University of Indianapolis Institutional Review Board Protecting Study Volunteers in Research

University of Indianapolis Institutional Review Board Membership Donna Konradi, IRB Chair Donna Konradi, IRB Chair Cory Clasemann, Human Protections Administrator Cory Clasemann, Human Protections Administrator Kristen LaEace (Community IRB Member) Kristen LaEace (Community IRB Member) Jennifer Fogo, Occupational Therapy Jennifer Fogo, Occupational Therapy Tracy Marschall, Social Sciences Tracy Marschall, Social Sciences Frederick May, Nursing Frederick May, Nursing Gordon Mendenhall, Teacher Education Gordon Mendenhall, Teacher Education Peter Rundquist, Physical Therapy Peter Rundquist, Physical Therapy John Somers, Teacher Education John Somers, Teacher Education Jacquie Wall, Psychology Jacquie Wall, Psychology

UIndy IRB Website

University of Indianapolis IRB Website Announcements Announcements IRB Committee Members IRB Committee Members IRB Meeting Schedule IRB Meeting Schedule Researcher Training Researcher Training Policies and Procedures Policies and Procedures Forms and Documents Forms and Documents External Links External Links

Maximize Benefit – Minimize Risk IRB Purposes Protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of University of Indianapolis. Protect the rights and welfare of human subjects recruited to participate in research activities conducted under the auspices of University of Indianapolis.

IRB Purposes Develop and implement institutional policies and procedures that reflect the ethical principles of the Belmont Report consistent with federal regulation. Develop and implement institutional policies and procedures that reflect the ethical principles of the Belmont Report consistent with federal regulation. Provide the UIndy community with Human Subjects’ Protections education. Provide the UIndy community with Human Subjects’ Protections education. Maintain an accurate system for tracking the status of research protocols. Maintain an accurate system for tracking the status of research protocols.

IRB Purposes Conduct prospective reviews of proposed research in order to safeguard the rights and welfare of participants. Conduct prospective reviews of proposed research in order to safeguard the rights and welfare of participants. Conduct continuing reviews of research in progress. The timeframe for the continuing reviews is determined for each protocol by the IRB. The maximum amount of time between reviews is 1 year. Conduct continuing reviews of research in progress. The timeframe for the continuing reviews is determined for each protocol by the IRB. The maximum amount of time between reviews is 1 year.

What is the IRB? Committee that reviews research proposals that involve the use of human participants Committee that reviews research proposals that involve the use of human participants Primary goal is to ensure that human participants are protected Primary goal is to ensure that human participants are protected Resource for students and faculty wanting to conduct research involving human participants Resource for students and faculty wanting to conduct research involving human participants

Who is the IRB? At least 5 members At least 5 members Varied professions, both scientific and nonscientific Varied professions, both scientific and nonscientific At least one community member NOT associated with institution At least one community member NOT associated with institution Experience, expertise and diversity to review proposals Experience, expertise and diversity to review proposals Knowledge of the federal regulations pertaining to research with human participants Knowledge of the federal regulations pertaining to research with human participants

What Does the IRB DO? Approve, disapprove or modify research protocols Approve, disapprove or modify research protocols Conduct continuing review of ongoing protocols Conduct continuing review of ongoing protocols Observe, monitor and audit protocols Observe, monitor and audit protocols Suspend or terminate approval of protocols Suspend or terminate approval of protocols The IRB CANNOT approve research that is already underway or is completed.

