Institutional Review Board(IRB)

Research Methods Professional Development

InstituteDecember 3, 2015

About Our Speaker• Katherine (Kathi) J. Conger, Professor of

Human Development and Family Studies, Department of Human Ecology, University of California, Davis

• Member of Social-Behavioral Committee C for past 5 years

IRB Process

• Why do we have an IRB?• How do we know if we need to submit our

research proposal to the IRB?• What happens once we hit “submit”? • Where does it go, what is the review

process?

Objectives for Today’s Talk

Explain the history of Institutional Review Boards (IRBs)

Describe the IRB review categories and regulatory criteria for approval

Discuss the IRB application process

Discuss tips for success

4

An earlier time…..

Edward Jenner - Founder of Immunology - Known for contribution to Small Pox eradication Hand of Mary Nelms, Milkmaid

“On May 14, 1796, using matter from Nelms' lesions, he inoculated an 8-year-old boy, James Phipps. Subsequently, the boy developed mild fever and discomfort in the axillae. Nine days after the procedure he felt cold and had lost his appetite, but on the next day he was much better. In July 1796, Jenner inoculated the boy again, this time with matter from a fresh smallpox lesion. No disease developed, and Jenner concluded that protection was complete.”

NAZI Experiments

Tuskegee Syphilis Study

Tuskegee Syphilis Study Funded by Public Health ServiceObjective was to study the lifespan of syphilis.Enrolled African American sharecroppers who were infected with syphilis.The men were never treated and were told they had “bad-blood.”Information about the study became public in 1972. Congress reaction by requiring DHHS to develop regulations. Congress formed the National Commission for the Study of Ethical Problems in Research.In 1997 President Clinton apologized to the participants

US History of Human Research Protections

Resulted from the Nuremberg Trials

Created the first principles of: • Informed Consent• Proper formulated

scientific experimentation

• Beneficence towards participants

Adopted into the Declaration of Helsinki

No legal precedent

Nuremberg Code (1947)

11

US History of Human Research Protection (cont.)

Prompted by the Tuskegee Syphilis Study Established three fundamental ethical principles:

Respect for PersonsBeneficenceJustice

Expanded and revised regulations that protect human research subjects in the United States

Led to the establishment of the Office for Human Research Protections (OHRP)

Led to the creation of Institutional Review Boards (IRBs)

Belmont Report (1978)

12

Institutional Review Board (IRB)

UC Davis IRB AdministrationFederalwide Assurance #00004557Approve/modify/disapprove research

protocols involving human subjectsProtect rights and welfare of human

subjects Four Committees: Biomedical,

Social/Behavioral, and Fast TrackFull committees and expedited/exempt

reviewersMulti-campus collaborative review and

agreementsEducation and trainingAdministration and record-keeping

13

The Common Rule

Basic Policy for Protection of Human Research Subjects

Extra Protections for Pregnant Women, Human Fetuses and Neonates Involved in Research

Extra Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects

Extra Protections for Children Involved as Research Subjects

45 CFR 46 (Public Welfare)

14

Research as defined by Department of Health and Human Services:

What is Research?

“A systematic investigation, including research

development, testing and evaluation, designed to develop or contribute to

generalizable knowledge”

45 CFR 46.102(d) 15

What is a Human Subject?

A living individual about whom an investigator (professional or student) conducting research obtains:data through intervention or

interaction with the individual, oridentifiable private information.

45 CFR 46.102(f)16

My protocol is ready, what do

I do now?

17

Submit the Protocol Through IRBNet

Complete the Smart Form Administrative Approvals (HRP-226) Protocol Consent Document Subject facing documents

The following forms, if applicable: Sponsor Fee Form Qualifying Clinical Trials Form Others? (HINT: Secondary Reviews)

IRB Submission Forms

18

REQUEST FOR INFO

INITIAL SUBMISSION

SCREENING

PI RESPONSE

REVIEW

APPROVAL ACCEPT w/CHANGES

MEETS REQUEST

19

IRB Determinations and Definitions

• Full Committee Review• Expedited • Exempt • Determined as Not Human Research

Full Committee Review

Most rigorous level of review Any study which does not meet the Exemption

or Expedited Criteria A full quorum is assembled Members receive all study documents All members participate in the discussion and

vote Decision is rendered by a majority of the

assembled quorum. No member with a conflict of interest can

participate and vote in the decision.

