Frequently Asked Questions
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Frequently Asked Questions
Index of FAQ Topics
PI Eligibility & Role of a Faculty Advisor
Collaborative & International Research
Informed Consent Process
Unanticipated Events & Adverse Events
Confidentiality & Privacy
Compensating Human Participants
Research Participant Information
What is the role of the University of Illinois at Urbana-Champaign's IRB?
All research involving human subjects that is conducted at or sponsored by the University of Illinois at Urbana-Champaign, whether funded or unfunded, and whether conducted by Illinois faculty or others, must be reviewed and approved by the IRB, receive an exemption determination, or receive a determination of not human subjects research from the OPRS/IRB. An investigator must receive a written approval, exemption determination, or not human subjects determination prior to starting the research. This process is designed to ensure that during the conduct of the research the rights and welfare of human subjects are protected (minimizing risks, selecting subjects equitably without coercion, obtaining informed consent, ensuring privacy and confidentiality).
Why do I have to work with the IRB?
The University of Illinois at Urbana-Champaign is responsible for guaranteeing that the rights and well-being of research participants, or human subjects, are appropriately protected in research performed by the University's faculty, staff and students. Federal laws require this protection, and in order for the University to fulfill its responsibility, all research projects that meet the regulatory definition of research with human subjects require review and approval by an Institutional Review Board (IRB) before research can begin.
Who is the Office for the Protection of Research Subjects?
The Office for the Protection of Research Subjects (OPRS) provides administrative support for the Institutional Review Boards (IRB) and ensures ethical and compliant research for human subject research at Illinois. The office is the central point of contact for investigators, research subjects, and regulatory agencies. OPRS organizes and documents the IRB review process, monitors research regulations, produces educational resources for the research communityIland provides assurance that the Urbana campus is in compliance with federal, state, and campus policies.
How do I know if I am conducting research with human subjects?
Research is defined as “…a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.”
Activities which meet this definition constitute research for this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human subjects are “…living individuals about whom an investigator (whether professional or student) conducting research obtains
- data through intervention or interaction with the individual,
- identifiable private information.”
In order for your project to be considered human participant research covered by Illinois’ IRB, the criteria for both definitions must be met.
Intervention includes both physical procedures by which data are gathered (e.g., venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes (e.g, providing stimuli to gauge reaction and response).
Interaction includes communication or interpersonal contact between investigator and subject (for example, surveys and interviews).
Private information includes:
- information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and
- information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
If you are unsure if your project involves research with human subjects, please consult with IRB staff who can provide guidance in making this determination.
When am I required to submit a proposal involving research with human participants to the IRB?
All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
I am just doing a simple survey; do I need to submit my proposal to the IRB?
Yes, if the study meets the definition for research with human participants, as explained above. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
I am not collecting any identifying information in my human participant research project. Do I need to submit my proposal to the IRB for review?
Yes, if your research project involves active data collection. The campus IRB policies require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review.
Do research projects conducted by U of I students need IRB approval?
Yes. Projects conducted by UofI undergraduate and graduate students need IRB approval, if the project fits the definitions of “research” and “human participants” as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.
What are the types of Review of Research Submissions?
All projects that meet the federal definition of research with human subjects (45 CFR 46.102) must be reviewed and approved, or receive an exempt determination, by an IRB prior to beginning the research. The IRB staff initially screens submissions to determine the completeness and the appropriate type of review. Submissions may be returned to the study team for changes before the review type is assigned. The review type may be reassessed at any time during the review process.
Types of IRB Review
There are three (3) types of review paths for an IRB application: Full Board, Expedited, and Exempt.
- Full Board Review – Research posing more than minimal risk to subjects or minimal risk projects involving vulnerable subjects or complex protocols are reviewed by the convened IRB.
- Expedited Review –No more than minimal risk research meeting one of nine categories of expedited research. These protocols are often reviewed by one IRB member.
