Guidelines for Developing an Informed Consent

[Printable Word Document]

The consent process is a fundamental mechanism to ensure respect for persons through provision of thoughtful consent for a voluntary act.

The consent form is the document most often requiring revision or modification after IRB review. It is important to review and follow local standards as well as Federal regulations (21CFR50 and 45CFR46) for consent form preparation. These instructions are designed to assist investigators in meeting the requirements and to help minimize the need for revisions.

Index

General principles
Informed consent process
Basic elements of informed consent
Additional elements of informed consent
Helpful hints
Future Use of Stored Samples

General Principles

In writing the consent, it is essential to remember that you are inviting a person to join a research study.  Fully informing the subject about the project is important for their comfort and cooperation, for assuring that they understand the risks and discomforts imposed by the research and for safeguarding against legal problems in the future.  Be aware, however, that this is an information document, not a legal contract.

It is also important to remember that the consent document is only a part of the entire consent process. In addition to providing the written document to the potential subject it is the investigator’s responsibility to assure that the subject has adequate verbal explanation and answers all questions as truthfully as possible. It is also the investigator’s responsibility to assess whether or not the subject is able to adequately understand the nature of the research project and any associated risks, and is able to give genuinely informed consent.

Return to Top

Informed Consent Process

Informed consent is a process, not just a form. Information must be presented to enable persons to voluntarily decide whether or not to participate as a research subject.  The procedures used in obtaining informed consent should be designed to educate the subject population in terms that they can understand. Therefore, informed consent language and its documentation (especially explanation of the study's purpose, duration, experimental procedures, alternatives, risks, and benefits) must be written in "lay language", (i.e. understandable to the people being asked to participate). The written presentation of information is used to document the basis for consent and for the subjects' future reference.

• Use of the first person (e.g., "I understand that ...") can be interpreted as suggestive, may be relied upon as a substitute for sufficient factual information, and can constitute coercive influence over a subject. Use of scientific jargon and legalese is not appropriate. Think of the document primarily as a teaching tool not as a legal instrument.
• Describe the overall experience that will be encountered. Explain the research activity, how it is experimental (e.g., a new drug, extra tests, separate research records, or nonstandard means of management, such as flipping a coin for random assignment or other design issues).  Inform the human subjects of the reasonably foreseeable harms, discomforts, inconvenience and risks that are associated with the research activity. If additional risks are identified during the course of the research, the consent process and documentation will require revisions to inform subjects as they are re-contacted or newly contacted.
• Describe the benefits that subjects may reasonably expect to encounter. There may be none other than a sense of helping the public at large.
• Describe any alternatives to participating in the research project. For example, in drug studies the medication(s) may be available through their family doctor or clinic without the need to volunteer for the research activity. Choosing not to participate in the research study is always an alternative.
• The regulations insist that the subjects be told the extent to which their personally identifiable private information will be held in confidence.  The IRB will determine the level of adequate requirements for confidentiality in light of its mandate to ensure minimization of risk and determination that the residual risks warrant involvement of subjects. 
• If research-related injury (i.e. physical, psychological, social, financial, or otherwise) is possible in research that is more than minimal risk (see 45 CFR 46.102[g]), an explanation must be given of whatever voluntary compensation and treatment will be provided. Note that the regulations do not limit injury to "physical injury".
• The regulations prohibit waiving or appearing to waive any legal rights of subjects. Therefore, for example, consent language must be carefully selected that deals with what the institution is voluntarily willing to do under circumstances, such as providing for compensation beyond the provision of immediate or therapeutic intervention in response to a research-related injury. In short, subjects should not be given the impression that they have agreed to and are without recourse to seek satisfaction beyond the institutions voluntarily chosen limits. 
• The regulations provide for the identification of contact persons who would be knowledgeable to answer questions of subjects about the research, rights as a research subject, and research-related injuries. These three areas must be explicitly stated and addressed in the consent process and documentation. Furthermore, a single person is not likely to be appropriate to answer questions in all areas. This is because of potential conflicts of interest or the appearance of such. Questions about the research are frequently best answered by the investigator(s). However, questions about the rights of research subjects or research-related injuries (where applicable) may best be referred to those not on the research team. These questions could be addressed to the IRB, an ombudsman, an ethics committee, or other informed administrative body. Therefore, each consent document can be expected to have at least two names with local telephone numbers for contacts to answer questions in these specified areas. 
• The statement regarding voluntary participation and the right to withdraw at any time can be taken almost verbatim from the regulations (45 CFR 46.116[a][8]). It is important not to overlook the need to point out that no penalty or loss of benefits will occur as a result of not participating or withdrawing. It is equally important to alert potential subjects to any foreseeable consequences to them should they unilaterally withdraw while dependent on some intervention to maintain normal function.
• Informed consent must be prospectively obtained from the subject or the legally authorized representative of the subject.
• Subjects must be given sufficient opportunity to consider whether they want to participate.

