UNIVERSITY OF INDIANAPOLIS - Institutional review …irb.uindy.edu/.../IRB_Review_Application_Worksheet.docx · Web viewAND ARE NOT COLOR-CODED. THE FORM YOU COMPLETE IN IRBMANAGER

Application WorksheetDraft 03/23/2012

UNIVERSITY OF INDIANAPOLISINSTITUTIONAL REVIEW BOARD (IRB)

Worksheet for IRBManager Submission ofProjects Requiring Expedited or Full IRB Review

The purpose of this worksheet is provide investigators a template for drafting answers they must submit to IRBManager when applying for IRB review of a research project involving human participants. This template provides all data entry fields and “Help Notes” investigators will see when submitting answers to IRBManager. Please contact the IRB Office with questions or

concerns about this template, IRBManager, or other IRB matters.

The following color scheme will assist you through the template:RED (MANDATORY); ALL applications must answer these questions

YELLOW (OPTIONAL); Only if a project includes multiple personnel

ORANGE (CONDITIONAL); Applicable according to preceding answers

NOTE: IN IRBMANAGER, THE CONDITIONAL QUESTIONS WILL AUTOMATICALLY APPEAR AS NEEDED AND ARE NOT COLOR-CODED. THE FORM YOU COMPLETE IN IRBMANAGER IS NOT AS LENGTHY AS

THIS TEMPLATE.

Page 1: Identification of Application Type (MANDATORY)

1. Please identify the type of application you are submitting. Make your selection from the drop down menu. The accompanying drop down menu provides the following options:Initial Application Revisions Prior to Approval (first time)Revisions Prior to Approval (second time)Amendment

2. If you are submitting revisions prior to approval, you must attach the investigator’s response letter here.If you select either of the “Revisions Prior to Approval” options from the drop down menu, you must attach a response letter before IRBManager will allow you to proceed to the next page. The response letter must detail the revisions made and where (i.e., the heading of the data entry field) the revisions appear in the application form.

**This is an “attachment” field**

Page 2: Project Title

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(MANDATORY)1. The project title is:

This exact title must appear throughout the application and on all accompanying documentation (e.g., funding documentation, informed consent document, etc.).

Page 3: Principal Investigator (PI) Information (MANDATORY)

1. Principal Investigator’s email address Enter the email address and press “Tab”. If the IRBManager has contact information for the Principal Investigator, the information will auto-fill. If the contact information does not auto-fill, please contact the IRB Coordinator for assistance.

2. List human research protections training, which the PI has successfully completed in the past two years. Describe the PI's training and/or education relevant to the research activities of this project. You may attach below the PI's curriculum vitae to support validation. (MANDATORY)

Per UIndy IRB policy, all principal investigators must complete CITI human protections training BEFORE the IRB will begin regulatory review of a project. The IRB Office will verify all CITI training. If the PI has not completed CITI training as a UIndy affiliate, please contact the IRB Coordinator for assistance.

3. Attach Principal Investigator's curriculum vitae (CV) and/or other supporting documentation here. Please attach CV if this submission is the PI's FIRST research project as a UIndy affiliate.

This is NOT a requirement for UIndy faculty/affiliates who have previously conducted projects with UIndy IRB approval.


Page 4: Co-investigators (OPTIONAL)

1. Co-investigator’s email address.

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Enter the email address and press “Tab”. If the IRBManager has contact information for the Principal Investigator, the information will auto-fill. If the contact information does not auto-fill, please fill in the information below.

2. Co-investigator’s First Name

3. Co-investigator’s Last Name

4. Co-investigator’s Telephone Number

5. Co-investigator’s Email Address

6. Co-investigator Validation List human research protections training, which the co-investigator has successfully completed in the past two years. Describe the co-investigator's training and/or education relevant to the research activities of this project. You may attach below the co-investigator's curriculum vitae and/or other documentation to support validation. Per UIndy IRB policy, all co-investigators must complete CITI human protections training before the IRB will approve a project. The IRB Office will verify all CITI training completed by UIndy affiliates. If the co-investigator has not completed CITI training as a UIndy affiliate, please contact the IRB Coordinator for assistance.