- Exempt Review ‐ Projects meeting one of seven categories of exempt research. Reviewed by a designated individual.
The Office for Human Research Protections [OHRP] provide decision charts to determine whether or not an activity involves human subjects and the appropriate review type. These charts address decisions on the following:
- Whether an activity is research that must be reviewed by the IRB
- Whether the research may qualify for an exempt determination
- Whether the review may be performed using expedited procedures
- Whether informed consent, or its documentation, may be waived
How do I apply for IRB review?
Formulate your research question and study design –This includes development of survey instruments or interview protocols and identifying your subject population and recruitment strategy.
Determine how you will obtain informed consent –Refer to the OPRS| IRB web-site for guidance on consent types and templates
Complete the CITI human subjects training required for everyone listed as a research team member on an IRB protocol. Refer to Education & Training for the university policy and instructions on how to access the training program.
Prepare your IRB application – You will need the following materials:
- Research Protocol
- Performance site information, including site approval letters or IRB approval
- Informed consent documents (including text for studies using an oral consent process)
- Recruitment materials (flyers, posters, letters, text of emails or oral recruitment scripts)
- Survey/interview/focus group questions
Submit your application for IRB review – Your advisor will need to review and sign the application before submission.
Conduct your research as approved by the IRB – Any changes to research projects requiring IRB oversight must be approved by the IRB before implementation.
Renew your IRB approval prior to the expiration date – Submit the renewal paperwork at least 30 days prior to expiration to allow for sufficient time to process the submission.
Report adverse events or other problems to the IRB – Be sure that any adverse events, other research‐related problems, and unanticipated events are reported to the IRB as soon as possible.
I want to conduct a study that involves the use of deception. Is this allowed? What do I need to consider?
Deliberate deception of participants may occur only in situations where withholding information about the nature of the study is necessary to ensure valid results, and never to get participants to do something that they would not do if the information was fully disclosed to them.
At some level the use of deception in research violates the trust that the participant puts in the researcher, this method should be considered carefully. Researchers should describe for the IRB the method, rationale and the process of informing participants of the purpose of the research as early as is feasible – preferably at the conclusion of an individual’s participation (but no later than at the conclusion of data collection) to permit participants to withdraw their data. Additionally, researchers should provide a justification for the deception techniques and document that there are no equally effective non-deceptive techniques available.
PI Eligibility & Role of a Faculty Advisor
Who can be the PI on a study?
The Campus Administrative Manual [CAM] has clear guidance on Eligibility to Serve as PI: http://cam.illinois.edu/xi/xi-4.htm
If you are a student, undergraduate or graduate, you are unable to serve as the Pi on the study, but you will be considered a co-investigator
Identify a faculty advisor – This is your dissertation chair, masters or undergraduate research advisor. Your advisor will mentor you through the research process and must be included as a study team member on your IRB application.
Does my student’s project require IRB oversight?
Not all student research activities that involve people, their data, or specimens require IRB oversight. Refer to the Determinations of Human Subjects Checklist to confirm whether or not your protocol requires IRB oversight.
Class Activities – Activities that are designed for educational purposes to teach research methods or demonstrate course concepts that are not intended to create new knowledge do not require IRB review. Refer to the Human Participants and Class Activities for more information.
Student Internships and Research Practicum – Student activities associated with internships or practicum may or may not require IRB oversight depending on the design of the activity and whether the student is engaged in the conduct of research.
What is the faculty advisor’s role in student conducted research?
The faculty advisor is an active mentor to the student researcher and shares the responsibility for the ethical conduct of the research with the student. The advisor is expected to discuss the general principles of research ethics prior to the initiation of any project involving human subjects, help students determine whether their project requires Institutional Review Board (IRB) review, and guide students through the IRB application process. The advisor must support the student in the conduct of the research project after IRB approval is attained.
What are the faculty advisor’s responsibilities for student conduct human subject research?
