Informed Consent is a process. It must be conducted in language understandable to the persons being informed. Consent documents should be written in plain, every day language and include the following. Note – not every project’s consent process will require every item from this checklist. Generally, those checklist items containing bold/underlined portions should be considered mandatory.

q On BGSU Letterhead, which includes the department of the researcher (P.I).

q Consent written in first person (e.g., I, me, my)

q Language at the level appropriate for the participants (the mean adult reading level in the U.S. is 6-8^th grade).

q Explanation that the study is a research study or project.

q Explanations of the nature, purpose, and duration of the study. If it is experimental, participants must be informed of this.

q Explanation of procedures to be employed in the study (i.e., exactly what the participants are expected to do) and the time commitment required of the participants to complete those procedures.

q Description of risks (hazards, inconveniences, discomforts, stress) the participant may experience, as far as they are known and how any risks will be minimized.

q Benefits of the study in general and benefits to participants as individuals. All studies must have some benefit in order to receive HSRB approval.

q How confidentiality will be maintained and any limits to confidentiality.

q That the participant can withdraw her/his consent to the research or discontinue participation in the research at any time without penalty.

q Contact person(s). Include the researchers’ name and telephone number (students must include faculty advisor’s name and telephone number), as well as the following statement: “You may also contact the Chair, Human Subjects Review Board, Bowling Green State University, (419) 372-7716 (hsrb@bgnet.bgsu.edu), if any problems or concerns arise during the course of the study.” Alternate wording could be: "If you have questions regarding the conduct of this study or about your rights as a research participant, you may contact the Chair of Bowling Green State University's Human Subjects Review Board at (419) 372-7716 (hsrb@bgnet.bgsu.edu)."

q A place for signature and date of the participant if obtaining written consent; witness line should be included ONLY if required. Please note that the researcher is not a valid witness to the process of consent. (If you need assistance in making this determination contact the HSRB).

q If the signature portion of the form is intended to be a “tear off” for your records, make sure it has at least the project title on it so you can associate consent forms to their projects (in the event you are conducting multiple projects).

q That the participant may obtain a copy of the consent document(s), including the signed consent form, if they wish.

q NO use of “understand” phrases (e.g. “you understand,” “I understand”) – Substitute “I have been informed”, “It has been explained to me” or words to that effect

q No language that would absolve the researcher of negligence.

q If appropriate, that any significant new findings affecting risks will be reported to the participant.

q If audio or videotaping is involved, the uses to which the tapes may be put, how they will be secured and how long they will be retained by the researcher.

q If participant(s) are Non-English speakers, consent documents should be in their native language.

q If appropriate, debriefing procedures.

q If appropriate, that any significant new findings affecting risks will be reported to the participant.

q If appropriate, that any significant new findings affecting risks will be reported to the participant.

q If appropriate, circumstances under which the PI may terminate subject participation without subject consent.

q Conditions of participation such as age, health status, etc.

q If the study is therapeutically related, disclosure of alternate procedures the subject might choose.

q The following statement, if there are possibilities of physical risk: “As in all research, there may be unforeseen risks to the participant. If an accidental injury occurs, appropriate emergency measures will be taken.”