Carthage College Carthage College Institutional Review Institutional Review

Board Board (IRB)(IRB)Understanding the Review

Process

Charge of the IRB To ensure the safety and well-being of To ensure the safety and well-being of

human participants (and animal human participants (and animal subjects) in researchsubjects) in research Applies to research done at Carthage Applies to research done at Carthage

College or done by Carthage InvestigatorsCollege or done by Carthage Investigators

Ethics, Risks and Safeguards, Liability, Ethics, Risks and Safeguards, Liability, Confidentiality, Anonymity, Security, Confidentiality, Anonymity, Security, and Research Integrityand Research Integrity

The IRB Review Process You file a proposal with the Institutional You file a proposal with the Institutional

Review Board Office that explains the Review Board Office that explains the research and its use of participantsresearch and its use of participants Exempt, Standard or Full ReviewExempt, Standard or Full Review

The IRB may request or demand changes The IRB may request or demand changes to improve safety, confidentiality; resubmitto improve safety, confidentiality; resubmit

The IRB may request or recommend The IRB may request or recommend clarifications on methods or improvements clarifications on methods or improvements to the study; address concerns or justify… to the study; address concerns or justify…

The IRB ultimately approves the studyThe IRB ultimately approves the study

Categories of Review (Human Participants)

ExemptExempt Claim of no potential risks to participantsClaim of no potential risks to participants Belief that no written consent form Belief that no written consent form

necessarynecessary Verbal consent is adequate and in study designVerbal consent is adequate and in study design

Request for Exemption is filed is filed with the with the IRB OfficeIRB Office

IRB Chair reviews the research proposal IRB Chair reviews the research proposal and will grant exemption if it meets the and will grant exemption if it meets the criteriacriteria

Categories of Review Standard ReviewStandard Review

Minimal risk (not minors, no deception, Minimal risk (not minors, no deception, not sensitive)not sensitive)

Requires filing the full Human Requires filing the full Human Participants proposal formParticipants proposal form

Study participants voluntarily sign a Study participants voluntarily sign a written consent form:written consent form:

1 reviewer + IRB Chair 1 reviewer + IRB Chair

Categories of Review Full ReviewFull Review

Required when the research design Required when the research design involves involves minorsminors or other sensitive or other sensitive populationspopulations Parental and minor consent formsParental and minor consent forms

If physical/emotional “risk” is involved to If physical/emotional “risk” is involved to participants; sensitive, personal subjectsparticipants; sensitive, personal subjects

If any deception is used If any deception is used Requires the Full Proposal FormRequires the Full Proposal Form 3 reviewers + IRB Chair3 reviewers + IRB Chair

Members of the IRB Cynthia Allen (Health/Physical Education)Cynthia Allen (Health/Physical Education) Thomas Carr (Biology)Thomas Carr (Biology) Scott Hegrenes (Biology, Chair)Scott Hegrenes (Biology, Chair) Dan Miller (Neuroscience & Psychology)Dan Miller (Neuroscience & Psychology) Mark Miller (Business Administration)Mark Miller (Business Administration) Isabel Rivero-Vila (Modern Languages)Isabel Rivero-Vila (Modern Languages) Wayne Thompson (Sociology)Wayne Thompson (Sociology) Matt Zorn (Geography)Matt Zorn (Geography)

With support fromWith support from Deborah Usinger (Administrative Assistant)Deborah Usinger (Administrative Assistant)

Where can I get the forms? Faculty Principal Investigator can Faculty Principal Investigator can

access the Faculty page:access the Faculty page:http://www.carthage.edu/provost/faculty/http://www.carthage.edu/provost/faculty/committees/institutional-review-board/committees/institutional-review-board/

Faculty can search for IRB on Carthage homepageFaculty can search for IRB on Carthage homepage See Deborah Usinger , Clausen 213See Deborah Usinger , Clausen 213

IRB Administrative AssistantIRB Administrative Assistant proposals are processed, distributedproposals are processed, distributed

Are you Exempt from an IRB Review?

