Sorting out Single IRB Review: What Investigators Need to Know at MHRI

As of January 2018, most non-exempt multi-site human subjects research (HSR) projects funded through NIH agencies require single IRB review. Additionally, in recent years, there has been an increasing trend toward the use of a single IRB (sIRB) review for multi-site HSR projects funded through other sources.  Specifically, many commercial sponsors prefer single IRB review for their multi-site projects.

Finally, the revised common rule includes a requirement for single IRB review of most federally funded multi-site non-exempt human subjects research projects. Initially, the Office of Human Research Protections (OHRP) indicated only that compliance with this common rule requirement was required starting on January 20, 2020. In a recent communication OHRP clarified that although sIRB review is required for all federally funded multi-site non-exempt HSR projects, the agency has granted an exemption for all projects approved prior to January 20, 2020. This eliminates the need to transition currently approve projects from review by multiple IRBs to sIRB review.

For all future federally-funded projects, it is strongly suggested that investigators include IRB review fees in the budget for their grant proposals. In most cases it is assumed that sIRB review will be conducted by a commercial IRB (such as WIRB or Advarra) or a larger academic/medical institution IRB. In some limited cases, the MHRI IRB may agree to serve as the IRB of record for a multi-site HSR project but this will not be the norm.

In all cases (regardless of funding) for which a MedStar investigator intends to request the MHRI IRB serve as the IRB of record, they must submit a request to the ORI office. The request must be submitted before the investigator commits the MHRI IRB to the responsibility of serving as IRB of record for other sites and before discussing reliance with any outside institution. The request should include a copy of the research protocol, an indication of the source of funding (if any), a list of all sites that may be engaged in the project, and the scope of involvement for each site. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request will  be approved or should be declined.

This process is similar to  that for investigators requesting reliance on an external IRB. When an investigator would like to rely on an external IRB for review of their non-exempt HSR project, a request to cede review must be submitted to ORI in advance. In the case of the commercial IRBs for which there is a master reliance agreement (currently WIRB and Advarra), the investigator may simply submit an external IRB application through the Huron system. For other IRBs, a reliance agreement must be executed for each individual project. In the event that MedStar has not previously had an agreement with the intended external IRB, a request should be submitted to the ORI by email. The ORI Director will evaluate the request and in consultation with the Institutional Official determine if the request may be approved or should be declined. If approved the organization will be added to the Huron system and the investigator may submit the external IRB application for the project.

Please note that in most cases request for reliance involving exempt HSR projects will not be approved. Generally speaking, it is more efficient for these projects to be reviewed individually by each institution and most institutions have not been willing to enter into a reliance agreement for these projects.

In all cases, requests for reliance (either for the MHRI IRB to serve as the IRB of record or for MedStar to rely on an external IRB) will be considered with regard to the need for reliance, the feasibility of the arraignment and nature of the project. Ultimately the determination of reliance is left to the discretion of the ORI Director and the Institutional Official.

If you have any questions regarding this process, please contact MHRI’s ORI Director, Jim Boscoe, at [email protected].

Update to Research Conflict of Interest Policy

The MedStar Health policy and procedures related to conflict of interest for researchers have been updated. It is every researcher’s responsibility to ensure that they are familiar with the applicable policies and procedures for conflict of interest within MedStar. The four documents for research conflict of interest that researchers should review and be familiar with are:

Any individual participating in the conduct of research within MedStar Health should complete the Fiscal Year 2020 conflict of interest questionnaire. After completing your disclosure, you may be contacted by Research Compliance to discuss a management plan. Not all disclosures require management plans for research. If you have any questions about what to disclose, who needs to disclose, or how to disclose, reference the Research COI FAQs.

It is important that disclosures accurately reflect the relationships that researchers have with external entities. These disclosures should be consistent with what the researcher has disclosed to researcher sponsors, regulatory agencies and collaborating institutions. Updating the MedStar conflict of interest questionnaire is not a substitute for also updating conflict of interest questionnaires that may be required by other organizations.

