IRB protocol Submission guide and tutorial
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 for the following sections of the Application for IRB Review:
Section A:
PROJECT OVERVIEW
The Institutional Review Board will require basic information about project personnel as well as the project itself. This information will need to be provided in the appropriate prompts in the Application for Review of Research Involving Human Subjects.
Estimated Start Date:
Indicate when it is intended for research to begin (upon IRB approval). Research cannot begin until after the IRB has approved a protocol.
A project typically begins with a planning phase and preliminary research (e.g. a literature review). However, contact with human subjects cannot occur until the IRB has approved the research protocol. The Estimated Start Date is an estimate of when the portion of your project that involves human beings will begin. For example:
- A student begins planning a project in October by developing a topic, planning the research process with their faculty advisor, 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 is therefore January 15.
Investigator(s):
Principal Investigator:
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.
If the Principal Investigator is a student:
- Student researchers are required to have a faculty sponsor or an executive, administrative, or professional (EAP) staff sponsor, who serves as Co-Investigator.
- The protocol must be compiled and written by the student PI, under the guidance of a faculty sponsor or EAP.
Status: Click in the textbox to select an option to indicate your status at EIU. If none of the available options apply, choose “other,” and explain your status when citing your qualifications in the “Qualifications of Investigator” prompt below.
Email: Provide your EIU e-mail address. If you are not an EIU student or employee, please provide the e-mail address associated with the institution through which you are conducting your research.
Phone: Provide your preferred contact number.
Department or Unit: Provide the name of the department or unit through which you are conducting your research.
Co-Investigator:
The Co-investigator is any other investigator, faculty sponsor, or executive, administrative, or professional (EAP) staff sponsor involved with directing the research project. If there are any additional Co-Investigators, complete the Application for IRB Review Addendum: Additional Co-Investigators and include it with your protocol submission.
If the Principal Investigator is a student:
- The primary responsibility of a Faculty Sponsor or EAP is to advise and support the PI in all aspects of the protection of human subjects on a given project.
Status: click in the textbox to select an option to indicate the co-investigator’s status at EIU. If none of the available options apply, choose “other,” and explain the co-investigator’s status when citing qualifications in the “Qualifications of Investigator” prompt.
Email: Provide the co-investigator’s EIU e-mail address. If the co-investigator is not an EIU employee, please provide the e-mail address associated with the institution the co-investigator is from.
Phone: Provide the preferred contact phone number of the co-investigator.
Department or Unit: Provide the name of the department or unit of the co-investigator.
Prompt A.1: Qualifications of Investigator(s):
Briefly describe the qualifications of all investigators(s) conducting this research project. Include an overview of any relevant education and experience.
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 for over 30 years.”
Prompt A.2: Project Description:
Describe the purpose of this research in layperson’s terms in 50 – 200 words. This description can be similar to an abstract and serves as a snapshot of your research.
The research purpose, questions, and hypotheses should be apparent. 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. Do not include rationale for conducting the research 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 gather 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.”
Prompt A.4: Project Dissemination:
Describe how the results of the research will be disseminated. Dissemination includes, but is not limited to the following: honors, master’s or doctoral theses; presentation at a scientific/professional meeting or conference; submission to or publication in a scientific/professional journal (paper or electronic); and internet postings.
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Section B:
PARTICIPANTS
As part of the review process, the IRB will require information regarding the potential participants in the study. This information will need to be provided in the appropriate prompts in the Application for Review of Research Involving Human Subjects.
Prompt B.1: Approximate number of human participants:
Indicate in this field how many participants you hope to recruit for your study.
Prompt B.2: Categories of Subjects and Controls:
Check all applicable categories of subjects and controls that will be included in the research:
University/College Students: applicable when the targeted participant population is college students.
Incarcerated Persons: any individual involuntarily confined or detained in a penal institution. Prisoners receive additional protections under 45 CFR 46, Subpart C.