Does the study meet the criteria for exempt?Does the study meet the criteria for exempt? Do you believe your study poses no risks to Do you believe your study poses no risks to

participants and no written Informed Consent is participants and no written Informed Consent is needed?needed?

If YES, file the Request for ExemptionIf YES, file the Request for Exemption The IRB will determine whether your proposal The IRB will determine whether your proposal

qualifies as exemptqualifies as exempt

What are the exempt criteria?What are the exempt criteria?

Informed Consent Any person who agrees to participate Any person who agrees to participate

needs disclosure…needs disclosure… Survey Survey – if you ask somebody to take an – if you ask somebody to take an

anonymous survey, they need to know anonymous survey, they need to know the subject matter (politics, religion, the subject matter (politics, religion, embryonic stem cells, facebook, etc.)embryonic stem cells, facebook, etc.) Survey Monkey and online data gatheringSurvey Monkey and online data gathering

The willingness to participate IS their The willingness to participate IS their consent in a no-risk Exempt surveyconsent in a no-risk Exempt survey

Anonymous, no signed forms Anonymous, no signed forms

Written Informed Consent A Formal Legal Document, A Formal Legal Document,

signed, duplicates (participant, researcher)signed, duplicates (participant, researcher) Openly identifies the potential risks Openly identifies the potential risks

facing the participants facing the participants no surprises, can withdraw at any timeno surprises, can withdraw at any time

Wording must be clear, unambiguousWording must be clear, unambiguous If using minors, need parental consentIf using minors, need parental consent If using adults, include the declaration…If using adults, include the declaration…

I am 18 years of age or older… I am 18 years of age or older…

How do I start the IRB Review process?

You fill out the forms and submit paperwork to You fill out the forms and submit paperwork to Deborah Usinger, CC213Deborah Usinger, CC213 Work with your Faculty Principal Investigator and Work with your Faculty Principal Investigator and

Department Chair for signaturesDepartment Chair for signatures IRB Chair responds via email IRB Chair responds via email (within a few weeks)(within a few weeks)

If your research proposal is clear, well-planned, ethical – you If your research proposal is clear, well-planned, ethical – you are given approvalare given approval

Potential problems may be uncovered: incomplete Potential problems may be uncovered: incomplete proposal, wrong form, methods unclear, subject recruitment proposal, wrong form, methods unclear, subject recruitment not feasible, unsupported claims, poor science…not feasible, unsupported claims, poor science…

Clear up the issues – you get approved! Clear up the issues – you get approved!

What is in a Complete Proposal?

ready for IRB review Include any survey or questionnaire Include any survey or questionnaire Reviewed as part of the proposalReviewed as part of the proposal

Include any “specific instructions”Include any “specific instructions” Ex. a script of what is read to each participantEx. a script of what is read to each participant

Signatures/Approval of AdministratorsSignatures/Approval of Administrators Principal Investigator, Dept Chair, School Principal Investigator, Dept Chair, School

Administrators (off-campus) Administrators (off-campus) A Reasonable Start Date!A Reasonable Start Date!

IRB approval lasts for 1 year, extensions, IRB approval lasts for 1 year, extensions, addendum are possibleaddendum are possible

IRB Snafus are Lurking! The process can be frustrating!The process can be frustrating! The IRB wants to know details!The IRB wants to know details! So many checklists on the form!So many checklists on the form!

