Your participants should be made aware of certain information, including:
Research Purpose: State the purpose of the research and give a fair explanation of your research procedures. Experimental procedures must also be identified.
Research Procedures: Explain tasks and procedures from the subject's point of view (what will he or she be expected to do?). Estimate the total amount of time for the person involved in the study. Explain the frequency of procedures and include any additional costs or charges for the research procedures with estimated amounts. State why the individual is eligible to participate or what criteria will be used to determine eligibility.
Risks: Describe any foreseeable risks or discomforts the subject will bear. Include all reasonably common risks as well as potentially serious risks and, if possible, indicate the likelihood of occurrence. Risks may range from inconvenience to bodily pain. Do not overlook "soft" risks such as confidentiality and embarrassment. Decisions about invasive procedures will always involve a degree of uncertainty regarding the harmful effects. Calculating the probability that these situations will occur can aid in explaining the risks.
The view of the nature of a risk will vary from participant to
participant. Be sensitive to the difficult task of determining if the
participant is more of a risk taker, is ignoring the risk(s), or has not
adequately understood the probability of the risk(s).
However, in special circumstances, such as for reportable conditions like
HIV positive, absolute confidentiality may not be possible. If this or a
similar possibility exists, then disclose the condition under which
information must be disclosed and to whom.
Contact Information: Give the names of people who can answer questions about the research; include the principal investigator. If the reseacher is a student, include the names and phone numbers of the principal investigator and, where applicable, the faculty supervisor for questions. Furnish the contact name of a neutral third party who can explain the rights of research participants if the participant has any questions.
Withdrawal: Always stress the fact that participation is voluntary. State that refusing to participate will involve no penalty or decrease in benefits to which the participant is otherwise entitled. Emphasize that the individual may discontinue participation at any time without penalty or loss of benefits. If there are limitations or risks involved in withdrawal, such as a danger to the participant's health, these must also be clearly explained.