Students that you are teaching, supervising, or observing: applicable when potential participants are students at any educational level and are being taught, supervised, or observed (in an educational capacity separate from the research) by any investigator in the study.
Minors: applicable when potential participants are children aged 17 years or under. Age range of targeted population must be supplied when this box is checked. Minors have not yet attained the age of consent to treatments or procedures involved in the research, and receive additional protections under 45 CFR 46, Subpart D.
Decisionally Impaired Persons: applicable when potential participants’ ability to understand and provide informed consent is impaired due to a condition, illness, educational and/or another disadvantage.
Institutionalized Decisionally Impaired Persons: applicable when potential participants’ ability to understand and provide informed consent is impaired due to a condition, illness, and/or other disadvantage, and that person is institutionalized.
Pregnant Persons: applicable when the targeted population is pregnant people
Persons with medical, psychological, or mental health conditions relevants to the research: applicable when potential participants are sought because they have been diagnosed with, or are receiving treatment for, an illness or condition is that is pertinent to the research, or they are being provided with diagnostic and/or medical care by any investigator in the study.
Prompt B.3: Characteristics:
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.”
"Potential participants will be residents of three privately-funded 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 comorbidities. This study seeks to study the dietary habits and nutritional intake of persons with Alzheimer's disease and dementia, and cannot be take place without participation from this population."
If the study will include participants whose ability to give voluntary informed consent may be in question, explain the rationale for their inclusion. See 45 CFR 46, subparts B, C, and D for guidance regarding special populations. Special populations include, but are not limited to:
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Incarcerated persons
- Minors
- Decisionally-impaired persons
- Populations that may be vulnerable to coercion, such as parolees, students of a researcher, or persons with a serious health condition.
Prompt B.4: Recruitment:
Describe the process you will use to identify and recruit prospective subjects and include the agency(s) where prospective participants will be recruited from, when applicable. List any materials that will be utilized in marketing/recruitment.
For example:
“Participants will be recruited via a post for a Facebook group for spouses of lupus patients. The post will provide information about the study. A link to the on-line survey will be included in the post. After two weeks a second reminder post will be posted if the required number of participants has not been met. 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.”
Recruitment materials must contain identification of the institution(s) conducting the research. In addition, recruitment materials must include the following information:
- Name of the researcher
- A brief description of the research
- Criteria for participation
- A description of the procedures involved
- A description of risk, benefit, and incentives (when applicable).
When recruitment materials are condensed (such as flyers 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.
Attach a draft or final copy of all recruitment materials to the Application for Review of Research Involving Human Subjects.
Prompt B.5: Incentives and Research Related Costs (if applicable):
Describe any incentives being offered to subjects for their participation in the research study. Incentives include, but are not limited to, monetary compensation, free or discounted services, course or assignment credit.
- If monetary compensation is offered, specify the amount to be paid and the terms of payment. If other compensation is to be offered, describe the terms of the compensation in detail.
- Explain how incentives will be affected if subjects withdraw before completion of the research.
If applicable, describe any cost(s) that the subjects would incur as a result of their participation in the research.
Prompt B.6: Health Care:
Indicate whether or not the research involves any topic that will be subject to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) by checking the appropriate box.
Topics that are subject to HIPAA include, but are not limited to:
- Past, present, or future physical health of the participants - applicable when potential participants are sought because they are diagnosed with, are being treated for, or are perceived to be at risk of developing an illness or condition, and/or they are being provided with diagnostic care, treatment, or monitoring by any investigator in the study.
- Mental health (as defined in DSM-V TR) - applicable when potential participants are sought due to their diagnosis of, or treatment for a mental illness or condition, and/or they are being provided with diagnostic and/or mental health care by any investigator in the study.
- Provision of health care to the participants – applicable when subjects will receive health care treatment and/or diagnostics as part of the research.