7. Co-investigator Validation DocumentationAttach curriculum vitae (CV) or other supporting documentation here.


**This page is repeatable for each co-investigator on the project**

Page 5: Non-investigator Personnel (OPTIONAL)

1. Non-investigator Personnel EmailPlease type in the email address of the non-investigator personnel. Press the "tab" key to locate the co-investigator. If the non-investigator personnel is not found, please submit the contact information below. Please click the "repeat" button to add additional personnel, or click the "next"

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button to continue with the form.

2. Non-investigator Personnel First Name

3. Non-investigator Personnel Last Name

4. Non-investigator Personnel Telephone Number

5. Non-investigator Personnel Email Address

6. Non-investigator Personnel ResponsibilitiesDescribe the responsibilities for the non-investigator personnel. If the non-investigator personnel will interact with participants (e.g., conduct informed consent procedures and/or collect data directly from participants) and/or manipulate identifiable data, then the personnel does NOT qualify as "non-investigator", and thus, must meet all eligibility and validity criteria for investigator personnel.

**This page is repeatable for each non-investigator on the project**

Page 6: Declaration of Funding/Sponsorship (MANDATORY)

1. Will you receive or have you received funding/sponsorship in order to conduct this research project?

Select "YES" if investigators receive any funding from any source for the conduct of this project. If investigators are "self-funding", then answer "NO".

**This is a screening question**

If the answer is “yes”, another page (Page 7 below) will appear requiring relevant

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information. If the answer is “no”, then the application will skip to Page 8: Introduction, Purpose and Background.

Page 7: Funding/Sponsorship Information (CONDITIONAL)

(applicable if Page 6, #1 is “yes”)1. Select the most appropriate answer from the drop-down menu.

2. Describe "Other" funding source here.You must complete this field if you selected “Other” from the drop down menu above. Include name of grantor/sponsor, title of grant, and amount of grant.

3. Attach grant award letter or similar documentation here.Contact the IRB Office with questions or concerns about appropriate documentation to attach.


Page 8: Introduction, Purpose and Background (MANDATORY)

1. Briefly explain the purpose(s) for conducting this project and list the objective(s) of this project.

Write concisely and succinctly. Avoid discipline-specific jargon. Write for a reader who may have no previous knowledge of this field of study.

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2. Briefly explain (1) how the current body of literature supports this project and (2) how this project will contribute to the body of literature.

Attach below the reference list corresponding to the literature review.

3. Attach reference list here.**This is an “attachment” field**

4. Define relevant, discipline-specific terms to assist the IRB with review.

Define only those terms which are integral to the project, and which the IRB must understand to best review the project. If no terms require definition, then answer "N/A".

5. State hypothesis(es) and/or research question(s) here.Hypothesis(es) and/or research question(s) must be congruent with study purpose(s), objective(s), and design.

Page 9: Scientific Design and Research Methods (MANDATORY)

1. Does the research project involve interaction or intervention with living human beings?

"Interaction" includes activities, such as interviews, focus groups, or other activities whereby the participant communicates personal information to the investigators. "Intervention" includes experimental and data collection activities, such as manipulating the environment, physical measurements, intellectual

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measurements, collecting biological specimens, etc.


If you answer “yes”, the remainder of the application will require information relevant to intervention/interaction with living human beings. If you answer “no”, then the

remainder of the application will require answers to questions relevant to research involving data only (e.g., data mining, retrospective chart review, etc.).

2. Concisely and succinctly describe the project design. Design must be congruent with purpose(s), objective(s) and hypothesis(es) or research question(s). The IRB will not approve a protocol which (1) does not adequately or accurately describe study methodology or (2) describes an incomplete and/or overly flawed design.

3. Explain how the design and method(s) will achieve the objectives of the project.

4. Describe the research methods for this project. Identify all activities investigators will use to (1) interact with or intervene in the circumstances of participants (i.e., what will participants do and/or how will investigators influence participants' surroundings) and/or (2) generate data set for analysis.

Page 9: Scientific Design and Research Methods (cont.)

5. Briefly describe the anticipated time line for the project (e.g., approximate date to begin recruitment and enrollment, amount of time for all data collection, anticipated close date, etc.).

