1. IRB Educational Session - IRB Regulations and Types of Review
March 13, 2018

2. The Institutional Review Board (IRB) at UMKC
IRBs are mandated by the National Research Act to be established within each university or other institution that conducts biomedical or behavioral research involving human participants and receives federal funding for research involving human participants.
The UMKC IRB is regulated by
the Office of Human Research Compliance (OHRP) and
the U.S. Food and Drug Administration (FDA).

3. IRB Requirements for Human Subjects Research
Institutions and IRBs vary in the practices that assure they meet the federal regulations and in the details of the standards they apply.
What follows are the minimum federal requirements.

4. IRB Requirements for Human Subjects Research
Risk / anticipated benefit analysis.
Identification and assessment of risks and anticipated benefits.
Determination that risks are minimized.
Determination that risks are reasonable in relation to potential benefits.
Informed consent
Informed consent process and documentation.
Assent - The affirmative agreement of a minor or decisionally impaired individual to participate in research.
Assent process and documentation.
Selection of subjects
Equitable selection in terms of gender, race, ethnicity.
Benefits are distributed fairly among the community’s populations.
Additional safeguards are provided for vulnerable populations susceptible to pressure to participate.

5. IRB Requirements for Human Subjects Research
Safeguards - that ensure that subject recruitment does not invade individuals’ privacy and that procedures are in place to assure that the confidentiality of the information, collected during the research, is monitored.
Research plan for collection, storage, and analysis of data
Research design / methods - that are appropriate, scientifically valid and therefore, justify exposing subjects to research risks.

6. Is your activity Research?
Research:  a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research. 

7. Does your activity involve Human Subjects?
Human subject:  a living individual about whom an investigator (whether professional or student) conducting research obtains (1) Data through intervention or interaction with the individual, OR (2) Identifiable private information
Intervention includes both physical procedures by which data are gathered and manipulations of the subject or the subject's environment that are performed for research purposes. 
Interaction includes communication or interpersonal contact between investigator and subject. 
Identifiable private information Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. 

8. Types of Submissions Not Human Subjects Research (NHSR)
Determination made by the Research Compliance Office
Exempt Determinations
Expedited Review
Review by 1 or more members of the IRB
Full Board Review
Review by the fully convened IRB

9. Not Human Subjects Research
UMKC has a mechanism for investigators to submit for a determination of Not Human Subjects Research
For assurance the activity is not “human subjects research” and thus require additional oversight
Provides documentation to journals requesting confirmation of IRB* submission
*These submissions are determined to be Not Human Subjects by the UMKC Research Compliance Office not the IRB

10. Exempt Determinations
For a study to be eligible for exemption all of the research activities must fit in one or more of six categories.
Risk Assessment Considerations
Research eligible for exemption usually involves little or no risk to subjects. When determining “minimal risk” all the risks associated with the study must be identified.
minimal risk - “the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests” [45 CFR (2)(i)].

11. Exempt Determinations - Categories
Educational Practices
Educational Tests, Surveys, Interviews or Observation of Public Behavior
Elected/appointed public officials, candidates for public office, federal statutes require
Existing Data
Public Benefit and Service Programs
Taste and Food Quality

12. Exempt Determinations – Category 1
“Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (II) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.” (§46.101(b)(1))
Does the proposed activities constitute “normal educational practice” and if the setting is a “commonly accepted educational setting”?
A study to develop an innovative method for teaching math in the second grade would be eligible under this exemption provided the curriculum development methods reflected normal educational practices.
Commonly accepted educational settings include but are not limited to schools and universities, workplace educational programs and sites; libraries (adult learning classes), and other sites where educational activities regularly occur, including some nontraditional settings (e.g., nutrition class at a grocery store).  Normal educational practices are not restricted to traditional settings and can include a variety of acceptable educational practices.

