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 an d to the IRB.
Review of the Informed Consent Process
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 abou t 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 pro spective participants. Because informed consent is an ongoing process, it starts before any forms are signed, and it continues until the completion of the subject's involvement in the study. The consent document is only a confirmation of the consent proc ess. Simple Scenario: Informed Consent Process Flow If the study participants are members of a vulnerable population, more consideration must go into consent document development. Complex Scenario: Informed Consent Process Flow These flowcharts give you an summary of the issues that will require your attention when developing your consent document.
II. Selecting of 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, something will happen to them. Convenience should not be th e 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.
Participants often depend on physicians to make treatment recommendations, and then they just "go along" with the recommendations. They may not read the consent document fully because the physician has already explained the procedure orally, and they con sider the doctor the primary source for information. This might become a legal situation when the patient does not understand the consent document.
Physicians need to be aware of the complexities of the decision to consent to a research project and be sensitive to the potential for conflict of interest.
An additional problem is that researchers may not identify the need for informed consent if the study is not perceived to have physical or mental risks. Participants, including students, have the right to refuse involvement in a research project even if there is no identified risk.
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 shou ld 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.
III. Describing the 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.
Duration of Participant Involvement: State the expected duration of the individual's participation (indicate the number of sessions, if more than one).
Participant Qualification: State why the individual is eligible to participate.
Risks: Describe any foreseeable risks or discomforts the subject will bear. Include all reasonably common risks as well as potentially serious risks. Risks may range from inconvenience to bodily pain. Do not overlook "soft" risks such as confi dentiality and embarrassment. Treatment decisions will always involve a degree of uncertainty regarding the harmful effects. Calculating the probability that these situations will occur can aid in abating the risks; however, 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. If there are no benefits, clearly state this. 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.
Alternatives: State alternative procedures or courses of treatment, if any, that might be advantageous to the subject. 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. Include any techniques you may use for identifying data. The most common procedure is that the participant's identity will not be disclosed.
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. Incentives are sometimes offered by companies for recruiting subjects or conducting research on an investigational drug or device. This enticement may be either a monetary fee or a donation of equipment or materials. Researchers must report these incent ives to the IRB. The IRB might require that prospective participants be made aware of this information.
Compensation to Research Participants: 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 paym ent or no payment at all. Research-Related Injury: 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 inju ry can be obtained (for research involving physical contact or activity).
Contact Information: Give the name(s) of people who can answer questions about the research; include the principal investigator. Furnish the contact name of a neutral third party who can explain the rights of research participants if the partic ipant 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 discontinu e participation at any time without penalty or loss of benefits. If there are limitations to withdrawal, such as a danger to the participant's health, these must also be clearly stated.
IV. Discussing Participation
Informed consent involves educating prospective participants, not merely disclosing information. Providing information is part of the process. The essential elements to be conveyed are discussed in the previous section, "Describing the Research". Discussions with prospective participants should take place, if possible, prior to the research study - not on the day of the procedure. Participants may need time to think about their decision or to discuss their involvement with family, friends, or re ligious leaders. When possible, participants should be approached when they are rested and alert, and have access to eyeglasses or hearing devices if necessary.
The process of obtaining consent should include time for both discussion and reflection, as shown in the following steps:
V. Ensuring Readability
Readability of the consent document is an important component of the process. Your consent document information should be presented in non-technical terms at a level that your audience can understand. If your document is not understandable, a leg al 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.
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 an interpreter and document the resul ts.
You will find more information about this subject as you begin to write the consent document in module three.
VI. Assessing Participant Understanding of the Research
It is your responsibility as a researcher to ensure that prospective participants understand your research. Read through the consent document with them and discuss participation prior to their involvement in your research. During these discussion s 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:
VII. Process Quiz
Check your knowledge of the Informed Consent Process. Click on the correct answer to the question. Click on Return button to go to the next question.
When you are finished, the Next button will take you to the next module, or the Menu button will take you to the menu screen.
Question 1 of 5
Informed consent means that prospective participants understand and have consented to participate in a research study.
Question 2 of 5
It is not necessary for finder's fees to be reported to the IRB.
Question 3 of 5
When assessing participant knowledge of a research project, use ___________ questions.
Question 4 of 5
Discussions with prospective participants should take place on the day of the study.
Question 5 of 5
Participants must be informed of possible risks after they have consented to participation in a research project.
II. Selecting Participants
III. Describing Research
IV. Discussing Participation
VI. Assessing Understanding