University of IndianapolisUniversity of IndianapolisInstitutional Review BoardInstitutional Review Board

Protecting Study Volunteers in Protecting Study Volunteers in Research Research

University of Indianapolis Institutional University of Indianapolis Institutional Review BoardReview Board

Membership 2007-2008Membership 2007-2008

Donna Konradi, IRB Chair Donna Konradi, IRB Chair Cory Clasemann, Human Protections Cory Clasemann, Human Protections

AdministratorAdministrator Kristen LaEace (Community IRB Member)Kristen LaEace (Community IRB Member) Jennifer Fogo,Jennifer Fogo, Occupational TherapyOccupational Therapy Tracy Marschall, Social SciencesTracy Marschall, Social Sciences Frederick May, NursingFrederick May, Nursing Gordon Mendenhall, Teacher EducationGordon Mendenhall, Teacher Education Peter Rundquist, Physical TherapyPeter Rundquist, Physical Therapy John Somers, Teacher EducationJohn Somers, Teacher Education Jacquie Wall, PsychologyJacquie Wall, Psychology

UIndy IRB WebsiteUIndy IRB Website

http://irb.uindy.eduhttp://irb.uindy.edu

University of Indianapolis IRB University of Indianapolis IRB WebsiteWebsite

AnnouncementsAnnouncements IRB Committee MembersIRB Committee Members IRB Meeting ScheduleIRB Meeting Schedule Researcher TrainingResearcher Training Policies and ProceduresPolicies and Procedures Forms and DocumentsForms and Documents External LinksExternal Links

Maximize Benefit – Minimize RiskMaximize Benefit – Minimize RiskIRB PurposesIRB Purposes

Protect the rights and welfare of Protect the rights and welfare of human subjects recruited to human subjects recruited to participate in research activities participate in research activities conducted under the auspices of conducted under the auspices of University of Indianapolis. University of Indianapolis.

IRB PurposesIRB Purposes

Develop and implement institutional Develop and implement institutional policies and procedures that reflect the policies and procedures that reflect the ethical principles of the Belmont Report ethical principles of the Belmont Report consistent with federal regulation.consistent with federal regulation.

Provide the UIndy community with Human Provide the UIndy community with Human Subjects’ Protections education.Subjects’ Protections education.

Maintain an accurate system for tracking Maintain an accurate system for tracking the status of research protocols.the status of research protocols.

IRB PurposesIRB Purposes

Conduct Conduct prospectiveprospective reviews of reviews of proposed research in order to safeguard proposed research in order to safeguard the rights and welfare of participants.the rights and welfare of participants.

Conduct continuing reviews of research Conduct continuing reviews of research in progress. The timeframe for the in progress. The timeframe for the continuing reviews is determined for continuing reviews is determined for each protocol by the IRB. The maximum each protocol by the IRB. The maximum amount of time between reviews is 1 amount of time between reviews is 1 year. year.

WhatWhat is the IRB? is the IRB?

Committee that reviews research Committee that reviews research proposals that involve the use of proposals that involve the use of human participantshuman participants

Primary goal is to ensure that human Primary goal is to ensure that human participants are protectedparticipants are protected

Resource for students and faculty Resource for students and faculty wanting to conduct research wanting to conduct research involving human participantsinvolving human participants

WhoWho is the IRB? is the IRB?

At least 5 membersAt least 5 members Varied professions, both scientific and Varied professions, both scientific and

nonscientificnonscientific At least one community member NOT At least one community member NOT

associated with institutionassociated with institution Experience, expertise and diversity to Experience, expertise and diversity to

review proposalsreview proposals Knowledge of the federal regulations Knowledge of the federal regulations

pertaining to research with human pertaining to research with human participantsparticipants

What Does the IRB DO?What Does the IRB DO?

Approve, disapprove or modify Approve, disapprove or modify research protocolsresearch protocols

Conduct continuing review of ongoing Conduct continuing review of ongoing protocolsprotocols

Observe, monitor and audit protocolsObserve, monitor and audit protocols Suspend or terminate approval of Suspend or terminate approval of

protocolsprotocolsThe IRB The IRB CANNOTCANNOT approve research that approve research that

is already underway or is completed.is already underway or is completed.

