Checklist of IRB Requirements for Consent Forms
The consent form submitted to the IRB for approval MUST address the following:
1. “Consent Form” must be the title of the document, not “Informed Consent”. Informed consent is considered an action or an ongoing process of communication between the participant and research staff.
2. The consent form should be written in language that is easily understood by prospective subjects. Many consider it most appropriate to write the consent form between 5th and 8th grade reading levels.
3. Give the researcher(s)’ name(s) and contact information in the very first paragraph.
4. A statement that the study involves research.
5. A statement that identifies the funding source of the research project (if applicable).
6. Near the beginning, clearly state the purpose(s) of the research project.
7. Provide the reason(s) why the participant has been chosen/asked to participate.
8. Give procedures (including length of time assessment should take; number of questions included in a survey; etc.) that will be used to collect data.
9. For questionnaires/surveys/instruments that may be sensitive in nature, include in the consent form a sample question from the questionnaire/survey/instrument.
10. Identify any procedures that are experimental.
11. List the benefits to the participants.
12. List the physical and/or psychological risks to participants.
13. For studies that have the potential of being psychologically/emotionally distressful, a resource list of at least three mental health providers must be given to all participants. It must be stated who is responsible for covering expenses incurred in the event that the participant requires attention from a mental health provider. If the TxState Counseling Center is listed as a referral, please state that mental health services at the Counseling Center are free to registered students, but may be limited in the number of sessions allowed.
14. A protocol for the implementation of emergency medical procedures must be listed for studies with any risk of physical harm to participants. It must be stated who is responsible for covering medical expenses incurred in the event that the participant requires medical attention.
15. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the participant, must be included.
16. Give the details of any compensation offered to participants. If extra credit is provided to students who choose to participate, it must be stated that an alternative form of extra credit will be made available to students who choose not to participate.
17. A statement that participation is voluntary and participants may withdraw from the study at any time without prejudice or jeopardy to their standing with the University.
18. A statement that participants may choose to not answer any question(s) for any reason.
19. A statement that pertinent questions about the research, research participants' rights, and/or research-related injuries to participants, should be directed to one or both of the IRB co-chairs, Dr. Eric Schmidt (512-245-3979 – es17@txstate.edu) and/or Dr. Lisa Lloyd (512-245-8358 – LL12@txstate.edu), or to the OSP Administrator, Ms. Becky Northcut, at 512-245-2102.
20. Regarding the data collection procedures, the consent form must include a statement of confidentiality or anonymity. If the data collection is conducted in such a fashion where the participant is known to the researcher and the participant’s name can be matched to his/her data, the data collection procedure is confidential. If not, then the data collection procedure is anonymous.
21. Regarding data records and record keeping, include a statement describing the extent, if any, to which confidentiality of records identifying the participant will be maintained and how they will be secured.
22. The location and length of time the survey data, videotapes, audio recordings etc. will be kept must be explicitly stated.
23. The consent form must state that a summary of the findings will be provided to participants upon completion of the study if requested.
24. On the consent form, the IRB approval number must be noted.
25. In most circumstances, participants (or parent/guardian) and researchers must sign the consent form. If the data collection is to be conducted anonymously, then signed consent forms must be collected separately from other data (e.g. surveys, experimental behavior, etc.). In some instances, a signed consent form might not be required, but such instances must be approved by the IRB, requiring that the applicant provide the IRB with sufficient rationale for the complete omission of a signed consent form. The IRB may waive the requirement for the researcher to obtain a signed consent form for some or all participants if it finds either of the following:
a. That the only record linking the participant and the research would be the consent document, and the principal risk associated with the study is the potential harm resulting from a breach of confidentiality. In that event, each participant will be asked whether the participant wants documentation linking the participant with the research, and the participant's wishes will govern; or
b. That the research presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the research context. However, in cases in which the requirement to have signed consent forms is waived, the IRB may require the researcher to provide participants with a written statement regarding the research.
26. If the data is collected via an internet-BASED survey, the consent form must be included for the respondent to review before he/she starts the online survey. Furthermore, each respondent must indicate that he/she fully understands the consent form and its contents in order before participation is allowed. This is typically done by including a “check box” or some similar “field” that would allow the participant to consent/agree to participate simply by clicking on the field.
27. Participants must receive a copy of the consent form for all data collection protocols except internet surveys.