Informed consent means the knowing consent of an individual or their legally authorized representative without undue inducement or any element of force, fraud, duress or any other form of constraint or coercion. Sufficient information that a reasonable person would want to have in order to make an informed decision about whether to participate must be presented in understandable language such that the potential subject can make an informed judgment about participation.
Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate. This part of the consent must be organized and presented in a way that facilitates comprehension. Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
Research involving human subjects can pose complex ethical issues that require careful thought and consideration on the part of both researchers and research participants. Prospective participants must be given key information to allow them to make informed decisions about whether or not to participate in the research.
Key Information Elements:
- A statement that the project is research and participation is voluntary.
- A summary of the purpose of the research, procedures, and duration of participation.
- Reasonable, foreseeable risks of discomforts.
- Reasonable, expected benefits.
- Alternative procedures or course of treatment, if any
As a researcher, it is your responsibility to educate the participants about the study purpose, the procedures, the risks and benefits, and obtain their consent before involving them in your research, and keep them informed. While a consent document that gives this information, and more, is a vital part of the process, the opportunity to discuss any questions or concerns with a knowledgeable research team member is also necessary. This is the “informed consent process”.
It is essential that consent forms be written in plain language that research subjects can understand. The consent document should always be revised if there are changes in the study that might affect the participant or when additional information will improve the consent process.
In addition, the consent form should not contain any exculpatory language. That is, subjects should not be asked to waive (or appear to waive) any of their legal rights, nor should they be asked to release the investigator, sponsor, or institution (or its agents) from liability for negligence.
NOTE: All informed consent documents must be submitted on appropriate letterhead.
- A statement that the study involves research
- Explanation of the purposes of the research
- Name(s) of the principal researchers and sponsor(s) where appropriate
- Expected duration of the subject’s participation
- Description of the procedures to be followed
- Identification of any procedures which are experimental
- Description of any reasonably foreseeable risks or discomforts to the subject
- Description of any benefits to the subject or to others which may reasonably be expected from the research
- For research involving more than minimal risk, an explanation as to whether there are any treatments or compensation if injury occurs and, if so, what they consist of, or where further information may be obtained
- NOTE: A risk is considered “minimal” when the probability and magnitude of harm or discomfort anticipated in the proposed research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests)
- Explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights
- Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
- Statement that participation is voluntary, their right to decline to participate and to withdraw from the research once participation has begun and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
- Statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility
- Statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies
- If applicable, a statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit
- If applicable, a statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions; and
- For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen)
Course requirements: When research participation is a course requirement or an opportunity for extra credit, the prospective participant is given the choice of equitable alternative activities.
Participants incapable of giving informed consent: For persons who are legally incapable of giving informed consent, you must, nevertheless (1) provide an appropriate explanation, (2) seek the individual’s assent, (3) consider such persons’ preferences and best interests, and (4) obtain appropriate permission from a legally authorized person, if such substitute consent is permitted or required by law.
Web-based studies and obtaining consent: In the case of web-based studies, informed consent can be “documented” by requiring participants to click on a link or image that indicates acceptance of the consent form (i.e. a button that says “I accept” or “I agree”, and advances participants to an online study web page that is otherwise inaccessible. The consent form for web-based studies must include required elements of consent as/if applicable to the study.
Assent from minors: Assent is defined as “a child’s affirmative agreement to participate in research.” By the same token, a child’s passive resignation to submit to an intervention or procedure should not be considered assent.
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research recommends that the assent of children should be required when they are seven years of age or old (i.e. ages 7-17).
UNC Charlotte’s IRB believes that children should be given the opportunity to express or discuss their willingness to participate in a given research project or not and recommends that the assent process should be developmentally appropriate to the age of the children. For the intelligent older child, the assent process may be almost indistinguishable from the consent process one would use with a competent adult. For a younger child, it may be a much simpler process.
The researcher should take into account the child’s experience and level of understanding and compose a document that is at the same time respectful of the child and conveys the essential information the child needs to make a decision.
In language the child can understand, the form should:
- include a brief statement of purpose;
- describe procedures (including time commitment);
- affirm the voluntary nature of the assent process;
- describe, if applicable, any pain or discomfort that may be experienced;
- include a brief explanation of alternatives, if applicable;
- describe benefit or compensation, if any; and
- offer to answer questions.
While the design of an assent form is a critical component of the assent process, no form will ever replace the thoughtful discussion of assent with a child.
Other thoughts on the assent form: Limit the document to one page if possible. Include or attach pictures or any graphics that might be helpful to convey information to the child. The use of a larger font size might also be helpful to young children. Studies involving older children or adolescents should include more information and may use more complex language than studies involving younger children.
