Step One

Is this Human Subjects Research? Action items in BOLD

Under the Common Rule 

Research:  A systematic investigational, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge

Drug/Device/Biologic: May be subject to FDA regulations and require IRB review.  Any project subject to FDA regulations is automatically under the purview of the IRB.

Human Subject: Living individual about whom an investigator (1) obtains information or biospecimens through intervention or interaction with the individual and uses, studies or analyzes the information or biospecimens; or (2) obtains uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens

Intervention: Physical procedure by which data are gathered and manipulations of the subject or the subject’s environment that are performed for research purposes

            

Use the following table for evaluation to assist in answering questions:

  

COMPARISON OF THE CHARACTERISTICS OF RESEARCH, QUALITY IMPROVEMENT, AND PROGRAM EVALUATION ACTIVITIES 

When determining whether a project requires IRB review depends on whether it constitutes research involving human subjects.  The table below is intended to help in determining whether a project requires submission to the IRB as a research project involving human subjects. If the project involves some characteristics of a research project, submission to the IRB for review is expected.  Please contact your IRB Office with any questions or for assistance in making a determination.

		RESEARCH	QUALITY IMPROVEMENT	PROGRAM EVALUATION
INTENT		Intent of project is to develop or contribute to generalizable knowledge (e.g., testing hypotheses)	Intent of project is to improve a practice or process within a particular institution or ensure it confirms with expected norms	Intent of project is to improve a specific program
MOTIVATION FOR PROJECT		Project occurs in large part as a result of individual professional goals and requirements (e.g., seeking tenure; obtaining grants)	Project occurs regardless of whether individual(s) conducting it may benefit professionally from conducting the project	Project not initiated by the evaluator and occurs regardless of whether individual(s) conducting it may benefit professionally from conducting the project
DESIGN		Designed to develop or contribute to generalizable knowledge; may involve randomization of individuals to different treatments, regimens, or processes	Not designed to develop or contribute to generalizable knowledge; generally, does not involve randomization to different practices or processes	Not designed to develop or contribute to generalizable knowledge; does not involve randomization of individuals, but may involve comparison of variations in programs
MANDATE		Activities not mandated by institution or program	Activity mandated by the institution or clinic as part of its operations	Activity mandated by the program, usually its funder, as part of its operations
EFFECT ON PROGRAM OR PRACTICE EVALUATED		Findings of the study are not expected  to directly affect institutional or  programmatic practice	Findings of the study are expected to directly affect institutional practice and identify corrective action(s) needed	Findings of the evaluation are expected to directly affect the conduct of the program and identify improvements
POPULATION		Usually involves a subset of individuals - universal participation of an entire clinic, program, or department is not expected; generally, statistical justification for sample size used to ensure endpoints can be met	Information on all or most receiving a particular treatment or undergoing a particular practice or process expected to be included; exclusion of information from some individuals significantly affects conclusions	Information on all or most participants within or affected by receiving a particular treatment or undergoing a particular practice or process expected to be used; exclusion of information from some individuals significantly affects conclusions
BENEFITS		Participants may or may not benefit directly – benefit, if any, to individuals incidental or delayed	Participants expected to benefit directly from the activities	No benefit to participants expected; evaluation concentrates on program improvements or whether the program should continue
DISSEMINATION OF RESULTS		Intent to publish or present generally presumed at the outset of project as part of professional expectations, obligations; dissemination of information usually occurs in research/scientific publications or other research/scientific fora; results expected to develop or contribute to generalizable knowledge by filling a gap in scientific knowledge or supporting, refining, or refuting results from other research studies	Intent to publish or present generally not be presumed at the outset of the project; dissemination of information often does not occur beyond the institution evaluated; dissemination of information may occur in quality improvement publications/fora; when published or presented to a wider audience, the intent is to suggest potentially effective models, strategies, assessment tools or provide benchmarks or base rates rather  than to develop or contribute to generalizable knowledge	Intent to publish or present generally presumed at the outset of the project; dissemination of information to program stakeholders and participants; may be publicly posted (e.g., website) to ensure transparency of results; when published or presented to a wider audience, the intent is to suggest potentially effective models, strategies,  assessment tools or provide benchmarks or base rates rather than to develop or contribute to generalizable knowledge
USE OF PLACEBO		Use of placebo may be planned	Comparison of standard treatments, practices, techniques, processes – placebo would NOT be used
DEVIATION FROM  STANDARD PRACTICE		May involve significant deviation from standard practice	Unlikely to involve significant deviation from standard practice

