This guide will provide expanded instructions and relevant examples for each prompt in the Application for IRB Review. Click on any of the following links to jump to guidance each section of the application:
Waiver of Documentation of Informed Consent or Assent
Protocol Submission Instructions
The Institutional Review Board IRB) will require basic information about project personnel as well as the project itself.
Indicate when it is intended for research to begin (upon IRB approval). Research cannot begin until after the IRB has approved a protocol.
For example:A student begins planning a project in October by developing a topic, planning the research process with their faculty sponsor, and completing a literature review. The student submits a protocol in December, estimating that direct recruitment and the surveying of participants will begin in mid January. The estimated start date in this circumstance is January 15.
The Principal Investigator (PI) has primary responsibility for all aspects of the protection of human subjects on a given project, ensuring that the study is conducted in accordance with the ethical standards described in the Belmont Report, federal regulations, EIU policy, and the protocol as approved by the IRB.
For example:“The Principal Investigator is a candidate for a Master of Science in Communication Disorders and Science degree at EIU. She has completed CITI Training and has 200 hours of supervised clinical experience with the targeted population. Dr. Jones has been conducting and guiding student research in this discipline for over 30 years.”
Describe the purpose of this research in layperson’s terms in 50 – 200 words. The description should be concise and written so that a person who is not trained in the research subject discipline would be able to understand it. Your response to this prompt should serve as a snapshot of your project and the research purpose, questions, and hypotheses should be apparent. Do not include rationale for conducting the research, citations, or literature reviews.
For example:“This project will seek to discover whether gross motor movement during classroom time improves student focus. For a 6-week period, approximately 25 second grade students will engage in teacher-guided gross motor activity prior to the daily spelling lesson. Student spelling scores during this time will be compared to spelling scores prior to the study, as well as scores gathered for a 4-week period after the classroom gross motor activity ceases. The researcher hypothesizes that spelling scores will be improved during the 6-week period of gross motor activity.”
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As part of the review process, the IRB will require information about the potential participants in the study, their characteristics, and what methods will be utilized to recruit them.
Check all applicable categories of subjects and controls that will be included in the research. If your research participants are not members of any of the following populations, leave this prompt blank:
Describe the characteristics/demographics of the population you will be studying. Characteristics can include, but are not limited to: age range, gender, ethnicity, health status, socioeconomic status. Provide inclusion and exclusion criteria. If participants include vulnerable persons, explain why their inclusion is necessary for the research.
For example:“Potential participants will be college students between the ages of 18 and 23 who are enrolled full-time at a mid-sized public university located in the Midwestern United States. Potential participants will comprise of all races, genders, religious beliefs, socioeconomic status and ethnicities. Participants must be U.S. citizens.”
For example:"Potential participants will be residents of three privately-owned memory care facilities in the Midwestern United States. Potential participants can comprise of all races, genders, religious beliefs and ethnicities, but must range in age from 70 to 85, and must not present with any known comorbidities. This study seeks to research the dietary habits and nutritional intake of persons with Alzheimer's disease and dementia, and cannot be take place without participation from this population."
Examples:“Participants will be recruited via a post for a Facebook group for spouses of lupus patients. The post will provide information about the study, and a link to the on-line survey. If the required number of participants has not been met after two weeks a reminder will be posted. A copy of the wording of the initial recruitment and reminder posts are attached to this application.”
“Potential Participants are students in my classroom at Hawthorne School. A letter explaining the study will be sent to parents/guardians via their children. This letter will also serve as informed consent. There will be no direct recruitment, rather, parents will be given the option to opt their child out of the study. The letter is included with this application.”
When recruitment materials are condensed (such as fliers or social media posts), briefer versions of the information can be supplied, and a direct link to (or instructions for accessing) more detailed information can be supplied.
Refer to Appendix 4, HIPAA Information, in EIU Policy and Procedures for the Review of Research Involving Human Subjects.
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When reviewing your protocol, the IRB will evaluate the research process, conditions, and procedures that participants will experience. Your response in this prompt should be written in a way that makes it clear to the reviewer what will occur, and what study participants will encounter and/or what tasks they will perform when participating. If you have more than one set of participants or more than one procedure, then procedures for each group or process must be detailed.
The following information must be addressed in your response to this prompt:
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.
Routine Procedures: Indicate whether any procedures are not routine and will be performed specifically for this research project.