Return to Top

Comprehension/Competency to Consent

• Even if the IRB has approved a consent procedure, it is the investigator's responsibility to ensure that each potential subject understands the information and to take the appropriate steps necessary to gain that comprehension.
• Individuals may not be involved as research subjects unless they understand the information that has been provided.
• Informed consent must be legally effective under applicable State law. Only legally competent adults can give consent.
• In most cases, minors cannot give consent – only parents or legal guardians can give permission for minors to participate in research.
• The evaluation of competency must be made on a case-by-case basis.
• In addition to obtaining permission from parents or legal guardians, provisions must be made for soliciting the assent of the children or incompetent adults. Assent documents are required for all child participants 7 years old and older unless the requirement is waived by the IRB.

Return to Top

Basic Elements of Informed Consent

All of the following elements will be provided to each subject:

• A statement that the study involves research
• An explanation of the purposes of the research
• The expected duration of the subject's participation
• A description of the procedures to be followed
• Identification of any procedures which are experimental
• A description of any reasonably foreseeable risks or discomforts to the subject
• A description of any benefits to the subject or to others which may reasonably be expected from the research
• A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
• A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
• For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained
• An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject
• A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits, to which the subject is otherwise entitled

Return to Top

Additional elements of informed consent

When appropriate, one or more of the following elements of information shall also be provided to each subject:

• A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant), which are currently unforeseeable
• Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent
• Any additional costs to the subject that may result from participation in the research
• The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject
• A statement that significant new findings developed during the course of the research, which may relate to the subject's willingness to continue participation, will be provided to the subject
• The approximate number of subjects involved in the study

Return to Top

Helpful Hints

The following are some basic principles that will enhance the readability of the consent and decrease the required revisions.

• Write in the second person ("you", the person spoken to.)
• Use simple language.
• Aim for a reading level of 8th grade or below.
• Use three syllable or shorter words.
• Avoid sentences longer than 20 words.
• Avoid paragraphs longer than ten sentences.
• Avoid medical terminology and abbreviations unless explained.
• Avoid medical jargon.
• Do not include excessive detail

Return to Top

Use an Appealing Format

• Use sufficiently large and readable fonts. Use larger fonts if the potential subjects are elderly or likely to be sight impaired.
• Use white space effectively
• Use bullets, tables, time lines or diagrams
• Avoid overuse of text styles
• Use section headings as outlined in the NJCIRB Template Consent if possible.
• Provide an initial line on each page.

Return to Top

Future use of stored samples

The collection and storage of human biological materials (samples) has become an integral part of the design of many research protocols. It is therefore most important that when subjects agree to participate in research, they understand that samples may be collected and stored for future research use. They must also know of any foreseeable risks and benefits associated with the collection, storage and future research use of their samples. Principal Investigators and IRBs should consider the following points when developing and evaluating informed consent documents that involve the collection, storage and future research use of human samples.

Written informed consent should be sought from subjects when biological materials are to be collected and stored for research purposes.

The consent document should include a thorough description of:

• The kind of samples to be collected
• The means of sample collection
• How long the samples will be stored
• The short-term intended use of the samples (e.g. for purposes of the current protocol only).
• The long-term intended use of stored samples (e.g. for future studies on the disease or condition covered by the current protocol, or for future non-specific studies).

The informed consent document should discuss issues of confidentiality:

• Will the samples include personal identifiers?
• Will the samples likely be shared with other investigators?
• Will the subjects have the option of specifying future use or no-use of the samples?
• Are there any foreseeable risks or benefits to subjects in collection, storage, and subsequent research use of their samples?
• Will results or interim findings of subsequent research be conveyed to subjects (if applicable)?
• The subject must give consent if cell lines are to be developed.

The Informed Consent document cannot imply that the subject has "donated" the specimen.  "Donation" implies abandonment of rights to the "property" and federal regulations prohibit requiring subjects to waive or appear to waive any rights as a condition for participation in the study. Whether or not the wording is contained in "the actual consent form" is immaterial.

Return to Top