Complete the CITI human subjects training required for everyone listed as a research team member on an IRB protocol. Refer to Education & Training for the university policy and instructions on how to access the training program. Advisors are expected to be familiar with the ethical and regulatory requirements for the conduct of human subjects research and to discuss research ethics with students, including the professional ethics of the discipline.
Assist students in designing and planning the research project – Student research projects must be appropriate to their level of training and experience. Students must allocate time for IRB review and approval in their process, especially for projects conducted in international settings, involving non‐UIUC collaborators, or involving federal sponsorship. Be sure that the student understands IRB approval must be in place before they can begin their work.
Oversee preparation of the IRB application – A clear, complete, consistent application will move more quickly through the IRB review process. Be sure the application includes informed consent documents, recruitment materials, and surveys or other data collection instruments.
Accepting roles and submitting the IRB application ‐ Advisors are required to acknowledge their responsibility for the student application by signing all submission forms.
Support students conducting research in field settings, particularly international research –Advisors must be sure that students are aware of local customs and regulations, for the safety of their subjects and the students themselves. Provide assistance with establishing local contacts or sponsorship. Establish a communication plan with students. Develop effective plans for data security.
Monitor student research – Check in with students to ensure that research is being conducted as approved, that no problems have been encountered, and that all study modifications are submitted for IRB approval. Be sure that any adverse events or other research‐related problems, and unanticipated events are reported to the IRB as soon as possible.
What happens when my protocol is reviewed?
Projects that meet the regulatory definition of research with human subjects require documented IRB approval or a determination of exemption before starting any research activities. All applications are submitted to OPRS for review. Once submitted, applications undergo one of the following types of review: exempt, expedited, or, full board review. Studies that meet specific exemption categories are reviewed via the exempt review process by an OPRS administrator. Research involving no more than minimal risk is generally reviewed via expedited review. Studies that involve greater than minimal risk are reviewed by the convened IRB. Studies with complicated research elements or research that involves vulnerable or special populations may also be reviewed by the convened IRB. Assignments of protocols take place on Wednesdays and are pre-reviewed before the following Wednesday.
Review the Illinois IRB Review Process for more information.
How long does it take for my project to get IRB approval?
Protocols are processed as they are received by OPRS. They are logged into the internal tracking database and assigned an IRB number within 2 business days. Once protocols are logged in, an email is sent to the PI indicating receipt of the protocol, the designated IRB number, and that it is in the queue for assignment to an OPRS staff member. Assignments of protocols take place on Wednesdays and are pre-reviewed before the following Wednesday.
There are several factors that will determine the time frame for approval. Depending on risk level and subject populations, protocols will proceed for exempt, expedited or full board review. When the reviewer contacts you with any pre-review issues and determines the review type, the processing time is dependent on when you are able to respond to the issues.
- Exempt reviews: If your protocol qualifies for one of the exemption categories, once you address any issues we can provide approval. Please allow 2-3 weeks from submission to approval.
- Expedited review: The protocol will be sent to one IRB member for their review. Once you have addressed any issues we can provide approval. Please allow 4-5 weeks from submission to approval.
- Full Board review: The protocol will be placed on an IRB meeting agenda. Full board protocols must be ready (all pre-review issues addressed) before it may be placed on an agenda at least 2 weeks before the scheduled meeting.
Review time is dependent on the Board’s stipulations and the duration for these to be resolved. Please keep in mind that these timelines may be shorter or longer depending on how busy our office is and how quickly you respond to any issues/questions.
If you have any questions or need any assistance throughout the process the Office for The Protection of Research Subjects is always available to assist you.
What is meant by “exempt” protocol? What are the requirements?
Under certain circumstances, human participant research activities may be granted exempt status. Technically, exemption means that all the research activities fall under one or more of the exemption categories specified by the federal regulations.