What an IRB is NOT…What an IRB is NOT…

Group wanting to develop your Group wanting to develop your research designresearch design

Group wanting to micromanage your Group wanting to micromanage your projectproject

Faculty with endless time to give to Faculty with endless time to give to your projectyour project

Definition: ResearchDefinition: Research

““A systematic investigation designed A systematic investigation designed to develop or contribute to to develop or contribute to generalizable knowledge.” (45 CFR generalizable knowledge.” (45 CFR 46.102[d])46.102[d])

In other words: to develop or In other words: to develop or contribute to the general body of contribute to the general body of knowledgeknowledge

Definition: Human ParticipantDefinition: Human Participant

A living individual A living individual about whom an about whom an investigator investigator obtains data or obtains data or private, identifiable private, identifiable informationinformation

45 CFR 46.102[f]45 CFR 46.102[f]

Definition: Vulnerable Definition: Vulnerable PopulationsPopulations

Women and Women and fetusesfetuses

PrisonersPrisoners ChildrenChildren Mentally DisabledMentally Disabled Economically or Economically or

Educationally Educationally DisadvantagedDisadvantaged

Definition: Minimal RiskDefinition: Minimal Risk

Probability of harm Probability of harm no greater than in no greater than in daily life activities daily life activities or during routine or during routine physical or physical or psychological testspsychological tests

Exempt or Expedited ReviewExempt or Expedited Review

No more than “minimal risk”No more than “minimal risk” Noninvasive data collectionNoninvasive data collection Video, voice and image recordings Video, voice and image recordings

where risk of breach of where risk of breach of confidentiality is minimalconfidentiality is minimal

Research involving the evaluation of Research involving the evaluation of “normal educational practices”“normal educational practices”

Exempt or Expedited ReviewExempt or Expedited Review

The Federal standards describe the The Federal standards describe the minimal review procedures required for minimal review procedures required for various types of research. The IRB always various types of research. The IRB always has the option of reviewing any protocol has the option of reviewing any protocol using more vigorous procedures. using more vigorous procedures.

Submit 4 copies of protocol to the IRB Submit 4 copies of protocol to the IRB officeoffice

Reviewed by IRB chair and 1 or more Reviewed by IRB chair and 1 or more experienced reviewers using the reviewer experienced reviewers using the reviewer template as a blueprint.template as a blueprint.

Does NOT mean review is quicker!Does NOT mean review is quicker!

Full ReviewFull Review

Requires quorum of members to take action Requires quorum of members to take action regarding a protocol at a IRB convened regarding a protocol at a IRB convened meetingmeeting

Submit 11 copies Submit 11 copies at leastat least 2 weeks prior to 2 weeks prior to IRB meetingIRB meeting

A primary review team (approximately 3 IRB A primary review team (approximately 3 IRB members) is assigned to complete a members) is assigned to complete a preliminary review and lead the committee’s preliminary review and lead the committee’s discussion. The reviewer template is used as discussion. The reviewer template is used as the blueprint for the reviewthe blueprint for the review

Informed ConsentInformed Consent

A A processprocess…not just a document…not just a document The researcher has the responsibility of The researcher has the responsibility of

documenting that the research participant documenting that the research participant is fully informed and meets all inclusion is fully informed and meets all inclusion criteria criteria priorprior to the initiation of research to the initiation of research procedures procedures

Participant and/or legally authorized Participant and/or legally authorized representative (specific elements may representative (specific elements may vary by state)vary by state)

Language suitable to participant group Language suitable to participant group No exculpatory languageNo exculpatory language

Informed ConsentInformed Consent

The participant must The participant must have sufficient time have sufficient time to consider optionsto consider options

The researcher must The researcher must design informed design informed consent procedures consent procedures that minimize that minimize coercion and undue coercion and undue influence/pressure to influence/pressure to participateparticipate

Key Elements of Informed ConsentKey Elements of Informed Consent

Statement that Statement that activity is researchactivity is research

Purpose of studyPurpose of study Duration of studyDuration of study Number of Number of

participants participants Description of all Description of all

related proceduresrelated procedures

Estimated time Estimated time commitmentcommitment

Identification of Identification of risksrisks

Identification of Identification of benefitsbenefits

Alternatives to Alternatives to participationparticipation

Key Elements of Informed ConsentKey Elements of Informed Consent

Description of the Description of the extent of extent of confidentialityconfidentiality

