What the IRB is looking for when reviewing your protocol

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

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

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

Human Subjects Research Research is “a systematic investigation designed to contribute to generalizable knowledge.” (paraphrased from 45 CFR 46.102)

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

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

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

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

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 46.102

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 21 CFR 50.3(g)

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

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 (816 235-5927) or email the main IRB office (umkcirb@umkc.edu)

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

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.

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

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.

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.

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.

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.

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

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.

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

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?

Questions? IRB Contacts on the QA and Education team: Rebekah Lee (816) 235-6150 or leerebek@umkc.edu Crystal Simonis (816) 235-1358 or turnercd@umkc.edu Bailey Walton (816) 235-1764 or waltonbl@umkc.edu Chris Winders (816) 235-5370 or windersc@umkc.edu

Thank You!