- Past, present, or future payments for the provision of health care to the participants – applicable when subjects will receive compensation for the cost of health care treatment and/or diagnostics as a result of participating in the research.
Refer to Appendix 4, HIPAA Information, in EIU Policy and Procedures for the Review of Research Involving Human Subjects.
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Section C:
STUDY LOCATION
The IRB will need to know where participants will be physically located when participating in a study. This information will need to be provided in the appropriate prompt in the Application for Review of Research Involving Human Subjects.
If the study will take place at a specific location (or locations), provide the name of the site or agency, along with pertinent identifying information.
For example:
“Memorial Hospital, Springfield, Illinois”
“Eastern Illinois University”
“Lincoln Elementary School, Tinley Park, Illinois”
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.
For example:
“Online surveys will be conducted using Qualtrics. Participants will access the survey via the device of their choice and will be located in a site of their own choosing.”
“A Google Workspace survey will be distributed to all students in Mrs. John’s third grade class at Sandburg School in Pekin, Illinois. Students will use their district-issues laptops to access the survey.”
When a facility being utilized is not owned and operated by Eastern Illinois University, a letter from an appropriate administrator of the facility must be submitted with the protocol.
The letter must be on the facility’s letterhead stationery or e-mail, and should contain the following:
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Agreement for the study to be conducted at the site
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Identification of someone at the site who will provide information about appropriateness of the study for its population
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Assurance of adequate capabilities to perform the research as approved by the IRB; and if applicable
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Assurance that facility personnel involved in data collection have appropriate expertise and will follow IRB approved procedures.
Exceptions
If administrator letters are not available at the time of IRB review, IRB approval will be contingent upon receipt of the letters. Indicate in the prompt that the letter is being sought and will be submitted once it is received. The IRB can review the protocol, and approval can be granted once the letter is reviewed by the IRB.
If the research project will receive federal funds and is being conducted at a facility that is not owned and operated by EIU, the facility must have a Federal Wide Assurance (FWA) with the Office for Human Research Protections (OHRP), and the FWA number must be provided in the Sponsored Research prompt in the Application for Review of Research Involving Human Subjects. See Sponsored Research instructions for more detail.
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Section D:
PROCEDURES
As part of the review process, the IRB will evaluate the research process and procedures that participants will experience. This information will need to be detailed in the Application for Review of Research Involving Human Subjects.
Prompt D.1: Study Process and Procedures:
Describe the study design, 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. The 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.
For example:
"Participants will be asked to complete an online survey regarding their views of tobacco use. Qualitative data will be analyzed to determine attitudes and trends toward tobacco use by age group."
"Saliva samples will be collected from participants in order to test for presence of COVID-19 to determine the number of asymptomatic cases. Results will be analyzed by region to determine if asymptomatic caseload varies by region and/or environmental conditions."
"Student participants will submit journal entries online after completing each history assignment. While the history work is part of the standard curriculum, journal entries will be completed solely for this study."
Prompt D.2: Setting:
Describe the setting and mode of administration. Be sure to include whether processes will be administered individually or in group settings, where the researcher and participants will be located, and any other relevant conditions (such as time of day, privacy, climate conditions, etc.).
For example:
"Assessments will be administered to all students at one time in the regular classroom during regular school hours."
"Samples will be collected from individual participants via the swab method in the BIO Laboratory in the Biological Sciences Building on campus. Participants will be swabbed on an appointment basis at a time of their choosing. Up to three participants could be present in the laboratory at one time."
"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."
"Surveys will be taken online at a location of the participant’s choosing. Surveys can be accessed via PC, smartphone, or tablet."
Prompt D.3: 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.
For example:
"Assessments will take up to 20 minutes per individual to complete. The survey will be online for data collection for 6 weeks."
"Samples will take about 30 seconds to collect. Participants can expect to spend 15 minutes at the BIO Lab to provide informed consent and provide the sample. Participants will provide two samples, three months apart, for a total of 30 minutes of participation."
