The Human Research Protection Programs (IRBs) at both Georgetown University (GU) and MedStar Health (MedStar) use the same 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 (eRIC and InfoEd).

All submissions for IRB review, including new projects, requests for reliance on external IRBs or single IRBs, as well as modifications and continuing review of active projects must be submitted through the new eIRB platform at gumedstarirb.georgetown.edu/IRB.

Click here to view FAQs on the eIRB system.

As of November 16, 2018, InfoEd was closed to submissions. Protocol records and critical documents have been maintained in archived form. If you require continued access to protocol records or documents please contact the Office of Research Integrity at MHRI-ORIHelpDesk@medstar.net.


General IRB guidance

Guidance for using the eIRB system can be found on the MHRI website here.

IRB policies and procedures are being updated as part of the new system. All policies currently in place are available on StarPort, on the Policies page under Research Integrity. Please refer to these policies for the procedures of record.

Case managers for IRB submissions

ORI administrators are assigned to assist specific departments. In addition, MHRI has 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 MHRI-ORIHelpDesk@medstar.net.


Case report forms

MedStar Health Institutional Review Board has determined that a case report of less than three (3) patients does not meet the DHHS definition of research (45 CFR 46.102(d)(pre-2018)/45 CFR 46.102(l)(1/19/2017)) or the FDA definition of clinical investigation (21 CFR 46.102(c)) and therefore are not subject to IRB review requirements and do not require IRB approval.

Case reports for publication may be considered a disclosure of protected health information (PHI) and therefore must be prepared in accordance with HIPAA. Please review the guidance below to determine if a patient’s authorization is required. Frequently Asked Questions on case reports are available below as well.

Questions related to this determination can be directed to MHRI ORI at MHRI-ORIHelpDesk@medstar.net. Questions related to HIPAA requirements should be directed to researchcompliance@medstar.net or the corporate Privacy Director at privacyofficer@medstar.net.

Amendment or Modification

Amendment or Modification application forms/templates are available in Microsoft Word format. To download a form, click on the link provided in the form title.

(1) Amendment/ Modification form

Form

Amendment/ Modification: IRB form #5

Type of review

Full or Expedited

(2) Updated informed consent, if applicable

Form

MHRI informed consent template

MHRI-GU joint informed consent template

MHRI genetic consent template

MHRI Assent template

(3) Updated HIPAA information, if applicable

Form

HIPAA authorization template

Waiver application

(4) Addition of sub investigator(s), if applicable

Form

Subinvestigator information: IRB form #2B

(5) Change of principal investigator, if applicable

Form

FDA form 1572

(6) Investigator agreement (IDE trials) - sponsor - generated.

Investigator's compliance statement template

Emergency use of an investigational product

Emergency use of an investigational product forms are available in Microsoft Word format. To download a form, click on the link provided in the form title.

Instructions for emergency use

Form

Emergency use guidelines

Application Forms/ Templates

(1) Cover memo

Form

Cover memo: IRB Form #1

Type of review

Full Board/Expedited

(2) Emergency use

Form

Emergency use report form: IRB form #11

(3) Investigator statement of compliance

Form

FDA form 1572

Investigator Agreement (IDE trials) - This form is supplied by the sponsor when an IDE is involved.

(4) Informed consent

Form

Emergency use consent template

Completion guidelines/instruction sheet

Customization guidelines: MHRI IC template

Lay terms for use in informed consent

(5) HIPAA

Form

Emergency use HIPAA authorization template

Completion guidelines/ instruction sheet

Guidelines for use of HIPAA forms

(6) Investigational product

Form

MHRI investigational drug/biologic information sheet

MHRI investigational device information sheet

Resources and guidelines/ instruction sheets

(1) Protocol review/ Submission

Emergency use guidelines

(2) Informed consent

Form

Customization guidelines: MHRI IC template

Lay terms for use in informed consent

HIPAA

HIPAA forms and templates are available in Microsoft Word format. To download a form, click on the link provided in the form title.

Form

HIPAA authorization form instructions (pdf)

HIPAA authorization form (Word)

Waiver application

Certificate for reviews preparatory to research

Certificate for research on decedents

Note: HIPAA Authorization Forms and Waiver Applications (Requests for Waiver of HIPAA Authorization to Use/Disclose PHI for Research) must be submitted to the IRB for review and approval.

The IRB does not approve the Certificates for Reviews Preparatory to Research or the Certificates for Research on Decedents. Please do not submit these forms for IRB approval.