21

Expedited Review

Must be minimal riskFits one or more of nine specific categoriesApproval requirements are the same as full

committee review, but only one IRB member reviews the project

Expedited reviewer may not disapprove research

22

Exempt Review

Must be minimal risk research Fits within one of six categories Determination is not an IRB

approval – instead the determination is that the research is exempt from IRB oversight.

Review is typically conducted by a designated IRB member

23

How does the IRB figure this all out?

Answer: Worksheets

HRP-310 Human Research Determination

HRP-311 Engagement Determination

HRP-312 Exemption Determination

HRP-313 Eligibility for Review Using the Expedited Procedure

The purpose of this worksheet is to provide support for individuals in determining whether an activity is Human Research or how it is regulated. This worksheet is to be used. It does not need to be completed or retained.

Is activity “Human Research” as defined by DHHS?

Is activity “Human Research” as defined by FDA?

“Human Research” under DHHS and FDA

Is activity “Human Research” as defined by FDA?

“Human Research” under DHHS only

NOT “Human Research”

“Human Research” under FDA only

No

NoNo

Yes

Yes Yes

START

1 Research as Defined by DHHS Regulationsi (Check if “Yes”.) Is the activity an investigation? (Investigation: A searching inquiry for facts; detailed or careful examination.) Is the investigation systematic? (Systematic: Having or involving a system, method, or plan.) Is the systematic investigation designed to develop or contribute to knowledge? (Designed: observable behaviors used to develop or

contribute to knowledge. Develop: to form the basis for a future contribution. Contribute: to result in. Knowledge: truths, facts, information.) Is the knowledge the systematic investigation is designed to develop or contribute generalizable? (Generalizable: Universally or widely

applicable.)

2 Human Subject Under DHHS Regulations (Check if “Yes”.) Is the investigator conducting the Research gathering data about living individuals?

3 Human Subject Under DHHS Regulations (Check if “Yes”.) Will the investigator gather that data through either of the following mechanisms (specify which mechanism(s) apply):

Physical procedures or manipulations of those individuals or their environment for research purposes (“intervention”). Communication or interpersonal contact with the individuals. ("interaction”).

4 Human Subject Under DHHS Regulations (Check if “Yes”) Will the investigator gather data that is either? Specify which category(s) apply if yes:

The data are about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place (i.e. “Private information”).

Individuals have provided the data for specific purposes in which the individuals can reasonably expect that it will NOT be made public, such as a medical record (i.e. “Private information”).

Can the individuals’ identities be readily ascertained or associated with the information by the investigator (i.e. “Identifiable information”)? If all items are checked under 1, 2, and 3 or 1, 2, and 4, the activity is Human Research under DHHS regulations.

5 Human Research Under FDA Regulations (Check if “Yes”) Does the activity involve any of the following? (Check all that apply)

In the United States: The use of a drugii in one or more persons other than use of an approved drug in the course of medical practiceiii. In the United States: The use of a deviceiv in one or more persons that evaluates the safety or effectiveness of that device. Data regarding subjects or control subjects submitted to or held for inspection by FDAv. Data regarding the use of a device on human specimens (identified or unidentified) submitted to or held for inspection by FDAvi.

If “Yes”, the activity is Human Research under FDA regulations. If the activity is Human Research under DHHS regulations or under FDA regulations, it is Human Research under organizational policy.

6 Engagement Determination (Complete if the activity is Human Research. (Check if “Yes”) The organization is engaged in Human Research. Use WORKSHEET: Engagement Determination (HRP-311))

24

Criteria for Approval of Research [45 CFR Part 46.111]1. Risks to subjects are minimized by using

procedures, which are consistent with sound research design and which do not unnecessarily expose subjects to risk.

