Researcher Guidance

Document Name Link to Document Type Summary
RGD: Advertisements RGD - Advertisements K1622.pdf262.53 KB Guidance

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.

RGD: Assent RGD - Assent L2922.pdf250.71 KB Guidance

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.

RGD: Basic Physiological Research RGD - Basic Physiological Research K2922.pdf237.67 KB Guidance

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. 

RGD: Certificates of Confidentiality RGD - Certificates of Confidentiality PDF259.43 KB Guidance

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. 

RGD: Compensation of Research Subjects RGD - Compensation of Research Subjects B2823.pdf251.51 KB Guidance

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.  

RGD: Concise Summary RGD - Concise Summary PDF222.8 KB Guidance

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. 

RGD: Department of Defense Research RGD - Department of Defense Research D0723.pdf248.57 KB Guidance

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).

RGD: Elements of a Data Monitoring Plan RGD - Elements of a Data Monitoring Plan L2922.pdf313.14 KB Guidance

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).

RGD: Elements of a Safety Monitoring Plan RGD - Elements of a Safety Monitoring Plan L2922.pdf265.63 KB Guidance

Safety Monitoring: The observations required to minimize threats to the safety and welfare of research subjects (White

RGD: Exempt Research RGD - Exempt Research version A0923.pdf332.6 KB Guidance

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.

RGD: Exercise Testing in Research RGD - Exercise Testing in Research K2922.pdf222.12 KB Guidance

When exercise testing is used as part of a research study, investigators must provide the IRB with information regarding the safety plan. 

RGD: Expedited Review of Research RGD - Expedited Review of Research PDF189.14 KB Guidance

Research activities may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110.

RGD: Gender Inclusive Language in Research RGD - Gender Inclusive Language in Research K2922.pdf238.74 KB Guidance

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.

RGD: HIPAA Privacy Rule & Authorization RGD - HIPAA Privacy Rule Authorization PDF344.57 KB Guidance

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.

RGD: IND Exemption Criteria RGD - IND Exemption Criteria K2922.pdf227.64 KB Guidance

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.  

RGD: Letters of Support RGD - Letters of Support A2423.pdf205.71 KB Guidance

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.

RGD: Multimedia Recordings RGD - Multimedia Recordings K2922.pdf244.87 KB Guidance

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.

RGD: New Study Application Annotated RGD - New Study Application Annotated440.11 KB Guidance

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.

RGD: Payments To Research Personnel RGD - Payments To Research Personnel pdf174.54 KB Guidance

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.

RGD: Privacy and Confidentiality RGD - Privacy and Confidentiality D0823.pdf236.97 KB Guidance

This guidance provides information about IRB considerations for privacy and confidentiality in research.

RGD: Recruitment and Enrollment of Employees RGD - Recruitment Enrollment Employees version L1322.pdf246.15 KB Guidance

Employees may be exposed to a greater risk of invasion of privacy than other research participants who have no association with the sponsoring institution. 

RGD: Recruitment Methods RGD - Recruitment Methods D1223.pdf251.35 KB Guidance

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.

RGD: Research Design RGD - Research Design K2922.pdf263.66 KB Guidance

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.  

RGD: Research Involving Children RGD - Research Involving Children D0723.pdf270.11 KB Guidance

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.  

RGD: Research Involving Economically or Educationally Disadvantaged Individuals RGD - Research Involving Economically or Educationally Disadvantaged Individuals L2922.pdf258 KB Guidance

In some cases, the IRB may provide additional safeguards for research involving economically or educationally disadvantaged individuals.

RGD: Research Involving Neonates RGD - Neonates L2922.pdf253.95 KB Guidance

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.

RGD: Research Involving Pregnant Women and Fetuses RGD - Research Involving Pregnant Women and Fetuses L2922.pdf268.83 KB Guidance

Federal regulations require additional safeguards when approving research involving pregnant women and fetuses. 

RGD: Research Involving Prisoners RGD - Research Involving Prisoners285 KB Guidance

Federal regulations place additional safeguards on research that involves prisoners as participants. The IRB reviews all research involving prisoners using the expertise of a prisoner representative (with no association to the prison involved in the research) and who is a member of the IRB.

RGD: Risk Assessment RGD - Risk Assessment233.67 KB Guidance

The IRB must conduct an assessment of the risks to participants in order to determine whether a study is approvable.

RGD: Secondary Analysis of Public Use Datasets RGD - Secondary Analysis of Public Use Datasets K2922.pdf243.86 KB Guidance

The University of Illinois Urbana-Champaign IRB has determined that data in the datasets in this guidance document has been stripped of identifiers and is publicly available. As a result, research using this data does not rise to the level of "human subjects research" under the federal Common Rule and University policies, and therefore, does not require IRB review.