Waiver or Alteration of Informed Consent Procedure: Investigators may request a waiver of informed consent or alteration of the consent procedure if certain criteria are met. In these cases, the IRB may approve a consent procedure that does not include or that alters some or all of the elements of informed consent. The following criteria must be met:
- The research involves no more than minimal risk to the subjects;
- The waiver or alteration will not adversely affect the rights and welfare of the subjects;
- The research could not practicably be carried out without the waiver or alteration and, where appropriate,
- The subjects will be provided with additional pertinent information after participation.
It is the responsibility of the investigator to provide sufficient reason(s) why the waiver is necessary and explain whether the entire informed consent is being waived.
Waiver of Documentation of Informed Consent: The regulations require written, signed documentation of consent unless waived by the IRB. The use of digital signatures is not yet a common practice and, in most cases, there is no way to obtain this kind of consent documentation over the Internet.
An IRB may waive the requirement for actual signatures if it finds either:
- That the only record linking the subject and the research would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality, or
- That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
Consent document revisions in on-going studies: Study participants need to be informed of any new and important information that might affect their willingness to participate. If new information, knowledge, or an adverse event has been discovered, it should be communicated to the subjects. This may require a revised consent document.
New information will require the investigator to evaluate the facts to decide on a revised consent document for future participants as well as what information should be given to former or current subjects. If existing subjects are being re-consented, then the changes should be highlighted for them instead of just giving them a new form to sign with the changes embedded in it.
Unexpected complications, adverse events, or breaches in confidentiality all signify developments that may require a revised consent form. Consult the Office of Research Protections and Integrity to establish if a revised document is required.
To discern the key components of informed consent, you need to understand the ethical issues of research involving human subjects. The principles of autonomy, beneficence, and justice are basic to these ethical issues and merit your consideration.
Autonomy means that each person should be given the respect, time, and opportunity necessary to make his or her own decisions. Prospective participants must be given the information they will need to decide to enter a study or not to participate. They should not be pressured to participate. Likewise, there should also be no unrealistic inducements to participate in a study.
The principle of autonomy requires that protection be given to potentially vulnerable populations such as children, the elderly, the mentally ill, or prisoners. Individuals in these groups may be incapable of understanding information that would enable them to make an informed decision about study participation. They are considered potentially “vulnerable.” Consequently, careful consideration of their situation and needs is required and extra care must be taken to protect them. For example, how will you assess the diminished capacity of an elderly individual, who will be the guardian, and how and when will you involve another individual as guardian in the process?
Beneficence obligates you, as the researcher, to secure the well-being of all study participants. It is your responsibility to protect participants from harm, as well as ensure that they have an equal opportunity to experience the possible benefits of involvement.
Balancing risks and benefits is an important consideration. The key, according to the 1979 Belmont Report on the protection of human subjects, is to “maximize possible benefits and minimize possible harms.”
When do the benefits to society outweigh the possible risks of research? This is an ethical question that researchers face. The peer review process and the principle of beneficence help you answer this question and protect your research participant’s rights.
The ethical considerations of risks versus benefits raise the question of justice. Who should bear the risk of a study? Who is equal and who is not? Who should receive the benefits of the study?
The concept of justice may be questioned when we attempt to decide who will be given an opportunity to participate and who (and for what reason) will be excluded. Are some classes or persons being selected simply because of their availability, their compromised position, or their manipulability while others are not?
Keep the following tips in mind when selecting prospective participants:
- Participants should not be selected due to class, socioeconomic status, or race unless justified by study objectives.
- Provide justification or sound arguments for the exclusion criteria.
- Avoid the potential for “power-based” coercion. An existing relationship might require special consideration when expanding that relationship to include an investigator-subject role. Provision, or adjustments, might need to be made to attempt to equalize the roles.
- Professors should avoid administering surveys in their own classrooms. It is recommended that an unbiased person to perform that duty.
- Teacher-student relationships always carry a perception of inequality in roles. The informed consent process should reflect the precautions taken to balance the relationship and guard against even the perception of coercion.
Justice is a difficult and complex ethical issue. However, attempt at all times in your study to distribute the risks and benefits fairly and without bias.
Keep the principles of autonomy, beneficence, and justice in mind when you are selecting participants, obtaining consent, and conducting your study. The responsibility to protect and inform research participants is ultimately yours and cannot be ignored or delegated. Although you may delegate various tasks to certain team members, you cannot delegate the responsibility of protecting and informing participants of their rights to individuals who are not part of the research team identified in the protocol application.