Getting Through the IRB Approval

Q: Does a process improvement project require IRB approval?

A: Only if you want to publish the results to an external audience (outside of Duke).

Two steps of review are required to obtain IRB approval; Internal or departmental review and formal IRB review. When you submit a new study to the eIRB, departmental review is completed first and is done by the SBR (Site Based Research). When review is complete the study automatically progresses to the next step, IRB review.

Step 1: Review

The primary purpose of review is to review the proposal for feasibility and scientific merit, and to ensure the proposal is complete prior to submission to the IRB. Per review examines the importance of the study to clinical practice and the appropriateness of the research materials and methods for meeting the study objectives. At Duke, standardized guidelines are used and are available on the ‘Downloadable Forms’ website under the eIRB. The review committee uses these evaluations to form the basis of their summarized recommendations to the author. A copy of your proposal, complete with all appendices and references, is electronically submitted for review when you choose Nursing or Heart Center as your site based research (SBR) and click “submit” on the eIRB submission page at https://eirb.mc.duke.edu.

The purpose of review is to facilitate your IRB review, so take advantage of this opportunity! See the checklist online for things to complete prior to submitting your proposal for eIRB review.

STEP 2: Institutional Review Board (IRB) Review

The purpose of the institutional review board is to protect the rights of human subjects, who will be enrolled in the study, and to evaluate and resolve any ethical issues that may arise in the course of the study. Most of the standards for ethical conduct or research on human subjects are developed at a national level by the National Institute of Health (NIH) and are required for all approved research. Some guidelines are specific to Duke. The guidelines apply to all studies involving human subjects in any capacity, and are available on-line at https://www.eirb.mc.duke.edu.

Who is on the IRB?

IRB members generally include clinical experts, nurses, physicians, ethicists, clergy, social workers, lawyers, risk management representatives, and non-healthcare members of the community. Because of the variety of individuals and the range of expertise and experiences represented, one must be prepared to address a wide range of questions and concerns in the written proposal. For this reason, the more clearly and simply the proposal is written for the IRB, the better.

What Needs Approval?

The IRB must review and approve all research involving human subjects, both patient and staff-focused research. Research, as defined by the IRB, is “any activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge.”¹

Information or data that is collected for the purposes of quality improvement activities, process and/or program evaluations is not likely to be classified as “research” by most IRBs, but should go through IRB approval prior to being published or presented outside of the institution. For example, doing patient satisfaction surveys after discharge to identify areas for practice improvements would be unlikely to be called research by most IRBs. Another example would be data collection to track complication rates and patient outcomes of usual nursing or medical care. These types of projects can be conducted as process improvement or quality monitors and then, if the data are considered to be of interest to others, IRB approval may be obtained to sue the data as research.

Your study, based on the design and how human subjects will be involved, may qualify for either expedited review or exemption from review. Criteria for these two categories of review are listed below. If your protocol is expedited or exempt, it will not require full board review, but still must be submitted and approved prior to beginning the study. In expedited review, the IRB chair or his/her designee may quickly review the protocol, without requiring the full IRB committee review. To undergo expedited review the protocol must involve no more than minimal risk and the only involvement of human subjects must fit into designated categories shown below. If you do qualify for expedited review, it may be helpful to include a cover letter to the IRB chair when you submit your protocol that spells out how your protocol meets the criteria for expedited review.

The interpretation of what constitutes human subjects research, and therefore what requires IRB review and approval, varies with each institution. When it is not clear if IRB review is required or not, it is best to consult with the IRB chair and follow his/her guidance. The motto, “when in doubt, submit it to the IRB” would always be a prudent approach to follow!

What does the IRB need from me?

The IRB meets every 2 weeks at Duke, and at designated times throughout the year for proposal review. These dates are available on-line from the IRB website. Specific requirements for submission of a research proposal and all downloadable templates and required forms are also available here under “Downloadable Forms.”

¹Blemont Report: Ethical Principals and Guidelines for the Protection of Human Subjects of Research, OPRR Reports. US Government Printing Office: Washington, DC, April 18, 1979, page3.

Expedited Criteria

45 CFR 46.110 and 21 CFR 56.110

Permissible categories – which apply regardless of the age of subjects, except as noted:

• Clinical studies of drugs for which an investigational new drug application is not required.
• Clinical studies of medical devices for which an investigational device exemption application is not required; or the device is cleared/approved for marketing and is being used in accordance with its cleared/approved labeling.
• Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture from healthy, nonpregnant adults who weigh at least 110 pounds (not to exceed 500 ml in an 8-week period, and not more than 5 such amounts per year, or collection more than 2 times per week.)
• Prospective collection of biological specimens by noninvasive means (e.g., hair and nail clippings in a nondisfiguring manner).
• Collection of data through noninvasive procedures, and without 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. (Evaluation of safety and effectiveness of device not generally eligible for expedited review, including studies of cleared devices for new indications.)
• Research involving materials (data, documents, records, specimens) that have been collected or will be collected solely for nonresearch purposes (e.g., medical treatment or diagnosis).
• Collection of data from voice, video, digital, or image recordings made for research purposes.
• Research on individual or group characteristics or behavior.

Exempt Criteria

45CFR46.101(B)(2)

Exempt is: If you can collect the information anonymously, that is provide subjects with your questionnaire and instruct them not to add any identifying information (none of the 18 HIPAA identifiers) the study meets the criteria for exemption under 45CRF46.101(b)(2), which is the following:

• Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
• Information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and
• Any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.

Research Resources

In this phase, the support staff can help you with:

• Navigating the eIRB website (by appointment please)
• Creating cover letters for expedited or exempt proposals

Staff Nurse Participant Responsibilities

In this phase, your responsibilities as a research nurse include:

• Uploading your final protocol to eIRB
• Responding promptly to all emails and queries from Departmental and IRB reviewers!
• Plotting team member’s timelines for certification and protocol renewals in your electronic study workbook

*To initiate a new study log into eIRB using your net ID and password (https://eirb.mc.duke.edu)

18 HIPAA Identifiers

1. Names
2. Geographic locations
3. All elements of dates (except year). Ages of 90 may be aggregated into a single category.
4. Telephone numbers
5. FAX numbers
6. Electronic mail addresses
7. Social security numbers
8. Medical record numbers
9. Health plan beneficiary numbers
10. Account numbers, Certificate/license numbers
11. Vehicle identifiers and serial numbers; license plate numbers
12. Device identifiers and serial numbers
13. Web Universal Resource Locators (URLs)
14. Internet Protocol (IP) address numbers
15. Biometric identifiers
16. Full face photographic images and any comparable images
17. Any other unique identifying number, characteristic, or code except a code to permit re-identification of the de-identified data by the Honest Broker.