Human Research Protection Programs (IRBs)| MedStar Health

The MedStar Health Research Institute is designated as the Executive Agent for administration of and policy development for research at conducted at all MedStar facilities as well as research conducted at other sites by MedStar associates. Georgetown University (GU) and MedStar Health (MedStar) use the same electronic (eIRB) system to manage their respective Human Research Protection Programs and the IRB review process. While a common eIRB system is used by both institutions it is important to remember that there are 2 separate IRB systems. Although we work to harmonize the process and procedures across these two IRB systems there are some requirements and processes that may be differnt. These include, but may not be limited to, the need for Georgetown University to comply with the Catholic Directive, the process for establishing accounts in the Huron eIRB system, compliance training requirements and the disclosure of outside interests / review and management of financial conflict of interest.

The following includes information specific to the MHRI IRB and MedStar requirements and guidance for the IRB process. For information regarding the Georgetown IRB system and process please contact the GU IRB office.

All projects that require IRB review or documentation of a formal determination (including exempt and nonexempt human subjects research projects, quality improvement projects that do not include research components and other projects that may be considered not human subjects research) must be submitted for consideration through the Huron eIRB system at gumedstarirb.georgetown.edu/IRB. This includes all new protocols, requests for reliance on external IRBs or single IRBs, as well as modifications and continuing review of current active projects.

Prior to November 16, 2018, MHRI used InfoEd for the submission and management if IRB application. InfoEd was closed to new submissions in November 2018 at the time of transition to the Huron eIRB system. Protocol records and critical documents have been maintained in archived form but are accessible only to ORI and IS staff.

If you have questions about or require access to protocol records or documents for applications submitted prior to November 16, 2018, or any questions related to the MHRI IRB process or procedres, please contact the Office of Research Integrity at MHRI-ORIHelpDesk@medstar.net.

IRB policies and procedures have been updated and have been consolidated into the MedStar Health Human Research Protections Program Policies and Procedures Manual (coming soon).

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.

Basic Guidance

  • Is this Research?

    The Health and Human Service Regulations (Common Rule) define research as follows [45 CFR 46.102(e)]:

    Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:

    1. Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on the specific individuals about whom the information is collected.
    2. Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
    3. Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
    4. Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.

    The U.S. Food and Drug Administration (FDA) regulations defines Clinical Investigation* as follows [21CFR56.102 (c)]:

    A Clinical Investigation means any experiment that involves a test article [a drug, biologic, or medical device for human use] and one or more human subjects and either

    Must meet the requirements for prior submission to the FDA

    or

    Need not meet the requirements for prior submission to the FDA but the results of which are intended to be later submitted or held for a research pr marketing permit

    This does not include nonclinical laboratory studies.

    *The terms research, clinical research, clinical study, study, and clinical investigation are deemed to be synonymous for the purposes of FDA regulations.

     

  • Does my research meet the regulatory requirement for involving human subjects?

    In most cases it is easy to determine if research involves human subjects. In some cases, it may not be clear who should be considered the subjects of the research under the Common Rule. Please see below for the regulatory definitions of Human Subjects and an example for consideration under the Common Rule definition.

    The Health and Human Service Regulations (Common Rule) define Human Subject as follows [45 CFR 46.102I]:

    Human subject means a living individual about whom an investigator (whether professional or student) conducting research:

    (ii) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or

    (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.

    Example: An investigator is conducting a study on pediatric sleep disorder. The child is admitted to the hospital for overnight observation and data collection. The investigator will also interview one or more of the child’s care givers for additional data collection.

    In this example it is easy to identify the child as a study subject. If the investigator interviews the child’s mother, is she also a study subject? It depends:

    If the investigator collects data only about the child (when sleep disturbance started, details about the child’s behavior etc.) then no the mother is not a study subject.

    If the investigator collects data about both the mother and the child (what are the mothers sleep habits, how does the child’s sleep disturbance impact the mother etc) then yes, the mother is also a subject of the study.

    The U.S. Food and Drug Administration (FDA) regulations defines Human Subject as follows [21CFR56.102 (e)]:

    Human subject means an individual who is or becomes a participant in research, either as a recipient of the test article or as a control. A subject may be either a healthy individual or a patient.

  • Does HIPAA apply to my study?

    When research involves the used and disclosure of Protected Health Information HIPAA authorization is required. In most cases research requiring HIPAA authorization also requires research consent. In these cases MedStar Health uses a combined consent / HIPAA authorization form. Please see the Informed Consent Template which includes HIPAA authorization language.

    In some cases, such as with Secondary Use of Data (typically but not limited to records review) consent may not be required but HIPAA still applies. In these cases you will need to request a waiver of HIPAA authorization. This request should be included in you research protocol and should address the following items. Please note: These items are designed to address the specific regulatory criteria for a waiver of HIPAA authorization and should be included in the protocol without modification.

