Instructions for Developing an Informed Consent Document General Information. Describe the purpose(s) of this research study in lay terms. Purpose of the Study. Procedures. Risks. Benefits. Compensation, Costs and Reimbursement. Withdrawal or Termination from Study. Confidentiality.
Basic Elements of Informed Consent Purpose of the Research. Description of the Research. Risks. Benefits. Alternatives to Participation.
You should focus on explaining why the question is important, summarizing the history of the question, and describing previous theories and data that are relevant to the study you will describe. Finally, you should present the hypothesis that you have tested (or will test) in your study.
Follow these steps to write an effective consent form. Step 1: Title and introduction. Step 2: Description of the activity. Step 3: Risks and benefits. Step 4: Confidentiality and data handling. Step 5: Voluntary participation and withdrawal. Step 6: Consent statement. Step 7: Signature and date. Step 8: Contact information.
Please indicate with your signature on the space below that you understand your rights and agree to participate in the experiment. Your participation is solicited, yet strictly voluntary. All information will be kept confidential and your name will not be associated with any research findings.
Informed consent language should be written in the second person (“you”), not in the first person (“I”). Minimize passive voice to the extent possible. Example of passive voice: “A summary of results will be sent to all study participants.” Example of active voice: “We will send you a summary of the results.”