Compensation ( or Compensation ( or lack of) for injury lack of) for injury

Whom to contact Whom to contact with questionswith questions

Whom to contact in Whom to contact in event of injuryevent of injury

Right to refuse to Right to refuse to participate participate (voluntary)(voluntary)

Right to withdraw Right to withdraw at any timeat any time

IRB DecisionsIRB Decisions

ApproveApprove Modify (approve Modify (approve

pending clarifications pending clarifications and revisions)and revisions)

TableTable Disapprove Disapprove

(reserved for full (reserved for full review only)review only)

Principal Investigator (PI) Principal Investigator (PI) ObligationsObligations

Faculty advisors are ULTIMATELY Faculty advisors are ULTIMATELY RESPONSIBLE for the research study RESPONSIBLE for the research study and are identified as the Principal and are identified as the Principal InvestigatorsInvestigators

All members of research team must be All members of research team must be identified by name and must complete identified by name and must complete on-line training. Verification of training on-line training. Verification of training is a prerequisite for IRB review.is a prerequisite for IRB review.

Submit a project update when new Submit a project update when new team members are addedteam members are added

Investigator ObligationsInvestigator Obligations

Design ethical researchDesign ethical research Comply with federal regulationsComply with federal regulations Obtain approval from IRB before Obtain approval from IRB before

recruiting participantsrecruiting participants Implement research only as Implement research only as

approved by the IRB. Obtain PRIOR approved by the IRB. Obtain PRIOR approval for protocol modifications approval for protocol modifications and updatesand updates

Investigator ObligationsInvestigator Obligations

Obtain and document informed Obtain and document informed consent/assent.consent/assent.

If an informed consent document is If an informed consent document is used, a copy of the document must used, a copy of the document must be given to the participants. If the be given to the participants. If the document is signed, the participants document is signed, the participants must receive a signed copy.must receive a signed copy.

Submit progress and revision reports Submit progress and revision reports as required.as required.

Investigator ObligationsInvestigator Obligations

Report unanticipated problems Report unanticipated problems promptly (adverse events).promptly (adverse events).

Notify the IRB when the research is Notify the IRB when the research is completed.completed.

Retain records for at least 3 years.Retain records for at least 3 years.

What is the IRB Looking For?What is the IRB Looking For?

I. Introduction, Purpose and I. Introduction, Purpose and BackgroundBackground

Are the purposes clearly specified?Are the purposes clearly specified? Are there adequate preliminary data Are there adequate preliminary data

to justify the research?to justify the research? Is there appropriate justification for Is there appropriate justification for

this research protocol?this research protocol? Are adequate references provided?Are adequate references provided?

II. Scientific DesignII. Scientific Design

Is the scientific design adequate to Is the scientific design adequate to answer the research question?answer the research question?

Are the research objectives likely to be Are the research objectives likely to be achievable within a given time period?achievable within a given time period?

Is the scientific design described and Is the scientific design described and adequately justified?adequately justified?

III. Inclusion/Exclusion Criteria For III. Inclusion/Exclusion Criteria For SubjectsSubjects

Are inclusion and exclusion criteria clearly Are inclusion and exclusion criteria clearly specified and appropriate?specified and appropriate?

If women, minorities, or children are If women, minorities, or children are included or excluded, is this justified?included or excluded, is this justified?

Is the choice of subjects appropriate for the Is the choice of subjects appropriate for the question being asked?question being asked?

Is the principle of Is the principle of distributive justicedistributive justice adequately incorporated into the inclusion adequately incorporated into the inclusion and exclusion criteria? and exclusion criteria?

Is subject selection equitable?Is subject selection equitable?

IV. Recruitment of SubjectsIV. Recruitment of Subjects

Are the methods for recruiting potential Are the methods for recruiting potential subjects well defined?subjects well defined?

Are the location and timing of the Are the location and timing of the recruitment process acceptable?recruitment process acceptable?

Is the individual performing the recruitment Is the individual performing the recruitment appropriate for the process?appropriate for the process?

