In creating the informed consent form, the researcher should ask him or herself the following questions. Does the form…
» Introduce the participant to the research and researcher?
» Inform the participant about the purpose of the research?
» Estimate the time involved in participation?
» Estimate the number of participants involved?
» Read clearly at the fifth-sixth grade reading level?
» Identify where and when the study will take place?
» Describe the procedures involved in participating in the research?
» Identify any reasonably foreseeable risks, discomforts, or inconveniences that might occur as a result of participation?
» Inform participants of availability of follow-up or referral for treatment as necessary?
» Inform the participant of any potential benefits?
» Inform the participant of any alternatives to participation?
» Inform the participant of his/her right to decline to participate and to withdraw from the research once participation has begun, without any penalty?
» Include assurance of confidentiality/or in cases where anonymity is not guaranteed, explain how private data will be safeguarded?
» Include signatures and contact information for investigators?
» Include a place where participants might request information concerning the results of the research?
» Consider special cases such as research involving minors, pregnant women, or others unable to give informed consent? See links to policies concerning these groups if applicable.
Please feel free to contact the Charleston Southern Institutional Review Board at 863-7150 (or email the question to csinisi@csuniv.edu) if questions about these policies arise. Also, please see sample informed consent forms to aid you in the process of applying for approval of research. Sample informed consent forms include: Undergraduate Informed Consent and Parental Permission Forms.
Informed Consent Checklist
Informed consent is one of the primary ethical considerations underlying research with human subjects. When obtaining informed consent as required by Federal Guidelines and Professional organizations, researchers should make sure they do the following as minimum standards. More information should certainly be considered so that participants are comfortable, know what to expect, and feel free to withdraw from the research as personally necessary. 