Timeframe: Indicate the timeframe for data collection. If there are intervals between data collections, define the time between collection periods. Estimate the total amount of time a subject would spend participating in the research.
Location and Setting: Explain where participants and the researcher will be physically located during the study. Provide the name of the site or agency along with pertinent identifying information. Describe the setting and mode of administration, including whether processes will be administered individually or in group settings. Include any other relevant conditions (such as time of day, privacy, climate conditions, etc.). If research will be conducted online, indicate the platform to be utilized, the agency(s) where participants will be recruited from (if applicable), and the physical location of the participant and investigator, when possible.
If a facility being utilized as a location is not owned and operated by EIU (including direct recruitment from an agency where data is collected electronically), 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 this in the prompt. See below for more information regarding research at locations not owned and operated by EIU.
Examples for this prompt:"Participants will be asked to complete an online survey regarding their views of tobacco use (see Appendix B). Quantitative data will be analyzed to determine attitudes and trends toward tobacco use by age group. Data will be collected using Qualtrics online survey software.Likert scales will be utilized and all data will be numeric. Surveys will be taken online at a location of the participant’s choosing. Surveys can be accessed via PC, smartphone, or tablet. Surveys will take up to 20 minutes per individual to complete. The survey will be online for data collection for 6 weeks."
"Data collection will take place in my classroom at Alan Shepard High School in Tinley Park, Illinois. For a period of six weeks student participants will submit journal entries online after completing each history assignment. Participants will be provided a prompt for each journal entry (see Appendix A). Each student will utilize their district-provided laptops and will submit the journal entry through Canvas. Journal entries will take roughly 5 to 10 minutes to complete, and there will be time in class at the end of the history period for students to complete their entries. While the history work is part of the standard curriculum, journal entries will be completed solely for this study. Journal entries will be analyzed by the PI and faculty sponsor to look for trends in participant responses."
"Interviews will be conducted over Zoom, with the PI being in her private office, and the participant being at a place of their choosing. The participant will be advised to select a location that affords privacy. Interviews will be audio recorded and are expected to last up to 30 minutes. Participants may also receive a phone call if the PI needs to clarify any responses when transcribing. Qualitative data will then be evaluated and categorized by the PI."
"Collection will take place at Lab B of Memorial Hospital, Springfield, Illinois. Saliva samples will be collected from participants in order to test for presence of COVID-19 to determine the number of asymptomatic cases. Clinicians will use SalivaBio Oral Swab (SOS) collection devices to collect about 0.5cc of saliva from participants. Saliva samples will be analyzed to detect viral presence using enzyme-linked immunosorbent assay ELISA). Participants will be swabbed on an appointment basis at a time of their choosing. Samples will take about 30 seconds to collect. Participants can expect to spend 15 minutes at the BIO Lab to provide informed consent and the sample. Participants will provide two samples, three months apart, for a total of 30 minutes of participation."
Exempt research: a letter from the administrator is not required unless potential participants are children.
If a study will receive federal funding, an administrator letter is not required because Federal Wide Assurance must be provided (see below*).
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The collection, handling, and secure storage of data is critical to the safety and welfare of human participants in research. The IRB will require precise information in the following prompts regarding the collection, handling, and storage of data.
Electronic data shall be password-protected at the workstation or file level. If this level of protection is not feasible, electronic data should be stored on removable media in a secure (locked) area. Confidential hard copy information gathered from or about any research subject must be stored in a secure (locked) facility to which only the PI and authorized project staff have access.
The following information must be addressed in your response to this prompt:
Tools and Software: Describe what specifically will be used to record and store data/specimens through the duration of the research. You must account for all data and any identifiers collected.
Data Security: Describe in detail how data will be kept secure through the duration of the study and who will have access to it.
Data Transfer: If data will be transferred from initial collection source to another form of storage, indicate specific steps and methods.
For example:"Participant responses will be stored within the Survey Monkey software throughout the duration of the collection period. Survey Monkey has a secure data storage method within the program. A password is required to access it. Only the PI and Faculty Sponsor have the password. When the collection period has ended, data will be downloaded to the PI's password-protected PC and imported into Excel. The PI will be the only person to have access to the raw data."
"Once the saliva sample is collected, the swab will immediately be placed in a polypropylene tube and sealed. Tubes will be placed in a tray, and the tray will be placed in a locked cold-storage compartment until analysis occurs. Only the PI and co-investigators have keys to the cold storage compartment. Results, along with participant age, gender, and geographic region will be recorded in MS Access. The Access database will be stored on a password-protected PC in the Biosciences lab. Only the PI and Director will have access to the data."