When approximating start date, remember to include time estimate for IRB review and approval.

6. Does the project design involve therapeutic interventions/modalities with the intent to investigate efficacy/effectiveness to diagnosis,

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treatment, cure, or prevent disease or illness?Answer "YES" if the intent and purpose of the project is to investigate therapeutic efficacy/effectiveness of treatments and their modalities.


If the answer is “yes”, then a separate page (Page 11 below) will appear requiring relevant information about therapeutic research.

7. Will the project investigate safety, toxicity, efficacy or effectiveness of drug, device or biological (e.g., monoclonal antibody) towards approval or relabeling by the Food and Drug Administration (FDA)?


If the answer to this question is "yes", then the application form will automatically terminate. Contact the IRB Office for consultation.

If the answer is “no”, then the application will continue.

Page 10: Research Site Description (MANDATORY)

1. Identify the PRIMARY research site.Select the PRIMARY research site from the drop down menu. If you select "Other", then you must describe the other location(s) in the following text box.

2. Identify and describe the other location(s) where research activities will occur.

List ALL sites where data collection and/or data analyses will occur in addition to or instead of the UIndy campus.

Page 11: Therapeutic Research (CONDITIONAL)

(applicable if Page 9, #6 is “yes”) 1. Will investigators administer drugs or biologicals (e.g., monoclonal

antibodies) to study efficacy/effectiveness?ALL drugs or biologicals must have FDA approval for marketing to general public.

2. If this study involves the administration of drugs and/or biologicals, explain THOROUGHLY the safety, effectiveness and known side effects of the drug(s) and/or biological(s).

Please leave box empty if you answered no above.

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3. Will the project use FDA-approved devices (e.g., MRI, CT scan, ultrasound, etc.) for experimental purposes or for data collection?

4. If the answer to the preceding question is "yes", then explain THOROUGHLY the safety and effectiveness of the device as used in this project.

If the answer to the preceding question is "no", then do not enter information here.

5. Describe the therapeutic procedures investigated in the project. Distinguish experimental procedures from "standard of care" procedures.

Write succinctly and concisely. Avoid jargon and define terms as necessary.

6. Explain the advantages and disadvantages of the experimental therapy relative to current standard of care.

7. If project investigates different modes of a therapeutic intervention, then please explain THOROUGHLY the relative advantages and disadvantages of the experimental modality(ies).

In the project does NOT investigate different modalities of a therapeutic intervention, then answer "NA" here.

Page 12: Participant Characteristics (CONDITIONAL)

(applicable if Page 9, #1 is “yes”)1. (a) Delineate inclusion criteria, which are the defining characteristics

of your study population.

(b) Delineate exclusion criteria, which are those characteristics/conditions disqualifying a member of the study population from participation.

Exclusion criteria are not the opposite or negatives of inclusion criteria.

2. Explain how you will ensure equitable representation across various

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population/demographic categories in your study population.In order to uphold the principle of justice, your study population must represent those populations/demographics (e.g., gender, race/ethnic, age, etc.) who will benefit from the results of your study as well as those who will bear the risks from participation in your study. In order to meet the criterion of generalizability, your study population must attempt to represent the general population to which your study results pertain. For example: If your study attempts to explain a characteristic of college students, then your study population must represent fairly the demographics of college students.

3. Will you recruit and enroll participants who are incapacitated (e.g., diminished cognitive ability, unconscious, etc.) or legally incompetent (e.g., minor) and as such, unable to give voluntary informed consent?"Incapacitated" signifies the inability to give voluntary informed consent due to social/cultural, physical/medical, emotional, and/or psychological factors preventing a potential participant from understanding and evaluating risks and benefits, and communicating a deliberate and voluntary decision to participate in research. "Incompetent" signifies a legal/judicial determination that a person cannot make an informed, voluntary decision to participate in research. If you will enroll incapacitated and/or incompetent participants, you must answer the following question below.


If the answer is “yes”, then additional questions below will require answers relevant to informed consent procedures.

Page 12: Participant Characteristics (if applicable, cont.)