"Interviews 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."
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Section E:
INSTRUMENTS, RESEARCH MATERIALS, AND DATA STORAGE
The collection, handling, and secure storage of data is critical to the safety and welfare of human participants in research. As part of the review process, the IRB will require precise information regarding the collection, handling, and storage of data. This information will need to be provided in the appropriate prompts in the Application for Review of Research Involving Human Subjects.
Prompt E.1: Instruments
List all instruments, assessments, or other tools that will be used to collect data.
For example:
"The Childhood Autism Rating Scale (CARS2) will be administered to a parent or guardian of each child in the preschool class."
"Saliva will be collected from participants using SalivaBio Oral Swab (SOS) collection devices. Saliva samples analyzed using enzyme-linked immunosorbent assay (ELISA)."
If applicable, attach a copy of all instruments to be administered to the subjects. Standard assessments or equipment (such as CARS2, oral swabs, or Wechsler Intelligence Scales), do not need to be attached. If utilizing non-standard equipment, include a detailed description of the equipment and its source.
Prompt E.2: 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. If audio or video recording is being utilized, please explain why it is necessary for the study.
For example:
"Data will be collected using Survey Monkey online survey software. Likert scales will be utilized and all data will be numeric."
"Clinicians will use swabs to collect about 0.5cc of saliva from participants. Samples will be analyzed to detect viral presence. Results, along with participant age, gender, and geographic region will be recorded in MS Access."
"Reading FUNdementals worksheets completed by student participants will be analyzed to identify common errors. The worksheets are part of the regular classroom curriculum."
"Participants will be interviewed over Zoom. Interviews will be audio recorded. This is necessary in order to properly transcribe and then analyze participant responses."
Prompt E.3: Data:
Describe what tools and/or software will be used to record and store the data/specimens through the duration of the research.
For example:
"Participant responses will be stored within the Survey Monkey software throughout the duration of the collection period."
"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 refrigerator until analysis occurs. Once analysis occurs, results will be recorded in an Access database."
Prompt E.4: Confidentiality:
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.
For example:
"All responses will be anonymous."
"Samples will be labelled 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."
"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."
Note: Information containing subject identifiers (including signed consent forms) should be stored in a location separate from data. Be sure to include the processes by which this information will be kept separate.
Prompt 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.
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."
Prompt E.6: Data Security During Study:
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.
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 this prompt, describe how data will be kept secure through the duration of the study. If applicable, indicate how any identifiers (such as signed consent forms or indexes containing code or alias assignments) will be stored. Indicate who will have access to the data, forms, and/or any items that identify subjects. If data will be transferred from initial collection source to another form of storage, indicate specific steps and methods. You must account for all data and any identifiers collected.
For example:
"Data will be stored on a password-protected PC in the Biosciences lab. Only the PI and director will have access to the data. 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."
"Student worksheets will be stored in a locked file cabinet in the teacher researcher’s classroom. The teacher, school principal, and thesis advisor 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 advisor will have access to the spreadsheets."
"Survey Monkey has a data storage method within the program. A password is required to access the it. Only the PI and Faculty Advisor have the password."
Prompt E.7: Post-Study Data Storage:
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)].
In this prompt, describe how all records relating to the project will be securely stored when the research is completed. You must account for all data or identifiers in this prompt. Explain how materials will be destroyed once the mandated storage period has passed.
For example:
"Once the data collection period has ended, collected data will be downloaded from Survey Monkey to an excel spreadsheet, which will be stored on a secure password-protected Microsoft One drive."
"Student worksheets will be stored in a locked file cabinet in the teacher’s classroom. The spreadsheet will be moved to the Teacher researcher’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 cold-storage 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."
Prompt E.8: Public Use Data File:
If you will be creating a data file for public use, see Public Use Data File instructions
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Section F:
RISKS AND BENEFITS
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.