Are all recruitment materials submitted and Are all recruitment materials submitted and appropriate? appropriate?

Are there acceptable methods for screening Are there acceptable methods for screening subjects before recruitment? subjects before recruitment?

V. Research ProceduresV. Research Procedures

Are the rationale and details for the research Are the rationale and details for the research procedures accurately described and procedures accurately described and acceptable?acceptable?

Is there a clear differentiation between Is there a clear differentiation between research procedures and standard care?research procedures and standard care?

Are the individuals performing the procedures Are the individuals performing the procedures appropriately trained, and is the location of appropriately trained, and is the location of performing the procedure acceptable?performing the procedure acceptable?

Are there adequate plans to inform subjects Are there adequate plans to inform subjects about specific research results if necessary? about specific research results if necessary?

VI. Devices and DrugsVI. Devices and Drugs

Is the significant risk or non-significant Is the significant risk or non-significant risk status of the device described risk status of the device described and appropriate?and appropriate?

Are the device or drug safety and Are the device or drug safety and efficacy sufficient to warrant the type efficacy sufficient to warrant the type of testing?of testing?

Is the drug dosage and route of Is the drug dosage and route of administration appropriate? administration appropriate?

VII. Data Analysis and VII. Data Analysis and Statistical AnalysisStatistical Analysis

Is the rationale for the proposed Is the rationale for the proposed number of subjects reasonable?number of subjects reasonable?

Are the plans for data and statistical Are the plans for data and statistical analysis defined and justified? analysis defined and justified?

Are there adequate provisions for Are there adequate provisions for monitoring data? monitoring data?

VIII. Potential Risks, Discomforts VIII. Potential Risks, Discomforts and Benefits for Subjectsand Benefits for Subjects

Are the risks and benefits adequately Are the risks and benefits adequately identified, evaluated, and described?identified, evaluated, and described?

Are the potential risks minimized and Are the potential risks minimized and likelihood of benefits maximized?likelihood of benefits maximized?

Is the risk/benefit ratio acceptable for Is the risk/benefit ratio acceptable for proceeding with the research? proceeding with the research?

IX. Research Costs and IX. Research Costs and Compensation for ParticipantsCompensation for Participants

Is the amount or type of compensation Is the amount or type of compensation or reimbursement reasonable? or reimbursement reasonable?

Are there adequate provisions to avoid Are there adequate provisions to avoid out-of-pocket expenses by the out-of-pocket expenses by the research subject, or is there research subject, or is there sufficient justification to allow sufficient justification to allow subjects to pay?subjects to pay?

If children or adolescents are involved, If children or adolescents are involved, who receives the compensation, and who receives the compensation, and is this appropriate?is this appropriate?

X. Privacy and ConfidentialityX. Privacy and Confidentiality

Are there adequate provisions to Are there adequate provisions to protect the privacy and ensure the protect the privacy and ensure the confidentiality of the research confidentiality of the research subject? subject?

Are there adequate plans to store and Are there adequate plans to store and code the data?code the data?

Is Is the use of identifiers or links to the use of identifiers or links to identifiers necessary, and how is this identifiers necessary, and how is this information protected?information protected?

XI. Informed ConsentXI. Informed Consent

Is an informed consent waiver Is an informed consent waiver appropriate based on the regulations appropriate based on the regulations (46.116c, 46.116d, 46.117c)? If a (46.116c, 46.116d, 46.117c)? If a waiver is appropriate, specify the waiver is appropriate, specify the criteria that have been met.criteria that have been met.

XII. Other IssuesXII. Other Issues

Is there a Is there a potential conflict of interest potential conflict of interest for the investigator?for the investigator?

When should the next review occur? When should the next review occur?

If frequent reviews are necessary, how If frequent reviews are necessary, how should the interval be determined? should the interval be determined?

Questions?Questions?

Talk with your faculty memberTalk with your faculty member

Review the University of Indianapolis Review the University of Indianapolis IRB WebsiteIRB Website

Schedule an appointment with an IRB Schedule an appointment with an IRB membermember

Questions Still Unanswered?Questions Still Unanswered?

Contact the IRB ChairContact the IRB Chair