4. If you will recruit and enroll incapacitated and/or incompetent participants, explain (1) why this population is important to the study and (2) how you will protect the participants from coercion (i.e., forced and/or involuntary participation).

Depending on the population, the probability, severity and nature of risk, and the cognitive capabilities of the population, the IRB may require you to obtain informed assent from participants and informed consent from legally authorized decision makers (e.g., parents, guardians, powers of attorney, etc.).

5. Will you recruit and enroll participants from populations who may be susceptible to coercion, exploitation, and/or undue influence in your project?"Coercion" is defined as "to compel another person to a choice or act by threat or force"."Exploitation" is defined as "to treat another person in a mean or unfair way for one's own advantage".

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"Undue influence" is defined as "to persuade or entice a person to choose or act in order to gain some advantage (e.g., monetary gain) or avoid some disadvantage (e.g., avoid reduction in academic standing or employment).

Examples participants potentially vulnerable to coercion, exploitation, and/or undue influence include: (1) Low income(2) Poverty-stricken(3) Elderly (e.g., "frail", dependent, etc.)(4) Mentally ill and/or mentally retarded(5) University students (i.e., students who participate in research where the instructor is the Principal Investigator)(6) Other hierarchical/subordinate relationships (e.g., employee/employer relationship, soldier/officer relationship, provider/patient, etc.)


If the answer is “yes”, then the application will require additional information relative to protecting these populations.

6. Describe how investigators will minimize risks of coercion, exploitation and/or undue influence during the various phases (e.g., recruitment, informed consent, etc.) of this project.

This question requires a response. If you answered "no" to the preceding question, answer "NA" here.

Page 12: Participant Characteristics (if applicable, cont.)

7. Will your research target/require enrollment of participants from any of the following categories:(a) Children (i.e., people under the age of majority)(b) Pregnant women, fetus(es), and/or neonates (c) Prisoners [i.e., any person of any age under arrest or in incarceration

in any setting (e.g., house arrest, jail, hospital, etc.)]Answer "yes" IF AND ONLY IF your research focuses on any of these populations.


If the answer is “yes”, then the application will require below (Page 13) additional information relative to special protections and informed consent.

Page 13: Vulnerable Populations (CONDITIONAL)

(applicable if Page 12, #7 is “yes”)1. Will you enroll children as participants in your project?

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You must answer "yes" if you will enroll participants who are under the age of majority (18 years old in the state of Indiana). NOTE: If you will conduct research activities outside of Indiana, you must know the age of majority for the state in which you will enroll and research participants.


If the answer is “yes”, then the application will require answers to additional questions, as well as information relative to assent and parental permission. If the answer is “no”,

then after questions about children the application will require answers to questions about other vulnerable populations.

2. Complete and attach here the document "Children as Research Participants"

Use the embedded link to access the document.


3. (a) Explain why your project requires children as research participants.

(b) Explain how you will minimize risks of coercion, exploitation, and harm to children throughout the course of the research project.

Page 13: Vulnerable Populations (cont.)(applicable if Page 13, #1 is “no”)

4. Will your research project study pregnant women, fetuses and/or neonates (newborns)?


If the answer is “yes”, then the application will require additional information relevant to this population.

5. (a) Explain why your project requires pregnant women, fetuses and/or neonates as research participants.

(b) Explain how you will minimize risks of coercion, exploitation, and harms.

You must answer this question if you answered "yes" to the preceding screening question.

Page 13: Vulnerable Populations (cont.)(applicable if Page 13, #1 AND #2 is “no”)

6. Will you include prisoners of any age and in any setting as research participants?

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http://irb.uindy.edu/docs/forms/children_research_participants.doc

http://irb.uindy.edu/docs/forms/children_research_participants.doc


You must answer "yes" if you will recruit and enroll a person of any age who is under arrest or in incarceration at any facility (e.g., home detention, hospital, jail, penitentiary, etc.).


If the answer is “yes”, then the application will require additional information relevant to this population.

7. (a) Explain why prisoners are important to this research project.

(b) Explain how investigators will protect prisoners from coercion, exploitation, and other risks of harms (e.g., confidentiality).

You must answer this question if you answered "yes" to the preceding screening question.