If you have any questions about the updated policy and procedures, or the MedStar conflict of interest questionnaire and process, please contact the Research Compliance Program at [email protected]

Conflict of Interest Disclosures: More Than Just Your Institution

Sometimes it can feel that you are asked to do conflict of interest disclosures everywhere you turn. Whether it’s research related, required by your entity, or part of a relationship with an outside company, everyone asks for different information in different formats and for different timeframes. We know it can be frustrating! Recent news has reminded us how important it is to accurately disclose all financial relationships and interests in all of the places you are required to do so.

It is imperative that you keep your MedStar conflict of interest disclosures up to date. Additionally, it is your responsibility to ensure that you have accurately and consistently disclosed financial interests when you publish or present research. Individuals who completed the FY19 disclosure before July 1, 2019 must now go into the system to certify that the information entered previously is accurate for the entire fiscal year, or update as needed. The instructions for certifying your disclosure or revising the disclosure as needed are available here. As a researcher, the FY 2020 questionnaire is available for you to complete between July 1, 2019 and June 30, 2020.

Do you have a question about your conflict of interest obligations at MedStar? We can help! Questions about the conflict of interest process, disclosures, and requirements for research can be addressed by the Research Compliance Program at [email protected]. Questions about the MedStar conflict of interest process outside of the research context can be addressed by your entity compliance officer.

New Policies & Procedures for MedStar Health

MedStar Health Research Institute regularly updates, revises and creates new policies for the operational efficiency of MHRI. This month, the following policies were established or updated.

MedStar Health Introduces New Personal Use of Drugs and Alcohol in the Workplace Policy
HR 306 – Drug & Alcohol-Free Workplace

You can find all Human Resources policies on the myHR portal, under Tools & Resources > HR Policies.

New MHRI Policies
IAC.O-004: Reporting Animal Welfare Concerns
ORG.O-003: Individual Conflicts of Interests/Conflicts of Commitments in Research

New MHRI Procedures
IAC.O.004.01: Investigating and Reviewing Animal Welfare Concerns
IAC.O-003.01: Post-Approval Monitoring Procedure
ORG.O-003.01: Research Conflict of Interest Committee
ORG.O-003.02: Research Conflict of Interest Disclosure
ORG.O-003.03: Research Conflict of Interest Non Compliance

All MHRI policies and procedures can be found on MHRI’s StarPort Policies Portal.

Office of Research Integrity Updates

The Office of Research Integrity continues to work on improving the human subject protection research program and is preparing for enhancements to be made to the Huron Electronic IRB system (eIRB) this fall. We think you’ll be pleased!

These updates (8 and 9) will bring our system up to date with the latest version of the application and will provide several small enhancements and bug fixes.  Most of these changes are on the back end and will not modify the investigator team user experience with some exceptions listed below:  

  • Redesigned SmartForm for Submission of External IRB review
    • Improved user experience for External IRB studies
  • Redesigned SmartForm
    • A left navigator replaces the Jump-To menu and provides helpful status icons, the integrated Compare feature replaces View Differences, and slide-in views replace pop-ups, to improve the user experience.
  • Review Tracker
    • A new mode for reviewing projects features a single-page view of the entire SmartForm, ability to mark sections as reviewed, inline comparison with previous versions, and change indicators to narrow the scope of follow-up reviews.
  • Print Packets
    • All project types now support print packets that are available from within the SmartForm. Print packets provide new options for printer-friendly versions of projects including adding table of contents and related projects.  

The upgrade is anticipated to take place in the last week of September 2019.   The upgrade will take just a few hours and will be scheduled overnight so that system downtime will be limited.  You will be notified when the date has been finalized.  In addition, stay tuned for more details including webinar dates where the upgrade will be discussed, training provided and you will have a chance to ask any questions. 

MedStar Welcomes James Boscoe as Office of Research Integrity Director

James (Jim) Boscoe has joined MedStar Health Research Institute as the Director of Office of Research Integrity (ORI).

Jim joins us from The Johns Hopkins University School of Medicine, Office of Human Subjects Research and Institutional Review Boards where he was the IRB Operations Manager. Jim received his M.A. and B.A. in Psychology from the University of Maryland. He is a certified Institutional Review Board (IRB) professional with a history of administrative, research and clinical experience in hospital, residential, and academic settings.

