IIT Form Revised February 2018

APPLICATION FOR THE REVIEW OF RESEARCH INVOLVING HUMAN PARTICIPANTS

This application incorporates requirements from the Code of Federal Regulations, Title 45, Part 46, Protection of Human Participants(rev. 1/2009). Complete copies of 45 CFR 46 are available via this link:

There is a separate document of instructions for this form online. If you have trouble filling out this application, please refer to the instructions.

Handy Tip: After you have completed this form, please be sure to use the checklist provided at the end.

SECTION A.GENERAL INFORMATION

1. Responsible Project Investigator (Qualified faculty/staff/advisor)
Department
Phone
Email
2. Name of Investigator (If different from Responsible Project Investigator, e.g. PhD student)
Department
Phone
Email
List all other project personnel including co-investigators and anyone else who has contact with participantsor identifiable data from participants. Include name, email address, affiliation (IIT or specific outside location), and role. Please note: Human Subjects Training is mandatory for all IIT personnel engaged in human participants research and proof should be submitted with each protocol application.
3. Project Title:
4. Project Dates: / From: (MM/DD/YYYY) / To: (MM/DD/YYYY)
5. Type of Investigator(s):(check all that apply)
Faculty Staff Graduate Student Undergraduate Student
6. Status of Project: / New Periodic Review Amendment Renew
7. If you have previously used human participants in this research project, provide the information below for all participants of the last twelve months:
Number of participants screened / Number admitted to project / Number of withdrawals
Number who completed participation / Number still active
During the previously approved project period were there any adverse events affecting human participants? If yes, please attach a sheet containing details of the events. / {Make Selection}YESNO
8. Site of Work:
9. Types of Research Participants(check all that apply):
Adult, Non Student IIT Student Non-IIT Student
10. Vulnerable Populations(check all that apply):
Minor (under 18) / Elder (older than 65) / Pregnant woman, fetus
Individual with physical disability / Individual in jail or prison / Individual with Court-Appointed Guardian
Individual with substance use disorder / Individual with economic disadvantage / Individual with cognitive or physical impairment
Individual from the LGBTQ community / Individual engaging in criminal activity / Individual with psychiatric disability
Ethnic or Religious Minorities Immigrant
11. Number of Participants, including ‘controls’:
12. Is this human participant project receiving any type of funding? / Yes No
If there are multiple funding sources, the outside sponsor should be listed first and any affiliates listed second.
If applicable, state whether the funding is through a federal or non-federal agency: Federal Agency
Non-Federal Agency
If yes, please list the sponsor award number or cayuse numberassociated with the grant:
13. Certain categories of research are eligible for review by a single IRB member (“expedited review”) rather than by the full IRB. There are also some categories that are considered “exempt.” Does your research qualify for expedited review or exempt review? (For definition of categories see Section 2 of “IRB Application Instructions” document online)
My research qualifies for expedited (single reviewer) review.
My research qualifies for full committee review.
My research qualifies for review as “exempt.”
I’m not certain which category is appropriate for this research and I’d like the IRB office to make a
determination.

SECTION B. OBJECTIVES OF RESEARCH

Describe the objectives and significance of the proposed research involving human participants. (One half page maximum, please)

SECTION C. PROTOCOLS

Provide details of the procedures that relate to the research participants’ participation. WHAT WILL THE PARTICIPANTS DO, OR WHAT WILL BE DONE TO THEM?WHERE WILL THIS HAPPEN?
Please avoid using technical jargon. Provide a response in this section; do not simply attach an appendix. Please append copies of all questionnaires or test instruments; web links are acceptable for items of undue bulk.

SECTION D. SELECTION OF PARTICIPANTS

(See Section 3 ofIRB Application Instructions for IRB Policy on Student Participation as Participants in Research)

1. Will participants receive payment or course credit compensation for participation? If monetary compensation, state amount, form, and conditions. If course credit compensation for students is provided, you must attach a list of non-research credit alternativesprovided for students who choose not to participate. / {MAKE SELECTION}YesNo
Amount/Form: Conditions (if any):
2. Access to human participants will be gained through cooperating institutions. If agreement is conditional upon IIT approval, explain below. You will need a letter from each institution; please see checklist page. / {MAKE SELECTION}YesNo
Notes:
4. Describe the recruiting process. Append copies of all recruiting materials, including flyers, advertising copy, phone scripts, sample emails, etc.
5. Describe the criteria used to determine inclusion and/or exclusion of participants.

SECTION E. DECEPTION

Will participants be deceived or misled, or have information withheld? / {MAKE SELECTION}YesNo
If yes, identify the information involved, explain reason forthe deception, and describe the debriefing plan if there is one.