Page 14: Recruitment Screening Question (CONDITIONAL)

(applicable if Page 9, #1 OR #6 is “yes”)1. Will you use advertising or other recruitment procedures to invite

potential participants to enroll in your research?Recruitment procedures include:(1) All advertising in any medium (e.g, printed flyers, radio "spots", newspaper ads, etc.)(2) Personal presentations to groups (e.g., classes, support groups, etc.)(3) Individual invitations (e.g., "snowballing")(4) Use of social media (e.g., Facebook, Twitter, etc.)


If the answer is “yes”, then the application will require additional information about specific recruitment procedures. If the answer is “no”, the application will skip to the

next section.

Page 15: Recruitment Procedures (CONDITIONAL)

(applicable if Page 14, #1 is “yes”)1. Describe all procedures you will use to advertise your research and

recruit potential participants. Include details of media you will use (e.g., flyers, personal presentations, "snowball effect", etc.) as well as

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circumstances and conditions of recruitment (i.e, who, where, when, how, etc.).

You must explain how your recruitment procedures (1) minimize undue influence or coercion on potential participants to enroll in your research and (2) optimize fair/equal representation of those who may benefit from your research, and distribution of risks to those who will bear the burden of the research.

2. Attach all recruitment materials here.You must submit for IRB review all recruitment materials in the exact form you will present materials

to potential participants (i.e., the IRB must see what your participants will see). Recruitment materials include flyers, advertisements, scripts, etc.


Page 16: Requesting Waiver for Informed Consent Procedures (CONDITIONAL)

(applicable if Page 9, #1 OR #6 is “yes”)1. Will you request waiver for ALL informed consent procedures?

Please refer to the following document to ensure your request meets all federal regulatory criteria for granting a waiver for all informed consent procedures:

http://irb.uindy.edu/docs/forms/waiver_informed_consent.doc


If the answer is “yes”, the application will require additional information.

2. Justify your request for waiver of all informed consent procedures.This field requires information if the answer to the preceding screening question is “yes”.

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Page 16: Requesting Waiver for Informed Assent Procedures(CONDITIONAL)

(applicable if Page 12, #4 OR #7 is “yes”)3. Will you request waiver for ALL informed assent procedures?





4. Explain your justification of waiver for all informed assent procedures.

This field requires information if the answer to the preceding screening question is “yes”.

Page 16: Requesting Waiver for Parental Permission Procedures (cont.)

(applicable if Page 13, #1 is “yes”)5. Will you request a waiver for ALL parental permission procedures?




If the answer is “yes”, then the application will require additional information.

6. Explain the justification of your request for waiver for all parental permission procedures.


Page 17: Requesting Waiver for Documentation of Informed Consent

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(CONDITIONAL)(applicable if Page 16, #1 is “no”)

1. Will you request a waiver for documentation of (signed) informed consent?

IMPORTANT: This question pertains to subjects who are NOT children or otherwise incapacitated or incompetent. Please review the federal regulations relevant to waiver of informed consent. If the

embedded link is broken, you will find the document at http://irb.uindy.edu/docs/forms/waiver_informed_consent.doc.



2. Explain your request for waiver of documentation of (signed) informed consent.


Page 17: Requesting Waiver for Documentation of Informed Assent(CONDITIONAL)

(applicable if Page 16, #3 is “no”)3. Will you request a waiver for documentation of (signed) informed

assent?Please refer to the following document to ensure your request meets all federal regulatory criteria

for granting a waiver for all informed consent procedures: http://irb.uindy.edu/docs/forms/waiver_informed_consent.doc



4. Explain your justification of waiver for document of informed assent.This field requires information if the answer to the preceding screening question is “yes”.

Page 17: Requesting Waiver for Documentation of Parental

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Permission(CONDITIONAL)

(applicable if Page 16, #5 is “no”)5. Will you request a waiver for documentation of parental permission?





6. Explain your justification of waiver for documentation of parental permission.


Page 18: Informed Consent Procedures (CONDITIONAL)

(applicable if Page 16, #1 is “no”)1. Describe your informed consent procedures. Include specific details

describing (1) Who will conduct informed consent procedures, (2) Where investigators will conduct informed consent procedures, (3) How investigators will conduct informed consent procedures, (4) What steps investigators will take to ensure participants understand and weigh risks and benefits, and communicate voluntary consent to participate.

