Informed Consent Overview - Module 2s Sec 3


Module 2 Objectives
Selecting Participants

Describing Research
Discussing Participation
Ensuring Readability
Assessing Understanding

Describing Research

Your participants should be made aware of certain information,

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 client's diagnosis. What are the participant's
other options? (In nontherapeutic studies, the alternative may simply be

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
child abuse, absolute confidentiality may not be possible. If this or a
similar possibility exists, then explain the circumstances 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 this is 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

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

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 well being,
these must also be clearly explained.