Jim will manage the day-to-day activities of the Office of Research Integrity (ORI). He will be responsible for human research policy, oversight, education and training, IRB management, extramural relations, and oversight of the Institutional Animal Care and Use Committee (IACUC). He will serve as the liaison for MHRI to the Georgetown University Medical Center (GUMC) IRB office.

Jim Boscoe can be reached at [email protected].

Conflict of Interest Questionnaire for MedStar Health Researchers

MedStar Health policies require that all individuals engaged in the conduct of research complete the annual conflict of interest disclosure. The annual research conflicts of interest disclosure process is designed to manage financial and nonfinancial research interests. As you probably know, MedStar Health Research Institute is required to manage conflicts of interests as a condition of receiving federal funding for research.

If you held a research role at MedStar in fiscal year 2019 (FY19), you may have already entered data into the COISmart system during the fiscal year. If you have completed the questionnaire as a researcher during FY19, a link to the conflict of interest disclosure will be sent to you in July. You will be required to ensure that the disclosure on file for FY19 accurately reflects any external relationships you have for the entire fiscal year. When you receive that email in July, please follow the link in that email to certify your previous disclosure if it already reflects all external relationships you have had during FY19. Use the “revision” links in the questionnaire to update your answers if necessary and resubmit the questionnaire to ensure that it accurately reflects a full fiscal year of reporting (July 1, 2018, through June 30, 2019). The instructions for certifying your disclosure or revising the disclosure as needed are available here. As a researcher, the FY 2020 questionnaire is also available for you to complete between July 1, 2019, and June 30, 2020.

If you have any questions about the conflict of interest policy or accessing the COISmart system to make disclosures, contact the Research Compliance Program at [email protected].

Updates to Informed Consent Documentation & ORI Operations

Informed Consent for Clinical Research

The Informed Consent Form (ICF) template at MHRI was updated Spring 2018.  As of January 21, 2019 this template is required for all new submissions being reviewed by the MHRI IRB which require consent.  The new ICF template conforms to the revised common rule as well as institutional changes including:

  • Provision of a concise summary at the beginning of the consent form
  • Integration of HIPAA language into the body of the consent form, allowing for a combined HIPAA authorization/consent form
  • Revision to the signature block of the consent form, most notably removal of the requirement for an investigator signature

This ICF template may be downloaded from the MHRI website here and is also available in the library in the new eIRB system. 

ORI Operational Update

In order to improve customer service and IRB communication, the Office of Research Integrity (ORI) has assigned ORI Administrators to assist specific departments and identified a dedicated coordinator for IRB reliance agreements (use of external IRBs).

If you have a question/issue regarding a protocol or require pre-submission assistance, please contact the appropriate ORI administrator or coordinator listed below.  If you are unsure of who to contact, please email the Office of Research Integrity at [email protected].

Amy Harchelroad
ORI Administrator
[email protected]

  • Infectious Disease
  • Cardiology
  • Orthopedics
  • Emergency Medicine
  • Dermatology
  • Endocrinology
  • Hand Center
  • Infection Control
  • OB/GYN
  • Otolaryngology

TJ Rodriguez
ORI Administrator
[email protected]

  • MI2/Health Services Research and Human Factors
  • Neurology
  • National Rehabilitation Network/PM&R
  • Biostatistics
  • Critical Care
  • Family Medicine/Medicine/Internal Medicine
  • Surgery/Burn Center
  • Gastroenterology
  • Imaging
  • Pharmacy
  • Oncology/Hematology
  • Ophthalmology
  • Rheumatology
  • Urology
  • Palliative Care

Yessica Contreras
ORI Coordinator
[email protected]

  • IRB Reliance Agreements
  • Use of External IRBs
  • IRB Meeting Management
  • Human Subject Protection Training

Georgetown – MedStar IRB System Update

The new Georgetown-MedStar IRB system was installed on November 29, 2018 for both Georgetown University (GU) and MedStar Health and has been the only active system in use since then, with hundreds of protocols now submitted and managed through this electronic platform.  Nonetheless, we continue to make additional improvements and progress on migrating studies over to the new electronic system and identifying continued areas of concern.

