Informed Consent

Introduction

Federal code states that "[a]ny research project utilizing human subjects requires the informed consent of those subjects." The first step in the process is detailing the specifics of your study that are important to communicate to participants and to the IRB.

IRB Approval has to be considered

Remember that obtaining participant consent is a process.

Potential participants must understand the nature of the study and the risks and benefits involved if they are to make an informed decision about their participation. The details should be presented in simple language by someone who is knowledgeable about both the study and informed consent.

This process requires a "consent document" that explains the nature of the research and any risks and benefits to the participant. A copy of the consent document is reviewed by the IRB before it is presented to prospective participants.

Because informed consent is an ongoing process, it starts before any forms are signed, and it continues through the completion of the subject's involvement in the study. The consent document is only a confirmation of the consent process.

Selecting Participants

Recruitment of participants needs to be done in a nonbiased, non-power-based manner. It is important that none of the participants ever feel that if they do not participate in the study, they will be penalized. Convenience should not be the sole factor in the selection of participants. All avenues of recruiting participants should be investigated. The following relationships can be potentially troublesome for informed consent and have important points to be considered for ongoing care.

Therapist-Client

Therapist-client relationships between the investigator and participants should be avoided, when possible, to eliminate any power-based coercion. Clients can say no to someone they do not expect to see in the future, but it is very difficult for people to say no when they rely on someone for on-going care.

Participants often depend on therapists to make recommendations, and then they defer to the therapist's professional knowledge and judgment. They may not read the consent document fully because the therapist has already explained the procedure orally, and they consider the therapist the primary source for information.

There is a need to clearly distinguish the treatment from the research involvement and to exercise caution that the professional's influence does not dictate the subject's consent decision.

Teacher-Student

Special consideration of recruitment is also needed for instances when an instructor wants to include his or her students in a research study. The teacher cannot assume everyone in the class wants to be involved in the study. Students must be assured that their grade is not affected by their participation, and they should be able to decline participation without penalty.

Researchers may fail to identify the need for informed consent if the study is not perceived to have physical or psychological risks. Students may not see it this way. Participants, including students, have the right to refuse involvement in a research project even if there is no identified risk.

Employees as participants

Colleagues, subordinates, or peers should never be placed in a compromising situation with perceived retribution for not being a research participant. Recruiting through advertisements or a third party is a better strategy for avoiding coercion.

Proxy

When a participant is not of legal age or is deemed incompetent to consent to treatment, it is necessary for a proxy (family member, guardian, or friend) to decide consent.

Children

In justifying using children in your study, you must document the specific benefits the child will encounter. A parent or guardian must act as the proxy for the child and complete a parental permission form. Children also need to give their "assent." Assent is the affirmative agreement to participate in the study if the child is able to comprehend aspects of the research. You must develop a separate assent form. Try to tailor the assent document to the understanding of the child. Reasonable descriptions of discomfort should be included. Children can not give consent to research that entails risks that surpass the benefits.

Example:

The following documents are examples of consent and assent forms that have been approved by the Institutional Review Board (IRB).

Parental Consent Form

Children's assent form

Elderly

Participants that have diminished vision or hearing can oftentimes overcome the problems and consent themselves.If the person is determined to be incompetent, such as in the case of Alzheimer's disease or other brain diseases, the investigator must seek the consent of a proxy. The proxy may not know the wishes of the participant regarding research studies but should try to decide in the way the person would have decided. Investigators should ask proxies if they think that participants would have decided in the same manner if they were competent.

In either case, a proxy should discuss the decision with family members and/or the medical staff caring for the person. Even if the participant has been judged incompetent, the person should be considered competent to refuse.

Describing Research

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).

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 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 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 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 well being, these must also be clearly explained.

Discussing Participation

Informed consent involves educating prospective participants, not merely disclosing information. Providing information is part of the process. Discussions with prospective participants should take place with sufficient time for them to consider participation. Approaching them on the same day as the study would take place may not be sufficient. Participants may need time to think about their decision or to discuss their involvement with family, friends, or religious advisors. For best results, participants should be approached when they are willing to listen, and are open and ready to consider consenting.

The process of obtaining consent should include time for both discussion and reflection, as shown in the following steps:

1. Obtain approval from the IRB.
   
2. Present the prospective participant with the consent document.
3. Read through the document together, taking time to explain significant or difficult points about the research or participation. Answer any questions. Be certain to discuss risks, benefits, and alternative therapies in addition to purposes and procedures.
4. Give the prospective participant a copy of the consent document.
5. Allow the participant time to take the document home and discuss participation, if desired, with family or friends.
6. Meet with the participant again and ask open-ended questions about the nature of the study and participation to make certain he or she understands correctly.
7. If the participant is willing, have him or her sign the consent document.

Ensuring Readability

Readability of the consent document is an important component of the process. Your consent document information should be presented in nontechnical terms at a level that your audience can understand. If your document is not understandable, a claim could be made that the participant did not understand what was signed. A consent document must be made readable but without compromising the content.

• Direct it at an eighth-grade reading level.
• Use simple, straightforward sentences.
• Use commonly recognizable terms and measurement amounts.
• Avoid the use of jargon or technical language, and explain terms that may not be easily understood.

When you have finished writing the consent document, ask a lay person to read and explain it to you. A reader who has no association with the study can often help you to identify difficult or confusing areas in the document.

Study participants can not be excluded based on language barriers. If you have a participant who does not understand the language of the consent document, you must present a translated consent document or arrange for a qualified interpreter to translate your explanation and questions from the participant.

Assessing Participant Understanding

It is your responsibility as a researcher to ensure that prospective participants understand the extent of their role in your research. Read through the consent document with them and discuss participation prior to their involvement in your research. During these discussions you should answer questions and ask questions, too. Use open-ended and nondirective questions. Open-ended questions often begin with words such as "what," "where," "how often," "when," and "please describe."

A few of the questions you may want to ask are:

• Describe in your own words the purpose of the study.
• What more would you like to know?
• Would you please explain to me what you think we're going to ask you to do?
• What are your concerns?

However, the idea is not to quiz them. Foster an open exchange of information and encourage them to ask questions. Remind them to continue to ask questions as they occur during their participation. Their willingness to be proactive and ask questions does not release you from the responsibility to provide the necessary information on which their decision should be made.