"Student worksheets will be stored in a locked file cabinet in the teacher researcher’s classroom. The teacher, school principal, and thesis adviser will have access to the worksheets. Analysis of progress will be recorded in a spreadsheet on the teacher’s password protected laptop PC. Only the teacher researcher and thesis adviser will have access to the spreadsheets."
State whether data will be recorded with or without names or other identifying information. Explain specific steps that will be taken to ensure confidentiality, when applicable. If applicable, indicate how any identifiers (such as indexes containing code or alias assignments) will be stored. Indicate who will have access to any items that identify subjects. Be sure to include the processes by which this information will be kept separate from the research data.
For example:"All responses will be anonymous. None of the questions in the survey could lead to the collection of data that could identify the respondent. All responses are recorded as a number and no names or e-mail addresses will be collected. Participants who wish to enter the drawing for an Amazon gift card will be directed to a separate survey to provide their e-mail address. This info will not be connected to the survey data in any way and will also be password-protected. E-mail addresses will be downloaded to the PI's password-protected pc to conduct the drawing, then the database containing e-mail addresses will be immediately deleted."
"Samples will be labeled with a random number that is assigned to each participant. There will be no identifying information in the data. A spreadsheet tracking participant number assignments will be stored electronically on a PC in the director’s office, and is not the same PC that is housing the research data."
"Students will be asked not to put their name on their worksheets. However, if a student does sign their name on the worksheet, that portion of the worksheet will be cut off and shredded."
For example:"Interviews will be recorded using the recording tool in Zoom. This is necessary for accurate transcription of participants' responses and to ensure the proper context of participant responses are understood by reviewing their accompanying non-verbal queues and vocal inflections."
For example:"Data will not be collected if a participant closes the survey prior to completion."
"If a participant wishes to withdraw, the spreadsheet containing code assignments will be accessed in order to identify the specimen. The specimen will be removed from storage, the label will be removed, and the vial will be placed in the biohazard waste container. The participant’s code assignment will then be removed from the spreadsheet."
"There will be no way to identify student worksheets once they have been submitted. However, students who withdraw will not submit worksheets as the study continues."
Records (e.g., signed informed consent forms, data) relating to the research project must be retained for at least three years after completion of the research. All records must be accessible for inspection and copying by authorized representatives of the department or agency supporting or conducting the research at reasonable times and in a reasonable manner [45 CFR 46.115(b)].
For example:"The excel spreadsheet containing the data will be stored on a secure password-protected Microsoft One drive. After three years the spreadsheet will be deleted."
"Student worksheets will be stored in a locked file cabinet in the teacher’s classroom. The data spreadsheet will be moved to the PI’s password protected drive on the district’s network. After 3 years the worksheets will be shredded and the spreadsheet will be deleted."
"Saliva samples will be placed in a locked cold-storage box in the Biosciences lab. Analytical data will be stored on a password-protected PC in the Biosciences lab. Signed consent forms will be stored in a locked file cabinet in the director’s office. The spreadsheet containing identifiers will stored on a password-protected PC in the director’s office. After three years the saliva samples will be discarded in the biohazard waste receptacle in the Biosciences lab. Signed consent forms will be shredded. The spreadsheet containing identifiers will be deleted from the director’s PC. The Access database will remain active for a period of ten years as the study has the potential to expand."
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As part of the review process, the IRB will evaluate the level of risk to human participants in a study and will determine whether the risks outweigh the benefits of the study. Risk and benefit information will need to be provided in clear detail in the Application for Review of Research Involving Human Subjects.
Indicate the category of risk to participants that most accurately describes the research by checking the appropriate box on the form:
An example of research that is of minimal risk:University Students are invited to take an online survey regarding their experiences navigating campus during the first week of class.
For example:Persons over 50 years of age are invited to participate in a light exercise program that emphasizes physical fitness. Participant weight,BMI, and heart rate are tracked throughout the study to measure success. There is an elevated risk as participants engage in exercise, but the program should provide an overall benefit to each participant as their fitness improves.
