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Limited IRB Review

A “Limited IRB review” is required under the 2018 Revised Common Rule for certain Exempt human subjects research categories. Its purpose is to ensure privacy/confidentiality protections are in place with exempt research that involves the collection of sensitive, identifiable data (categories 2(iii) and 3(i)(C)).

The “Limited IRB reviewer” must determine that, per 45 CFR 46.111(a)(7), “When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.”

HIPAA Identifiers

HIPAA Protected Health Information is considered identifiable if any of the following identifiers are included:

Name
Geographic subdivisions smaller than a state.
All elements of dates (except year) for dates that are directly related to an individual; and all ages over 89 and all elements of dates (including year) indicative of such age
Telephone numbers
Fax numbers
Email addresses
Social security numbers
Medical record numbers
Health plan numbers
Account numbers
Certificate or license numbers
Vehicle identification/serial numbers, including license plate numbers
Device identification/serial numbers
Universal Resource Locators (URLs)
Internet protocol (IP) addresses
Biometric identifiers, including finger and voice prints
Full face photographs and comparable images
Any other unique identifying number, characteristic, or code

For details and exceptions, see Research A-Z webpage Protected Health Information, heading “HIPAA identifiers.”

Invasive Procedures

An invasive procedure is one in which the body is “invaded”, or entered by a needle, tube, device, or scope.

Some procedures routinely employed in clinical practice that are “minimally invasive” can be deemed to pose minimal physical risk to research participants: most commonly, blood draw by venipuncture or specimen collection by nasopharyngeal swab. Risk determination depends also on other contextual features of the study.

OHRP‘s Secretary’s Advisory Committee on Human Research Protections (SACHRP) offers suggested examples of “minimally invasive” procedures in a 12/2017 Recommendation on revisions to the list of “Expedited categories“:

4. Prospective collection of biological specimens, excluding blood, for research purposes by minimally invasive means and not requiring sedation for research purposes.

Examples: (a) tissues from non-facial, non-genital skin punch biopsy with allowable local anesthesia and limited to 2mm in diameter and not requiring sutures; (b) Specimens collected by swab (nasal, oral, urethral, vaginal, rectal); (c) teeth if routine patient care indicates a need for extraction.

SACHRP recommendations are not regulation-level, nor current official guidance from OHRP, but are often considered a reasonable basis for institutional guidance and policy.

Noninvasive Procedures

Noninvasive procedures do not involve tools that break the skin or physically enter the body. Noninvasive procedures for research purposes are usually deemed to pose minimal physical risk, though this is also dependent on other contextual factors.

OHRP‘s list Categories of Research that may be Reviewed Through an Expedited Review Procedure (1998) includes many examples:

#3. Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

#4. Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing….
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

MiChart

The patient-centric electronic health record (EHR) system used by more than 26,000 members of the Michigan Medicine community.

Title

Equivalent to the U-M Full Title in the eResearch Proposal Management system; ultimately, this should be the title as found exactly on the contract. Entries must be 4000 characters or less.

Task List Target Date

The expected date the document will be received and attached, or the activity will be completed. It is recommended these dates are completed when the task list is first applied to the protocol.

Task List Owner

The person (or role) responsible for completing the task. This may be a particular person (user) in OnCore or a role (such as CTSU Coordinator), which allows any user in that role (with access to the protocol) to be notified about Active or Upcoming Tasks.

Task List Completed Date

The date the document was actually received and attached to the protocol in OnCore, or the date the activity was actually completed. It is important to track these dates so that tasks are marked as completed and do not show up in the Active or Upcoming Task widgets in the OnCore dashboard.

Subject Related

Subject-related events are attributable to a specific subject and are associated with specific visits.

Study Completion Date

Final date on which data is expected to be collected at U-M.

Start Up

Activity on a study that is not open to accrual.

Short Title

A study requires a short title in OnCore which involves the reduction of the full study title to a logical description that is no more than 100 characters. ***It is necessary to include RESEARCH, at the beginning of the title. Including this prefix is required, as it drives the downstream MiChart billing process.*** The Short Title is the description displayed in several OnCore reports such as Data Table 4 for cancer centers.

Sequence Number

Sponsor-provided subject identifier for this clinical trial

Review Type

Studies will go through Administrative and/or Scientific Review and this should be documented in OnCore. To do so, select Administrative Only or Scientific (Administrative and Scientific). NOTE: Administrative Only is used when the protocol has already undergone scientific peer review by a recognized authority. Scientific is used when the protocol has not been peer-reviewed, indicating that a scientific review is needed in addition to the administrative review.

RC Total Accrual Goal (Upper)

When applying this information in OnCore, enter the U-M site accrual goal for the study. This value will change if the U-M site accrual goal is modified. Set both RC Total Accrual Goal (Upper) and RC Total Accrual Goal (Lower) to the same value.

RC Total Accrual Goal (Lower)

RC Annual Accrual Goal

The estimated number of U-M accruals per year for the study.

Protocol-Related Costs

The Protocol Related tab identifies all the events that relate to the operation of the protocol as a whole (IRB fees, IRB Amendment fees, Advertising fees, and Quarterly Pharmacy fees). These are fees that you would incur even without a single subject accrued.

Protocol Type

There are three different options for entering the Protocol Type into OnCore. When determining the Protocol Type, select from the drop-down list using the following definitions: 1. Treatment: Clinical trials with therapeutic intent using drugs, radiation, surgery, other biological agents, or behavioral or other interventions. 2. Diagnostic: Clinical trials directly testing the efficacy of devices, techniques, procedures; or tests for earlier or more accurate detection or diagnosis of disease. 3. Other

Protocol Target Accrual

Overall accrual goal for the protocol, including all affiliated institutions if a multisite trial.

Protocol Staff

Study Team members who will be engaged in the conduct of the trial as Protocol Staff

Protocol No.

This number should be updated with a study HUM# when assigned. Upon receiving the trial’s HUM number, DO NOT include the HUM prefix in this field. All leading zeros should be included. If not assigned during the feasibility process, enter it into the PC Console.

Protocol Coordinator

Individual who manages the study protocol (e.g., consenting, IRB applications, scheduling patients, monitor visits, data entry, query resolution, etc.)

PRMC (Protocol Review and Monitoring Committee) Approval

When the Medical Director Documents Review Determination as Approved

Principal Sponsor

The sponsor that enrollment should be attributed to for reporting purposes

Prime Sponsor

The original source of project funds named in the agreement, if not the Direct Sponsor. Some projects have Prime Sponsors

Primary Management Group

The Primary Management Group in OnCore is the CTSU that the trial is supported by.

Primary Completion Date

The date that the final subject is anticipated to be examined or receive an intervention at U-M for the purposes of final collection of data for the primary outcome.

Pass Thru Procedures

These charges are billable to the sponsor. When a procedure marked Pass Thru occurs on a subject visit, the charge appears as its own invoiceable item in the Financials Console. When added to an invoice, each Pass Thru procedure is listed as its own line item. Pass Thru charges are not included in the total calculated cost for billable milestones.