The consent form submitted to the IRB for approval MUST address/include 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 the researcher.
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. Depending on the target population, the consent form (and other relevant documents) may be required to be written in a language other than English. Translating documents is typically accomplished by having a qualified individual translate the document(s) from English to Spanish, then having a second qualified person translate the resulting Spanish version back to English. This is done to ensure that the meaning embodied in the document is retained and that the document(s) was not merely translated “word-for-word.” Also, the researcher should consider whether an interpreter should be present during data collection. If not, justification should be provided.
4. Give the researcher(s)’ name(s), contact information and affiliation(s) in the very first paragraph.
5. A statement that the study involves research should be included in one of the first few sentences of the consent form.
6. A statement that identifies the funding source of the research project (if applicable).
7. Near the beginning, clearly state the purpose(s) of the research project.
8. Provide the reason(s) why the participant has been chosen/asked to participate.
9. Describe procedures (including length of time assessment/participation will require, number of questions included in a survey, etc.) that will be used to collect data in easily understandable terms and language.
10. For questionnaires/surveys/instruments that may be sensitive in nature, include in the consent form a sample question(s) from the questionnaire/survey/instrument so that each participant is fully informed prior to giving consent.
11. Clearly identify any procedures that are experimental.
12. A disclosure of appropriate alternative procedures or courses of treatment, if any, which might be advantageous to the participant, must be included.
13. List the benefits to the participants.
14. List the physical and/or psychological risks to participants.
15. 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. ho 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, and if your participants are registered TxState students, please state that mental health services at the Counseling Center are free to registered students, though the number of sessions allowed may be limited.
16. A protocol for the implementation of emergency medical procedures must be listed for studies with any risk of physical harm/medical complications to participants.ho is responsible for covering medical expenses incurred in the event that the participant requires medical attention.
17. Give the details of any compensation offered to participants (e.g., the amount of money on a gift card, the amount of extra credit, etc.). 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. This alternative form of extra credit must be clearly described. Researcher should ensure that the alternative form of extra credit is comparable to the requirements of the study.
18. 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 and any other relevant organization/entity with which the participant is associated.
19. A statement that participants may choose to not answer any question(s) for any reason. 
20. A statement that pertinent questions about the research, research participants' rights, and/or research-related injuries to participants should be directed to the IRB chair, Dr. Jon Lasser (512-245-3413 – lasser@txstate.edu), or to Ms. Becky Northcut, Compliance Specialist (512-245-2102). 
21. 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.
22. 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 and where they will be secured.
23. The location and length of time the survey data, videotapes, audio recordings etc. will be kept must be explicitly stated.
24. The consent form must state that a summary of the findings will be provided to participants upon completion of the study, if requested. Researcher should include instructions for participant with regard to how to access results of study.
25. On the consent form, the IRB approval number must be clearly noted. 
26. 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/desired, 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 a signed consent form for some or all participants if it finds either of the following:
    • That the only record linking the participant and the research would be the consent form, 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
    • 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 researcher must still provide participants with a written statement describing the research. This document is often a consent form with the signature lines removed.
27. If the data is collected via an internet-based survey, the consent form must be included for the respondent to review before starting the online survey. Furthermore, each participant must indicate that he/she fully understands the consent form and its contents 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/box.
28. Research that involves children must include documentation of “Assent.” This can be achieved by including a separate document that is intended to meet the federal mandates that require researchers to seek and obtain assent from minors for their participation in research when those minors are capable of providing assent (typically those who are 8 years old and older). Assent may also be acquired by including a signature line on the parental consent form for the minor to sign.   
29. Participants must receive a copy of the consent form for all data collection protocols. For internet-based surveys, participants should be instructed to print the consent document for their records.
30. Signature lines for both the participant and the researcher.
31. The consent form should neither ask nor imply that subjects are waiving any rights or releasing you from liability.