Overview
Protecting the rights, safety, and well-being of research participants is a fundamental responsibility of MedStar Health Research Institute (MHRI).
MHRI's Human Research Protection Program (HRPP) oversees research involving human participants conducted across MedStar Health and ensures that studies meet the highest ethical, regulatory, and scientific standards. The program brings together the Office of Research Compliance, Office of Research Integrity, Office of Grant and Contract Management, and Institutional Review Board (IRB) to provide comprehensive oversight and support for human subjects research.
MHRI is accredited by the Association for the Accreditation of Human Research Protection Programs (AAHRPP), the nation's leading accrediting body for human research protection programs. This accreditation reflects our commitment to ethical research practices, continuous improvement, and the protection of research participants.
All research involving human participants conducted under the auspices of MedStar Health must receive appropriate institutional and IRB review and approval before any research activities begin.
HRPP scope and authority
The HRPP oversees:
- Funded and unfunded human subjects research conducted at MedStar Health facilities
- Research conducted by MedStar Health associates, faculty, and students
- Research reviewed by either the MedStar IRB or an authorized external IRB operating under a reliance agreement
Institutional oversight
MedStar Health maintains a Federal wide Assurance (FWA00000504) with the U.S. Department of Health and Human Services, affirming its commitment to protecting human research participants and complying with applicable federal regulations.
Institutional Review Board (IRB)
The MedStar IRB is responsible for reviewing research involving human participants to ensure that studies are ethical, scientifically sound, and appropriately safeguard participant rights and welfare. The IRB serves MedStar Health facilities and approved external collaborators.
HRPP training | Conflict of interest reporting | Revised common rule | Institutional review boards | Other resources
Any individual engaged in human subjects research is required to have training. You can find details on what training courses and how to access the training in this FAQ. CITI training can be accessed at www.citiprogram.org.
Institutional Review Boards (IRBs) assure that all human research conducted under the auspices of MedStar Health are ethically and methodologically sound as required under public law and, most importantly, as expected by the public trust. All research (whether funded or not) involving human participants conducted at MedStar Health must be reviewed by an IRB prior to the initiation of the research. IRBs are concerned with protecting the welfare, rights, and privacy of human subjects. The IRB has the authority to approve, disapprove, monitor, and require modifications in all research activities that fall within its jurisdiction as specified by both the federal regulations and institutional policy. Other resources
MHRI IRB
The Human Research Protection Programs (IRBs) at MedStar Health uses an electronic system to manage their respective Human Research Protection Programs and the IRB review process. Learn more about the process for MHRI’s IRB here.
Georgetown-MedStar eIRB
Georgetown University and MedStar Health implemented a new eIRB system to replace their existing systems in Fall 2018. The eIRB platform can be accessed at gumedstarirb.georgetown.edu/IRB. More information, including training materials, policies, and templates are available here.
GHUCCTS IRB
Georgetown Howard Universities Center for Clinical and Translational Science (GHUCCTS) Institutional Review Board is the IRB for the GHUCCTS consortium; its purpose is to review consortium research studies. Learn more about this IRB here.
External or single IRBs
When collaborating with other institutions, sometimes a single or joint IRB review may be preferred over separate reviews at each institution. The institution will enter into an IRB authorization agreement with other institutions, a Central IRB, and/or Independent IRB with whom the institution and employees collaborate on single or multiple projects. Learn more about this process at MedStar Health here.
The revised common rule is an exciting opportunity for the future of clinical research. MHRI made updates to bring our IRB submission processes into compliance with the new rule by January 21, 2019. The implementation of the new IRB system along with the introduction of a new informed consent template, limited IRB review, and new continuing review options are all part of that process. For more information on Common Rule regulation changes, please see below, and feel free to reach out to the ORI at MHRI-ORIHelpDesk@MedStar.net. if you have a question that is not answered here.