HIPAA template instruction sheets

Instruction sheet

HIPAA Guidance for Case Reports (PDF) 
 
HIPAA decision matrix

HIPAA waiver checklist

HIPAA certifications

Certification description

PI Statement of Assurance

InfoEd registration form

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Informed consent

Informed consent forms and templates are available in Microsoft Word format. To download a form, click on the link provided in the form title.

(1) Informed consent

Form

MHRI informed consent template

MHRI-GU joint informed consent template

MHRI genetic consent template

MHRI educational research informed consent template

(2) Assent

Form

MHRI assent template

Exceptions/Waiver

(1) Informed consent process

Form

Request for waiver of IC requirements

Request for IC Waiver for Planned Emergency Research

Instruction sheets

(1) Informed consent

Instruction Sheet

Customization guidelines: MHRI IC template

Lay terms for use in informed consent

Checklist - elements of an ic document

New project submission

New project submission application forms and templates are available in Microsoft Word format. To download a form, click on the link provided in the form title.

Protocol review

Form

New protocol review request: IRB form #2

Type of review

Full Board/Expedited

Chart/Medical record review: IRB form #2A

Expedited Only

Subinvestigator information: IRB form #2B

Full Board/Expedited

Social and behavioral research protocol review: IRB form #2D

Full Board/Expedited

Note: Do Not use the above forms for research activities for which you wish to request a determination of exempt status. Instead, please refer to the "Request for Exempt Status" page.

Sponsor IND/IDE Statement of Assurance

Sponsor IND/IDE Statement of Assurance form

Investigator Statement of Compliance

FDA form 1572

Investigator agreement (IDE trials) - sponsor - generated.

Investigator's compliance statement template

HIPAA

HIPAA authorization template

Waiver application

Certificate for reviews preparatory to research

Certificate for research on decedents

Investigational product

MHRI investigational drug/biologic information sheet

MHRI investigational device information sheet

Protocol deviation and waiver reporting

Protocol deviation and waiver reporting forms are available in Microsoft Word format. To download a form, click on the link provided in the form title.

(1) Cover memo

Form

Cover memo: IRB form #1

Type of review

Full Board/Expedited

(2) Protocol deviation/Waiver

Form

Protocol deviation/Waiver: IRB form #10

Type of review

Full or Expedited

Request for project exemption

Request for project exemption forms are available in Microsoft Word format. To download a form, click on the link provided in the form title.

Guidelines/Request for exempt status

All research involving human subjects conducted at MHRI Institutions MUST go through the MHRI IRB. However, some minimal risk research may be eligible for Exemption from IRB review. This is referred to as granting "Exempt Status" to a protocol/research activity.

The IRB, not the investigator, has the authority to determine and confirm "Exempt Status." Therefore, a "Request for Exempt Status" form MUST be submitted to the IRB to allow confirmation of "Exempt Status" of the research activity.

Please read the Guidelines for Requesting "Exempt Status" for a Protocol" in their entirety. If, subsequent to reading the Guidelines, the research activity is determined to be eligible for "Exempt Status," please complete the "Request for Exempt Status" review form below.

Form name

Request for Exempt Status: IRB Form #3

Type of review

Exempt

Important Information

  • The above form is an application for Exemption from IRB Review only. Granting of "Exempt Status" for a protocol in no way negates the requirement for informed consent or HIPAA authorization, where applicable.

  • The form should be utilized for minimal risk research activities eligible for exemption from IRB review as indicated in the Exempt Categories listed on the "Request for Protocol Exemption" form and Guidelines above.

  • The IRB, not the investigator, has the authority to determine and confirm exempt status. Therefore, a "Request for Protocol Exemption" form MUST be submitted to the IRB to allow confirmation of "Exempt Status" of the research activity.

  • Research activities may NOT begin until a letter granting "Exempt Status" to the protocol is received.

  • If "Exempt Status" is granted, amendments or modifications to the protocol may NOT be implemented until submitted to the IRB for confirmation that the amendment or modification does not in any way alter the existing Exempt Status of the protocol. Implementation of the amendment or modification may NOT occur until a letter granting approval for continued Exempt Status of the protocol (with the inclusion of the amendment or modification) is received.

  • HIPAA requirements still apply to the Use/Disclosure of Protected Health Information (PHI) specifically for research purposes. Please see the 18 identifiers that constitute PHI. Please carefully review the HIPAA Decision Matrix to determine whether or not HIPAA documentation is required for the research activity. When in doubt, please contact ORA staff for guidance.