For example:Persons who have experienced a trauma in the past are asked to discuss their traumatic event and their subsequent coping mechanisms in order to determine the most commonly utilized coping mechanisms, whether or not they were considered to be successful, and what barriers existed when accessing post-trauma care. There is an elevated risk as participants discuss traumatic events in their lives, and participants will derive no benefit from discussing those events. However, society will benefit by the discovery of trauma coping mechanisms and the information can help toward reduction of barriers. Participants may also benefit from what is learned in the study.
For example:A common medication that has been utilized by adults for cholesterol management is found to help adults with hypersensitivities to sound. A drug trial will be conducted to determine if the medication can be effective in treating children with these same hypersensitivities. Several of the minor participants are on the autism spectrum.
Every study comes with some risk. It is important for investigators to convey that they have carefully considered any potential risk their subjects may encounter, no matter how small that risk may appear to be. Describe specific short-term and/or long-term potential risk(s) to subjects, including confidentiality. Risks can be - but are not limited to - physical, psychological, social, or legal. Assess and describe the likelihood and seriousness of each risk identified.
Example:"Participants may feel uncomfortable or frustrated when trying the various pencil grips.”
"Some survey items ask participants to recall experiences that may have been unpleasant or in rare cases, traumatizing."
In this prompt, you will need to describe what processes are in place to ensure all aspects of the study do not potentially harm members of a marginalized community.
Protecting marginalized people from harm in research does not mean that all people must be included in a study, or that a study’s focus must be about all people. What it means is that, when a human being meets the criteria for participation in a study, they are not to be harmed by the study's language or processes.
For example:All students who live on campus at a Midwestern college are invited to participate in an online survey. The invitation states that the study is about students' eating habits throughout finals week. Once students consent to participate and click on the link to the survey, they find that the survey focuses primarily on the consumption of bacon in student dining areas during this time period.
The study is potentially harmful to participants who are unable to consume bacon/pork for religious reasons (or due to a health condition). The feelings of exclusion students may already be experiencing are compounded when they are invited to participate in a study only to find that their religion has been disregarded. The invitation implies that all students are able to eat bacon and fails to recognize their religious practice.
If the researchers truly wish to specifically examine the consumption of pork in student dining areas, then the purpose of the study needs to be made clear when inviting students to participate, and/or the participation criteria needs to be narrowed. The following examples of invitation language would be clearer and therefore, more inclusive:
“The purpose of this study is to determine the frequency of the consumption of bacon during stressful times in the student experience.”
“Students who live on campus and who consume pork and bacon products are invited to participate in the research.”
If, in this scenario, researchers seek to understand students' reasons for eating/not eating bacon during finals week - including for religious reasons - then the invitation can remain broad, but considerations would need to be made in the survey itself.
For example:All students are invited to participate in the online survey. A question in the survey asks if participants eat bacon in the dining halls.Respondents who answer "no" would be directed to a question that seeks to know why they do not eat dining hall bacon.
“Because there are religious practices that forbid the consumption of pork products, the invitation is worded so that potential participants understand the nature of the study.”
"Participants will be asked if they consume bacon in the dining halls; those who do not will be invited to provide reasons why they do not eat bacon in the dining halls."
“Gender inclusive language is included in all communication with potential participants. Because this study seeks to understand exercise habits during menstruation cycles, the recruitment flier requests participants who have experienced menstruation.”
“As this study will seek to understand the experiences of students who live with autism on a college campus, all survey items were reviewed by a licensed counselor on campus who specializes in autism spectrum counseling. In addition, participants will be provided with the contact information for this counselor.”
“Translation services will be available for all participants.”
Differing abilities refers to the diverse range of abilities human participants may have.
Differing needs refers to barriers that may affect a person’s ability to participate in a study. Barriers can be (but are not limited to) socioeconomic, educational, or linguistic factors.
Prompt examples describing accommodation for differing ability:“The researcher will be aware of and will provide accommodations as specified in student participants’ individualized education plan IEP) during the assessment period.”
“The laboratory where collection will occur is fully accessible: the lab entrance is labeled in large print and braille and there are no stairs at the entrance. An outdoor collection tent will be available for participants who do not feel comfortable in the laboratory.”
Prompt examples describing accommodation for differing need:“Translations of the survey and informed consent will be available to participants who need it.”
“Potential interviewees who do not have internet access will be provided with a private space at the University library in order to participate in a discussion over Zoom.”
For Example:"Students will be reminded that they do not have to try the new pencil grips if they don't want to, and can stop using them at any time and no one will be upset with them."