The significance of exempt status is that the research activity is not monitored by the IRB. Assuming the project does not change, it also is not subject to continuing IRB oversight. Exempt protocols are closed and archived after five years. An extension can be made by the P.I. when the five year date approaches.
Exempt status does not lessen the ethical obligations to subjects as articulated in the Belmont Report and in disciplinary codes of professional conduct. Thus, depending on the circumstances, investigators performing exempt studies may need to make provisions to obtain informed consent, protect confidentiality, minimize risks, and address problems or complaints.
In order to have a research project recognized as exempt, investigators will need to submit a Exemption Form, along with other study related materials (e.g., consent forms, surveys, questionnaires, interview scripts/outlines, etc.) to OPRS. An OPRS administrator will review the exempt application and notify investigators if their projects are eligible.
Please note that for each change that is proposed or occurs during the execution of the research activity, the investigator will need to consult with OPRS to determine if the change affects the eligibility of the research activity to continue to be exempt from review and approval.
When may I begin data collection for my study?
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. An approval will be sent to you via e-mail when your project has IRB approval.
Can the IRB approve a project “retroactively?”
No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.
Who do I contact if I have any questions?
Office for the Protection of Research Subjects
805 West Pennsylvania Avenue, Second Floor
Urbana, IL 61801
What does the IRB look for in an application? Are there standard criteria for evaluation?
The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html). Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.
Considered another way, investigators could look at their plans from the point of view of a subject, or an observer concerned about responsible research. Who are the subjects and how are they recruited? Could they be lured or coerced to participate? Is it through an institution that may have responsibilities toward them (e.g., a school or hospital) and should be consulted? Do they understand, in advance, what they are agreeing to participate in and give their consent willingly? What will they actually do, and what is done to them, during the study? Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences? Could the subject be endangered, compromised or embarrassed if information collected leaked out? There are many possible considerations, but they should not be difficult to understand if one assumes the subject's perspective. The IRB’s role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.
Collaborative & International Research
I will be collaborating with another institution. Do I need to submit to Illinois’ IRB and the other institution?
IRB approval is institutionally based, meaning that only those researchers affiliated with the Urbana campus are covered by Illinois’ IRB. If you are working with researchers from outside institutions, those researchers will need to check with their institution’s IRB office to see what type of review (if any) they require.
There are times when an IRB may serve as the IRB of Record for the protocol, thus, eliminating the need for additional reviews and oversight. Please refer to the additional guidance regarding collaborating research.
Illinois is also on SmartIRB, an online reliance system to aid in collaborative research across institutions. If an Illinois researcher is collaborating with someone at an institution that is also on SmartIRB, the system can be used to identify who should be the IRB of record, arrange the terms of the collaborative agreement, and track agreements. Researchers can request a researcher account here and learn more about SmartIRB here.
The Urbana and Chicago campuses are autonomous offices and work independently. A Memorandum of Understanding [MOU] has been established between the two institutions allowing one IRB to provide oversight. Please contact OPRS to see if your study may fall under the MOU.
My research will be done in another country. Do I have to obtain IRB review and approval from the University of Illinois IRB?
IRB review and approval are required for all studies regardless of where the research takes place. There are additional considerations reviewed for studies conducted outside the United States. If your research will take place internationally, please complete and submit an International Research Form and a Certificate of Translation Form, if applicable.
How can I find out if another country has an Ethics Committee or an international institution has an FWA?
The Office for Human Research Protections (OHRP) has a list of laws, regulations, and guidelines from over 100 countries. Because the laws are expanding and evolving the compilation is not an exhaustive source and may not be current. While reasonable efforts have been made to assure the accuracy and completeness of the information provided, it is ultimately the responsibility of the researchers to check with local authorities and/or research ethics committees before starting research activities. Please note that some countries require researchers to register their research with the government or even with the local university ethics committee.
Informed Consent Process
What is informed consent?
