Informed Consent Procedure
Informed consent is not a single event or just a form to be signed. Rather, it is an ongoing process that takes place between the investigator and the subject. Informed consent is a basic tenet of ethical research with human subjects.
The basic concepts of the consent process include:
- full disclosure of the nature of the research and the subject’s participation,
- adequate comprehension on the part of the potential subject, and
- the subject’s voluntary choice to participate.
The Informed Consent Form must be on GS letterhead or maintain the letterhead elements and include the required Common Rule elements. (See the sample and/or checklist below.)
General Requirements for Consent
- Informed consent must be prospectively obtained from the subject or a legally authorized representative of the subject unless all or some element is specifically waived by your IRB approval.
- Information must be conveyed in language that is understandable to the subject and/or the subject’s legally authorized representative.
- The subject must be given sufficient opportunity to consider whether or not to participate.
- Consent must be sought only under circumstances that minimize the possibility of coercion or undue influence.
- Informed consent may not include any exculpatory language. For example, subjects must not be made to give up legal rights or be given the impression that they are being asked to do so.
- The format and language used for Informed Consent documents should be tailored to the subjects needs and level of comprehension.
- Even though 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. This may require multiple forms of delivery for your information.
- Individuals may not be involved as research subjects unless
- they understand the information that has been provided and informed consent has been obtained, or
- the IRB has approved a waiver for informed consent of the subject.
Factors involved in consent
- Ability to Provide Consent
- Informed consent assures that prospective participants understand the nature of the research and can knowledgeably and voluntarily decide whether or not to participate.
- It is a continuing process, not just a piece of paper; especially in a lengthy study, it may be necessary to obtain consent on more than one occasion or by more than one approach.
- It protects both the participant and the investigator, who otherwise faces legal hazards.
- Investigators may seek consent only under circumstances that provide prospective participants or their representatives sufficient opportunity to consider whether or not to participate and that minimize the possibility of coercion or undue influence.
- Furthermore, the information must be written/provided in language that is understandable to the participants.
- If the prospective participants include persons who are unlikely to be familiar with specific technical terms, persons with limited verbal or cognitive skills, or persons whose primary language is not English, special care must be taken to ensure that both oral presentations and written consent forms are comprehensible to all participants.
- When participants may include members of a vulnerable population (such as children, elderly persons, prisoners, or economically or educationally disadvantaged persons), additional safeguards are needed to protect the rights and welfare of those subjects.
Assent from Children and/or Adolescents
- When children and/or adolescents are participants in a research study, the investigator must solicit both the assent of the children and the permission of their parents or guardians. (There are limited exceptions for situations in which the parents’ interests may not adequately reflect the child’s interests.)
- In certain circumstances, older adolescents may have the legal authority to give their consent even though they are not yet legally considered adults (i.e., are under the age of 18).
- Also, the Buckley Amendment (FERPA) requires parental consent for release of records or identifiable information about children in public schools, and instructional materials to be used in connection with research must be available for inspection by parents or guardians.
- To minimize the possibility of coercion or undue influence, it is generally preferred that participants be recruited by open, written invitation rather than by personal solicitation.
- For similar reasons, it is also preferred that professors not solicit their own students as participants and that supervisors not include their own employees in research.
- If advertising will be used to recruit participants, the IRB needs to review that advertising to be sure that the information will not be misleading to potential participants.
- Similarly, if participants are to be paid for their time, the IRB needs to review the amount of the payment and provisions for full, partial, or no payment (for example, if a participant withdraws part way through the research) to assure that participants will not be unduly influenced by the payment.
The Consent Form
- In most cases, federal regulations require that participants sign a written consent form [45 CFR 46.117], although the written consent document is not a substitute for discussion of the relevant information with prospective participants.
- Participants must be given a clear and fair explanation of the research procedures, their risks and benefits, and provisions for confidentiality in the research.
Each participant must provide informed consent prior to participation. The person who signed the consent form must be given a copy as a reference and reminder of the information conveyed
- A “short form” may sometimes be approved for the consent [45 CFR 46.117 (b)(2)]. This means that the information is presented orally to prospective participants without a written version of it in the consent document.
- The IRB must review and approve a written summary of what will be presented orally.
- The participant must sign the short consent form (stating that the information has been provided orally), and a third person must witness the oral presentation and must sign both the short consent form and a copy of the written summary of the oral presentation. The investigator obtaining the consent must also sign the written summary.