"Informed consent will clearly state that there are items in the survey that ask participants to recall experiences where they may have witnessed a crime. Information for Counseling Services is provided in the informed consent letter and in a debrief form that will be provided at the end of the survey. Participants are advised that they can skip questions and/or discontinue their participation at any time with no penalty to them."
Describe the potential direct benefits subjects may receive as a result of participating in this research (this does not include incentives for participation). Describe the potential benefits to society that may be expected from this research.
For Example:"Some participants may benefit from learning about new pencil grips and which ones might be right for them. Results from this project will inform other educators about the efficacy of the new pencil grips."
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 as a result of the study. TheIRBB will evaluate the level of risk to human participants in a study, and whether the risks outweigh the benefits of the study as part of the review process.
For Example:"While beginning a light exercise program does come with some risk, participants will most likely see an improvement in their strength, balance, and coordination. If this is the case, further study could reveal that this specific exercise program could be of benefit to seniors."
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Complete this section of the application if your research involves participants who are adults.
“Informed consent is one of the primary ethical requirements underpinning research with human subjects; it reflects the basic principle of respect for persons. Informed consent assures that prospective human subjects will understand the nature of the research and can knowledgeably and voluntarily decide whether to participate” IRB Guidebook).
Informed consent is the two-part process of
2. Obtaining their agreement to participate.
For further guidance and informed consent phrasing assistance, see the Informed Consent Template and Informed Consent Checklist at the EIU IRB Forms website.
The IRB will need to review your plan for providing informed consent information (along with the informed consent information that will be provided to potential participants), and your plan for obtaining subjects' consent to participate.
Describe how informed consent information will be provided to potential participants. If your study has more than one data collection period (e.g., surveys and in-person interviews), provide a description for each process.
For Example:
"Potential participants will be presented with a letter of informed consent upon arrival. The researchers will discuss the letter with the each potential participant and will answer any questions they may have."
"Potential participants for the online survey portion of the study will be presented with informed consent information in the e-mail that invites them to participate. Participants who will participate in interviews will be given a letter of informed consent when they arrive. The researcher will go over any questions they may have."
For Example:
"Participants will sign and date the form. The researcher will provide the participant with a copy of the signed form and will retain the original for their records."
"After reading the informed consent information in the invitation e-mail, the participant will click the link to the survey, which indicates consent to participate."
Note: If you will not be collecting signed consent forms, you must provide a response in Prompt F.4.
For example:"Signed forms will be locked in a file cabinet in a locked office that only the principal investigator has access to. This file cabinet is in a different location from the data storage unit."
In certain circumstances, the IRB can approve a waiver of documentation of informed consent, meaning, informed consent information is provided to potential participants, but signatures of consent are not collected.
Online surveys in which participants check a box to indicate their consent before beginning the survey require a waiver of documentation of informed consent because their consent is not being documented.
This prompt provides the circumstances allowed to obtain this waiver. Check the box next to the circumstance that most accurately describes your research. Complete this prompt only if you are providing informed consent information to your potential participants, but are not collecting signatures.
For example:"The waiver is being requested for the online survey portion of the study only; signatures will be collected from participants prior to the in-person interview portion.""The waiver is being requested for all phases of the study."
Include full text of the informed consent document with your application.
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Complete this section if your research involves participants who are minors or who are adults with decisional impairment.
2. Obtain parent/guardian agreement to allow their child or ward to participate in the research. If a parent/guardian does not give consent, you cannot seek a subject's assent under any circumstances.
2. Obtain their permission (assent) to participate as subjects in the research.
Note: A parent or guardian may provide consent for their child or ward to participant, however, the child or ward still has the right to decline to participate.
For assent guidance and phrasing assistance, see “Assent Guidelines” and the Informed Consent Templates and Checklist at the EIU IRB Forms website.
The IRB will need to review your plan for providing obtaining informed consent from parents/guardians, and assent from potential participants. Informed consent and assent information that will be provided to parents, guardians, and potential participants must also be reviewed. If assent is to be delivered verbally, the IRB will need to review the script of what will be stated.
This section of the Application contains two areas: one for parent/guardian informed consent, and one for participant assent.
Parent/Guardian Informed Consent:
For Example:
"Parents or guardians of potential participants will be presented with a letter of informed consent upon arrival. The researchers will discuss the letter with the each potential participant and will answer any questions they may have."
"A letter of informed consent will be sent home to parents one week prior to the beginning of the collection of data in the classroom. For the interview portion of the study, parents of potential participants will be presented with informed consent information upon arrival."