Categories of studies
- Exempt determination
- Expedited categories
Q&As on MHRI IRB
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How will MHRI address Revised Common Rule consent form requirements?
- Investigators generally will have to comply with the revised common rule requirements for informed consent after the January 21, 2019 compliance date. These requirements will be enforced at the time of continuing review or modification, whichever comes first. The ORI will work with investigative sites to help review and edit consent forms for studies submitted under the new Common Rule. In addition, MHRI has revised our consent form templates (available through the link above and in the eIRB system library) to accommodate the new consent elements (e.g., concise summary of key information).
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Will MHRI be responsible for posting consent forms to the public federal website as required for federally funded studies?
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No, the research sponsor is ultimately responsible for compliance with this requirement; however, MHRI will be happy to work with investigators and sponsors to ensure that consent forms meet the criteria for posting (e.g., contain the requisite information and suggestions for redaction).
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What is broad consent?
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Broad consent is a non-study specific consenting avenue that can be utilized for both exempt and non-exempt secondary research use of identifiable private information or identifiable specimens (including storage and maintenance of specimens for such use). The revised Common Rule provides a new voluntary option for consent for the storage/maintenance/future use of identifiable data and biospecimens. Currently, researchers have the options to obtain consent from subjects or ask the IRB for a consent waiver. Broad consent is now an additional consent option for these specific activities. Once implemented, the institution is required to keep track of any individual’s refusal to provide broad consent so that the IRB does not waive consent for that individual in the future. MHRI supports the concept behind the broad consent portions of the Common Rule revisions and will support a broad consent process once a technical infrastructure is implemented to track which individuals have been approached and whether they denied broad consent. Since the technical aspects of broad consent have not yet been addressed nationally or locally, MHRI has opted NOT to adopt the broad consent provisions. More information will follow once it is available.
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What is limited IRB review?
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Limited IRB review is focused on reviewing studies (certain categories of exempt research) to ensure adequate privacy and confidentiality safeguards, especially for exempt research utilizing individually identifiable information/biospecimens.
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Note: HHS plans to release guidance in the future, establishing standards for this category of review. MHRI policies and procedures will be in line with guidance when it is issued.
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Will MHRI offer review for all categories of exempt research as promulgated in the revised Common Rule?
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Yes, MHRI will provide review for all categories of exempt research as promulgated in the revised Common Rule.
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Will MHRI apply the new Common Rule criteria when conducting a continuing review?
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Yes, MHRI will conduct continuing review under the new Common Rule criteria for continuing reviews that take place after January 21, 2019. Continuing review will no longer be required for studies that meet the following conditions: (1) eligible for expedited review, (2) research that underwent “limited review,” and (3) research that has progressed and involves only data analysis and/or accessing follow up clinical data for standard of care procedures. Despite the elimination of the continuing review requirement, institutions have the flexibility to require an accounting of ongoing research. At MHRI, one final formal continuing review submission and approval will be required and the IRB will make a risk determination based on the nature of the protocol and history of review whether to require an additional check-in for studies that fall into the above categories of review.
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The MedStar Health Research Institute utilizes Sabai IBC Services and WCG IBC for Institutional Biosafety Committee (IBC) review. The IBC reviews and monitors all research activities involving infectious agents, hazardous chemicals, recombinant DNA, and genetically altered organisms and agents.
Biohazards are defined as biological agents and materials which are potentially hazardous to humans, animals and other forms of life. They include known pathogens and infectious agents including bacteria and their plasmids and phages, viruses, fungi, mycoplasmas, and parasites. Also included are potentially biohazardous organisms used in procedures such as recombinant DNA and genetic manipulations. Biohazards are to be classified according to risk levels requiring appropriate containment.
To submit your study for for Sabai IBC review, please contact Sabai IBC Services at info@sabaiglobal.com.
To submit your study for WCG IBC review, please contact WCG IBC please see instruction on the WCG web site for “Site-level Study Submission.”