Expeditable Research

The general criteria for expedited review are that:

45 CFR 46.110 (b)(1) An IRB may use the expedited review procedure to review the following:

Adjunct List of Categories Qualifying for Expedited Review

Category 1

Clinical studies of drugs and medical devices only when condition (a) or (b) is met, (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

Category 2

Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: (a) from healthy, non-pregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or (b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

Category 3

Prospective collection of biological specimens for research purposes by noninvasive means, Examples: (a) Hair and nail clippings in a non-disfiguring 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); and (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 removal 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.

Category 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. (Studies intended to evaluate the safety and effectiveness of the medial device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.) 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 subjects 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.

Category 5

Research involving materials (data, documents, records, or specimens) that have been collected for any reason or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis)

Category 6

Collection of data from voice, video, digital, or image recordings made for research purposes.

Category 7

Research on group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs, or practices, and social behavior or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.

Category 8

Continuing review of research previously approved by a convened IRB as follows: (a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for the long term follow-up of subjects; or (b) where no subjects have been enrolled and no additional risks have been identified or (c) where the remaining research activities are limited to data analysis.

Category 9

Continuing review of research not conducted under an investigational new drug application or investigational drug exemption where categories 2 through 8 do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

Research Exempt from Full Review

(effective 21 JAN 2019)

Although the category is called “exempt,” this type of research does require the principle investigator to submit a CUHSR application. Only CUSHR can make the determination if a human subject research protocol is exempt from a full review and thus exempt from all the federal regulations regarding human subjects in research. The exempt review process is less rigorous than an expedited or full-committee review. To qualify, research must fall into one of eight (8) federally-defined exempt categories. These categories present the lowest amount of risk to potential subjects because, generally speaking, they involve either collection of anonymous, publicly-available or de-identified data, or the conduction of very benign behavioral research experiments. The exempt human subjects research must still be conducted in a manner that meets general ethical guidelines such as:

Some of the following factors that may raise questions in the review whether a protocol is exempt or not:

The following are the eight categories exempt research specified by the Department of Health and Human services 45 CFR 46.104

Category 1 Exemption: Normal Educational Practices and Settings

Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

Category 2 Exemption: Anonymous Education tests, Surveys, Interviews or Observations

Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:

Category 3 Exemption: Benign behavioral interventions

Category 4 Exemption: Secondary Research for which consent is not required

Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:

Category 5 Exemption: Public Benefit or Service Program

Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.

Category 6 Exemption: Taste and Food Evaluation and Acceptance Studies

Taste and food quality evaluation and consumer acceptance studies:

Category 7 Exemption: Storage or maintenance for secondary research for which broad consent is required

Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations required by §46.111(a)(8).

Category 8 Exemption: Secondary research for which broad consent is required

Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:

Criteria for CUSHR Approval of Research

CUHSR reviews and has the authority to approve, require modification (to receive approval) or disapprove all research activities covered by HHS guidelines. In order to approve a research project, CUHSR shall determine that all of the following requirements are satisfied (from 45 CFR 46.111):

CUHSR shall have the authority to suspend or terminate approval of research that is not being conducted in accordance with its requirements or that has been associated with unexpected serious harm to subjects.

CUHSR regulations require that research involving any level of deception be followed by an appropriate debriefing of all subjects. Debriefing procedures should be specified in the CUHSR application form.

Not Human Subjects Research and Quality Assurance Projects

The area of QA/QI and human subjects review has been controversial and unclear for many institutions. The confusion arises because QA/QI activities and research activities both use scientific methods, however, most QA/QI projects do not fall squarely into the definition of human subject research as established by the federal regulations thus making it technically exempt from review by an IRB. QA/QI projects are typically management activities collecting and analyzing data to assess some internal operation for monitoring and improvement purposes. These activities typically do not attempt to be systematic about subject selection related to a population. Nor do QA/QI projects try to make broad inferences (generalize) beyond the scope of the institution. Thus QA/QI typically falls outside the regulatory definition of research which states: “Research means a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” 45CFR46.102(l). Research tends to be an investigation with a question or hypothesis driving the activity. The answer to the question is typically interpreted broadly and inferences are made beyond the sample.

Many QA/QI projects involve interactions or interventions with human subjects. Though a project may not be technically “research,” it might involve human subjects. An institution, such as Bradley University, still has a duty in assuring human protections and follows certain ethical principles and guidelines as it applies to all investigations involving human subjects with interactions, interventions or collecting personal information. Bradley University is committed to follow the guidelines of the Belmont report. The three ethical concepts in the Belmont report are 1) respect for persons, 2) beneficence, and 3) justice. Thus, in the application of these principles, protocols are carefully considered with regard to informed consent, privacy of personal information, risk benefit assessment, and selection of subjects. These principles should be applied to all investigations involving human subjects even if that project technically is exempt or falls outside of the technical definitions of the federal regulations. QA/QI projects involving human subjects with interactions or interventions or collecting personally identifiable information (and biospecimens) should follow ethical principles. The question remains whether these projects should be reviewed by CUHSR.

What types of QA/QI projects DO NOT need CUHSR review?

What types of QA/QI project need a review?

Technically, if it is clearly a QA/QI project, it does not need an IRB review according to the federal regulations. However, there are cases where we as an institution would highly recommended and in some cases, require that project be reviewed. When in doubt, it is always good to fill out an application and have your project reviewed.