Informed consent is the process by which potential participants are provided important information about the research study. Human subjects can only be involved in your study if they voluntarily agree to participate after having been adequately informed about the research. If the human subjects in your study are part of a vulnerable population (e.g., children, students, prisoners), special protections may be required.
Are there different types of informed consent? What are they?
The informed consent process can take on various forms:
- Signed informed consent is the standard expectation in research with human participants. This is in the form of a document with the elements of informed consent, signed and dated by the participant and kept as a record by the researcher.
- In research with children (individuals under 18 years old), assent of the child and parental permission are standard requirements. For more information, see the Children and Minors page.
- In some circumstances, investigators can seek alternatives to standard informed consent procedures, such as:
- Waiver of Documentation of Informed Consent: Consent is given, but there is no signature; waiving physical signed consent. (e.g., using oral consent procedures, online surveys, etc.)
- Waiver of Informed Consent: None of the required elements of consent are given; waiving the informed consent process entirely. (e.g., sending home an information sheet, passive consent, retrospective records review, etc.)
- Alteration of Informed Consent: One or more of the required elements of consent are eliminated or altered. (e.g., in research that involves deception, where the subjects’ responses may be biased, etc.)
- The OPRS and the IRB will review your request to waive or alter the consent process and will determine if the request is appropriate for the proposed study.
It is not uncommon for a research project to involve one or more of the above scenarios.
What is signed informed consent?
Used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.
Do research participants always have to sign the consent document?
Not always. In certain situations, the IRB can waive the requirement that you obtain the participant's signature on the consent form.
What is a "waiver of documentation" of informed consent?
A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:
- The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation) OR
- The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews).
What is a "waiver" of informed consent? How is it different from a “waiver of documentation” of informed consent?
A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:
- The research involves no more than minimal risk
- The waiver of informed consent will not adversely affect the rights and welfare of the subjects
- It is not practicable to conduct the research without the waiver or alteration
- Whenever appropriate, participants will be provided with additional pertinent information after their participation.
PLEASE NOTE: The IRB will take into consideration the risks and potential harms involved in the research before granting a waiver of informed consent. Additionally, there are restrictions for when the IRB may waive the requirements for child assent and parental permission.
What do the terms “consent” and “assent” mean?
Both consent and assent involve informing potential participants about the research and its risks and benefits, and documenting their understanding and agreement to participate.
The reason the different terms are used has to do with the age of the participants. In research involving adults, “consent” is obtained from individuals to participate in the study. In research involving minors, a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to “assent” or agree to participate as well.
Do I always have to obtain written permission from parents for children to participate?
No. There are two sets of circumstances where the IRB may waive the requirement for parental permission:
- The first involves research or demonstration projects that:
- Are conducted by or subject to the approval of state or local government officials and are designed to study, evaluate, or otherwise examine: (i) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs; and
- Could not practicably be carried out without the waiver or alteration.
- The second involves research that:
- Poses no more than minimal risk to the children;
- Would not adversely affect the rights and welfare of children if the IRB approved a waiver or alteration of the requirement for parental permission;
- Could not be carried out without the waiver or alteration; and
- Whenever appropriate, would provide the children with additional pertinent information after participation.
I am not collecting any identifying information. Do I still need an informed consent form?
Yes. If the proposed study is truly "anonymous" - no coding for identifiers (e.g., names, social security numbers, drivers license numbers, etc.), a modified informed consent form may be used. All the elements of consent must be documented for the participant, but the signature line is replaced with a statement informing the participant that completion and return of the survey (or by clicking “Submit” if online) is considered implied consent. If, however, the procedures involve risk or biological sample collections, written consent may be required.
What is "implied" consent?
Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research.
Implied consent is actually a type of a waiver of documentation of informed consent. Before granting such a waiver, the IRB often requires the researcher to provide the participants with a written summary or an information sheet about the research, including: (1) purpose of research; (2) time involved; (3) assessment of minimal risk; (4) statement regarding benefit to participants; (5) contact for questions about the research; and (6) contact for questions about rights as a research participant.