Prompt F.1: Category of Risk:
Indicate the category of risk to participants that most accurately describes the research by checking the appropriate box on the form:
Not greater than minimal risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
For example:
"University Students are invited to take an online survey regarding their experiences navigating campus during the first week of class."
Greater than minimal risk, but presenting the prospect of direct benefit to individual subjects: The probability and magnitude of harm or discomfort anticipated in the research is slightly greater in than those ordinarily encountered in daily life, but direct benefit to the participant is anticipated.
For example:
"Persons over 50 years of age are invited to participate in an 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."
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: The probability and magnitude of harm or discomfort anticipated in the research is slightly greater in than those ordinarily encountered in daily life and no direct benefit to the participant is anticipated. However, knowledge about the topic will be of benefit to society, and/or indirect benefit to the participant is anticipated.
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 common coping mechanisms, whether or not they were considered to be successful, and what tools are needed for those who have experienced trauma. 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 participants may also benefit by what is learned in the study."
Higher in potential risk to participants, but has the potential to directly benefit participants, or to impactfully benefit society at large: Study is considered to be high-risk or involves unusual types of risk to subjects, and/or potential subjects are members of a vulnerable population. However, it is anticipated that the research will elicit knowledge about the topic that will be of benefit to society, and/or of direct benefit to the participant.
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."
Prompt F.2: Identification of Risk(s):
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.
Examples of minimal risks could include (but are not limited to): loss of time out of a busy day, feeling uncomfortable talking to a new person, being afraid of not knowing a response, becoming frustrated with a study's process.
Prompt F.3: Safety Precautions:
Describe the processes and procedures that will be in place to protect subjects from, or minimize the potential risk(s) that had been identified.
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Where appropriate, discuss provisions for ensuring necessary medical or professional intervention in the event of adverse effects to the subject(s) and attach a referral list.
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When applicable, describe alternative treatments or procedures that might be advantageous to the subjects.
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Where appropriate, describe the provisions and procedures for monitoring the data collected to ensure the safety of subjects
Prompt F.4: Benefits:
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.
Prompt F.5: 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 as a result of the study. The IRB 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.
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Section G:
IMPLICIT BIAS AND DIVERSITY, EQUITY, AND INCLUSION (DEI)
Researchers must ensure that all aspects of their study are inclusive in nature and do not potentially harm members of a marginalized community. As part of the review process, the IRB will review plans to ensure participants are safe from the potential harms of implicit biases and exclusion. This information will need to be provided in the appropriate prompts in the Application for Review of Research Involving Human Subjects.
Members of a marginalized community include, but are not limited to: women, members of the LGBTQ community, people of color, religious communities, or people of varying ages, socioeconomic backgrounds, and abilities.
Diversity, equity, and inclusion 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 unconscious bias or exclusionary 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 student eating habits when experiencing stress or anxiety. 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 and its availability in student dining areas.
The study is potentially harmful to participants who are members of several religions that prohibit the consumption of pork products. 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 religious practices have been disregarded. The invitation implies that all students consume pork and fails to recognize the religious practices of some students.
If the researchers truly wish to specifically examine the consumption of bacon in student dining areas during stressful times, 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 products are invited to participate in the research.”
In these examples, students who do not consume pork are alerted to the fact that the study may not be one they wish to participate in, and more importantly, the invitation respectfully acknowledges that there are people who do not consume pork.
In this prompt in the Application for Review of Research Involving Human Subjects, describe what processes 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. Using the previous example:
“Because there are religious practices that prohibit the consumption of pork products, the invitation is worded so that potential participants understand the nature of the study.”
Other examples:
“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 Black students on a college campus located in a town with a predominately White population, all survey items were reviewed by a licensed counselor on campus who specializes in multicultural counseling. In addition, participants will be provided with the contact information for this counselor.”
“Standardized assessments that are culturally and linguistically appropriate will be utilized.”
Differing abilities or needs:
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.