13. Exempt Determinations – Category 2
“Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
(i) Information obtained is recorded in such a manner that human subjects cannot be identified, directly or through identifiers linked to the subject,
AND
(ii) 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.” (§46.101(b)(2))
Category 2 exemption criteria allows for both anonymously collected data (i) and data collected with identifiers (ii).
Category 2 exemption cannot include an intervention

14. Exempt Determinations – Category 2 cont.
Category 2 exemption cannot include an intervention
No standard definition exists to define when research involving an educational tests, survey procedures, interview procedures, or observation of public behavior is eligible for a category #2 exemption, and when research involves more than these procedures and therefore would be ineligible.
A useful standard is to define educational tests, survey procedures, or interview procedures as activities that consist entirely of data gathering through interaction and include no data gathering through intervention with the subject. The only logical and consistent definition the UMKC Research Compliance Office can surmise is that category #2 encompasses all behaviors that are limited to interaction (communication and personnel contact), where the only intervention is the manipulation of the environment through doing the educational test, survey or interview.

15. Exempt Determinations – Category 4
“Research involving 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.” (§46.101(b)(4)) In order to qualify for this exemption, the materials to be used in the research must satisfy two criteria: 
The data/specimens must be existing or "on the shelf" at the time the research is proposed to the IRB (i.e., date of the IRB application). This category does not apply to the prospective collection of data or specimens. 
The data to be used cannot include direct identifiers (e.g., names, social security numbers, addresses, phone numbers) or indirect identifiers (codes or pseudonyms that are linked to the subject's identity). 

16. Expedited Review
To qualify for an expedited review, research must fall into one of 9 federally-defined expedited categories. These categories involve collection of samples and data in a manner that involves no more than minimal risk to subjects.
Expedited review as defined by federal regulations allows the IRB chairperson or one or more experienced reviewers designated by the chairperson from among members of the IRB to evaluate and approve specific types of research.

17. Expedited Review - Categories
Clinical studies of drugs and medical device
Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture 
Prospective collection of biological specimens for research purposes by noninvasive means.
Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. 
Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as 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 (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.

18. Expedited Review/Full Board – Criteria for Approval
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 from each prospective subject
Informed consent will be appropriately documented
When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects
When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data

19. General Points – Children in Research
Children in Exempt Research
Exemptions may be applied to research involving children with one exception.
Exempt Category 2 - Research involving surveys, questionnaires and observation of public behavior can only be exempt if it involves observation of public behavior in which the investigator plays no part (in research in which no identifiers are recorded).
Children in Expedited Research
For research that is not exempt, federal regulations identify four categories of research that may be allowable in children. Three of them may be approved by the local IRB; the fourth also needs special federal approval.
Explanations and what's required for IRB approval under each category is provided below:
Research involving no more than minimal risk. (45 CFR )
Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects. (45 CFR )
Research involving greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject's disorder or condition. (45 CFR )
Research not otherwise approvable which presents an opportunity to understand, prevent, or alleviate a serious problem affecting the health or welfare of children. (45 CFR )

20. General Points – Consent, Assent, Parental Permission
Exempt Research does not require an informed consent but good practice is to supply an information sheet
For non-exempt human subjects research
Signed Consent is required
Unless choosing a waiver of documentation
Assent is required
Parental permission is required
Consent, Assent and Parental permission documents must be written in a language understandable to the participant
Translated documents are required for non-English speakers

21. General Points – Random
For research conducted at locations other than UMKC, site permissions are required
If a research participant is going to see it, the IRB needs to see it
Be sure your application is consistent
Privacy and Confidentiality of information is incomplete
The Risk to Benefit ratio is not adequately addressed
When asked to describe the procedures that are experimental be sure to address what is being asked of the participants that is research driven in comparison to what might otherwise be standard of care or established practice.

22. Submitting an Application

23. Submitting an Application
If you do not have an existing eProtocol account you must register for one

24. Submitting an Application
To create a protocol

25. Helpful Links IRB Home Page IRB Policies Informed Consent QA/QI
Exempt Determinations
Vulnerable Populations
Privacy and Confidentiality