There are a number of instances where this type of consent is helpful. For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the "implied" informed consent form. The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.
How is the consent process handled for internet-based research?
Generally for internet-based surveys, the consent form is the first page or question of the survey where participants must read and click “Submit” before entering the survey. In some instances, implied informed consent may be appropriate.
If, for study design purposes, the researcher needs to keep track of who participated or if the IRB determines that some sort of documented consent is required, instead of "signed" informed consent, the researcher may email the consent form to participants who may then type their name and the date into the spaces provided on the consent form, and return it to the researcher via email. This process may be appropriate for data collected via email, chat rooms, online interviews, etc.
What are the consent requirements for phone based research?
For protocols involving oral consent the following information is required to be communicated to the participant:
- study purpose and procedures involved
- what will participant be asked to do - as well as the amount of time participant will spend
- the voluntary nature of participation in the study
- the participant is free to withdraw at any time
- the information collected will remain confidential
- offer the participant contact information for the researcher and/or the IRB
It may be pertinent to request the PI to offer additional information depending on the nature of the study. It is up to the Administrator to suggest additional information to be included in order to further protect the participant.
Are there any consent form templates with suggested language?
Yes, the OPRS has developed consent form instructions, templates, and a document for additional language to use when applicable. The documents are provided for both social/behavioral science research as well as bio-medical research.
To access all the templates visit:
All members of the research team are required to complete human research subject training.
Investigators and research staff must have the necessary training and expertise to:
- Ensure the rights, welfare and safety of participants are protected
- Comply with regulations concerning IRB review and approval, including
- Informed consent requirements
- Reporting requirements
- Maintenance and retention of records (keep complete files during and 5 years after research ends)
- Supervise research conduct
- Apply relevant professional standards that are applicable to the research
University of Illinois recognizes the Collaborative Institutional Training Initiative [CITI] as a leader in providing human research subject training. Completion of the required modules in CITI will meet the OPRS training requirement.
Initial education certification is good for three (3) years, after which recertification and continuing education requirements must be met. To recertify, investigators must recomplete the Core Basic Training modules through the CITI platform.
Please see: Education and Training for instructions on how to complete the required training.
Who is required to complete the human participants training?
All faculty, students, and staff proposing to use human participants in research under the auspices of the university are required to complete the human participants training. Approvals for including human participants in proposed research projects will be not be granted until this training has been completed and verified by OPRS.
After initial approval, will I still be required to submit material to the IRB?
Yes, any changes made to your protocol, including, but not limited to procedures, recruitment strategies, subject enrollment, funding changes, etc. must be submitted to the IRB through the Protocol Amendment Form. These changes must be approved and reviewed by the IRB prior to implementing.
All minimal and more than minimal risks studies are required to be reviewed by the IRB no less than one year from the time of review. The OPRS makes every effort possible to send renewal reminders. The renewal process is a time the IRB can see what research has transpired during the approval period.
Does approval of an amendment to an approved research study extend the original approval date?
No. The expiration date of the original approval is not changed by the review and approval of an amendment.
After my approved protocol has passed the one year expiration date what do I do?
If IRB approval of the human research expires, all study procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing human research procedures is a violation of federal regulations. You need to receive continued approval from the IRB in order to continue research.
Protocols that have been determined to be exempt are approved for a 5 year period. After that time the protocols are closed and archived. A researcher can always ask for extension to the approval period, in writing.
How do I obtain continued approval (renewal) for my research study?
It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. As a courtesy, approximately 40 days prior to the approval expiration date, the OPRS office will send an email to the principal investigator, alerting them to the impending approval expiration. If no response is received to the reminders, a notice indicating the approval for the study expired may be sent after the approval expiration date. If approval is allowed to expire, all research on the study must cease until renewed approval is granted. Progress of approved research must be reported, in the manner prescribed by the IRB, on the basis of risks to participants, no less than once a year. If OPRS archives a study because approval has been expired for at least 14 days, you will need to submit a new application for review in order to receive approval to start the study again.
