Which Forms Should I Complete?
The IRB requires several forms to be submitted before your application is considered “complete”. Most of the forms were created using form fields to facilitate the paperwork process, with the exception of the consent/assent forms. On all forms where questions are asked requiring text responses, the field will expand up to 4000 characters. When accessing the forms below, do not “Open” the forms since you will receive an error message. Instead, please “Save” the applicable file(s) to your desktop and rename the file(s) using the following format [Principal Investigator’s last name_Type of Form] and submit each via email to irb@lawrence.edu. Be sure to follow the instructions on each form to complete the submission process accurately.
Forms and Templates
New Protocol Application docx doc rtf
All activities that meet the federal definitions of “research” and “human subject” should complete a new protocol application.
Continuation Review docx doc rtf
Federal regulations require that IRB approved protocols be reviewed and approved no less than once a year. The IRB sets the review date based on the level of risk. Complete this form if your review is coming due.
Modification Request docx doc rtf
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 docx doc rtf
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. 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.
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.
Debriefing Form docx doc rtf
If your research involves deception or manipulation, please complete the debriefing form.
Protocol Closure Form docx doc rtf
Complete this form when an approved human subject research project is concluded or cancelled. Projects that involve long-term follow-up of participants must remain open, even if enrollment of new participants has ended. Please include a final summary of the project with this form. Attach any results, articles, and reports to support the closure.
Protocol Violation Form docx doc rtf
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 irb@lawrence.edu to report the event/problem and a form will be sent to you for completion.
Student Researchers
In addition to the above forms, students must also submit the following:
Supervisory Faculty Assurance Form docx doc rtf
ALL student investigators must have a supervisory faculty member for their research project. Supervisory faculty members need to review and approve the student’s protocol application before it is submitted to IRB, and indicate their approval by completing this form.
Researching involving children:
Child Assent Form template docx doc rtf
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 docx doc rtf
Parental consent documents explain to the parents of potential participants: the nature of the research project, what risks, benefits, and alternatives are asociated 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.