Get it done right the first timeGet it done right the first time

IRB is the advocate for participants’ IRB is the advocate for participants’ rights & safety – as you write your rights & safety – as you write your proposal think about what the IRB needs proposal think about what the IRB needs to know in order to do our job effectivelyto know in order to do our job effectively

Does my study need the Full Form or the Exempt

Form? It depends…It depends… Exempt studies need to meet certain Exempt studies need to meet certain

criteria to qualify for exempt…criteria to qualify for exempt…

If there is any risk or deception – use the If there is any risk or deception – use the full formfull form Informed Consent Statement SignedInformed Consent Statement Signed

This is This is our guideour guide……

(Federal Standards for) (Federal Standards for) Criterion 1 for Exemption

Research conducted in established Research conducted in established or commonly accepted educational or commonly accepted educational settings, involving normal settings, involving normal educational practices, such as: educational practices, such as: research on regular and special education research on regular and special education

instructional strategies, or instructional strategies, or research on the effectiveness of or the research on the effectiveness of or the

comparison among instructional techniques, comparison among instructional techniques, curricula, or classroom management methods.curricula, or classroom management methods.

Criterion 2 for Exemption Research involving the use of Research involving the use of

educational tests (cognitive, diagnostic, educational tests (cognitive, diagnostic, aptitude, achievement), survey aptitude, achievement), survey procedures, interview procedures or procedures, interview procedures or observation of public behavior, unless: observation of public behavior, unless: subjects can be identifiedsubjects can be identified subjects' responses outside the research could subjects' responses outside the research could

reasonably place the subjects at risk of criminal or reasonably place the subjects at risk of criminal or civil liability or be damaging to the subject's civil liability or be damaging to the subject's financial standing, employability, or reputation. financial standing, employability, or reputation.

Criterion 3 for Exemption Research described in criterion 2 Research described in criterion 2

that is not exempt if: that is not exempt if: The human subjects are elected or appointed The human subjects are elected or appointed

public officials or candidates for public office; public officials or candidates for public office; or or

federal statutes(s) require(s) without federal statutes(s) require(s) without exception that the confidentiality of the exception that the confidentiality of the personally identifiable information will be personally identifiable information will be maintained throughout the research and maintained throughout the research and thereafter.thereafter.

Criterion 4 for Exemption Research, involving the collection or study Research, involving the collection or study

of existing data, documents, records, of existing data, documents, records, pathological specimens, or diagnostic pathological specimens, or diagnostic specimens, if these sources are publicly specimens, if these sources are publicly available or if the information is recorded available or if the information is recorded by the investigator in such a manner that by the investigator in such a manner that subjects cannot be identified, directly or subjects cannot be identified, directly or through identifiers linked to the subjects. through identifiers linked to the subjects. Data needs to be coded, anonymous, cannot Data needs to be coded, anonymous, cannot

be traced back to or linked to any individualbe traced back to or linked to any individual

Criterion 5 for Exemption Research and demonstration projects which are Research and demonstration projects which are

conducted by or subject to the approval of conducted by or subject to the approval of department or agency heads, and which are department or agency heads, and which are designed to study, evaluate, or otherwise examine: designed to study, evaluate, or otherwise examine: Public benefit or service programs; Public benefit or service programs; Procedures for obtaining benefits or services under Procedures for obtaining benefits or services under

those programs; those programs; Possible changes in or alternatives to those programs or Possible changes in or alternatives to those programs or

procedures; or procedures; or Possible changes in methods or levels of payment for Possible changes in methods or levels of payment for

benefits or services under those programs. benefits or services under those programs.

Criterion 6 for Exemption Taste and food quality evaluation and consumer Taste and food quality evaluation and consumer

acceptance studies,acceptance studies, if wholesome foods without additives are consumed if wholesome foods without additives are consumed

or or if a food is consumed that contains a food ingredient if a food is consumed that contains a food ingredient

at or below the level and for a use found to be safe, at or below the level and for a use found to be safe, or agricultural chemical or environmental or agricultural chemical or environmental contaminant at or below the level found to be safe, contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by by the Food and Drug Administration or approved by the Environmental Protection Agency of the Food the Environmental Protection Agency of the Food Safety and Inspection Service of the U.S. Department Safety and Inspection Service of the U.S. Department of Agriculture.of Agriculture.