What an IRB is NOT… Group wanting to develop your research design Group wanting to develop your research design Group wanting to micromanage your project Group wanting to micromanage your project Faculty with endless time to give to your project Faculty with endless time to give to your project

Definition: Research “A systematic investigation designed to develop or contribute to generalizable knowledge.” (45 CFR [d]) “A systematic investigation designed to develop or contribute to generalizable knowledge.” (45 CFR [d]) In other words: to develop or contribute to the general body of knowledge In other words: to develop or contribute to the general body of knowledge

Definition: Human Participant A living individual about whom an investigator obtains data or private, identifiable information A living individual about whom an investigator obtains data or private, identifiable information 45 CFR [f] 45 CFR [f]

Definition: Vulnerable Populations Women and fetuses Prisoners Children Mentally Disabled Economically or Educationally Disadvantaged

Definition: Minimal Risk Definition: Minimal Risk Probability of harm no greater than in daily life activities or during routine physical or psychological tests

Exempt or Expedited Review No more than “minimal risk” No more than “minimal risk” Noninvasive data collection Noninvasive data collection Video, voice and image recordings where risk of breach of confidentiality is minimal Video, voice and image recordings where risk of breach of confidentiality is minimal Research involving the evaluation of “normal educational practices” Research involving the evaluation of “normal educational practices”

Exempt or Expedited Review The Federal standards describe the minimal review procedures required for various types of research. The IRB always has the option of reviewing any protocol using more vigorous procedures. The Federal standards describe the minimal review procedures required for various types of research. The IRB always has the option of reviewing any protocol using more vigorous procedures. Submit 4 copies of protocol to the IRB office Submit 4 copies of protocol to the IRB office Reviewed by IRB chair and 1 or more experienced reviewers using the reviewer template as a blueprint. Reviewed by IRB chair and 1 or more experienced reviewers using the reviewer template as a blueprint. Does NOT mean review is quicker! Does NOT mean review is quicker!

Full Review Requires quorum of members to take action regarding a protocol at a IRB convened meeting Requires quorum of members to take action regarding a protocol at a IRB convened meeting Submit 11 copies at least 2 weeks prior to IRB meeting Submit 11 copies at least 2 weeks prior to IRB meeting A primary review team (approximately 3 IRB members) is assigned to complete a preliminary review and lead the committee’s discussion. The reviewer template is used as the blueprint for the review A primary review team (approximately 3 IRB members) is assigned to complete a preliminary review and lead the committee’s discussion. The reviewer template is used as the blueprint for the review

Informed Consent A process…not just a document A process…not just a document The researcher has the responsibility of documenting that the research participant is fully informed and meets all inclusion criteria prior to the initiation of research procedures The researcher has the responsibility of documenting that the research participant is fully informed and meets all inclusion criteria prior to the initiation of research procedures Participant and/or legally authorized representative (specific elements may vary by state) Participant and/or legally authorized representative (specific elements may vary by state) Language suitable to participant group Language suitable to participant group No exculpatory language No exculpatory language

Informed Consent The participant must have sufficient time to consider options The participant must have sufficient time to consider options The researcher must design informed consent procedures that minimize coercion and undue influence/pressure to participate The researcher must design informed consent procedures that minimize coercion and undue influence/pressure to participate

Key Elements of Informed Consent Statement that activity is research Statement that activity is research Purpose of study Purpose of study Duration of study Duration of study Number of participants Number of participants Description of all related procedures Description of all related procedures Estimated time commitment Identification of risks Identification of benefits Alternatives to participation

Key Elements of Informed Consent Description of the extent of confidentiality Description of the extent of confidentiality Compensation ( or lack of) for injury Compensation ( or lack of) for injury Whom to contact with questions Whom to contact with questions Whom to contact in event of injury Right to refuse to participate (voluntary) Right to withdraw at any time

IRB Decisions Approve Approve Modify (approve pending clarifications and revisions) Modify (approve pending clarifications and revisions) Table Table Disapprove (reserved for full review only) Disapprove (reserved for full review only)

Principal Investigator (PI) Obligations Faculty advisors are ULTIMATELY RESPONSIBLE for the research study and are identified as the Principal Investigators Faculty advisors are ULTIMATELY RESPONSIBLE for the research study and are identified as the Principal Investigators All members of research team must be identified by name and must complete on- line training. Verification of training is a prerequisite for IRB review. All members of research team must be identified by name and must complete on- line training. Verification of training is a prerequisite for IRB review. Submit a project update when new team members are added Submit a project update when new team members are added

