the Gap webinar, which presents additional information about its relevance to the new NIH requirements for clinical trials applications, a summary of the methodological issues inherent in nested study designs, and a demonstration of how to use the Group-Randomized Trials (GRT) Sample Size Calculator.


Working with Special Populations


Inclusion Across the Lifespan:

The Inclusion Across the Lifespan Policy (NOT-OD-18-116) applies to all grant applications for human subject research submitted on or after January 25, 2019.

The purpose of this policy is to ensure individuals are included in clinical research in a manner appropriate to the scientific question under study so that the knowledge gained from NIH-funded research is applicable to all those affected by the researched diseases/conditions. The policy expands the Inclusion of Children as Participants in Clinical Research Policy to include individuals of all ages. The policy also:

  • Clarifies potential justifications for age-based exclusion criteria
  • Requires participant age at enrollment to be provided in progress reports

See the NIH Policy Information website for links to the policies and additional information.         

Sex as a Biologic Variable:

NIH expects that sex as a biological variable will be factored into research designs, analyses, and reporting in vertebrate animal and human studies. Strong justification from the scientific literature, preliminary data, or other relevant considerations must be provided for applications proposing to study only one sex. Investigators are strongly encouraged to discuss these issues with NIH program staff prior to submission of applications. Consideration of Sex as a Biological Variable in NIH-funded Research.

Women's Health - VA Research - Veterans Affairs:

New initiatives to accelerate women Veterans' healthcare research and its impacts include the VA Women's Health Research Network, the Women Veterans' Healthcare CREATE, and the EMPOWER Quality Enhancement Research Initiative (QUERI).


Rigor and Reproducibility


Enhancing Reproducibility through Rigor and Transparency  

Rigor and Transparency FAQ

Rigor and Reproducibility Training Resources

HHS - Office of Research Integrity (ORI) and ORI General Resources


Responsible Conduct of Research

US Office of Research Integrity (ORI)

AAMC: A Conversation: Considerations for Assessing Conflicted Investigators' Involvement in Research


Additional Useful Information


NIH - Genomic Data Sharing Policy

NIH - Office of Clinical Research and Bioethics Policy (OCRBP)

Society of Clinical Research Associates (SOCRA)

U.S. Patent and Trademark Office FAQs