If you are seeking approval to not provide some or all informed consent information to parents or guardians of potential participants, complete the Application for IRB Review Addendum Waiver of Informed Consent or Assent and include it with your submission.
For Example:"Parents or guardians of potential participants will sign and date the form. The researcher will provide the parent/guardian with a copy of the signed form and will retain the original for their records.""Parents will be asked to contact the teacher researcher if they wish to opt their child out of the study. Otherwise, consent is implied."
Describe, in detail, how signed consent forms will be securely stored. Signed forms must be kept separate from any collected data, and your response to this prompt must specify how this will be accomplished.
Note: If you will not be collecting signed consent forms, you must provide a response in Prompt G.4.
For example:"Signed forms will be locked in a file cabinet in a locked office that only the principal investigator has access to."
In certain circumstances, the IRB can approve a waiver of documentation of parent/guardian informed consent, meaning, informed consent information is provided to parents/guardians of potential participants, but signatures of consent are not collected. This prompt provides the criteria for this waiver. Check the box next to the circumstance that most accurately describes your research. Complete this prompt only if you are providing informed consent information to the parents/guardians of potential participants, but are not collecting signatures.
Note: It should be apparent throughout your application - particularity in Section E (Risk) why the selected criterion would be met.
If your research involves more than one period of data collection (e.g., surveys and in-person interviews), indicate which process you are requesting the waiver for.
For example:"The waiver is being requested for the classroom data collection portion of the study only; signatures will be collected from parents of potential participants prior to the in-person interview portion."
Minor or Adult with Decisional Impairment Assent to Participate:
For Example:
"Potential participants will be presented with a letter containing assent information when they arrive. The researchers will discuss the letter with the each potential participant and will answer any questions they may have."
"The researcher will read an assent script to all potential participants the morning that data collection will begin. Students who do not wish to participate will be instructed to inform the researcher when the class is preparing for the lunch break."
Note: it is sometimes necessary to simplify assent information so that it is developmentally appropriate for the targeted population. These adjustments do not require a waiver of assent as long as the information is being provided in a developmentally-appropriate way.
For Example:
"Participants will sign and date the form. The researcher will provide the participant with a copy of the signed form and will retain the original for their records.""The potential participant will be asked verbally if they would like to stack blocks with the researcher. If they agree to, the researcher will ask if it's ok to film them playing so that she and her teacher can look at it later to learn things about the way kids play with blocks. If the child agrees, recording will begin. The researcher will ask the subject, 'say yes if you agreed to play blocks with me and for us to record it so that me and my teacher can watch later.' Once the child affirms, the session will begin. If the child disagrees, recording will stop and the session will end."
Describe, in detail, how signed assent forms or recordings of assent (when developmentally appropriate) will be securely stored. If you will not be collecting signed forms or recordings, you must provide a response in Prompt G.9.
Note: Signed forms and recordings must be kept separate from any collected data, and your response to this prompt must specify how this will be accomplished.
For example:"Signed forms will be locked in a file cabinet in a locked office that only the principal investigator has access to."
"Recordings of assent are included as part of the session; however, the participant's name will not be used in the recorded assent process or the session. Transcription and any identifying information will be stored on a separate password protected pc."
This prompt provides the criteria for this waiver. Check the box next to the circumstance that most accurately describes your research. Complete this prompt only if you are providing assent information to potential participants, but are not recording assent.
Note: It should be apparent throughout your application - particularity in Section E (Risk) why the selected criterion would be met.
If your research involves more than one period of data collection involving participants who are minors or adults who are decisionally-impaired (e.g., collection of data in a classroom and then in-person interviews), indicate which process you are requesting the waiver for.
For example:"The waiver is being requested for the classroom data collection portion of the study only; signatures will be collected potential participants prior to the in-person interview portion."
Include full text of the informed consent and assent documents (or assent script if delivered verbally) with the application.
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The Primary Investigator must read all assurance items and check each corresponding box prior to signing the application:
Certify that the information provided on the application for your project is accurate and compiled by you.
Agree to conduct the research as described in the application and the attached supporting documents, and that no other procedures will be used in this research.
Verify that you will request approval from the IRB for changes to the study’s protocol and/or consent forms and will not implement the changes until IRB approval for any changes is received.