What types “research” projects DO NOT need a review?

If a project meets the definition of research and human subject interaction by the federal guidelines, then it need an IRB review. Occasionally projects are set up like research (hypothesis driven) yet there is clearly not an intent to share the results with the purpose of contributing to generalizable knowledge. The case where this happens the most is in undergraduate research classes. As part of the class, the students may be asked to conduct “research” that involves human subjects in a low risk activity, but there is not an intent that the results are disseminated beyond that class (or department). In this case, the instructor is the one responsible that the projects are carried out following ethical principles. CUHSR is more than willing to assist instructors in understanding human subject’s review process. All our review procedures and forms are available to use by the instructor and class in order to simulate an actual review. Ethical training (CITI) is available for anyone on campus. If the projects are being disseminated beyond the department, including the Bradley Student Expo, then a CUHSR review needs to occur prior to collecting data on human subjects.

What if I am not sure if I have a QA/QI project or if it is research?

Often the intent of your project is what determines whether it is research or not. So, if you are assessing an existing process with no intent to share the results broadly and with the intent to assess or improve the process, then this is clearly a QA/QI project. In this case there is no research question or hypothesis and no intent to contribute to generalizable knowledge. In doing a similar project, you might assess a process with the intent of determining the variables that affect that process, so that this could be shared broadly to contribute to the general knowledge of that process. This has the appearance of research and needs to be reviewed if it involves human subjects. When the purpose of the project is stated on the application, research intent should be clear in that brief statement. When there is a doubt, you should submit an application to CUHSR.

Can I publish or present my QA/QI project?

Yes, you can – but please note, if you are doing QA/QI it would be unlawful to refer to it as research as this implies that it meets the federal definition of research as was approved by an IRB under the federal guidelines. Intent to disseminate results is not the criteria for something to be consider research and thus require a prospective review. Some QA/QI projects are worthy of dissemination broadly, but if they are disseminated, the authors should state clearly the intent as QA/QI and not research. If your ultimate intent is to publish or have your work disseminated, we might recommend that you adapt your project to reflect research and have it reviewed. Many journals will not accept a paper unless there was proof that it was approved by an IRB.

Once I collect data on a QA/QI project that was not approved by CUHSR, can I go back and get approval of the project as research?

ZOnce an investigation is conducted and the data is collected under QA/QI an investigator cannot change the status of their study by getting it approved as research by an IRB. The federal regulations make no provision for a retrospective review. The regulations are clear that approval of research is prospective. CUHSR recommends that you think that you might have a QA/QI project that many have results that could make a contribution to generalizable knowledge, then the investigator should seek IRB approval of the project as research before it commences. In some cases, a project might have a dual purpose to evaluate an internal process and evaluate the result in a broader context. If this is the case then the project should be reviewed prospectively as research.

Some QA/QI projects may involve personal information, such as a GPAs, or salaries, however if that information is collected in such a way that the data cannot be tracked to an identifiable person and the project does not involve interaction with individuals, then it would not necessarily need a review. This scenario may be another mater in areas where there are additional protections on personal data, such as in health care (HIPAA or FERPA). In a health care setting or an educational setting, a review should occur so there are assurances that no HIPAA or FERPA violations have occurred. When in doubt, the investigator should contact the CUHSR chair or their immediate supervisor.

The type of interaction or intervention will also dictate the need for a review. As previously mentioned, an anonymous survey with the intent to look at an internal process and that does not collect sensitive or personal information may not need a review. However, if you survey the effectiveness of an intervention and that intervention has some risk or the population was inherently at risk, then is should be reviewed. For example, if you are a Bradley student and want to determine the effectiveness of community exercise program that brings in people who may not ordinarily exercise, then this should be reviewed because these people may be at risk of harm from your intervention. This should be reviewed even if your intent is not to broadly interpret the results. Also, if your survey has sensitive questions that might disturb or upset the participants, or if a breach of confidentiality would bring harm, then it should be reviewed.

IRB/CUHSR Application and Review	Characteristic of investigation
NO	Most QA/QI investigations Most QA/QI investigations No Human Interaction, Intervention, or collection of identifiable information. Not Research (Not systematic or intent to be generalizable). Example: De-identified data used to evaluate internal processes or status (Health care settings may need approval of CUHSR or Privacy board)
NO	Many QA/QI investigations Begin Human Interaction, Intervention or collection of de-identified information. Not Research (Not systematic or intent to be generalizable). Example: Anonymous survey about effectiveness of a workshop Class survey about teaching effectiveness (Any human interaction should still have a voluntary consent process).
YES	Some QA/QI investigations – Gray zone Human Interaction, intervention or collection of identifiable information. Not research (not systematic or intent to be generalizable). Example: Anonymous survey about a deliberate change in process that may involve some risk (even if minor) to subject. Anonymous survey about a sensitive subject. A survey that collects identifiable information. This may be QA/QI but will be approved under the standards of research by CUHSR.
YES	Appears to be QA/QI but intent is research No Human Interaction, Intervention, or collection of identifiable information. Research (systematic with intent to be generalizable). Example: Retrospective review of a de-identified data base. Very likely to be reviewed as Exempt research.
YES	Reviewed as Research Human Interaction, intervention or collection of identifiable information. Research (systematic with intent to be generalizable). Example: All other investigations reviewed under the federal regulations.