    Request for a Waiver of HIPAA Authorization: regardless of IRB review category, research involving Protected Health Information (PHI) requires HIPAA authorization from the participant or a Waiver of HIPAA Authorization for the use or disclosure of PHI. The following elements from 45 CFR 164.512 (i) (1) (i) must be met for the IRB to waive the requirement:

    • A waiver of HIPAA authorization is being requested the following must be addressed:
      • Discuss how the use or disclosure of protected health information in the research involves no more than minimal risk to the privacy of individuals, based on, at least, the presence of the following elements
        • Describe the plan to protect any identifiers from improper use and disclosure
        • Describe the plan to destroy the identifiers at the earliest opportunity consistent with conduct of the research, unless there is a health or research justification for retaining the identifiers or such retention is otherwise required by law
        • Provide assurances that the protected health information will not be reused or disclosed to any other person or entity, except as required by law, for authorized oversight of the research study, or for other research for which the use or disclosure of protected health information would be otherwise permitted (Example: This study involves reviewing non-sensitive data. The only risk to this study is confidentiality risk, which is minimized through using standard HIPAA provision and data security. All MedStar HIPAA policies will be followed. Study documents are saved on password protected drives, no identifiable data will be transferred from the covered entity and access is restricted to personnel listed on the IRB-approved study.)
      • Discuss how the research could not practicably be carried out without the requested waiver or alteration.
      • Discuss how the research could not practicably be conducted without access to and use of the protected health information (Note: There may be ethical, scientific or logistical rationales to justify the practicability standard such as (i) the consent procedure would itself create additional threats to privacy that would otherwise not exist, by identifying an individual as having or experiencing what is being studied by virtue of their signature on a consent form identifying the condition or event or (ii) there is a risk of inflicting significant psychological, social or other harm by contacting individuals or families or (iii) scientific validity would be compromised if consent were required because it would introduce bias to the sample selection by limiting the inclusion to those individuals who consented to use of their data when researchers may need to understand the experience of all eligible participants. For example, a study assessing flu outbreaks and its relationship to vaccination rates needs to understand the health and vaccination status of all individuals in a region or a study of conditions in the ICU with a limited population such that obtaining a valis result would not be possible if some patients decline consent; or (iv) a logistical rationale are these subjects still accessible, still being seen in the clinic? Are they lost to follow up? Are the numbers so large that it would not be practical or feasible to contact every possible individual?

    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

    19. Is a formal determination needed?

      All research involving human subjects must have IRB approval before research activities may begin.

      If your project fits the regulatory definition of both research and human subject a formal determination is required.

      In many cases it is recommended that you obtain a formal determination even if you think your project would not be considered research involving human subjects.

      For example, in recent years publication of results from Quality Improvement (QI) projects has become more common. It is important to remember that QI projects may also include research components and require IRB approval. Others may be considered Not Human Subjects Research (NHSR). In any case, if there is a possibility of sharing results through presentation or publication the conference organizer or publisher may require documentation of a formal determination (either IRB approval or an NHSR determination). That determination may only be made before the project begins.

      For those reasons it is generally recommended that a formal determination be obtained before starting a Quality Improvement project to ensure that it is not considered research and obtain documentation of approval.

       

    20. Learning Library

      Coming soon.

    Templates and forms

    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. 

    Full or Expedited

    (1) Updated informed consent, if applicable

    Form 

    MHRI-GU joint informed consent template

    MHRI genetic consent template

    MHRI Assent template

    (2) Updated HIPAA information, if applicable

    Form

    HIPAA authorization template 

    (3) Change of principal investigator, if applicable

    Form

    FDA form 1572

    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) Investigator statement of compliance

    Form

    FDA form 1572

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

    (2) Informed consent

    Form

    Emergency use consent template 

    Customization guidelines: MHRI IC template

    Lay terms for use in informed consent

    (3) HIPAA

    Emergency use HIPAA authorization template

    Completion guidelines/ instruction sheet

    Guidelines for use of HIPAA forms

    Resources and guidelines/ instruction sheets

    (1) Protocol review/ Submission

    Emergency use guidelines

    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 genetic consent template

    MHRI educational research informed consent template

    (2) Assent

    Form

    MHRI assent template

    Exceptions/Waiver

    (1) Informed consent process

    Form 

    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. 

    Type of review

    Full Board/Expedited

    Expedited Only 

    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. 

    Investigator Statement of Compliance

    FDA form 1572

    Investigator agreement (IDE trials) - sponsor - generated. 

    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

    Type of review

    Full Board/Expedited

    (2) Protocol deviation/Waiver

    Form 

    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.

    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.

    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 

    Type of review

    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 

    Type of review

    Full Board/Expedited 

    Type of review

    Full board review

    (1) Sponsor IND/IDE Statement of Assurance 

    (2) Investigator Statement of Compliance

    Form

    FDA form 1572

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

    (3) Conflict of Interest

    Form

    FDA Form 3455 

    (4) Investigational product

    Resources and guidelines/ instruction sheets

    (1) Protocol review/ new project submission

    Instruction sheet 

    IRB reviewer checklist for new protocols

    New project submission: full board review 

    (2) 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. 

    Type of review

    Full Board/Expedited 

    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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