1. What the IRB is looking for when reviewing your protocol

2. Back to Basics…
Anyone engaged in human subjects research at UMKC is bound to comply with regulations and policies for protecting participants.
These include but are not limited to:
45 CFR 46, DHHS
21 CFR 56, 21 CFR 50, 21 CFR 312, 21 CFR 812, FDA
UMKC IRB Policies & Procedures
Ethical Principles in the Belmont Report

3. Back to Basics…
The IRB exists to protect human research participants, but there are many projects for which the regulations do not require IRB review
We try to limit our scope to what is required by the regulations

4. The Big Question The rules only apply to certain projects, so…
What types of projects must the IRB review?

5. Human Subjects Research
Research is “a systematic investigation designed to contribute to generalizable knowledge.”
(paraphrased from 45 CFR )

6. Human Subjects Research
Systematic Investigation?
Methodical exploration of a question or theory
Typically includes data collection and analysis
Includes development, design, and testing phases

7. Human Subjects Research
Typically Includes:
Interviews, surveys, chart reviews, epidemiological studies, observational studies
Typically does NOT include:
Training others on how to use a device, provided activities do not include data collection/analysis

8. Human Subjects Research
Designed to be Generalizable?
Difficult to define, but typically designed to be generalizable if:
Aims to draw conclusions about people or practices beyond a specific individual or internal program
The intent to generalize makes it research, whether results are published or presented does not matter

9. Human Subjects Research
Typically does NOT include:
Quality Assurance/Quality Improvement
Public Health Practice
Case Reports (if small number of reports)
Academic Course Evaluations
Most Oral Histories and Biographies

10. Human Subjects Research
DHHS Definition:
A Human Subject is a living individual about whom an investigator obtains:
Data through intervention or interaction; or
Identifiable private information
Identifiable if identity can be ascertained (e.g. 18 HIPAA identifiers)
Private means a reasonable expectation that no recording is taking place, and information is used for intended purposes
45 CFR

11. Human Subjects Research
FDA Definition:
A Human Subject is an individual who is or becomes a participant in research, either as a recipient of the test article or as a control.
May be either a healthy human or a patient.
Clinical investigations with human specimens
e.g. assays or in vitro diagnostic devices CFR 50.3(g)

12. Human Subjects Research
Typically does NOT include human subjects:
Analysis of deidentified dataset
Research with deidentified samples
Exception for FDA definition, in which it is a clinical investigation involving human specimens
Deceased individuals

13. Contact the IRB for a Determination
Determining whether a project requires IRB oversight can have significant consequences.
Unless absolutely sure, it is best to contact the IRB
Can always call ( ) or the main IRB office

14. Once it has been determined you are conducting human subjects research
The protocol is then classified as
Exempt
Expedited review
Full board review

15. Exempt
At UMKC Exempt applications are handled by the Research Compliance Office
Applications meeting one or more of the six federal categories are exempt from further IRB review.

16. Exempt - Categories
Exempt 1 - Research conducted in established or commonly accepted educational settings, involving normal educational practices
Exempt 2 & 3 - Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior
Category 3 is specific to elected or appointed public officials or candidates for public office

17. Exempt - Categories
Exempt 4 - Research involving the collection or study of existing* data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
*Note: "Existing" means existing before the research is proposed.

18. Exempt - Categories
Exempt 5 - Research and demonstration projects which are conducted by or subject to the approval of department or agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.

19. Exempt - Categories
Exempt 6 - 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 approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

20. Expedited and full board review
IRB review is either expedited (no more than minimal risk) and applicable to one of the federal categories of expedited review or full board review (more than minimal risk)
Expedited review is conducted by 2 or more IRB members.
Full board review is conducted by the fully convened IRB.

21. Expedited and full board review
The IRB has the authority to:
Approve all research activities
Require modifications prior to approval
Disapprove all research activities
Ensure that information given to subjects in the informed consent meets federal informed consent requirements
Require documentation of consent or waive documentation
Notify investigators of its decision to approve or disapprove or of modifications required to secure approval
Conduct continuing review

22. Expedited and full board review – Criteria for approval
In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
Risks to subjects are minimized
Risks to subjects are reasonable in relation to anticipated benefits
Selection of subjects is equitable
Informed consent will be sought
Informed consent will be appropriately documented
the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
When some or all of the subjects are likely to be vulnerable to coercion or undue influence additional safeguards have been included in the study to protect the rights and welfare of these subjects.

23. Expedited review - Categories
Clinical studies where an IND or IDE is not required
Blood Collection
Prospective collection of biological specimens for research purposes by noninvasive means
Collection of data through noninvasive procedures routinely employed in clinical practice
Research involving materials that have been collected for any purpose
Collection of data via audio/visual recordings made for research purposes
Research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies

24. Review Basics Reducing the number of review cycles is the key
Researcher vs participant perspective
Inconsistencies in the application
Separate routine care from the research
Include copies of anything you will communicate/share with the participant
Be specific in your recruitment approach(es)
Be specific in your plan to protect privacy and confidentiality
Does your consent include all the required elements?

25. Questions? IRB Contacts on the QA and Education team: Rebekah Lee
(816) or
Crystal Simonis
(816) or
Bailey Walton
(816) or
Chris Winders
(816) or

26. Thank You!