NOTE: This is one of the primary foci for IRB review. Your description of informed consent procedures should be clear and detailed.

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2. Will you allow proxy decision makers to provide informed consent on

behalf of participants?You must answer "yes" if you will allow legal guardians, durable powers of attorney or other

designated individuals to make decisions on behalf of the research participants. Additionally, the informed consent document and the project proposal must include appropriate information for and

about proxy decision makers.

3. Attach all informed consent documents here.**This is an “attachment” field**

Page 18: Informed Assent Procedures (CONDITIONAL)

(applicable if Page 16, #3 is “no”)4. Describe your informed assent procedures. Include specific details

describing (1) Who will conduct informed assent procedures, (2) Where investigators will conduct informed assent procedures, (3) How investigators will conduct informed assent procedures, (4) What steps investigators will take to ensure participants understand and communicate assent to participate.

This is one of the primary foci for IRB review. Your description of informed assent procedures should be clear and detailed.

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5. Attach informed assent documents here.**This is an “attachment” field**

Page 18: Parental Permission Procedures (CONDITIONAL)

(applicable if Page 16, #5 is “no”)6. Describe how investigators will obtain informed permission from

parents of children who are research participants.You must include descriptions of how investigators will share information and validate parents' permission as voluntary and informed. You must also describe which member(s) of the research team will obtain permission and where the process will occur.

7. Attach parental permission document(s) here.**This is an “attachment” field**

Page 19: Data Management (MANDATORY)

1. Concisely and succinctly describe (1) ALL data collection procedures (i.e., personnel, processes, forms, surveys, etc.) and (2) the nature of the collected data (e.g., electronic, hard copy, anonymous, etc.). This includes demographic AND research data.

Description of data and data collection procedures must include the following specifics:(1) Whether the data collection procedures are anonymous or confidential;(2) Whether the resulting data are anonymous or confidential;(3) Justification for collecting personally (individually) identifiable information (e.g., name, birth date, email address, Social Security or other account numbers, etc.).

UIndy follows HIPAA (i.e., "Health Information Portability and Accountability Act") regulations regarding the use of individually identifiable information and protected health

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information (PHI). For assistance with individually identifiable information and/or PHI, click here.

For assistance with how to use and understand "anonymous", "confidential", and "de-identified" relative to research data and data collection, click here.

2. Attach ALL data collection instruments (e.g., survey, standardized test, etc.) and forms (e.g., spreadsheet) here.IRB must review all instruments in the same format and configuration presented to participants. Please include an active link to any and all online data collection instruments (e.g., survey). If copyright law or other security issues prevent copying or scanning instruments for attachment, please contact the IRB Coordinator for further instructions. You can attach up to 40 separate document files.


3. Describe how investigators will protect participants from unwanted public exposure while participating in the project.

If this section does not apply to your project, type "NA". The description of privacy protection must include details about the circumstances surrounding data collection (e.g., where, how, and when you will conduct a face-to-face interview, a physical examination, etc.), as well as suggestions for participants to protect their own privacy (e.g., complete an online survey at home and not at a public computer lab).

Page 19: Data Management (cont.)

4. Describe how investigators will collect, store, secure, transport and/or transmit, and ultimately destroy data in order to protect confidentiality of participants' identities.

If investigators will collect, store, transport/transmit personally identifiable data in association with research data in electronic format [e.g., email, electronic files on computers or portable storage devices (e.g., flash drives or portable hard drives)], then investigators must use encryption technology (e.g., True Crypt).

5. What is the MINIMUM number of participants from whom you must collect all data (i.e., complete all research activities) in order to obtain (statistically) significant results allowing generalization of results to populations and phenomena beyond the current project?

The sample size must not be too few, thereby rendering the project meaningless and exposing participants to unnecessary risk. Moreover, the number should not be too great, thereby exposing

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http://irb.uindy.edu/docs/forms/Guidance_on_Anonymity_Confidentiality_and_De-identification_Ver_031011.pdf

http://privacyruleandresearch.nih.gov/pr_08.asp#8a


too many participants to risk.