Unanticipated Events & Adverse Events
In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRB?
Serious adverse events must be reported to the IRB immediately, with a written report by the PI following within 24 hours of the PI’s becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant.
All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the Protocol PI or another researcher, OPRS, or a member of the IRB. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRB.
Can the IRB temporarily or permanently discontinue a research project as result of an unanticipated problem involving risks to participants or others?
Yes. If an unanticipated problem poses a risk(s) to the participants or others, the IRB may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRB may request changes to a research study or permanently discontinue the research study.
Can the IRB request revisions to the approved research study and the informed consent form as a result of an unanticipated problem?
Yes. As a result of the IRB's investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.
Confidentiality & Privacy
What is the difference between confidentiality and privacy?
Privacy: refers to an individual’s desire to control who has access to him/herself
The IRB will review whether there are adequate provisions to protect the privacy interests of participants.
Confidentiality: refers to maintenance of the researcher’s agreement with the participant about how the participant’s identifiable private information will be handled, managed, and disseminated.
The IRB will review whether there are adequate provisions to maintain the confidentiality of data.
What is a Certificate of Confidentiality?
Certificate of Confidentiality (COC): A COC is issued by the National Institutes of Health (NIH) to protect identifiable research information from forced disclosure (a subpoena). It allows the investigator and others who have access to research records to refuse to disclose identifying information on research participants in any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.
COCs may be granted for studies collecting information that, if disclosed, could have adverse consequences for participants or damage their financial standing, employability, insurability, or reputation.
A COC may be appropriate when research includes sensitive information, such as; establishing a repository that includes genetic information, collecting information about unlawful drug use or other illegal behaviors, collecting information on the participants psychological well being, sexual practices, preferences or attitudes.
How do I obtain a Certificate of Confidentiality?
The National Institutes of Health (NIH) issues Certificates through its Institutes/Centers (ICs). If NIH funds the research project for which you would like to request a Certificate, you should apply through the funding IC. If your research is not supported by NIH, you should apply for a Certificate through the NIH IC that supports research in a scientific area similar to your project. Please note that NIH is authorized to issue Certificates only for important research within its mission areas. Detailed application information is available on the NIH website at the Certificates of Confidentiality Kiosk.
Where can I store electronic Protected Health Information?
Box is now available for storing Protected Health Information (PHI). Individuals who would like to use Box to store PHI may only do so in a provided Box Health Data Folder. A request for a Box Health Data Folder can be submitted here. Researchers are responsible for following the set policies and guidance listed at the previous webpage.
Compensating Human Participants
Are there special considerations to keep in mind when compensating participants?
The federal regulations that govern human subject research require that researchers seek participants’ consent using procedures that minimize the possibility of coercion or undue influence [45 CFR 46.116]. Research incentives may limit the ability of a subject to provide truly voluntary, informed consent. Subjects should be able to make informed decisions to participate based on the real risks and benefits of participation, not on compensation. Subject compensation should be equitable, and the confidentiality of information related to payments should be protected. When reviewing research protocols that include subject compensation, the IRB does so guided by these principles.
Research Participant Information
What are my rights as a research participant?
It is your decision whether or not you want to participate. In most cases you do not have to decide right away. You have the right to make this decision without any pressure. There will not be any consequences if you refuse.
To help you make an informed decision, you have the right to receive information about the study. Information will almost always be given to you in writing (written study information is called an "informed consent form" or "research information sheet"). The information must always be in a language you can understand.
If you do not understand something, the study team must explain it for you in a way that you can understand. You have the right to ask questions at any time and to have your questions answered.
If you decide to participate, you will be asked to sign and date the informed consent form. You have the right to receive a copy of the signed and dated written consent form.