Adverse events can include, but are not limited to: physical or psychological harm, or a change in risk to, or breach in confidentiality. Adverse effects may be directly or indirectly related to the research and may be expected or unexpected. The IRB should always be informed of any problems or accidents in a study. You are encouraged to contact the IRB chairperson or IRB vice chairperson if anything occurs that causes concern regarding the protection of human subjects. See Section H of the IRB Policy Document for more information regarding risk, adverse effects, and noncompliance.
If CITI training was completed for another institution, you must add EIU as an affiliation at the CITI website and verify that the training fulfills EIU’s CITI training requirement by viewing the courses in your institutional course listing for EIU.
The form can then be signed either by pen or electronically.
Faculty or EAP Sponsor assurance is required when Primary Investigator is a student. The Sponsor must read all assurance items and check each corresponding box prior to signing the application:
The sponsor must certify that they have reviewed the research protocol and can attest to the scientific merit of the study and the competency of the investigator(s) to conduct the project.
The sponsor must assure that the investigator(s) is knowledgeable about the regulations and policies governing research with human subjects.
The sponsor must 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.
The sponsor must certify that they have completed CITI training within 3 years prior to the project’s estimated start date.
The sponsor must assure that they understand the responsibilities and what is required of them when sponsoring student research.
Signed protocols can be e-mailed as attachments to the Office of Research and Sponsored Programs at eiuirb@eiu.edu. When the Principal Investigator is a student researcher, the faculty or EAP sponsor must be copied (cc) in the submission e-mail.
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 Outlook or Google docs).
Protocols will be screened by the Office of Research and Sponsored Programs to verify all required information is included before a protocol is reviewed by the IRB. Screening will be conducted within ten business days of protocol submission. Protocols are screened in the order they are received, regardless of estimated project start date. The Principal Investigator (and Faculty Sponsor, when applicable) will receive notification via e-mail regarding their project’s status within this ten-day timeframe.
Additional information and/or a modification to the protocol may be requested. These requests will be sent via e-mail. Investigators will have the opportunity to respond to concerns, ask questions, update and resubmit their application, which will be reviewed within 10 business days of receipt of the resubmission.
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Many private organizations and public agencies make individual level data available to the public. If data files have been reviewed by the appropriate IRB and have been classified as public use data files, then it is not necessary to obtain EIU IRB review and approval to use public use data files in your research.
Many funding agencies require or recommend that projects produce public use data files for future use. If a public use data file will be created, you must indicate this in the Application for Review of Research Involving Human Subjects.
The funding agency may provide guidance in creation of public use files. Provide this information to the IRB when submitting the protocol to prepare a public use data file.
If you did not initially plan to develop a public use data file, but it is determined later that you wish to develop one, you must submit a modification request to the IRB.
Once the project is completed, submit the proposed public use data file to the IRB for inspection.
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Complete application addendum only if:
For example:
“There is very little risk to participants, and they are being told that they can choose not to participate and can withdraw at any time. The research will involve participants producing drawings with a variety of non-toxic instruments of their choosing. Participants will be asked to draw a flower. The researcher will watch for signs of frustration or distress among participants.”
For example:
“Participants are being told that they can choose not to participate and can withdraw at any time."
For example:
“If participants are made aware that their participation in the flower drawing exercise is part of research, it may alter their artistic expression and provide erroneous data."
For example:
“All participants will be provided with a debrief that explains the nature of the study once the session is complete or if they withdraw."
For example:
“Because the research involves participants' feeling about their names, names must be collected.""Blood work could indicate evidence of infectious disease; if this occurs, the participant must be contacted."
For example:
“Informed consent will not be provided during the initial survey phase, but will be provided (and forms will be signed) during the interview phase."
For example:
“All elements of informed consent except the purpose for the research will be provided."
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If your research is being funded by an external source, such as a grant, you will need to complete the Application for IRB Review Addendum Sponsored Research.
If the research project receives funds from any federal agency (such as NIH), each study site must have a Federal Wide Assurance FWA) with the Office for Human Research Protections OHRP).
Provide the FWA number in this section of the application 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. Any organization’s FWA may be searched for at the Office for Human Research Protections web site.
FWAs are a requirement of OHRP and not EIU’s Institutional Review Board (IRB) or EIU’s Office of Research and Sponsored Programs.
If you are applying for federal funding and require EIU’s FWA, contact the Office of Research and Sponsored Programs at 217-581-2125 for this and any other information regarding FWA documentation that is required on the funding agency’s application form.
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