Human subjects involvement

Does the research involve human subjects?

  • A human subject is involved if:

  • The person is alive and

  • Data pertaining to the person will be obtained through:

    • Intervention (e.g. taking a blood sample).

    • Interaction (e.g. taking a medical history).

    • A private/confidential source (e.g. from medical records).

In most cases, the determination of whether a particular research activity involves human subjects is not difficult. In some cases, however, the issue is not clear. When in doubt, seek advice from the MHRI Office of Regulatory Affairs (ORA).

NO

STOP. If your research does not involve humans, IRB approval is not required.

YES

If your answers to the previous questions are YES, then IRB approval is usually required.

In some instances, research may be Exempt from IRB approval.

PHI identifiers

18 identifiers that constitute PHI - Protected Health Information

(Note: If all of the following 18 identifiers are removed, then the data is considered de-identified and may be used/disclosed without restriction.)

  1. Names

  2. All geographic subdivisions smaller than a state, including: street address, city, county, precinct, ZIP Code, and their equivalent geographical codes, except for the initial 3 digits of a ZIP Code if, according to the current publicly available data from the Bureau of the Census.

  3. All elements of dates (except year) for dates directly related to an individual, including birth date, admission date, discharge date, date of death; and all ages over 89 and all elements of dates (including year) indicative of such age, except that such ages and elements may be aggregated into a single category of age 90 or older.

  4. Telephone number

  5. Fax number

  6. E-mail address

  7. Social security number

  8. Medical record number

  9. Health plan beneficiary number

  10. Account numbers

  11. Certificate/License number

  12. Vehicle identifiers and serial numbers (including license plates)

  13. Device identifiers and serial numbers

  14. URL Address

  15. IP Address

  16. Biometric identifiers, like fingerprints and voiceprints

  17. Full-face photos and any comparable images

  18. Any other unique identifying number, characteristic, or code

    Serious or unanticipated adverse event reporting

    Serious or unanticipated adverse event reporting forms are available in Microsoft Word format. To download a form, click on the link provided in the form title.

    Serious/unanticipated adverse event

    Form

    SAE: IRB form #4

    Type of review

    Expedited

    Notification of death form #4A

    Expedited

    Unanticipated problem form #4B

    Expedited

    Single patient use of an investigational product

    Single patient use of an investigational product forms are available in Microsoft Word format. To download a form, click on the link provided in the form title.

    Instructions for single-patient use

    Form

    Single patient use instructions

    Application forms/ templates

    (1) Cover memo

    Form

    Cover memo: IRB form #1

    Type of review

    Full Board/Expedited

    (2) Protocol review

    Form

    New protocol review request: IRB form #2

    Type of review

    Full board review

    (3) Sponsor IND/IDE Statement of Assurance

    Form

    Sponsor IND/IDE Statement of Assurance

    Statement of Assurance Completion Guidelines

    (4) Investigator Statement of Compliance

    Form

    FDA form 1572

    Investigator Agreement (IDE trials) - This form is supplied by the sponsor when an IDE is involved.

    (5) Conflict of Interest

    Form

    FDA Form 3455

    (6) Informed consent

    Form

    MHRI informed consent template

    MHRI-GU joint informed consent template

    MHRI genetic consent template

    MHRI assent template

    (7) HIPAA

    Form

    HIPAA authorization template

    Waiver application

    (8) Investigational product

    Form

    MHRI investigational drug/biologic information sheet

    MHRI investigational device information sheet

    Resources and guidelines/ instruction sheets

    (1) Protocol review/ new project submission

    Instruction sheet

    Single patient use instructions

    IRB reviewer checklist for new protocols

    New project submission: full board review

    Department administrator checklist

    (2) Informed consent

    Form

    Customization guidelines: MHRI IC template

    Lay terms for use in informed consent

    IRB reviewer checklist - elements of an IC document

    (3) HIPAA

    Form

    HIPAA decision matrix

    Tissue sample and repository

    Tissue sample and repository application forms/templates are available in Microsoft Word format. To download a form, click on the link provided in the form title.

    (1) Cover memo

    Form

    Cover memo: IRB form #1

    Type of review

    Full Board/Expedited

    (2) Tissue sample/repository form

    Form

    Tissue sample/repository: IRB form (#7)

    Type of review

    Full or Expedited

    Note: This form must be attached to all new protocol review requests involving a Tissue Collection or submitted separately for any Request to Establish a Tissue Repository.

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