What is a research subject?
A research subject is a person who is taking part in a research study. A research subject may be either a healthy individual or an individual with a specific disease or condition.
Can anyone be in a research study?
Each study has a list of who can and cannot be included in that study. This is written in the protocol. In order to protect research subjects, only people who qualify can be in the study.
What is research?
Research typically involves a study designed to answer a question. The question could be about human behavior, diagnosis and treatment of a disease, preventing injuries, how people communicate, or how children learn. Research procedures could include activities such as surveys, interviews, observations, or new treatments for disease or disorder, or clinical trials.
Why is research important?
Research has led to important discoveries that can improve our lives. For example, research has helped discover new ways to treat emotional disorders, it has shown how exercise and physical activity help keep us healthy, it has helped to find new or improved medical procedures, and found effective ways to stop bullying in schools.
What is a protocol?
All research studies follow a protocol. A protocol is like a cookbook. It tells the researcher what can and cannot be done when he/she is conducting the study. All of this is done to protect the research subject, and this protocol is reviewed by the Institutional Review Board.
What is an investigator?
An investigator is the person responsible for the conduct of the research study. The investigator is the individual who conducts the research study or oversees/leads a team who is conducting the research study.
What is informed consent?
Federal law requires that an individual interested in taking part in research studies be given sufficient information with which to make an informed decision as to whether or not to participate in the study. This is known as the informed consent process. If the individual agrees to participate, he or she must read and sign an informed consent document, which provides the following information:
- That the study involves research;
- The purpose of the research;
- How long the study is expected to last; What the study involves and which parts are investigational;
- Possible risks and/or discomforts;
- Possible benefits;
- Alternative to participation in the study;
- That the study records will be kept confidential to the extent required by law;
- What will happen in the event of a study-related illness or injury, including whether any compensation and/or medical treatments are available;
- Who to contact: in case of an emergency, with any complaints about the study, with questions about research subjects’ rights, and with questions about injuries related to the research; and
- That being in the study is voluntary and subjects may quit at any time.
Who should I talk to about the study before I decide whether or not to participate?
Before signing the informed consent document, you should discuss the study in detail with the investigator or a study staff member. This discussion must take place in private, and you must be given enough time to make an informed decision. In most studies, you should be allowed to take the consent document home for further discussion with others, such as family and primary care physicians. In addition, the investigator and/or study staff must answer all questions to your satisfaction. You must also be told about any new information learned during the study that may affect your willingness to continue to take part in the study. You may ask questions at any time throughout the study and may decide to stop taking part for any reason.
What questions should I ask about the study?
Examples of questions you may want to ask include:
- Why is the study being done and what is the purpose?
- What exactly will I be doing?
- How much of my time will be required?
- What are the costs to me?
- What are the benefits of me being in this study?
- Will I be paid for being in the study? And, if so, how and when will I be paid?
- Will there be any follow-up/treatment after the study is over?
- What happens if I decide to quit early?
- Who should I contact if I have a study-related illness or injury?
- What alternatives are there to being in the study?
Can I quit or leave a study at any time?
Yes. Participation in a research study is voluntary. You are free to decline to participate for any reason. You may also stop participating at any time or refuse to answer any individual questions. Even after you sign the consent form, you can stop. Should you decide to decline or stop participating, this decision will in no way influence any services to which you are otherwise entitled. For example, if you are a student, your teacher or professor cannot hold this against you when determining your grade. If you are receiving treatment, that treatment cannot be withheld if you do not agree to participate.
Who should I contact with general questions about the study?
The consent form that was given to you should have the contact information listed for the responsible investigator for the study. First, please try to contact the research team about any general questions such as a study payment.
When should I contact the IRB?
If you have questions, concerns, or complaints about the study as well as questions about your rights as a research participant, please contact the University of Illinois Institutional Review Board at 217-333-2670 or via email at firstname.lastname@example.org.