SECTION F. CONFIDENTIALITY OF DATA

(See IRB ApplicationInstructions for IRB policy on Retention of identifying information and consent forms)

1. Indicate which of the following categories describes this research.
Append supporting information as needed.
Responses will be anonymous. No one, including the researchers, will be able to identify participants, whether through names or identifiers linked to names.
Responses will be confidential. Identifying information will be accessible only by the project researchers.
If responses will be confidential, describe the methods to be used to ensure confidentiality , including where identifying data will be stored:
Responses will not be confidential. Explain:
Other. Explain:
2. If data will be collected using audio or video recordings, will those recordings be destroyed or altered to remove identifying information? / {MAKE SELECTION}YesNoN/A
If yes, indicate when and how recordings will be destroyed or altered:
If no, explain why recordings will not be destroyed or altered; Describe how recordings will be stored anyother measures to protect participant confidentiality:
3. If biological samples will be collected, will the samples be destroyed? / {MAKE SELECTION}YesNoN/A
If yes, indicate when and how biological samples will be destroyed:
If no, explain why biological samples will not be destroyed; Describe how samples will be stored and any other measures to protect participant confidentiality:
4.IRB Policy on Maintenance and Disposal of Identifying Records:
Identifying records that are linked to research data (e.g. names, social security numbers, video recordings, etc.) should be maintained in a secure location, and only as long as required for completion of the research. It is expected that all identifying records will be disposed of within no more than six years after the data are collected in a manner that protects participant confidentiality.
Will the research comply with this policy? / {MAKE SELECTION}YesNo
If no, explain why an exception to this policy is required:
5.IRB Policy on Maintenance and Disposal of Informed Consent Documents:
Signed consent documents represent a record that can link participants to the research, and therefore should be treated with the same care given to other identifying information. Signed consent documents should be maintained by the researcher(s) in a secure location for six years after the participant has completed research participation. After six years, the documents should be disposed of in a manner that protects participant confidentiality.
Will the research comply with this policy? / {MAKE SELECTION}YesNo
If no, explain why an exception to this policy is required:

SECTION G. INFORMED CONSENT

(See Section 5 ofIRB Application Instructions for required elements of Informed Consent & sample consent document)

Type of Informed Consent used: / {MAKE SELECTION}Consent but not signedNo consentSigned informed consent
Are you requesting a waiver or alteration of signed informed consent? / {MAKE SELECTION}YesNo
If yes, please explain:
If the research involves minors, describe the procedure for obtaining written or verbal assent appropriate for the age of the minor participants:
Please attach a copy of your consent form to the completed protocol application.

SECTION H. RISKS

Will participants in the proposed research be placed at more than minimal risk? (For definition of risk, see “IRB Application Instructions” document online) / Minimal
More than minimal
risk
1. Describe the risks and the precautions that will be taken to minimize them, even if risk is minimal:(‘No Risk’ is not an acceptable answer)
Please respond in this space
2. Will any part of this research allow the investigator to identify participants who are likely to cause harm to themselves or others? (e.g. suicidal thoughts, child abuse) / {MAKE SELECTION}YesNo
If Yes, what procedures will be implemented:

SECTION I. BENEFITS

Describe the benefits to the participant and/or to society. The IRB must have sufficient information to make a determination that the benefits outweigh whatever risks are involved.
Please respond in this space

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IIT Form Revised February 2018

  1. CERTIFICATIONS

(See Section 7 ofIRB Application Instructions for additional information regarding ethics in research)

I am familiar with the ethical guidelines and application requirements provided by the IRB and will adhere to the policies and procedures explained.

I understand that the IIT research team on this project must complete the required training in human participants research prior to beginning work on this project.

Should any change in procedures involving human participants become advisable, I will submit it for review prior to initiating the change.

I certify I will use only the consent form approved and stamped by IIT IRB.

If any problems involving a human participant occur, I will immediately notify the Director of Research Compliance, who is also Executive Officer of the IRB.

______

Signature of Responsible Project Investigator (Qualified faculty/staff/advisor)Date

______

Signature of Investigator (if different from Responsible Project Date

Investigator, e.g. PhD student)


IRB APPLICATION CHECKLIST

Help speed the processing of your application with this handy guide:

Complete / NA
If any of my human participants research takes place at collaborating institutions, I will obtain letters of acknowledgement from those institutions and will not gather data at any such site unless I have obtained such permission. I will provide copies of these letters to the IRB office.
I have listed all IIT personnel involved in this research. All IIT personnel will complete the Human Subjects Training as required by the IRB before beginning participation. (This includes Graduate Assistants, Research Assistants, IPRO Team Members, Principal Investigators, and Research Collaborators at IIT.)
I have attached a clearly written consent form that includes all of the required elements listed in Section V of the instructions. Note: All participants should receive a consent document, whether or not the procedure includes collecting a signature.
I have described the risks to my human participants clearly, both in my protocol and in my consent document.
I have attached all questionnaires/measures. If measures are proprietary (cannot be photocopied), or would add an undue burden due to their bulk, contact the IRB to discuss alternative arrangements, and attach a note of explanation.
I have attached copies of all recruitment materials/flyers.
If minors are involved, I have attached an assent form or script, in addition to the parental consent form.
An Investigator with authority to make changes to the project will be present at the convened committee meeting if the application requires full IRB review.
If this is a renewal application, I have attached a separate sheet describing any adverse events involving human participants.

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