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 Kate Cohen, Research Compliance Director at (301) 560-7396 or [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 gumedstarirb.georgetown.edu/IRB.

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]

Georgetown – MedStar IRB System Update

The Human Research Protection Programs (IRBs) at both Georgetown University (GU) and MedStar Health (MedStar) use an electronic system to manage their respective Human Research Protection Programs and the IRB review process. On November 29, 2018, the joint system went live for research at both institutions, replacing existing IRB systems.

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

Logging In
Individuals who do not have a MedStar ID or Huron login must request one to obtain access to the system. Not all study personnel who needed Huron IDs were automatically provided with a Huron Login, creating delays in submission and access. While approximately 1,000 MedStar individuals were automatically provisioned with access to the Huron system, it was not enough. The ORI and IS worked with HR and the GME Office to obtain coordinator and resident lists. Regulatory coordinators and residents were uploaded into the system by January 15, 2019.

For those who are non MedStar employees and do not have a MedStar ID and are unable to access the Huron eiRB system, all studies will be assigned to a scientific center. The Scientific Center Administrator assigned to that center will be asked to assist the researcher who needs access. The SCA or designee will reach out to the study team and obtain the necessary information.

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

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
Protocols not yet approved and or those with items actively being reviewed by the MHRI IRB will have those reviews completed in InfoEd and then migrated to the new system in February 2019.

Investigative sites generally have a 12 month grace period to upload documents and update the record. Investigative sites should upload the most current version of the protocol, consent(s), and other study documents at the time of continuing review or modification to the study, whichever comes first.

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

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.

Launching this Month: Georgetown – MedStar IRB System

Georgetown University and MedStar Health have decided to jointly invest in a new IRB software system. After reviewing several options, faculty and staff from GU and MedStar recommended adoption of a system widely used by many of our peer institutions, provided by Huron, a market leader in IRB systems software.

This fall, a joint IRB system will go live for research at Georgetown University and MedStar Health, replacing existing IRB systems (eRIC and InfoEd) on Thursday, November 29, 2018.  This new system, provided by Huron, will better support our rapidly expanding research enterprises. We are working hard to make the transition process as seamless as possible.  We have developed an eIRB implementation page on StarPort which contains detailed information regarding training, system rollout, and transition of existing protocols to the new joint IRB system. Please use this page as a resource during the transition.  We will be updating it as new materials are available for distribution. 

Here are important dates you need to know:

Important Dates to Know Date
Last day investigators may submit to the MHRI IRB using InfoEd November 16, 2018
Dates that InfoEd will not be accessible to investigative sites or ORI staff to allow data migration November 26 to November 29, 2018
Date investigative sites and the ORI will begin using the Huron eIRB system November 29, 2018

Training

The schedule of training dates, methods and locations for the month of November 2018 is below. All attendees will need to bring their laptop for training.

Dates & Location Times
Wednesday, November 7
Columbia Corporate Office
Conference Room 6A
Presentation & training session:
2:30 to 3:30 pm

Drop-in questions and answers:
2 to 2:30 pm
3:30 to 4:30 pm

Tuesday, November 13
MedStar Washington Hospital Center
East Building Conference Room, 1st floor (EB1002)
Presentations & training sessions:
9 to 10 am
11 am to 12:00 pm
2 pm to 3pm

Drop-in questions and answers:
8 to 9 am
10 to 11 am
1 to 2 pm
3 to 4:30 pm

Wednesday, November 14
MedStar Washington Hospital Center
East Building Conference Room, 1st floor (EB1002)
Presentations & training sessions:
9 to 10 am
1 to 12:00 pm
2 to 3 pm

Drop-in questions and answers:
8 to 9 am
10 to 11 am
1 to 2 pm
3 to 4:30 pm

Thursday, November 15
MedStar Union Memorial Hospital
Cafeteria Conference Room
Presentation & training session:
9 to 10 am

Drop-in questions and answers:
8 to 9 am
10 to 12 noon

Thursday, November 15
MedStar Franklin Square Medical Center
Cancer Center Conference Room
Presentation & training session:
2:30 to 3:30 pm

Drop-in questions and answers:
1:30 to 2:30 pm
3:30 to 4:30 pm

As a state-of-the-art program, the Georgetown-MedStar IRB system has an intuitive user interface, shorter applications and improved system stability, which will lead to an easier, more satisfying investigator experience. In addition, the system will bring us into compliance with changes to the Federal Policy for the Protection of Human Subjects (45 CFR, Part 46), also known as the “Common Rule.” It will also reduce the regulatory burden on all human subject researchers at GU and MedStar, ensuring robust protection for research participants.

We are working hard to make the transition process as seamless as possible. We thank you for your support in this ongoing growth as we modernize our joint research infrastructure.

If you have any questions, please contact [email protected].

New Mandatory Course: Drug Diversion Prevention Awareness

The safety of our patients and associates is the most important thing we do. Drug diversion is the theft, misuse, or tampering of a controlled substance. It is a real risk for everyone in health care. As a High Reliability Organization (HRO), MedStar is committed to preventing, detecting and responding to drug diversion.

Education and training for all associates are the foundation of our system-wide Drug Diversion Prevention program, and all MedStar associates have been enrolled in a required online course with SiTEL. This course provides information about drug diversion, warning signs, and what to do if you have a diversion concern. 

This course is now live. It must be completed before December 14th, 2018. Please reach out to your supervisor with any questions about this course or MedStar’s Drug Diversion Prevention program. To access the course, please sign in to https://www.sitelms.org/ and click on Drug Diversion Prevention Awareness.

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.

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 Director, Kate Cohen, [email protected], 301-560-7396. Questions about the MedStar conflict of interest process outside of the research context can be addressed by your entity compliance officer.

Responding to Government Audits and Investigations

Did you know that MHRI has a policy that governs how you should respond if you are notified by a government agency that your research will be audited or inspected? The organizational policy, titled “Responding to Government Inquiries” can be found on StarPort here. There is also a corresponding procedure which can be found on StarPort here.

The research overseen by MHRI is subject to many different federal and state laws, regulation and guidance. MHRI will assist researchers to respond appropriately to all inquiries from government agencies for audits and inspections of research activities.

If you are contacted by a government agency to notify you of an audit or inspection, you must contact appropriate individuals of the audit or inspection. At a minimum, this includes your Scientific Center Administrator and the Research Compliance Director.

MHRI has the expertise to help guide you through an audit or inspection and respond to the audit or inspection appropriately. Please contact Kate Cohen, Research Compliance Director, at (301) 560-7396 or [email protected] with any questions.