Common Problems with Informed Consents
The review of IRB protocols is often delayed due to flaws in the consent procedure. Here is a list of common problems with IRB02 submissions.
- Not written to the reading/comprehension level of the prospective participant. All consent documents should be written at an 8th grade level or (if appropriate for population) below. All assent scripts must be written to be age/comprehension appropriate.
- Does not provide an assent script when minors may be involved.
- Does not list separately risks to individual participants and how these have been minimized, benefits to individual participants, and compensation to participants. Note that compensation is not a benefit.
- Uses technical terminology and/or jargon. All terms that are above an 8th grade reading level must be paraphrased or defined so to be absolutely clear. Think of the consent dialogue as a conversation with the potential participants, not as a legal document for the protection or benefit of the researcher or IRB.
- Wording does not reflect voluntariness of participation (replace statements like You will… with You will be asked to… or precede a statement with If you agree to participate… or With your permission… )
- Does not provide an explanation of how participants’ privacy will be protected.
- Does not detail information regarding compensation or include a statement noting that compensation is not provided. When credit is offered as compensation, does not state how many credits are offered for what anticipated amount/period of time. Does not explain if this is extra credit, credit added to an exam, or experimental credit. Does not explain what procedure will be used to assure participant receives credit when offering credit and promising anonymity.
- Does not identify Principal Investigator (and where applicable, the faculty supervisor) by name and connection to the University of Florida.
- Places conditions on participant’s right to not answer questions (e.g., You do not have to answer any question that makes you uncomfortable.).
- Does not inform potential participant of intent to make “audio” or “video” tape recordings during data collection, who will have access to the tape(s) and what will be done with the tape(s).
- Statements in the informed consent are inconsistent with or contradict statements in the protocol submitted. One common inconsistency is when the protocol describes the treatment of data as anonymous, but the consent document describes how a list linking their names to their data will be maintained. If you don’t need to maintain such a linking, don’t do it, and don’t say that such a list will be used.
- Does not adequately explain the procedures from the perspective of the participant.
- Does not inform participants of the length of time anticipated for participation or how many sessions (if more than one) and over what period of time participation is requested.
- Contains grammatical errors (subject – verb agreement, use of affect vs. effect, punctuation).
- Contains typographical errors.
- Uses technical terminology and/or jargon.
- Uses the term(s) “waiver” or “release.” Federal regulations prohibit the use of “exculpatory” language in the cosent process
- Contact Us
- Deadlines for Full Board Review
- Directions to IRB02 Office
- Required Training for IRB-02
- Other Resources
- Report Non-Compliance to IRB-02
- Web-Based Submission Tracking for Paper Studies within IRB-02
Investigator Information & Guidelines
- myIRB Phase-in Announcement
- Preparing to Submit a Study for Review in myIRB
- Types of Study Review by the IRB
- Converting Paper Studies to myIRB
- FERPA Information for use of Educational Records in Research
- Lotteries and “Random Awards” as Incentives for Research Participation
- Guidelines for Revising an Approved Study
- Definition of Terms Used in IRB02 Documents
- Student Roles & PI Qualifications for IRB-02
- Use of Amazon Mechanical Turk (MTurk) for social/behavioral Research Projects
- Informed Consent Instructions & Procedures
- Adverse Event Reporting Form
- Clinical Trials Assessment Form
- Continuing Review/Study Closure Form
- Cumulative Adverse Event Table for Continuing Review
- Cumulative Deviation Table for Continuing Review
- Debriefing Form: Sample
- Deviation/Non-Compliance Reporting Form
- Legacy Paper Study Submission Form
- Legacy Paper Study Revision Form
- myIRB Protocol Submission Form
- Unaffiliated Investigator IRB02