Request to Determine Exclusion from IRB Review
Some projects involving human subjects or biospecimens are excluded from IRB review and oversight. The criteria for exclusion can be found in the federal regulations at 45 CFR 46.104. However, these regulations and the OHRP guidelines for interpreting them are vague and often open to a wide range of interpretations. For that reason the IRB encourages anyone who believes their project is excluded from IRB review and oversight to submit a request for determination of exclusion. The OHRP discourages individuals planning projects involving human subjects from making this determination themselves.
New Protocol Application
All activities that meet the federal definitions of “research” and “human subject” should complete a new protocol application.
Under 45 CHR 46.116(d) the IRB may waive the requirement for obtaining informed consent or approve a consent procedure that leaves out or alters some or all of the elements of informed consent, provided that the IRB finds and documents that all of the following four criteria are met:
- the research involves no more than minimal risk to the subjects;
- the waiver or alteration will not adversely affect the rights and welfare of the subjects;
- the research could not practicably be carried out without the waiver or alteration; and,
- whenever appropriate, the subjects will be provided with additional pertinent information after participation.
ALL STUDENT investigators must have a supervisory faculty member for their research project. Supervisory faculty members need to review, approve, and sign the student's application before it is submitted to IRB.
IT IS IMPORTANT to note that a new protocol application should not be made until all research instruments, including recruitment scripts, informed consent forms, surveys, interview questions, etc. are in their complete and final form. Submitting incomplete or draft versions of any material will cause the protocol to be immediately rejected without further review.
Incomplete or incorrectly completed protocol applications will be immediately rejected without review.
Federal regulations require that IRB approved protocols that exceed minimal risk must be reviewed and approved once a year. For minimal risk projects there is no longer an expiration date or need to file a continuation review. Complete this form if your project poses more than minimal risk and review is coming due.
The IRB should be notified before a change is made to a protocol, research instruments, or the informed consent process. If you are requesting modifications to your currently approved IRB proposal, please complete this form. No research can be implemented prior to IRB approval of the changes. If risks or subject populations have changed, the IRB may re-review a protocol at a different level of review than previously.
Informed Consent Form Template
Informed consent forms are used with children 13 years of age and older and adults. The required elements of informed consent are included in this template. The italicized words should be replaced with the recommended content or deleted if irrelevant. All other wording is standardized.
Researchers should print hard copies of this form (once all italicized words are replaced) for participants to sign. A copy must be provided to participants. Researchers should keep the signed original or a copy of it for their records. Informed consent may be obtained on-line. Documentation of the informed consent – either the signed informed consent form or documentation of consent obtained on-line – are typically held by researchers and must be retained for three years after the research is completed, unless otherwise approved by the IRB.
If you intend to develop your own informed consent form, please make sure that the essential elements of informed consent are included (in accordance with the OHRP informed consent checklist). The checklist summarizes the basic and additional elements of informed consent. Appropriate documentation for oral and written consent is detailed. In addition, it explains the certain conditions that must be met before IRB can waive the requirement for signed consent. Additional protections for children involved as research participants are discussed.
If your research involves deception or manipulation, please complete the debriefing form.
Protocol Violation Form
Complete this form within 14 working days of the occurrence when there is a protocol violation to an approved human subject research project. The IRB defines and categorizes protocol violations in two categories: Protocol Exceptions and Protocol Deviations. Protocol Exceptions are defined as the enrollment of a research subject in a protocol that fails to meet protocol inclusion criteria or a person who should not have been enrolled based on protocol exclusion criteria. Protocol Deviations are defined as a departure from the protocol for a research subject once that subject has actually been satisfactorily enrolled.
Adverse Events/Unanticipated Problems Reporting
It is the responsibility of the Principal Investigator (PI) to promptly report ALL adverse events and (un)anticipated problems to the IRB. Please contact email@example.com to report the event/problem and a form will be sent to you for completion.
Child Assent Form Template
Assent forms are typically used with children who are 7-12 years of age. Therefore, the target language level is a 4th grade reading level. This means that some very young children will need to have the assent read to them. For these reasons, the biggest challenge in writing assent forms is keeping the language and concepts appropriately simple.
Children 13 years of age and older are expected to give assent by signing the informed consent form used by adults. Some IRBs require a separate assent form for children 13 years of age or older, however this is not the policy of the LU IRB. However, if an investigator believes an assent form is better for this age group because of the complexity of the study or the nature of the study population, one may be used.
Please be sure to read the instructions on the form. Researchers should print hard copies of the form (once all italicized words are replaced or a different version of this form is approved by IRB for use) for parents/guardians. Assent and/or parent informed consent must be obtained prior to beginning research. Researchers should keep the signed original or a copy of it for their records. Documentation of the assent is typically held by researchers and must be retained for three years after the research is completed, unless otherwise approved by the IRB.
Parental Informed Consent Form Template
Parental consent documents explain to the parents of potential participants who are 7-12 years of age: the nature of the research project, what risks, benefits, and alternatives are associated with the research, and what rights their child has as a research subject.
Researchers should print hard copies of this form (once all italicized words are replaced) for their participants to sign. A copy must be provided to the child’s parent/guardian. Researchers should keep the signed original or a copy of it for their records. Documentation of the informed consent – either the signed informed consent form, short form, or written research summary – are typically held by researchers and must be retained for three years after the research is completed, unless otherwise approved by the IRB.