For IRB use only IRB File Number: Level of Review: Eastern Illinois University

Institutional Review Board (IRB)

Application for Review of Research Involving Human Subjects

All Investigators, Co-Investigators, and Sponsors must complete CITI Program training. Training can be accessed at: http://www.citiprogram.org/

Directions: All items require a response unless otherwise indicated. The completed application should be e-mailed to eiuirb@eiu.edu.

Section A: PROJECT OVERVIEW:

For guidelines regarding the requirements for this section of the application, click here.

Title of Project:
Estimated Start Date:	Estimated Completion Date:

INVESTIGATOR(S):

If there is more than one Co-Investigator, complete the Application for IRB Review Addendum: Additional Co-Investigators and include it with this submission.

Principal Investigator:	Status:	Choose an item.
Email:	Phone:
Department or Unit:
Co-Investigator:	Status:	Choose an item.
Email:	Phone:
Department or Unit:
A.1 QUALIFICATIONS OF INVESTIGATOR(S): Briefly describe the qualifications of the investigators(s) conducting this research project.
A.2 PROJECT DESCRIPTION: Describe the purpose of this research using layperson’s terms in 50 – 200 words. This description can be similar to an abstract and serves as a snapshot of your research.
A.3 Is the research being conducted to meet the requirements of a course or an academic degree?
☐ Yes (do not submit your dissertation or thesis proposal) ☐ No
A.4 PROJECT DISSEMINATION: Describe how the results of the research will be disseminated.

Section B: PARTICIPANTS:

For guidelines regarding the requirements for this section of the application, click here.

B.1 Approximate number of human participants:
B.2 Check all applicable categories of subjects and controls that will be included in this research:
☐ University/College Students	☐ Decisionally Impaired Persons
☐ Incarcerated Persons	☐ Institutionalized Decisionally Impaired Persons
☐ Students you are teaching, supervising, or observing	☐ Pregnant Persons
☐ Abortuses/Fetuses
☐ Minors	☐ Persons with medical, psychological, or mental health conditions relevant to the research
Age range of minors: Age Range
B.3 CHARACTERISTICS: Describe the characteristics/demographics of the population you will be studying. Provide inclusion and exclusion criteria. If participants include vulnerable persons, explain why their inclusion is necessary for the research.
B.4 RECRUITMENT: Describe how you will identify and recruit prospective subjects. List any materials that will be utilized in marketing/recruitment. Attach a draft or final copy of all recruitment materials to this application.
B.5 INCENTIVES AND COSTS (if applicable): Describe any incentives being offered to subjects for their participation in the research study. If monetary compensation is offered, specify the amount to be paid and terms of payment. Explain how incentives will be affected if subjects withdraw before completion of the research. Describe any costs the subjects will incur as a result of participating in the research.
B.6 Does this research involve any topic that will be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA)? Topics include, but are not limited to: Past, present, or future physical or mental health of participants, provision of health care to participants, or payment for the provision of health care to participants.
☐ No ☐ Yes (refer Appendix 4, HIPAA Information, in EIU Policy and Procedures for the Review of Research Involving Human Subjects)

Section C: STUDY LOCATION:

For guidelines regarding the requirements for this section of the application, click here.

List specific sites, agencies, or platforms to be utilized. If any facility is not owned and operated by EIU, a letter from an appropriate administrator of the facility must be submitted with this application (if facility administrator will not provide a letter until IRB approval is obtained, state that in this prompt).

Section D: PROCEDURES:

For guidelines regarding the requirements for this section of the application, click here.

D.1 STUDY PROCESS AND PROCEDURES: Describe the research process and all procedures that will be carried out with each group of subjects. Indicate whether any procedures are not routine and will be performed specifically for this research project.
D.2 INSTRUMENTS: List all instruments, assessments, or other tools that will be used to collect the research data. Attach a copy of all instruments to be administered to the subjects, if applicable.
D.3 DATA: Describe the data/research material that will be obtained from subjects and how it will be collected. Indicate whether the data will be obtained specifically for the research.
D.4 SETTING: Describe the setting and mode of administration.
D.5 TIMEFRAME: Indicate the timeframe for data collection (and intervals between collection, if applicable). Estimate the total amount of time a subject would spend participating in the research.