2. Risks to subjects are minimized by using procedures already being performed on the subjects for other purposes.

3. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result.

4. Selection of subjects is equitable. 5. The research plan makes adequate provision for

monitoring the data collected to ensure the safety of subjects.

25

Criteria for Approval of Research (cont.)6. There are adequate provisions to protect the

privacy of subjects.7. There are adequate provisions to maintain the

confidentiality of data.8. Additional safeguards have been included in

the study to protect the rights and welfare of subjects vulnerable to coercion or undue influence. (“N/A” if no vulnerable subjects)

9. The informed consent process is adequate. 10.The documentation of informed consent is

adequate.

26

How Do Researchers Meet These Regulations?

27

28

IRB Documents (Available on the IRB Website)

Human Research Protection Program Plan (HRP-101)

Investigator Manual(HRP-103)

Submission Information

Initial Review Application Smart Form Continuing Review Progress Report (HRP-212)

Modification (HRP-213)

Reportable New Information Form (HRP-214)

Template Protocol (HRP-503)

Template Consent Document (HRP-502)

SOPs on consent process and documentation (HRP-90, HRP-91)

When Do I Need an IRB?

• As a general rule of thumb, evaluation done for program improvement does not require IRB approval - - -

• Information collected for research does. • Given that we work mainly with youth, it’s

better to be safe than sorry– Always go back to definition of human research

Program Improvement ExampleYou deliver a nutrition education program to youth at an afterschool program. You deliver pre-program and post-program surveys to youth. You notice that youth show increases in the knowledge about healthy choices, but not in their behavior. You share a summary these results with your staff and volunteers involved in the program so that you can alter the program to help increase healthy behavior change.

Research ExampleYou and colleagues administer a survey to gain youth and adult attitudes and perspectives on a program. You are interested in their satisfaction with the program so that you can make improvements, if needed. The results are much more interesting than you anticipated and you decide to share the results at a conference like the American Evaluation Association.

Yeah, it’s approved!

Anything else?

35

Investigator Responsibilities after Approval

Protect human subjects.Ensure all personnel comply with protocol

requirements and determinations of IRB.Avoid undue influence in enrolling subjects.Ensure that informed consent is adequate and

understandable to subjects.Report new information as stated within HRP-

214, Reportable New Information Form.Submit changes in research to IRB for approval

prior to implementation.

36

4-H STATE OFFICE RESOURCES

4-H State Office IRBsWho’s covered? Delivery

ModeAges Measures Data Collection Type

4-H Individually Enrolled Youth Club 9-19 http://4h.ucanr.edu/Re

sources/Evaluation/ORB, paper and pencil

4-H Group Enrolled Youth All 5-19 http://4h.ucanr.edu/Re

sources/Evaluation/Qualtrics*, paper and

pencil

Resources

• Basic IRB information: http://4h.ucanr.edu/Resources/Evaluation/Institutional_Review_Board/

• Sample Assent Language:http://4h.ucanr.edu/Resources/Evaluation/

Qualtrics

• Qualtrics is an online data collection tool like SurveyMonkey or Mturk.

• UCCE academics and staff can create an account for free (contact Kit Alviz- Kit.Alviz@ucop.edu)

• If data is collected this way, and is not through a 4-H State Office IRB, all 4-H academics and staff need to include Kendra Lewis & Kit Alviz on the IRB protocol as having access to the data, but “not engaged in the research”. Please contact Kendra Lewis (kmlewis@ucanr.edu) for language necessary for Qualtrics data collection to include in your IRB.

Action Steps

• Get CITI certified: https://www.citiprogram.org/• Also make sure everyone on your research project

is certified• Set up in IRBnet account:

http://research.ucdavis.edu/policiescompliance/irb-admin/irbnet/#IRBNet Registration

• Link your CITI certification to your IRBnet account

Other Resources

http://research.ucdavis.edu/policiescompliance/irb-admin/irb-faqs-3/

43

Questions?Thank you!