All new submissions for IRB review, including modifications and continuing review of active projects must be submitted through the new eIRB platform at

Logging In

All individuals to be listed on a study submission in Huron must have a valid Huron ID.

Individuals who do not have a MedStar ID or Huron login must request one to obtain access to the system. Submissions for new accounts can be made in MedStar’s ASAP request system. These requests can be entered by your department head or manager. ASAP can be accessed here or  through StarPort following this path: Select Departments > Information Services > ASAP – System Access Requests.

Proxy Designation
The PI Proxy can perform IRB submission responsibilities such as submitting studies, modifications, continuing reviews, and reportable new information. The principal investigator is responsible for ensuring these procedures are carried out, and that submissions are complete and accurate. The PI Proxy must be a study team member with engagement in the study conduct. A PI can designate a PI proxy at the time of study submission and must be assigned protocol by protocol. Designation of a PI Proxy does not defer PI responsibility in the conduct of research as defined in regulations, policies, and the Investigator Manual (HRP-103).

The PI proxy must provide a substantial contribution to the conception or design of the work; the implementation of the work; provides regulatory support to the work; or the acquisition, analysis, or interpretation of data for the work.

Data Migration
Protocol migration is nearing completion with over 98% of studies migrated from InfoEd to the new IRB platform. Reminder: Closed projects, those that were determined to be exempt, or those that were reviewed by an external IRB were not migrated.

In addition, limited administrative information was migrated from InfoEd to Huron to create a “protocol shell”. This protocol shell will need to be updated at the time of continuing review or modification, whichever comes first. This needs to be completed through the submission of a combined continuing review/modification request.

When submitting a continuing review for the first time in the new system if a modification was not previously submitted, the continuing review must be submitted as a combined continuing review/modification so protocol documents can be uploaded to the study. Investigative sites generally have a 12 month grace period to upload documents and update the record. When submitting the combined continuing review/modification request investigative sites should upload the most current version of the protocol, consent(s), and other study documents.

Continuing reviews submitted without modification will be returned to the investigative site as they do not allow for the upload of existing or new documents.

Please contact the Office of Research Integrity at [email protected] if you have any questions.

If you’d like to stay informed and have access to detailed information on training schedules, access to the system, links to policies, forms and templates as well as quick reference guides, training materials, and frequently asked questions, please visit here.

Revised Common Rule: What the Changes Mean to Your Research

The Revised Common Rule went into effect on January 21, 2019. The Office of Research Integrity and MHRI leadership are working to ensure required changes to our policies and processes are made to comply with the new requirements. Here are some frequently asked questions about the common rule.

What are the Key Changes and What Should I Expect?

Exempt Research
Some of the existing categories of exempt research have changed, while a few new ones have been added. For a few of the exempt categories, there will now be a limited Institutional Review Board (IRB) review required. Want more information about the new exemptions? A handout describing the changes is available here.

Continuing Review
Continuing review is no longer 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.

Informed Consent
Under the revised Common Rule, the informed consent document must provide information a reasonable person would want to have in order to make an informed decision. It must contain a concise and focused presentation of the key information that is most likely to assist a subject in understanding the reasons why one might or might not want to participate in the research. This portion of the informed consent document must be organized and presented in a way that facilitates comprehension. Certain specific statements must also be included in the Informed Consent Form (ICF) if you are working with identifiable private information or biospecimens.

When submitting to the MHRI IRB, you should use the new informed consent templates available in the library section of the new eIRB system. Note, that in addition to the above common rule requirements, this new consent template also folds the HIPAA authorization into the consent form for a combined consent/HIPAA authorization. If you need access to a consent template and do not yet have a Huron login please contact ORI.

Broad Consent
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.

Single IRB Review
The National Institutes of Health (NIH) is now requiring single IRB review for multi-site studies funded by the agency. The Common Rule revisions adopt a single IRB review requirement for multi-institutional research studies which mirrors the recent changes to the NIH policy. The Common Rule compliance date for single IRB review is January 2020. MHRI will be releasing information about single IRB review for multi-institutional studies funded by Common Rule agencies in the future.

Any questions about the Common Rule changes? Contact [email protected]