Dustin Yocum, MAInstitutional Review Board

University of Illinois

HUMAN SUBJECTS RESEARCH

Discuss what an Institutional Review Board (IRB) does

Find out why the IRB exists

Discuss the regulations and classifications

Discuss the application process

Discuss the elements of informed consent

Field questions

OBJECTIVES

Independent Review and Oversight Committee

Board of experts in conducting research

Uphold federal, state, and local regulations

Review research applications for ethical standards

Purpose of the IRB is to facilitate safe and ethical research with human subjects conducted by UIUC students, faculty, and staff

WHAT DOES THE IRB DO?

Examples of research with serious ethical issues

Tuskeegee Syphilis Study

Human Radiation Exeperiments

Milgram Study

Willowbrook State School Hepatitis Study

WHY DOES THE IRB EXIST?

45 CFR 46 – Common Rule - Regulations for the Protection of Human Subjects of Biomedical and Behavioral Research Basic regulations established in 1974

Adopted by 16 federal agencies as the Common Rule in 1991

Proposed changes in the regulations being reviewed

FEDERAL REGULATIONS

Respect for Persons Individual autonomy, above the value of the research, to

society or to any individual person Protection of individuals with reduced autonomy

Benefi cence Do not harm, regardless of benefits Maximize benefits and minimize the risk of doing harm Risk–benefit analysis should justify all risks

Justice Equitable subject selection and distribution of research

benefits and burdens

BELMONT PRINCIPLES

Physical harmEmotional distress, Psychological

TraumaInvasion of Privacy, Loss of

Confidentiality involving:Embarrassment, Loss of Social StatusRisk to Reputation, Employment, Financial Standing, Insurability

Criminal or Civil Liability

WHAT POSSIBLE HARM?

The investigator is ultimately responsible for protecting the subject.

The use of human volunteers in research is a privilege, not a right.

Society’s trust in the research process determines funding, support, regulation

INVESTIGATOR RESPONSIBILITIES

Research – A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.

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.

WHAT IS HUMAN SUBJECTS RESEARCH?

Intervention Includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes (45 CFR 46.102(f)).

Interaction Includes communication or interpersonal contact between investigator and subject (45 CFR 46.102(f)).

WHAT IS HUMAN SUBJECTS RESEARCH?

Private Information Information about behavior that occurs in a context in

which an individual can reasonably expect that no observation or recording is taking place

Information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record)

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.

WHAT IS HUMAN SUBJECTS RESEARCH?

Not Human Subjects Research

Exempt 45 CFR 46.101(b) 45 CFR 46.401(b) Children

Expedited (New and Continuing Cases) 45 CFR 46.110 No more than minimal risk and/or minor changes

Full IRB (New and Continuing Cases)

LEVELS OF REVIEW

In order to be considered human subjects research the activity must:be systematically designed to contribute to generalizable knowledge

obtain information about living individuals

involve intervention or interactionbe individually identifiableinvolve private information

NOT HUMAN SUBJECTS RESEARCH

Activity must classify as human subjects research

Submitted on Exempt application

Reviewed by staff member only

Minimal risk

3 year approval period

Federal regulation do not apply (University regulations apply)

EXEMPT RESEARCH

Exempts research conducted in established or commonly accepted educational settings, involving normal educational practices, such as:

(a) research on regular and special education instructional strategies, or

(b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management

EXEMPT CATEGORY 1

Exempts research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior, unless

(a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and

(b) 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

EXEMPT CATEGORY 2

Category 1 Research on physical education that involves exercise if the

activity is altered in a significant way for the purposes of the research

Category 2 Research involving surveys that may cause the subject to

experience severe emotional distress or discomfort Research involving psychologically invasive surveys Regarding Children: Research involving surveys, interviews,

or observations of public behavior when the investigator is a participant in the activities being observed

All Categories If the study is greater than minimal risk Prisoners Research involving deception

EXCEPTIONS TO THE RULE

Activity does not fall into one of the 6 exempt categories

Submitted on IRB-1 application

Review by staff and expert IRB member

Minimal Risk

1 year approval period (continuing reviews)

Federal regulations apply

EXPEDITED RESEARCH

When a study is considered more than minimal risk

Determined during review of IRB-1 applications

Reviewed by staff and full IRB committee

1 year approval period Approval period could be less if Board wants to review

again Board decides if study must stay Full Board after initial

approval

Federal regulations apply

FULL BOARD RESEARCH

Is it human subjects research?

IRB-1 or Exempt?

WHAT IS THE APPLICATION PROCESS?

Complete application (including signatures)

Research Team AttachmentRecruiting materialsData collection measuresConsent formsAdditional forms(device/equipment,

waivers, etc.)Funding proposalApprovals from outside institutions

WHAT DO I SUBMIT?

Application is submitted to www.irb@illinois.eduApplication is logged into system and assigned

to a reviewerPre-Review is conductedCorrespondence and revisionsOnce revisions are complete with IRB staff:

If exempt, study can be approved in IRB officeIf expedited/full board, study will be sent to an expert reviewer.Stipulations Approval

WHAT IS THE PROCESS AFTER I SUBMIT?

All researchers must have completed the following CITI online training requirements before approval will be given: Belmont Report - SBR

History and Ethical Principles - SBR

Defining Research with Human Subjects - SBR

Assessing Risk in Social Behavioral Sciences - SBR

Informed Consent - SBR

Privacy and Confidentiality – SBR

Online CITI training is good for 3 years

CITI REQUIREMENTS

Amendment Process

Complete the Research Amendment Form

Make revisions to all applicable parts of application

Make sure new documents are signed by RPI

Send revised/additional documents to staff reviewer

WHAT IF I NEED TO MAKE A CHANGE AFTER APPROVAL?

PurposeProceduresRisks and BenefitsVoluntarinessConfidentialityContact InformationSignature Statement

ELEMENTS OF INFORMED CONSENT

Signed (written) Informed Consent

Waiver of Informed Consent

Alteration of Informed Consent

Waiver of Documentation

INFORMED CONSENT OVERVIEW

Informed consent is an ongoing process rather than just given/obtained at a moment of time.

No exculpatory language, 8th grade reading level, correct grammar/typos

Give participants opportunities to ask questions

Ensure participants understand what they have consented to do

Ensure participants understand that they can discontinue at any time

INFORMED CONSENT OVERVIEW

QUESTIONS?

Campus IRB Web site: www.irb.illinois.eduUIUC IRB Training Module: http://www.irb.uiuc.edu/edu/module1.asp

Belmont Report: http://www.irb.uiuc.edu/ethics/belmont.asp

Offi ce for Human Research Protections (OHRP): http://ohrp.osophs.dhhs.gov/

U.S. Food and Drug Administration (FDA): http://www.fda.gov/cdrh/index.html

ADDITIONAL RESOURCES

Main IRB Offi ceSuite 203, MC–419

528 East Green StreetChampaign, IL 61820

Phone: 217-333-2670Fax: 217-333-0405

Email: irb@illinois.eduOnline: www.irb.illinois.edu

CONTACT INFORMATION