MedStar Health Research Institute - IRB

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.

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.

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.)

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.

Coming soon.

General guidance for external or single IRB (sIRB) review at MedStar Health

• 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.

MHRI IRB Quick Guidance For Humanitarian Use Device (HUD)

Quick reference guide for research involving deception or incomplete disclosure

DNP projects may require submission through the MHRI Hurons system. Typically the student will first submit the project to their DNP programs IRB. The determination of that IRB will help decide if a submission to MHRI is needed as follows:

• If the DNP program IRB issues a Not Human Research (NHSR) determination, a submission through the MHRI Huron system is not required.
• If the DNP program IRB determines the project fits the regulatory definition of research involving human subjects, a submission through the MHRI IRB system is required.
• If the DNP program IRB does not issue NHSR determinations and declines to review the project, a submission through the MHRI IRB system is required.

If the DNP project must be submitted through the Huron system who should be listed as the PI on the application and who should be listed as members of the study team?

• If the DNP student is a MedStar associate (currently employed by MedStar): The student may serve as PI on the project at the discretion of Nursing Leadership. If Nursing Leadership determines the student may not function as PI another appropriate MedStar associate (employee) should be listed as PI.
• If the DNP student is not a MedStar associate (not employed by MedStar): Another nurse or appropriate MedStar associate (employee) must be designated as the PI for the project.

If the DNP project must be submitted through the Huron system, which investigators may or may not be included in the study team list?

• The MHRI ORI/IRB will issue a determination for MedStar only. For this reason, only MedStar associates may be included in the Huron application. If the DNP student is not a MedStar associate their activity on the project will be covered by their DNP program IRB determination.

Please contact ORI with any questions regarding the requirements for submission through the MHRI Huron system.

In addition, the requirements described above DNP projects must have approval from the facility at which the activity will be conducted and approval from Nursing Leadership. Please also see the Nursing Research Council guidance on requirements for DNP projects.