Under the mandate of The Belmont Report, various ethical codes of conduct, and the U.S. Code of Federal Regulations, the MedStar Health Institutional Review Boards (IRB) are responsible for assuring the ethical protection of the rights and welfare of human subjects from research risks. The MedStar IRBs serve the human research needs of the various MedStar Health facilities as well as those of extramural collaborators. The IRBs assure that all human research conducted under the auspices of MedStar Health is ethically and methodologically sound as required under public law and, most importantly, as expected by the public trust.
MedStar Health Research Institute (MHRI) is the executive agent for research and provides central business, technical, administrative, financial, and regulatory infrastructure for employees and agents conducting research across MedStar Health.
MedStar Health Research Institute has established a system-wide Human Research Protection Program (HRPP) to oversee research conducted with human subjects. The team is comprised of staff in the Office of Research Compliance, staff in the ORI, staff in the Office of Grant and Contract Management and MHRI Institutional Review Board (IRB) with reliance agreements in place to rely on other authorized external IRBs.
The Human Research Protection Program (HRPP) jurisdiction extends to all research (funded and unfunded) involving human subjects conducted at MedStar Health by MedStar Health employees, faculty and students, as well as research conducted elsewhere by MedStar Health employees, faculty, and students, excluding research where involvement of human subjects falls within one or more exempt categories. This jurisdiction is effective regardless of the IRB of record reviewing the research study.
All faculty, students and staff who wish to conduct research with human subjects at any MedStar Health-owned or sponsored facility must obtain appropriate institutional and IRB approval before undertaking such research. No research with human subjects may commence without the approval of an authorized Institutional Review Board (IRB).
MedStar Health has a Federal Wide Assurance (FWA) to cover all of its facilities, which assures the Department of Health and Human Services (DHHS) that it will follow procedures to assure the protection of human subjects involved in research projects. The MedStar Health Federal Wide Assurance number is FWA00000504.
To learn more about the HRPP plan at MedStar Health, click here.
Human Research Protection Program Training
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.
MHRI Conflict of Interest Reporting
All researchers must complete a Conflict of Interest questionnaire. To receive instructions for completing the online disclosure form, please contact the MHRI Conflict of Interest Official here. To review the MedStar Health conflict of interest policy, click here.
The Revised Common Rule and Review by the MHRI IRB
The Revised Common Rule is an exciting opportunity for the future of clinical research. MHRI has been making updates to bring our IRB submission processes into compliance with the new rule by Jan 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 [email protected] if you have a question that is not answered here.
Categories of Studies
- Exempt Determination
- Expedited Categories
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).
Will MHRI be responsible for posting consent forms to the public federal website as required for federally funded studies?
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).
What is broad consent?
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.
What is limited IRB review?
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.
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.
Will MHRI offer review for all categories of exempt research as promulgated in the revised Common Rule?
Yes, MHRI will provide review for all categories of exempt research as promulgated in the revised Common Rule.
Will MHRI apply the new Common Rule criteria when conducting a continuing review?
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 post 1/21/19 and after that, moving forward, 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.
Institutional Review Boards
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.
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 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.
Georgetown Howard Universities Center for Clinical and Translational Science 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.