6. Describe the method for determining sample size and explain the rationale for choosing the method.

7. What is the MAXIMUM number of participants you will enroll to ensure data collection from determined sample size? Please explain your rationale for this maximum number of enrollees.

When calculating this number, investigators must factor (1) estimated "no shows", "drop outs" or voluntary early termination of participation and (2) exposing the minimum number of participants to potential risks of the research. The investigator will commit a reportable protocol deviation by exceeding this number during the course of the study. The investigator must submit an application to amend the project in order to alter this maximum number.

Page 19: Data Management (cont.)

8. Describe method(s) of data analysis(es) and explain rationale for these methods relative to project objectives and hypothesis(es) and/or research question(s).

Provide details of all quantitative (e.g., statistical, frequency of response, etc.) and qualitative (e.g., thematic analysis, member checking, etc.) data analyses.

9. Describe how investigator(s) will monitor data throughout the duration of the study to ensure safety of participants.

Investigators conducting research involving minimal or greater risk must describe how they will monitor data to ensure participants are not harmed. Do not describe a process for protecting safety of the data. If this section does not apply to your project, type "NA".

Page 20: Expenses, Reimbursement & Compensation (CONDITIONAL)

(applicable if Page 9, #1 OR #6 is “yes”)

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1. Will participants incur any expenses as a direct result of participation in this project?Expenses and costs include, but are not limited to the following examples: transportation expenses (e.g., driving or taking public transportation to a testing site, parking, etc.), meals, lodging, purchase of equipment, dues or fees, medical treatment due to injury or illness, lost wages, etc. Contact the IRB Office with questions about this matter.

2. Briefly describe all anticipated expenses and costs to participants as a direct result of participating in this project.

You must answer this question if your answer to the preceding question is "yes".

3. Will investigators reimburse participants for any or all expenses they incur as a direct result of participating in this project?

4. Describe procedures for reimbursing participant expenses as a direct result of participating in the project. You must include details on record keeping, source of funds, holding of funds, distribution of funds, and reconciling of financial statements.

You must answer this question if the answer to the preceding question is “yes”. Do not describe compensation or incentives (e.g., gift card raffle) in this field.

Page 20: Expenses, Reimbursement & Compensation (cont.)

5. Could participants incur medical expenses due to injury or illness as a direct result of participating in this research project?You must answer "yes" if the research activities in and of themselves pose a threat of injury or illness requiring medical attention and/or treatment resulting in expenses for the participants.

6. Describe procedures for reimbursing participant medical expenses (e.g., treatment, rehabilitation, loss wages, etc.) due to injury or illness as a direct result of participating in the research project.

If you will not reimburse medical expenses, then type "NA" here. UIndy does NOT provide funds or require investigators to reimburse participants for medical expenses incurred because of injury or illness as a direct result of participating in research. To reduce risk of financial liability, investigators should inform potential participants that they and/or their health insurance carriers will bear sole responsibility for all medical expenses incurred as a direct result of participating in research.

7. Will you provide compensation or incentive to encourage participant enrollment?

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You must answer "yes" if you will offer incentives/compensation, such as gift cards, monetary compensation (i.e., a check), material gain (e.g., clothing, electronics, etc.) or educational gain (e.g., extra credit, participation credit, etc.).

8. Describe procedures for offering and distributing compensation/incentive for participation. The description should include:(1) Description of the incentive/compensation (e.g., gift card, extra credit, etc.)(2) Description of the distribution process for incentive/compensation (e.g., raffle, application for credit, mailing of gift, etc.)(3) Explain how the incentive/compensation does NOT unduly influence a person's decision to participate in the research project.

Investigators may not offer incentives/compensation, which unduly influence a person's decision to participate in research. For example: a $25.00 gift card through a raffle for 30 minutes of participation time may not influence a person's decision to participate, whereas a $250.00 gift card may be an undue influence.

Page 21: Cooperating Entities (MANDATORY)

1. Does the project require cooperation with other entities either internal to UIndy (e.g., departments, student organizations, etc.) or external to UIndy (e.g., another university, a hospital, a school, etc.) to grant access for recruitment/enrollment of potential participants and/or conduct of research activities?