Investigator Obligations Design ethical research Design ethical research Comply with federal regulations Comply with federal regulations Obtain approval from IRB before recruiting participants Obtain approval from IRB before recruiting participants Implement research only as approved by the IRB. Obtain PRIOR approval for protocol modifications and updates Implement research only as approved by the IRB. Obtain PRIOR approval for protocol modifications and updates

Investigator Obligations Obtain and document informed consent/assent. Obtain and document informed consent/assent. If an informed consent document is used, a copy of the document must be given to the participants. If the document is signed, the participants must receive a signed copy. If an informed consent document is used, a copy of the document must be given to the participants. If the document is signed, the participants must receive a signed copy. Submit progress and revision reports as required. Submit progress and revision reports as required.

Investigator Obligations Report unanticipated problems promptly (adverse events). Report unanticipated problems promptly (adverse events). Notify the IRB when the research is completed. Notify the IRB when the research is completed. Retain records for at least 3 years. Retain records for at least 3 years.

What is the IRB Looking For?

I. Introduction, Purpose and Background Are the purposes clearly specified? Are the purposes clearly specified? Are there adequate preliminary data to justify the research? Are there adequate preliminary data to justify the research? Is there appropriate justification for this research protocol? Is there appropriate justification for this research protocol? Are adequate references provided? Are adequate references provided?

II. Scientific Design Is the scientific design adequate to answer the research question? Is the scientific design adequate to answer the research question? Are the research objectives likely to be achievable within a given time period? Are the research objectives likely to be achievable within a given time period? Is the scientific design described and adequately justified? Is the scientific design described and adequately justified?

III. Inclusion/Exclusion Criteria For Subjects Are inclusion and exclusion criteria clearly specified and appropriate? If women, minorities, or children are included or excluded, is this justified? Is the choice of subjects appropriate for the question being asked? Is the principle of distributive justice adequately incorporated into the inclusion and exclusion criteria? Is subject selection equitable?

IV. Recruitment of Subjects Are the methods for recruiting potential subjects well defined? Are the location and timing of the recruitment process acceptable? Is the individual performing the recruitment appropriate for the process? Are all recruitment materials submitted and appropriate? Are there acceptable methods for screening subjects before recruitment?

V. Research Procedures Are the rationale and details for the research procedures accurately described and acceptable? Is there a clear differentiation between research procedures and standard care? Are the individuals performing the procedures appropriately trained, and is the location of performing the procedure acceptable? Are there adequate plans to inform subjects about specific research results if necessary?

VI. Devices and Drugs Is the significant risk or non-significant risk status of the device described and appropriate? Are the device or drug safety and efficacy sufficient to warrant the type of testing? Is the drug dosage and route of administration appropriate?

VII. Data Analysis and Statistical Analysis Is the rationale for the proposed number of subjects reasonable? Are the plans for data and statistical analysis defined and justified? Are there adequate provisions for monitoring data?

VIII. Potential Risks, Discomforts and Benefits for Subjects Are the risks and benefits adequately identified, evaluated, and described? Are the potential risks minimized and likelihood of benefits maximized? Is the risk/benefit ratio acceptable for proceeding with the research?

IX. Research Costs and Compensation for Participants Is the amount or type of compensation or reimbursement reasonable? Are there adequate provisions to avoid out- of-pocket expenses by the research subject, or is there sufficient justification to allow subjects to pay? If children or adolescents are involved, who receives the compensation, and is this appropriate?

X. Privacy and Confidentiality Are there adequate provisions to protect the privacy and ensure the confidentiality of the research subject? Are there adequate plans to store and code the data? Is the use of identifiers or links to identifiers necessary, and how is this information protected?

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

XII. Other Issues Is there a potential conflict of interest for the investigator? When should the next review occur? If frequent reviews are necessary, how should the interval be determined?

Questions? Talk with your faculty member Review the University of Indianapolis IRB Website Schedule an appointment with an IRB member

Questions Still Unanswered? Contact the IRB Chair