When applicable, describe in this prompt accommodation(s) that will be in place for participants with differing abilities or needs.
Examples of 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 labelled in large print and braille. An outdoor collection tent will be available for participants who do not feel comfortable in the lab.”
Example of accommodation for differing need:
“A Spanish version of the survey and informed consent is available to participants who speak Spanish.”
“Potential interviewees who do not have internet access will be provided with a private space at the city library in order to participate in a discussion over Zoom.”
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Section H:
INFORMED CONSENT, ASSENT, AND WAIVERS
“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:
Informed consent is the two-part process of (1) providing potential participants with key information about the research and their rights as participants; and (2) obtaining their agreement to participate.
In certain circumstances, the IRB can approve an alteration the informed consent process. This is called a waiver. Waivers can be requested in this section of the application.
For further guidance and informed consent phrasing assistance, see the Informed Consent Template and Informed Consent Checklist at the EIU IRB website.
Assent:
When children (ages 0 through 17) and/or decisionally-impaired persons are the subjects of research, there is a four-part process to obtaining their permission to participate:
First, you must obtain informed consent from the parent or guardian of potential participants:
1. Provide parents/guardians with key information about the research and the potential participants' rights, using established informed consent guidelines.
2. Obtain parent/guardian agreement to allow their child or ward to participate
Once informed consent is obtained from the parent or guardian, only then can you seek and obtain assent from the potential participant:
3. Provide developmentally appropriate information about research to the potential participants, then
4. Obtain their permission (assent) to utilize them as subjects in the research.
In certain circumstances, the IRB can approve an alteration to the usual assent process (including to the parent/guardian informed consent portion of the process). This is called a waiver. Waivers can be requested in this section of the application.
For assent guidance and phrasing assistance, see “Assent Guidelines” at the EIU IRB website.
Completing the Informed Consent, Assent, and Waivers section of the Application:
The IRB will need to review your plan for providing and obtaining informed consent (and assent, when applicable), and your justification for any waivers you may be seeking. The first two prompts (H.1 and H.2) in this section will be utilized to indicate whether you plan to complete the informed consent/assent processes in their entirety, or if you will be seeking a waiver for either (or both) of these processes.
Informed Consent and Assent Processes:
There are three options for the informed consent and assent processes. In Prompts H.1 and H.2 you will indicate which process you will be using. These options are: Check the box that describes the informed consent process for your study:
Option 1: Informed consent information will be sought and obtained. Participants (or their parents/guardians) will sign the informed consent document to indicate their consent, and documents will be collected by the researcher.
- This is typically done via a letter that the participant would then sign and return to the researcher.
- When utilizing this option, the IRB will need to know how and when participants will be provided with informed consent information, and how their consent will be documented. You must describe the circumstances under which informed consent will be sought, obtained, and documented in the space provided on the form. All steps of the process and all phases of data collection must be accounted for.
- If the research has multiple phases of data collection the process for each phase must be described. For example: A study contains an online survey involving 100 participants. Then, 10 people are interviewed in-person:
“Potential participants taking the online survey will be provided with all informed consent information upon opening the survey. They will consent to participate by clicking a link at the end of the page to take the survey. Potential participants for the interview portion of the study will be presented with an informed consent document upon arrival. The researcher will answer any questions the participant may have. The participant will consent to participation by signing the informed consent letter and returning it to the researcher. Once consent is obtained, audio recording will begin. A copy of the signed letter will be provided to the participant."
Option 2: Informed consent information will be provided to potential participants. However, consent forms will not be signed and collected.
Option 3: It is being requested that some or all required informed consent information not be provided to potential participants.
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In very rare circumstances, the IRB can approve a waiver of some or all of the informed consent process, meaning, participants would not be provided with all typically-required information prior to participating in the research. This is known as a waiver of informed consent.
You must then complete Prompt H.4 if you are requesting this type of waiver.
