Informed Consent

Definition of informed consent:

Informed consent is one of the primary ethical principles governing research with human subjects; it assures that potential human subjects will understand the nature of the research and can make a well-informed and voluntarily decision whether or not to participate in a study.

“Informed consent” means that a person is granted the right to freely choose what they want to do.  The process of informed consent requires three key components to be ethically valid: information, understanding and voluntary agreement (these components are described more fully below).

New York State defines “Voluntary informed consent” (NY Public Health Law, Article 24-A; Section 2442: March 1998) as the legally effective knowing consent of an individual or his legally authorized representative, so situated as to be able to exercise free power of choice without undue inducement or any element of force, fraud, deceit, duress or other form of constraint or coercion.

The Federal definition of Elements of Informed Consent

Obtaining consent from subjects prior to their participation in a study is the foundation of ethical research.  Obtaining consent from potential subjects should be an ongoing process that takes place between the researcher and potential subject prior to participation and throughout the study.  Although a specific document is typically created to provide subjects with information, asking subjects to read and sign a document is only one part of the process.  A complete consent process should involve giving potential subjects verbal and written information about the study and allowing sufficient time to consider their options and ask questions about the study before making a decision.  Any new information that might affect their willingness to continue as a subject should be shared throughout the course of the study.

Consent is a legal concept – only legally competent adults can consent to participate in a study.  Children (individuals legally deemed to be a minor; younger than 18 years of age) or adults who are not competent (e.g., cognitively impaired persons) must give assent (affirmatively agree) to participate, but consent must be obtained from a parent or legally authorized representative.  Provisions must be made in the consent process of obtain both consent, and assent when subjects are not legally competent adults.  Even very young children (e.g., age 3 years and above) are able to give verbal and written assent provided the assent document is created within their developmental ability range.

Federal regulations specify certain information that subjects must be provided.  The requirements include eight pieces of information or “elements” that are listed below:

1. A statement that the study involves research.
2. An explanation of the purposes of the research and the approximate number of participants in the study (if it may have an impact on the decision to participate).
3. The expected duration of the subject’s participation.
4. A description of any reasonably foreseeable risks or discomforts to the subject.
5. A description of any benefits to the subject or to others that may reasonably be expected from the research.
6. A statement that describes the extent to which confidentiality of records identifying the subject will be maintained.
7. An explanation of whom to contact for answers to questions about the study itself, and whom to contact about questions about the rights of research subjects. NOTE: For student researchers, this must include the researcher, the faculty sponsor, and the campus HSRC Administrator.

Assessment of Risks

The risks to which research subjects may be exposed have been classified as physical, psychological, social, and economic. Since State University of New York at Fredonia research is primarily behavioral and social science research, a discussion of physical risks that typically occur in medical research is not included here. However, we want to remind all researchers is that it is rare for a study to have *no* risks at all, so we encourage you to think critically through the following.

            Psychological Harms:  Humans are by nature introspective, and pondering upon actions we have or have not taken may cause us emotional pain. Discovering that we are capable of violating societal and/or our own principles can be psychologically harmful. Emotional pain may be aroused when a subject is being interviewed or when filling out a questionnaire. Anxiety may occur when people they know (especially those in real or perceived authority) are involved. The range of psychological harm can run from temporary anxiety and distress to relapse of behavioral disorders. When research involves an element of deception, especially if the deception includes false feedback to the subjects about their own performance, there may be considerable psychological harm.

            Social and Economic Harms:  Social harms include both direct personal impact as well as effects upon the subject’s family and community. Invasions of privacy and breaches of confidentiality may results in embarrassment within one’s business and social group, loss of employment, stigmatization, and criminal prosecution. Areas of particular sensitivity are information regarding alcohol and drug use, mental illness, illegal activities, and sexual behavior. Confidentiality safeguards must be strong in these instances.

            Researchers must consider a wide range of potential harms and anticipate potential problem areas and design the study to provide an adequate level of protection. Risks, even when unavoidable, can be reduced or managed. Precautions, safeguards, and alternatives can be incorporated into the research activity to reduce the probability of harm or limit its severity or duration. IRBs are responsible for ensuring that risks are minimized to the extent possible.

Informed Consent Process with Children 

Federal definitions applicable to research and consent with children include:

(a) Children are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.

(b) Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.

(c) Permission means the agreement of parent(s) or guardian to the participation of their child or ward in research.

(d) Parent means a child's biological or adoptive parent.

(e) Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care.

When children are involved in research, federal regulations require the assent/consent of the child and the permission of the child’s parent(s).  Although children are incapable of giving legal informed consent, they usually are capable of providing assent/consent or refusal to participate in an activity. Out of respect for children as developing persons, they should be asked whether or not they wish to participate in the research once they reach the age of 2-3 years.

When conducting research with children, special consideration must be given to minimize coercion to participate. Researchers must be cognizant that children are in a dependent relationship with adults; thus, care must be taken to ensure that their decision to participate as human subjects is truly voluntary. The following factors should be taken into consideration when developing research procedures:

• Concrete rewards for participation may be used, but should not be so valuable, within the value system of the child, as to outweigh legitimate reluctance to participate.
• Consideration must to taken to minimize social pressure to participate, particularly peer pressure and fear of ridicule for not participating.
• Steps must be taken to minimize the coercion implicit in requests to participate from parents, teachers, or other adult authorities.

In general, researchers should refrain from having teachers or parents request children to participate in research. Researchers should avoid using phrases such as “will you help me” or “we would like your help with this” since children are not likely to refuse to help an adult. Rather, children should simply be asked if they want to participate. 

Because children cannot legally give consent, federal regulations require the permission of their parents and the assent (the affirmative agreement) of the child-subject. In general, the HSRC prefers that investigators first invite participation from the child and then the parents or legal guardian of the child. Circumstances in research protocols may make this order of consent impracticable; that is taken into consideration by the HSRC, but the application must explain why the proposed sequence is being requested. If a child refuses participation in a study, s/he should not be enrolled, even if the parent or legal guardian gives permission. Alternatively, if the child agrees to participate, but parental consent has not been granted, the child may not participate in the research.

Tips for creating a “user-friendly” Informed Consent Document

In order for the consent form(s), attend to the following tips:  

• Use language for adult consent forms that could be understood by someone with an 8^th grade education.
• Use bulleted lists rather than long sentences.
• Assure that the required elements are covered, including:

1. A statement that the study involves research.
2. An explanation of the purposes of the research and the approximate number of participants in the study (if it may have an impact on the decision to participate).
3. The expected duration of the subject’s participation.
4. A description of any reasonably foreseeable risks or discomforts to the subject.
5. A description of any benefits to the subject or to others that may reasonably be expected from the research
6. A statement that describes the extent to which confidentiality of records identifying the subject will be maintained.
7. An explanation of whom to contact for answers to questions about the study itself, and whom to contact about questions about the rights of research subjects. NOTE: For student researchers, you must include contact information for yourself, your faculty sponsor, and the campus HSRC Administrator.

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