If the answer to this question is “yes”, then another page will appear instructing you to add information about cooperating entities.

Page 22: Description of Cooperating Entities (CONDITIONAL)

(applicable if Page 21, #1 is “yes”)1. Provide the following information about entities cooperating with this

research project:(1) Name/title(2) Name and title of entity representative authorizing cooperation with this project(3) Description of cooperation activities (e.g., access to data,

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equipment, and/or potential participants, conduct recruitment procedures, etc.)

You must submit a letter of cooperation from each cooperating entity. Refer to the document, "Guidelines for Drafting a Letter of Cooperation". If the cooperating entity has an IRB, you must contact that IRB about review and approval. If the cooperating entity IRB reviews and approves this project, you must submit documentation of approval.

2. Attach document file of letter of cooperation for each entity.Maximum number of attachments is 20. Notify the IRB Coordinator if submitting hard copy of

letter.


3. Attach documentation of cooperating entity IRB approval.You can attach up to ten document files.


Page 23: Assessment & Evaluation of Risks and Benefits(MANDATORY)

1. Describe all POTENTIAL and REAL risks to participants in this project.Potential and real risks include psychological, emotional, social, legal, physical and financial harms which the participant may experience as a direct result of the research activities and/or a result of a breach of data security.

2. Briefly explain how investigators will minimalize potential and real risks associating with the project.

Explain how the overall design of the project, including the various procedures, work together to minimalize risks and harms.

3. Describe all potential and real benefits as direct results of participating in the project.

Compensation, incentives, and/or reimbursement of expenses are NOT benefits.

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http://irb.uindy.edu/docs/forms/Guidelines_Letter_Cooperation.pdf


4. Describe potential and real benefits this project could make to society and science.

5. Do you find the benefits outweigh the risks of this project?The basis of the answer to this question is overall assessment and evaluation of risks and benefits.

Page 24: Availability and Distribution of Project Results(MANDATORY)

1. Describe procedures for distributing results to participants. If you will NOT make results available to participants, then you must explain.

Description should include details such as how participants can request results, how results will be reported, format of results, etc.

2. Describe how you will distribute results to the public, including academic and professional settings. If you will NOT publicly distribute results, then you must explain.

Examples include publication, presentation, etc.

Page 25: Declaration of Conflict of Interest(MANDATORY)

1. Does any member of the research team have real or perceptual conflict(s) of interest relative to the potential benefits (e.g., academic, professional, financial, etc.) which may accrue as a result of this project?

**This is a screening question**If the answer is “yes”, another page will appear for you to provide a description and

explanation of the conflict.

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Page 26: Description and Explanation of Conflict of Interest(CONDITIONAL)

(applicable if Page 25, #1 is “yes”)1. Identify and describe conflicts of interest for all members of the

research team.For more information on conflicts of interest, refer to the following resources:UIndy "Policy on Conflicts of Interest in Grants and Sponsored Research"UIndy "Conflict of Interest Disclosure" formOffice for Human Research Protections (OHRP) "Financial Conflict of Interest" Guidance

2. Attach "Conflict of Interest Disclosure" form here.If you have declared and identified financial conflicts of interest, you must complete and submit the document titled, "Conflicts of Interest in Grants and Sponsored Research Disclosure Form". Refer to the following documents for more information:UIndy "Policy on Conflicts of Interest in Grants and Sponsored Research"UIndy "Conflicts of Interest in Grants and Sponsored Research Disclosure Form"

**This is an attachment field**

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http://www2.uindy.edu/cms/channels/irg/Grants_Channel/UIndy_Grants_COI_Disclosure_Form.docx


http://www2.uindy.edu/cms/channels/irg/Grants_Channel/COI_in_Research_Policy_10.11.docx


http://www.dhhs.gov/ohrp/policy/fguid.pdf




Documents

UNIVERSITY OF INDIANAPOLIS - Institutional review …irb.uindy.edu/.../IRB_Review_Application_Worksheet.docx · Web viewAND ARE NOT COLOR-CODED. THE FORM YOU COMPLETE IN IRBMANAGER