Prompts H.1 and H.2:
These two prompts are to be completed based on the the characteristics of the subjects of your research:
If your study involves adults as subjects in research, complete Prompt H.1.
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- If the research involves only minors or decisionally impaired adults as subjects, do not complete this section.
If your study involves minors or adults who are decisionally impaired, complete Prompt H.2.
If your study involves both adults, minors, and/or adults who are decisionally-impaired complete both Prompts H.1 and H.2.
The next two prompts in this section (H.3 and H.4) of the application provide the IRB with justification for waiving some or all informed consent requirements (and assent, when applicable). These prompts are only required when Options 2 or 3 are selected in Prompts H.1 or H.2.
Prompt H.3:
If you checked Option 2 in Prompt H.1 and/or in either section of Prompt H.2, you are requesting a waiver of documentation of informed consent (or assent, when applicable), and intend to provide informed consent (or assent) information to potential participants, but are requesting to not collect their signatures. You must complete this prompt in order to provide justification for your request to forego the collection of signed consent/assent documents.
The requirement for the investigator to obtain a signed consent or assent form for some or all potential subjects can be waived by the IRB only in certain circumstances. Those circumstances are provided as options in this prompt. Check the box for the circumstance that most accurately describes your research. Then, provide justification for that selection in the space at the bottom of this prompt.
- If there is more than one phase of data collection (for example, an online survey and then an interview), be sure to specify which phase of data collection the waiver is being requested for.
Prompt H.4:
If you checked Option 3 in Prompt H.1 and/or in either area of Prompt H.2, you are requesting a waiver of informed consent (or assent, when applicable) and must complete this prompt in order to provide justification for this waiver. Items 1 – 4 are required in all circumstances, and item 5 is required when is applies to the research.
In some cases, a request is to waive some – but not all - elements of informed consent (or assent):
For example, participants are asked to participate in research, but the details of the research and the nature of its risk are not made known to them. They are only told that they can choose not to participate and can withdraw at any time.
When requesting to waive only some elements of informed consent, specify which elements are being waived and provide a detailed justification for each.
For example:
“Outcomes will be affected if participants are aware of the nature of the study. 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 researcher will watch for signs of distress among participants, and will provide all participants with a debrief that explains the nature of the study once the session is complete or if they withdraw.”
Attach full text of the informed consent document and, when applicable, assent document (or script if delivered verbally) to the application.
Section I:
SPONSORED RESEARCH
If your research is being funded by an external source, such as a grant, you will need to complete the “Sponsored Research” section in the Application for Review of Research Involving Human Subjects. If your research is not being funded by an external source, you may skip this section in the application.
Please call the Office of Research and Sponsored Programs at 217-581-2711 with any questions you may have regarding sponsored research.
Principal Investigator of Contract or Grant:
In some cases, the Principal Investigator (PI) named on the grant or contract may be different from the PI of the study. Indicate the name of the PI in the grant/contract, even if it is the same as the PI named in the study protocol.
Funding Source:
Indicate the full name of the agency that is funding the research.
Contract or Grant Title:
Indicate the name or title of the grant.
Contract or Grant Number:
Indicate the contract or grant number provided by the agency that is funding the project.
Prompt I.1: Requirements imposed by funding agencies that are not already covered in this application:
Many funding agencies have requirements that are in addition to those established in 45 CFR 46 or EIU policy. The PI will be responsible for understanding and complying with those requirements. These can include (but are not limited to):
- Production of public use data files
- Additional training requirements
- Personnel qualifications
- Reporting requirements
- Parent/Guardian rights and consent procedures
Thoroughly describe additional funding agency requirements and explain the process for ensuring those requirements will be met.
Prompt I.2: NIH Sponsored Research:
If your study is funded by the National Institutes of Health (NIH): NIH policy requires that grantees have procedures in place for data safety monitoring of clinical trials. Please provide a description of the data safety monitoring plan for your study.