Section E: DATA STORAGE AND SECURITY:

For guidelines regarding the requirements for this section of the application, click here.

E.1 DATA RECORDING AND SECURITY: Describe what tools and/or software will be used to record and store the data/specimens during the research. Explain in detail how the data will be kept secure through the duration of the study and who will have access to it. If data will be transferred from initial collection source to another form of storage, indicate specific steps and methods.
E.2 CONFIDENTIALITY: State whether data will be recorded with or without names or identifiers. Explain specific steps that will be taken to ensure confidentiality, when applicable.
E.3 SIGNED FORMS AND SUBJECT IDENTIFIERS: If applicable, describe how signed consent forms and/or other subject-identifying documents will be securely stored.
E.4 AV RECORDING: If audio or video recording is being utilized, please explain why it is necessary for the study.
E.5 PARTICIPANT WITHDRAWAL: Describe how collected data from subjects who formally withdraw from the study will be handled and whether or not the data will be utilized in the study’s results.
E.6 POST-STUDY DATA STORAGE: Describe how all records relating to the project will be securely stored when the research is completed and how those records will be destroyed when the mandated storage period has passed.
E.7 Will a public use data file be created?
☐ No ☐ Yes (see instructions)

Section F: RISKS AND BENEFITS:

For guidelines regarding the requirements for this section of the application, click here.

F.1 Indicate which category of risk to participants listed below accurately describes the research:
☐ Not greater than minimal risk ☐ Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects ☐ Greater than minimal risk, no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subjects’ situation, disorder, or condition ☐ Higher in potential risk to participants, but has the potential to directly benefit participants, or to impactfully benefit society at large
F.2 IDENTIFICATION OF RISK(S): Describe specific short-term and/or long-term potential risk(s) to subjects and the likelihood and seriousness of each risk.
F.3 MARGINALIZED POPULATIONS: Describe the processes that are in place to ensure that all aspects of the study are inclusive in nature and do not potentially harm members of a marginalized community. When applicable, describe accommodation(s) that will be in place for participants with differing abilities or needs. For more information about implicit bias, and diversity, equity, and inclusion (DEI) as it applies to research, click here.
F.4 SAFETY PRECAUTIONS: Describe the processes and procedures that will be in place to protect subjects from the potential risk(s) described in the previous prompts.
F.5 BENEFITS: Describe the potential direct benefits subjects may receive as a result of participating in this research, along with potential benefits to society that may be expected from this research.
F.6 BENEFITS VS. RISKS: Discuss why the risks to subjects are reasonable in relation to any anticipated direct benefits to subjects and in relation to the importance of knowledge that may reasonably be expected to result.

Section G: INFORMED CONSENT, ASSENT AND WAIVERS:

Attach full text of informed consent document (and assent document, when applicable) to this application.

For guidelines regarding the requirements for this section of the application, click here.

Information and guidance regarding the consent, assent, and waiver processes is provided at the IRB Forms website.

There are two areas in this section:

The first area is to be completed if there are potential participants in the research who are adults.

The second area is to be completed if there are potential participants in the research who are minors, or who are decisionally impaired.

There are fields in this section to describe your process for obtaining informed consent from the parents or guardians of these potential participants – do not complete the section for adult participants unless there are adults potentially participating as subjects in the research.

