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This log should be used to track adverse events throughout the course of the study and to document the PI’s determination if the event(s) require prompt reporting to the IRB as a possible Unanticipated Problem.
All modifications to human subjects research must receive prior IRB approval before subjects are involved in the revised protocol. Prior to implementation, modifications must be submitted on a Research Amendment Form and reviewed and approved by an IRB committee or the IRB Office.
An Assent document is used for children aged 7-17 or cognitively impaired adults who are unable to provide legal consent, but allows them to provide their understanding and agreement to research participation.
This worksheet can be used by researchers to conduct a self-audit of any social or behavioral science project. This worksheet may also be useful to assist with data monitoring or preparation for OPRS PAM or an external audit.
If UIUC faculty, staff, or students (including CI MED students) are required to submit an Exempt application to the Carle IRB, an application must also be submitted to UIUC via IRBOnline. Use this table map what responses from the Carle application can be directly input into the IRBOnline New Study Application. The table also includes other tips and recommendations to make the application process easier.
For research conducted in languages other than English, the Illinois IRB must have all versions of the research material [e.g. consents, recruitment, instruments, etc.] in both English and non-English to be retained in the research file.
This template includes Authorization for the use of Protected Health Information. This template should be used for research conducted with HIPAA-protected data.
This checklist can be used to ensure all consent requirements are included in your consent document. The Common Rule sets forth general requirements for documentation of informed consent. An informed consent form approved by the IRB and signed by the participant or the participant’s legally authorized representative should be used to document informed consent. A written copy should be given to the person signing the informed consent document.
This template should be used as a consent document for simple survey or questionnaire research. This document should be used when a signature will not be collected. For example, for an online survey the participant reads this consent cover letter which informs them about the study and if they agree to participate, they proceed and complete the survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form.
This is a standard consent document template to be used for adult participants in social behavioral or biomedical research. This standard template is geared towards minimal risk research. Please review the Supplemental Consent Language document for additional consent requirements for greater than minimal risk research and other study-specific requirements.
Comments on how to create a new project.
All research data and biospecimen banks/repositories managed by the University of Illinois Urbana-Champaign must have a management plan to receive IRB approval for the collection and use of the data and biospecimens for future research. Using the template below, attach your management plan to your IRB application. Attach the document under “Other Documents” in the Documents section.
A debriefing document is needed when a study involves deception, incomplete disclosure, or studies designed in such a way that providing complete background information will invalidate the study. The debriefing document is provided to the participant following their participation to give them full information about the study. An Alteration of Consent is required in order to use deception or incomplete disclosure in research. Submit a Waiver of Informed Consent Form as it includes the Alteration of Consent request.
One option for use to document the research staff and what research activities the PI has delegated to others. Also meets the requirements for a Staff Signature Log. Other options are also available.
This form should be completed and submitted as part of the IRB application for any project that has involvement in any capacity from the Department of Defense.
This log should be used to track deviations from the protocol, IRB policies, or regulations. The PI’s determination can also be documented as to whether the deviation meets the IRB’s prompt reporting criteria.
The completion or termination of a study is a change in activity and must be reported to the IRB.
At the time a study is complete or discontinued, the investigator must submit a Final Project Report.
This form can be used by participants, research staff, and others to report potential complaints or concerns about research. Individuals can choose to remain anonymous. You also have the option of being known to OPRS, but anonymous to the researcher.
This form should not be used by a researcher informing OPRS about a complaint made by a research participant. In that case, the researcher should follow standard reporting guidelines by using a Report Form application.
This worksheet can be used by researchers to conduct a self-audit of any health science or biomedical research project. This worksheet may also be useful to assist with data monitoring or preparation for OPRS PAM or an external audit.
This template can be used to obtain informed consent without a signature. This template is similar to the Consent Cover Letter template, but includes more details for potentially more involved research than one simple survey. Consent is implied by the fact that the participant completed the survey, or participated in the focus group, or answered the interview questions. To utilize this form, a Waiver of Documentation of Consent must be requested on the Informed Consent Process Form.
This document provides tips for transitioning an existing, active project to the IRBOnline system.
This template can be used to document various events or issues that occur throughout the course of a research study.
Use this mapping table for existing applications submitted on the Protocol Form version 03/02/2022 to map the responses to the New Study Application in IRBOnline.
These worksheets will be used by OPRS to conduct any audits/Post-Approval Monitoring of research projects. Not all items or all pages are applicable to every project. These worksheets are provided to assist researchers with preparation for a monitoring visit, for use in conducting their own monitoring, and for general research compliance.
The Parental Permission form is the consent document that is used when the research participant is a child and the consent is being provided by the parent/guardian.
The Participating Site Application Form is used when UIUC will be acting as the IRB for an external site. A site might be another university, a hospital, a company, a community center, or an individual.
One Participating Site Application Form should be used for each university, company, etc. that is being added to an IRB application.
A Reliance Consultation is required before adding a site to an IRB application. Submit a Reliance Consultation Request if you need to schedule a consultation.
State radiation safety regulations require that all radiation administered to humans must be “authorized by a licensed practitioner of the healing arts.” This includes research as well as medical care.
The Campus Administrative Manual defines who is eligible to act as PI of a study. https://cam.illinois.edu/policies/rp-06/
As per this policy, upon approval by the applicable academic dean, institute director, or campus administrative officer, an individual in certain other positions may be permitted to act as PI.