- A copy of the written summary must be provided to the participants even though they are not asked to sign the written summary.
Waiver of Written Consent
- Waiver of written consent or use of an alternate method of documenting consent may only be considered if
- (1) the research involves no more than minimal risk,
- (2) the waiver or alteration will not adversely affect the rights and welfare of the participants,
- (3) the research could not reasonably be carried out without the waiver or alteration, and
- (4) whenever appropriate, participants are provided with additional pertinent information in a debriefing after their participation [Federal Policy §46.116(d)].
- Furthermore, especially in studies which involve the collection of sensitive information (e.g., sexual or criminal activity), a request to waive written consent may be considered only if
- (1) the only record linking the participant to the research would be the consent document and the main risk in the research would be the potential harm from a breach of confidentiality (in this case, participants must be asked whether they want documentation of their consent, and they may elect to sign a consent form or not), or
- (2) the research is no more than minimal risk and involves no procedures for which written consent would normally be required outside of the research context [Federal Policy §46.117(c)].
- The IRB may still require that a written statement of pertinent information be provided to participants who do not sign a consent form.
- It may be appropriate to waive written consent (but not informed consent) for fieldwork studies where the nature of the continuing interactions with the researcher is not easily reduced to a consent form.
- For some observational studies of people who are not aware that they are being observed or who are unaware that their behavior is being recorded for research purposes, it may be appropriate to completely waive the consent requirement if the knowledge to be gained is important, but such research can also raise serious ethical concerns about protecting the privacy of the unwitting participants.
- Similarly, it may be appropriate to waive the consent requirement for studies of pre-existing records if the information contained in the files is not particularly sensitive, the investigator has devised procedures to protect the confidentiality of the information to be collected, and the study could not practicably be carried out if consent were required.
- Sometimes investigators plan to withhold information about the real purpose of the research, or even to give participants false information about some aspect of the research. This means that the participant’s consent may not be fully informed.
- The degree to which this is acceptable depends on whether the information to be withheld would influence the decision of prospective subjects about participating in the research.
- When subjects have unwittingly participated in research or have knowingly participated in research that involved some form of deception, they should be debriefed afterward with pertinent information about the study whenever this can be done in a way that reduces rather than produces pain, stress, or anxiety.
- Additional resource information should be provided in case your subjects need someone to talk to after they leave you. This may be access to a counseling center, hotline or similar resource.
Special Conditions – Potential Injury or Personal Harm
- Although institutions are not required to provide care or payment for research injuries, the IRB generally expects investigators to provide a way for participants to obtain at little or no cost any services necessitated by research injuries. This information needs to be provided in the consent form if possible.
- In any case, the consent process must not involve the use of any exculpatory language through which the participant is made to waive or to appear to waive any of his or her legal rights, or releases or appears to release the investigator, sponsor, institution, or their agents from liability for negligence [Federal Policy §46.116].
Special Conditions – Psychological Harm – Potential and Minor
- The IRB strongly suggests that researchers consider the possibility of psychological distress which may result from discussion of disturbing events, reading or listening to possibly disturbing information, etc.
- Researchers should advise participants of psychological and/or counseling resources available to them, should psychological or emotional distress occur.
Special Conditions – Incentives
- Researchers are advised to consider the impact of incentives (if provided) will exert of potential participants.
- You must provide an explanation of compensation and an explanation of any additional costs the participant may incur are to be included in the Informed Consent Form. [45 CFR 46.116 (a)(6) & (b)(3)]
- You also must include conditions under which the participant may receive full payment, partial payment or no payment.
- Any payment that is provided from University or Grant funds must follow the procedures outlined in the GS Human Subjects Incentive Payment Policy.
- If compensation is to be given to participants, it must be reasonable and non-coercive. Keep in mind the economy of your subjects.
- g., $20 gift card will have a different value to small child versus an adult.
- g., A study occurring over a time period of several weeks with participants receiving payment of a $100 at the end of the study. In case participants need to terminate their participation (e.g., illness, family emergency, etc.) prior to their completing the study, prorating payment to the participant needs to be addressed in order to avoid coercion.
- g., If participants are Georgia Southern University students and extra credit points are being offered as compensation, a comparable alternate means of earning the extra credit points needs to be offered in order to avoid coercion.
Last updated: 12/17/2018