1. Adult Participants:

If your research involves adult participants, select the option below that best describes your study’s informed consent process. Provide responses to the prompts for the option selected.
☐	Option 1: Full Process: Informed consent will be sought and obtained. Participants will sign the informed consent document to indicate their consent, and documents will be collected by the researcher.
Describe the circumstances under which informed consent will be sought, obtained, documented, and securely stored:
☐	Option 2: Waiver of Documentation of Informed Consent: Informed consent information will be provided to potential participants. However, consent forms not be signed and collected.
Describe the circumstances under which informed consent information will be provided to participants:
The requirement for the investigator to obtain a signed consent form for some or all potential subjects can be waived by the IRB only in certain circumstances. Check the box that most accurately describes your research and respond to the prompt directly below:
☐ The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern. ☐ The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. ☐ The subjects are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects. There will be a mechanism for documenting that informed consent was obtained.
Provide a detailed explanation to justify the criterion selected in the above prompt:
☐	Option 3: Waiver of Informed Consent/Elements of Informed Consent: Some or all required informed consent information will not be provided to potential participants.
The IRB may waive the requirement to obtain informed consent only in limited circumstances. The IRB may also approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent. Provide detailed responses to each of the items below:
Explain in detail how the research involves no more than minimal risk to the subjects.
Describe how the waiver or alteration will not adversely affect the rights and welfare of the subjects.
Explain why the research could not practicably be carried out without the waiver or alteration.
Describe the process in which the subjects will be provided with additional pertinent information after participation, and what that information would entail. If providing additional information would not be appropriate, explain.
If the research involves using identifiable private information or identifiable biospecimens: Explain why the research could not be practicably carried out without using such information or biospecimens in an identifiable format.
If not all of the elements of informed consent are being waived, list the elements of informed consent for which the waiver is being requested and a justification for each.

2. Minors/Decisionally Impaired Participants:

If your research involves participants who are minors or who are decisionally impaired, select the option below that best describes your informed consent and assent processes. Provide responses to the prompts for the options selected.
Parental Informed Consent:
☐	Option 1: Parent/Guardian Informed Consent Full Process: Informed consent will be sought and obtained from potential participants’ parent or guardian. Parents/guardians will sign the informed consent document to indicate their consent, and documents will be collected by the researcher.
Describe the circumstances under which parent/guardian informed consent will be sought, obtained, documented, and securely stored:
☐	Option 2: Parent/Guardian Informed Consent Full Process: Informed consent information will be provided to potential participants’ parent or guardian. However, consent forms not be signed and collected.
Describe the circumstances under which informed consent information will be provided to participants:
The requirement for the investigator to obtain a signed consent form for some or all potential subjects’ parent or guardian can be waived by the IRB only in certain circumstances. Check the box that most accurately describes your research:
☐ The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern. ☐ The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. ☐ The subjects are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects. There will be a mechanism for documenting that informed consent was obtained.
Provide a detailed explanation to justify the criterion selected in the above prompt:
☐	Option 3: Waiver of Parent/Guardian Informed Consent/Elements of Informed Consent: Some or all required informed consent information will not be provided to potential participants’ parent or guardian.
The IRB may waive the requirement to obtain informed consent only in limited circumstances. The IRB may also approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent. Provide detailed responses to each of the items below:
Explain in detail how the research involves no more than minimal risk to the subjects.
Describe how the waiver or alteration will not adversely affect the rights and welfare of the subjects.
Explain why the research could not practicably be carried out without the waiver or alteration.
Describe the process in which the subjects will be provided with additional pertinent information after participation, and what that information would entail. If providing additional information would not be appropriate, explain.
If the research involves using identifiable private information or identifiable biospecimens: Explain why the research could not be practicably carried out without using such information or biospecimens in an identifiable format.
If not all of the elements of informed consent are being waived, list the elements of informed consent for which the waiver is being requested and a justification for each.
Participant Assent:
☐	Option 1: Full Assent Process: Assent will be sought obtained from potential participants in a manner that is appropriate to their level of comprehension. Participants’ assent will be recorded via a signed assent document.
Describe the circumstances under which assent will be sought, obtained, documented, and securely stored:
☐	Option 2: Waiver of Documentation of Assent: Assent information will be provided to potential participants in a manner that is appropriate to their level of comprehension. However, assent forms will not be signed and collected.
Describe the circumstances under which assent information will be provided to potential participants.
The requirement for the investigator to obtain a signed assent form for some or all potential subjects can be waived by the IRB only in certain circumstances. Check the box that most accurately describes your research:
☐ The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern. ☐ The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context. ☐ The subjects are members of a distinct cultural group or community in which signing forms is not the norm and the research presents no more than minimal risk of harm to subjects. There will be a mechanism for documenting that informed consent was obtained.
Provide a detailed explanation to justify the criterion selected in the above prompt:
☐	Option 3: Waiver of Assent/Elements of Assent: Some or all required assent information will not be provided to potential participants. Note: If some elements of assent are not being provided simply because it is not appropriate for the subjects’ level of comprehension, then you do not need to request this waiver.
The IRB may waive the requirement to obtain assent, only in limited circumstances. The IRB may also approve an assent procedure which does not include, or which alters, some or all of the elements of assent. Provide detailed responses to each of the items below.
Explain how the research involves no more than minimal risk to the subjects.
Describe how the waiver or alteration will not adversely affect the rights and welfare of the subjects.
Explain why the research could not practicably be carried out without the waiver or alteration.
Describe the process in which the subjects will be provided with additional pertinent information after participation, and what that information would entail. If providing additional information would not be appropriate, explain.
If the research involves using identifiable private information or identifiable biospecimens: Explain why the research could not be practicably carried out without using such information or biospecimens in an identifiable format
If not all of the elements of assent are being waived, list the elements of assent for which the waiver is being requested and a justification for each.

