agenda 1. introduce the irb 2. define research 3. discuss protection of human subjects 4. identify...

Institutional Review Board (IRB) Basics

Agenda

1. Introduce the IRB2. Define research3. Discuss protection of human subjects4. Identify ethics in research, consent5. Explain what the IRB does6. Describe how you interact with the IRB7. Address next steps

Introducing the CCGA IRBThe Institutional Review Board (IRB):Operates under federal regulations Charged with protecting the rights and welfare of

people involved in researchKeeps pace with the ever changing environment of

human subjects researchFacilitates and strengthens human subjects

research conducted by investigators (faculty, administrators, staff, & students) at the institution

IRB: Role & ResponsibilityOversees all research that involves human

subjects.Protect the rights & welfare of human subjects

recruited to participate in research activities conducted at or on behalf of your institution

Responsible for approving and continuingly reviewing all research projects involving human subjects

What Do These Studies Have in Common? Were human research participants fully

protected?Nuremberg TrialsTuskeegee Syphilis ExperimentsWichita Jury StudyThe Thalidomide ExperienceTearoom Trade StudyMilgram Studies of Obedience to AuthoritySan Antonio Contraception Study

http://www.hhs.gov/ohrp/archive/related.htmlhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC3272525/

IRB FoundationsMandated by Federal Government:HHS: 45 CFR 46FDA: 21 CFR 50 & 56

Ethical Guidance:Nuremburg CodeDeclaration of HelsinkiBelmont Report

State and local bodies

Effective research practice

The Challenge of Self-Regulation

Each institutional IRB functions independentlyFederal oversight from the Office of Human Research

Protection (OHRP)Defines the Common Rule and implements the

regulations (45 Code of Federal Regulations 46, subpart A)

The FDA has additional regulations governing new drug and device trials

State statutes and local legal counsel

What is Research?Regulations define research as “…a systematic

investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”“Systematic” means that research methods are

employed to test a hypothesis/propositions and draw conclusions.

“Generalizable” refers to the dissemination of or intent to circulate findings to a scientific or professional audience. This generally includes the following:

What is Research? - continuedMasters and doctoral theses Presentation at a scientific or professional meeting

or conference, including poster presentation and abstract submissions

Submission to or publication in a professional or scientific journal

Generalizable knowledge is usually that which is disseminated through presentation and/or publication, and placed in the public domain

How is a “Human Subject” defined?

Definition of HUMAN SUBJECT according to 45 CFR 46: “living individual (s) 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 obtained for this research in a form associable with the individual (that is, the identity of the subject is or may readily be ascertained or associated with information)

Vulnerable PopulationsThe IRB is mandated to apply a rigorous

evaluation of the risk and benefits of the study, particularly when vulnerable subjects are asked to participate.

If more than minimal risk is involved, some degree of benefit is usually required.

Vulnerable PopulationsChildren (under 18 years)Cognitively ImpairedPregnant WomenFetusesHuman in vitro FertilizationPrisoners

What is Minimal Risk?

“the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.”

(45CFR, part 46, secs. 102i and 111)

A Few Key Ethical Principles of Human Research

• Beneficence (i.e., minimize risk & maximize benefits)• Justice (i.e., fairness in distribution of risks and

benefits)• Respect for Persons (i.e., acknowledging

autonomy of participants/research subjects)

Competing Moral PrinciplesFulfillment of duties to

research subjectsPromotion of the general welfare of society through the conduct of

researchTakes precedence under most

Circumstances . . . Autonomy, privacyFair treatmentMinimize risksGood clinical practice standard

Research subjects have a moral responsibility to bear some of the risk in promoting the general welfare of society.

Risks are reasonable in proportion to anticipated benefits

The Role of Consent

Conducting human subjects research in a responsible manner requires that informed consent be obtained from potential subjects.

Three of the fundamental components of informed consent are:1. Give potential subjects adequate information about risks &

benefits

2. Decision by subjects to enroll must be voluntary.

3. Subject must be competent to make choice of participation.

When is IRB review required?

