Informed Consent Overview - Module 2m Sec 3


Module 2 Objectives
Selecting Participants
Describing Research
Discussing Participation
Ensuring Readability
Assessing Understanding

Describing Research

our 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).

Benefits: Describe any benefits to the participant or others that can reasonably be expected. Benefits may range from feeling good about participation to monetary compensation to free access to an experimental drug. Be careful, however, not to oversell any benefits. Calculate the probability that these beneficial effects will occur. This will aid in determining the weight given to the benefits. If there are no benefits, clearly state this. The consent document must describe the terms of any payments used to compensate individuals for their participation. This includes the conditions under which research participants would receive partial payment or no payment at all.

Alternatives: State alternative procedures or courses of treatment, if any, that might be advantageous and available to the subject. Provide information on what would be considered the standard treatment(s) for the disease being studied. What are the participant's other options? (In nontherapeutic studies, the alternative may simply be nonparticipation.)

Confidentiality: The informed consent process must describe the level of confidentiality of the research data and the measures that you plan to take to ensure that confidentiality is maintained. Describe the steps that will be taken to protect the participant's privacy. Also describe under what circumstances records will be made available and to whom. Include any techniques you may use for identifying data, such as creation of a numeric code. Subjects should be assured that their identity will not be disclosed.

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.

Disclosure of Potential Conflict of Interest: Researchers must inform their participants of any conflicts of interest they have in the research, such as a stake in a company that might benefit from the research. The IRB might require that prospective participants be made aware of this information.

Research-Related Injury: Compensation can fall into one of these categories when applicable:

  • the sponsor of the study has some funds available to pay for care for injuries resulting directly from being in the study,
  • the research project has not yet identified the source of payment for injuries, or
  • there is no physical component to this research so compensation is not required.
Indicate whether compensation or medical treatments will be available if the participant becomes injured. Include what the compensation/treatment consists of and where further information regarding research-related injury can be obtained (for research involving physical contact or activity).

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.


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