Section H: SPONSORED RESEARCH:

For guidelines regarding the requirements for this section of the application, click here.

If this research is being funded by an external source, complete the table below.
Principal Investigator of Contract or Grant:
Funding Source:
Contract or Grant Title:
Contract or Grant Number:
I.1 Describe any requirements imposed by funding agencies that are not already covered in this application.
I.2 NIH SPONSORED RESEARCH: National Institutes of Health (NIH) policy requires that grantees have in place procedures for data safety monitoring of clinical trials. Please provide a description of the data safety monitoring plan, if applicable.
I.3 FEDERAL WIDE ASSURANCE (FWA): If this research receives federal funds, provide the FWA number for any organization that serves as a collaborative partner for this project, and/or for any facility not owned and operated by EIU in which the research will be conducted.

PROTOCOL SUBMISSION:

For guidelines regarding the requirements for this section of the application, click here.

Investigator Assurance:

All boxes must be checked, and the form must be signed, either by pen or electronically

☐ I certify that the information provided for this project is accurate and compiled by me.

☐ I agree to conduct this research as described in this form and in the attached supporting documents, and that no other procedures will be used in this research.

☐ I will request approval from the IRB for changes to the study’s protocol and/or consent forms and will not implement the changes until I receive IRB approval for these changes.

☐ I will comply with the IRB policy for the conduct of ethical research. I will promptly report significant or adverse effects to the IRB Chairperson or Vice Chairperson and will submit a Report of Adverse Effect or Noncompliance in writing to the Office of Research and Sponsored Programs.

☐ I certify that I have completed CITI training within 3 years prior to this project’s estimated start date.

If there are co-investigators other than faculty/EAP sponsors involved in this project:

☐ I assure that the co-investigator(s) is knowledgeable about the regulations and policies governing research with human subjects, and will monitor study progress and compliance with IRB policy for the conduct of ethical research.

__________________________________________	_______________________

Principal Investigator’s Signature	Date

Faculty or EAP Staff Sponsor Assurance (required when PI is a student):

All boxes must be checked, and the form must be signed, either by pen or electronically

☐ This is to certify that I have reviewed this research protocol and that I attest to the scientific merit of this study and the competency of the investigator(s) to conduct the project.

☐ I assure that the investigator(s) is knowledgeable about the regulations and policies governing research with human subjects.

☐ I agree to meet with the investigator on a regular basis to monitor study progress and compliance with IRB policy for the conduct of ethical research.

☐ I will report any significant or adverse effects or noncompliance to the IRB Chairperson or Vice Chairperson immediately upon becoming aware of the them.

☐ I certify that I have completed CITI training within 3 years prior to this project’s estimated start date.

☐ I understand my responsibilities and what is required of me when sponsoring student research

__________________________________________	_______________________

Faculty or EAP Staff Sponsor’s Signature	Date

Signed protocols can be e-mailed as attachments to the Office of Research and Sponsored Programs at eiuirb@eiu.edu.

While e-mail submission is preferred, paper copies will also be accepted. Deliver unstapled paper copies to the Office of Research & Sponsored Programs, 1102 Blair Hall.

Do not submit forms via links to personal or shared drives
(such as OneDrive or Google docs).