IRB review is required for all human subjects research carried out by CCGA faculty, staff or students:Federally funded research,Research involving FDA regulated products,Research not federally funded or not involving

FDA regulated products, i.e. “in house” studies, research conducted under departmental grants,

and unfunded research

Review Types & Risk LevelExemptAll research procedures must fall into one or more of the exemption

categoriesDo not need to inform IRB of any changes that occur during the

course of an exempt study unless the change affects the review level and/or risk to subject

ExpeditedReviews studies that are no more than minimal risk AND where

research procedures fall within one of the expedited categories

Full BoardAny study that is considered more than minimal risk is reviewed by

a fully convened IRB

How does the IRB review research? Initial Review – 3 Types:ExemptExpeditedFull Board

Continuing ReviewIRB decides renewal term (at least once annually for most

ongoing projects)

AmendmentsSignificant changes to study: protocol, consent, investigators,

publication.

Unanticipated ProblemsProtocol Deviation, Adverse Events, New Information, Subject

Complaint

TerminationsStudy end, final report

Common Model of Research Review

1. PI writes proposal

2. Scientific review of proposal

a. External – e.g., NIH or other sponsor

b. b. Internal – Unit-level review

c. None – IRB becomes de facto scientific reviewer

3. Submit proposal to IRB

4. Initial IRB reviewa. Conducted by IRB chair, or committee

b. b. May involve input from experts/consultants

c. c. May involve communication with other standing committees (COI, bio/radiation safety, etc.)

d. d. Communication with PI

Model of Research Review cont.5. Study conducted

a. Subjects recruited, consent obtained, enrolled

b. PI follows good clinical practice

6. Ongoing administrative review / Review of protocol revisions / Adverse Event reporting

7. PI submits IRB annual report/termination notice

8. IRB “close out” of study

Submission BasicsIRB Application (Word document from Website)Informed Consent documentStudy questionnaires/surveysCertificate of Human Subjects protection training for

PIs and key study staff (CITI training)Recruitment materials: ads, radio announcements,

brochures (if applicable)Investigational brochure or product labeling (e.g., for

drug/device studies, if applicable)

Submission Basics cont.• HIPAA Authorization or Waiver (if applicable)• Conflict of interest documentation (if applicable)• For grant funded research: Follow grant application procedures• All Submissions Must include :

• One complete IRB application (including all attachments) submitted electronically, and

• One complete hard copy (including all attachments)

• All materials must be submitted directly to the IRB Administrator in Academic Affairs as a complete package

• Incomplete materials will not be accepted.

Helpful Submission HintsInclude PI name on all submissionsInclude fax and email of PI and primary study contactEnsure page numbers are on all documentsUpdate version date on all revised documents (if applicable)Include both versions of revised documents:

Copy with changes highlighted or trackedClean copy with changes incorporated but not highlighted

Maintain required frequency of communication with your IRB throughout the life of the study – compliance is required even after receiving IRB approval

Finish your IRB paperwork and reporting once study is completed prior to or following annual review

Frequently Asked QuestionsWhere should I go if I have questions?

Consult the IRB websiteWhen do I submit my protocol? How long will the review take?

When submission packet is complete, you can submit to IRB for initial review. Allow IRB time to process review packet.

Turn around time frame depends upon the type of proposal, when it is submitted, and when the next committee review meeting will convene (typically the last Monday of every month).

When should I submit for continuing review? PI’s will be notified by IRB when their study is due for continuing review. CR’s should be submitted 8 weeks prior to the approval expiration date.

What should I do if my approval expires? All study activities should stop (interviews, data collection, recruitment, etc.). If the study expires, you must contact the IRB administrator for further

instruction on resubmission.

Where is the IRB located? IRB virtual home: http://www.ccga.edu/IRB/

IRB Chair (2012-13), Dr. M. Karen Hambright, Professor of Psychology

214 Academic Commons North

College of Coastal Georgia

One College Drive

Brunswick, GA 31520-3632 USA

Office: 912.279.5879 | Fax: 912.279.5878

khambright@ccga.edu

IRB Administrator, Ms. Sandra Bunn

Coordinator of Faculty and Academic Services

College of Coastal Georgia

One College Drive

Brunswick, GA 31520-3632 USA

Office: 912.279.5965 | Fax: 912.279.5721

sbunn@ccga.edu

Thank You.

2012-13Institutional Review Board

Questions?