Prompt I.3: Federal Wide Assurance (FWA):
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 217-581-2711 for this and any other information regarding FWA documentation that is required on the funding agency’s application form.
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Submit all supplemental materials with the completed application. Supplemental materials can include, but are not limited to:
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Informed Consent document
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If applicable, Assent document
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Questionnaires, surveys, tests, or other materials that will be administered to subjects.
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If applicable, any recruitment materials (including e-mails, advertisements, flyers, and/or text of social media posts)
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If applicable, written permission from other institutions or agencies involved in the research (e.g., school board, hospital, agency, prison).
Investigator Assurance:
The Primary Investigator must read all assurance items and check each corresponding box prior to signing the application:
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Certify that the information provided on the application for your project is accurate and compiled by you.
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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.
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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.
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Agree to comply with IRB policy for the conduct of ethical research and will promptly report significant or adverse effects to the IRB in writing within 5 days of occurrence.
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Confirm that you understand that you are responsible for ensuring that the work of others involved with this project complies with this protocol and IRB policy.
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Certify that you have completed CITI training within 3 years prior to this project’s estimated start date.
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If CITI training was completed under a different name, please provide that name in the space below this assurance.
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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.
- Assure that any co-investigators involved in the project (other than faculty/EAP sponsors) are knowledgeable about the regulations and policies governing research with human subjects, and that you will monitor study progress and compliance with IRB policy for the conduct of ethical research.
The form can then be signed either by pen or electronically.
Faculty or EAP Staff Sponsor Assurance
Faculty or EAP Sponsor assurance is required when Primary Investigator is a student. The Primary Investigator 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 agree to promptly report any significant or adverse effects that they are made aware of to the IRB in writing within 5 days of occurrence.
- 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.
Protocol Submission:
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 Outlook or Google docs).
*Student researchers are required to have a faculty sponsor or an executive, administrative, or professional (EAP) staff sponsor, who serves as Co-Investigator. The Sponsor must be copied (cc) on the submission e-mail.
Timeline for Review:
Protocols will be screened by the ORSP Compliance Coordinator 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 Primary Investigator (and Faculty Sponsor, when applicable) will receive notification via e-mail regarding their project’s status within this ten-day timeframe.
The Compliance Coordinator or IRB Reviewer may request additional information and/or a modification to the protocol. These requests will be sent via e-mail. PIs 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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PUBLIC USE DATA FILES
When Utilizing a Public Use Data File:
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.
When utilizing public use data files, be aware of the following:
When Creating a Public Use Data File:
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 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.
For the IRB to classify the file as a public use data file, one of the two following situations must apply:
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The data were anonymous when originally collected or data were collected from unknown persons.
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The data were collected from identified persons, but the file has been stripped of individual identifiers and any other information that may risk disclosure of any subject’s identity. The following elements must be considered in determining whether the risk of disclosure of subjects’ identity is properly addressed:
- All individual identifiers of each human research subject or any person named by any human research subject must be removed
- All variables that can be surrogates for individual identifiers (e.g., street address of subject) must be removed.
- To remove the possibility of identification when a human research subject is in a small subgroup within the sample, it may be necessary to collapse or combine categories of a variable. For example, detailed breakdowns of religious denomination in a survey question or medical diagnosis/procedure codes may need to be collapsed into fewer categories.
- Delete or mask, as described above, any variable that a secondary user may employ to identify any research subject. For example, the PI may need to assign a new subject ID to each individual if the original subject ID contained identifying information, such as letters from the last name or part of the date of birth.
- Use statistical methods to add random variation to variables that cannot otherwise be masked. For example, a data file may contain a combination of public and private information on a relatively small sample, perhaps demographic characteristics and salary of a public official, along with attitudinal information. The income variable may need to be altered so that it cannot be combined with the demographic characteristics to enable identifying the individual and thereby risking disclosure of private information. This option should be used only if other techniques do not work, because it may compromise the integrity of the data.
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