Use this form to document approval by the applicable academic dean, institute director, or campus administrative officer. Once completed and signed, attach this form in the Documents section of the study application in IRBOnline under the "Other Documents" field.
This form should be submitted as soon as an investigator becomes aware they are leaving the University of Illinois at Urbana-Champaign and are engaged in human subjects research on active IRB protocols.
The Report Form (RF) application is used to submit problems, events, or information issues to the IRB for review. These may include Adverse Events, Protocol Deviations, Reports of Non-Compliance, and Unanticipated Problems.
List all investigators engaged in the research study, including those from other institutions.
This document contains additional consent template language that can be added to consent documents depending on specific situations. Specifically, this document includes all consent requirements for Greater than Minimal Risk research. This document also includes a Table of Contents for ease of use finding the language you need.
The IRB reviews recruitment methods, including advertisements, to ensure that they do not interfere with the equitable selection of participants. The IRB reviews proposed advertisements and solicitations for research participation to ensure that they do not violate the regulatory requirements of consent.
Assent means a participant's affirmative agreement to participate in research. Assent is used for children or adults with diminished decision-making capacity when the participant is unable to provide legal consent, which is provided by the parent or legally authorized representative.
Research defined as “Basic Physiological Research” is considered to fall outside of the IDE regulations and is therefore not defined within FDA regulation. Although the IDE regulations do not apply to this type of research, IRB approval and informed consent should be obtained prior to initiation of the study.
Certificates of Confidentiality (CoCs) are intended to protect the privacy of research subjects by prohibiting disclosure of identifiable, sensitive information to anyone not connected to the research except when the subject consents, or in a few other specific situations.
The IRB reviews payment arrangements to research participants (compensation) to ensure an equitable selection of subjects by only approving payment methods that are not coercive and do not present undue influence.
The revised “common rule” (effective January 21, 2019) requires that key information be included in
the beginning of the informed consent in a concise and focused presentation.
This pdf provides guidance for researchers and IRBs about special requirements for conducting and reviewing human subjects research involving any component of the Department of Defense (DoD).
Data Monitoring: The regular evaluation of data and documentation collected during a study to ensure both adhere to the approved investigative plan and the validity of data collected (White 2007).
Safety Monitoring: The observations required to minimize threats to the safety and welfare of research subjects (White
Exempt studies are minimal risk and fit within a set of established exemption categories. Exemption determinations are made by the IRB and may not be made by the individual investigator.
When exercise testing is used as part of a research study, investigators must provide the IRB with information regarding the safety plan.
Research activities may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.
When researchers ask questions about sex, gender identity, and/or sexual orientation, there must be an understanding of what is being asked and what information is sought.
To protect patient privacy, “covered entities” (all health plans, health care “clearinghouses,” and health care providers) must obtain specific, written authorization from a patient to use or disclose PHI. Patients must also be notified about their right to restrict the use and disclosure of such information.
This checklist will assist investigators in determining if an IND is needed from the FDA in order to conduct a clinical trial using a drug or biologic. The IRB may determine that an IND is not necessary based on the criteria below. However, the IRB may also require that the investigator request and exemption from the FDA, which requires the submission of an IND application.
This guidance pertains to when the IRB requests letter of support from an authorized individual at proposed research site(s) as part of the review process. A letter of support indicates to the IRB that individuals who may be impacted by, or who have an interest in, the research are generally supportive of the project.
Using multimedia tools to record the image and/or voice of an individual creates a record that requires careful handling and storage, particularly if the content of media or the purpose of the research may be considered sensitive.
This document provides comments and suggestions to assist with completion of the New Study Application Form. Please be aware that all notes are inserted as "Comments" in the documents.
The IRB does not allow the use of finder’s fees or bonus payments made specifically to individuals, such as investigators and study staff, who are conducting the research. Exceptions must be reviewed by the IRB in order to determine that the use of such methods does not create coercion or undue influence.
This guidance provides information about IRB considerations for privacy and confidentiality in research.
Employees may be exposed to a greater risk of invasion of privacy than other research participants who have no association with the sponsoring institution.
The IRB reviews the process of screening, recruiting, and determining eligibility. The IRB reviews proposed recruitment procedures and advertisements to ensure that they do not violate the regulatory requirements of consent.
It is the obligation of the IRB to consider the study design and overall quality of a study in order to effectively evaluate the risk-benefit ratio. If the IRB cannot determine that the risk-benefit ratio of a study is acceptable, it cannot approve the protocol under applicable ethical codes and regulations.
The IRB must consider the general criteria for IRB approval for all studies, including those that involve children. Federal regulations require additional safeguards when approving research involving children.
In some cases, the IRB may provide additional safeguards for research involving economically or educationally disadvantaged individuals.
Neonate: Newborns from the time of delivery up until 28 days old. The IRB may have additional considerations for the research that involves children and neonates.
Federal regulations require additional safeguards when approving research involving pregnant women and fetuses.
This log can be used to document blood draw attempts. In some cases the IRB may require this log to be completed and submitted as part of the data or safety monitoring plan.
This log should be used to document participant screening/eligibility, enrollment, and withdrawal from the research study.
This log can be used to document planned or unplanned contact with research participants.
This log should be used to document study-specific trainings of the research team (e.g. training on study protocol).