 

If the Initial evaluation is that the project is NOT research and is either quality improvement or program evaluation, proceed with steps below.  If there are any elements that are uncertain or meet the Research Criteria, proceed to Step 2

Utilize the UW IRB Self-Certification Tool:

Review the questions and guidance as you complete the tool

· Will the project involve testing an experimental drug, device (including medical software or assays) or biologic?

YES:  IRB review likely required – falls into FDA regulated research

· Has the project received funding (e.g. federal, industry) to be conducted as a human research study?

   YES: If the funding agency determines this to be a human research study IRB review likely required

· Is this a multisite project? 

YES: If multisite, likely that multiple institutions are conducting the same activities and the results are generalizable (unlikely a QI or program evaluation at a local institution).  At minimum an IRB consult should be obtained to determine the correct submission path

· Is this a systematic investigation designed with the intent to contribute to generalizable knowledge (testing a hypothesis, randomization, comparison of case versus control, observational, comparative effectiveness research)
      YES: IRB review likely required

· Will the results of the project be published, presented or disseminated outside of the institution conducting it?

YES:  Publishing doesn’t automatically indicate it needs IRB Review 

· Will the project occur regardless of whether individuals conducting it may benefit professionally?

· Is the project intended to improve or evaluate the practice or process within a particular institution or a specific program?

RESULTS from the Self-Certification Tool

STOP HERE. This certification is not valid. IRB review is likely required. Recommend an IRB Consultation

If no message above is received, IRB Review is not required because in accordance with federal regulations the project does not constitute research under 45 CFR 46.102(d).  

·      Print a copy of the form and retain (save)

·      Do NOT refer to your project in any way as a research study.

·      Do not Proceed to Step 2

Step Two

·               Determine if your research may be applied to one of the Exemption Criteria under the Common Rule (revised 1-19)

·               Research study must be minimal risk and not involve an incarcerated population

·               Utilize the UW IRB Exemption Category Tool.  This will assist the user in determining if their research qualifies for possible exemption (and must be submitted as such) or if they need to submit for another type of application for review. Only the IRB can determine whether the research is exempt after submission.

·               Questions to consider

a.    Will the project involve testing a drug, biologic, and/or device including medical software or assays)?

YES:  Likely will not qualify for any exemption criteria as it falls under FDA regulations

b.    Will the project involve creation of a medical device?

YES:  Likely will not qualify for any exemption criteria 

No:  Options will show to select the type of exemption criteria the study may qualify for

c.     Choose the appropriate exemption category (UW IRB allows for first 6, the last two have not been adopted by our IRB, due to issues regarding broad consent requirements)

· Research conducted in established or commonly accepted 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.

· 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).

· Research involving benign behavioral interventions (i.e., brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on or be offensive or embarrassing to the subjects) with adult subjects who prospectively agree to the intervention and collection of information through verbal or written responses (including data entry) or audiovisual recording.

· Secondary research uses of identifiable private information or identifiable biospecimens.

·  Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of the department or agency heads, that are designed to study, evaluate, or otherwise examine: 

1.    procedures for obtaining benefits or services under those programs;

2.    possible changes in or alternatives to those programs or procedures; or

3.     possible changes in methods or levels of payment for benefits or services under those programs.

· Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approve by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture (45 CFR 46.101 (b)(6) and 21 CFR 56.104 (d).

d.    Depending upon the answers provided to the questions under the specific category, the tool will direct the user to the type of application to submit via Arrow. 

Step Three

·               Investigators new to research, those that are involved in multisite research, or those that are not sure despite guidance above are encouraged to submit an IRB Consultation Request or contact the IRB with questions at AsktheIRB@medicine.wisc.edu or 608-263-2362.  

·               Recommendation – Obtain an IRB Consultation 

 

Appendix Resources:

Pharmacy Staff/Resident Eligibility for Principal Investigator Status on Research VP Approval (Sharepoint Login Required)