1. The Informed Consent Process
- Every researcher (faculty, staff, or student) at Truman State University must obtain the informed consent of any human subject used in research before involving that person in the research project. Obtaining the informed consent of subjects is a matter of professional research ethics in every discipline at the University. Sample consent forms are included in this IRB Policy and Procedures Manual. The IRB strongly recommends that you use one of the sample informed consent documents enclosed in this information.
- The investigator must ensure that the circumstances under which consent is sought will provide the subjects (or their representative) with sufficient opportunity to consider whether or not to participate. The circumstances must also minimize the possibility of coercion or undue influence which might be experienced by the subjects. Many times the situation of the subjects may be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, their age, associations with certain groups, or their mental or physical capacities. Restriction of freedom of choice may also occur due to confinement in a mental hospital or in a jail, penitentiary, or correctional institution. Subjects in any of these categories are not excluded from research; rather, the investigator must make special efforts to ensure that potential subjects are given every opportunity to exercise free choice in consenting to participate in a research project.
- The consent document is not meant to be merely a legal record of the consent process. Nor is it meant to be the only communication between researcher and prospective subject. On the contrary, the document should be one part of the total process. Broadly, the informed consent document communicates to the prospective research subject the purpose, procedures, risks and benefits of the study, the subject’s rights in participating in research, and the freedom to decline to participate without any jeopardy. If applicable, the alternative treatments available will be explained. The individual will also be given the opportunity to obtain further information and answers to questions related to the study. The consent form should serve as a written summary of the exact information that was presented to the prospective subjects before their agreement to participate in the study. As such, it will provide a useful reference for both the subject and the investigator.
2. Obtaining Oral Consent
- If oral consent is necessary due to limited literacy or language comprehension, the subject or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. A witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation. The subject or his/her legal representative must be furnished with a copy of both signed documents.
3. Obtaining Assent If the subject is a minor
- An assent form must be signed by those subjects capable of reading and understanding a simplified version of the consent form signed by the parent or guardian. A copy of this assent form must accompany the parental consent form and the IRB project approval form. For those subjects who are too young to read an assent form, but who would be capable of understanding an oral explanation of the procedures, a copy of the oral explanation to be given must accompany the request for IRB approval, and be signed by the individual responsible for the oral explanation. The age, maturity, and psychological state of the subjects must be taken into account by the principal investigator when creating an assent form of an oral presentation to obtain oral assent from such subjects. Blanket consent forms cannot be substituted for consent or assent forms. Consent must be obtained for each research project.
4. Projects Which Meet the Criteria for Peer Review
- Research which meets the criteria for peer review, as listed on pages 11 and 12 of this document, may fulfill the requirement for informed consent by use of a cover letter or set of instructions. A sample cover letter is contained in this manual. A copy of the cover letter should, in most cases, should be presented to each subject. The investigator or faculty sponsor may present a justification for not presenting a cover letter to each subject on the “Application for Review of Investigations Involving Human Subjects”. This request must be approved by the peer review committee before the project begins.
5. Anonymous Questionnaires
- Many projects which meet the criteria for peer review use anonymous questionnaires returned by mail or placed in drop-box locations. (Remember that a subject is anonymous only if his/her identity remains individually unknown to the investigator. Where the identity is known but held secure from being known by others, the researcher is maintaining the confidentiality of the identity.) The researcher who is using an anonymous questionnaire may fulfill the requirements of informed consent by providing the subject with a cover letter or set of instructions about the project.
- The cover letter or set of instructions must contain, at a minimum, the following information:
- a. name of student conducting the project and name of the faculty sponsor and his/her academic division;
- b. the purpose of the project;
- c. a description of what the subject’s participation will involve, and the duration of the project;
- d. the possible benefit to the subject;
- e. an explanation of how confidentiality will be maintained;
- e. a telephone number where the faculty sponsor and student, if appropriate, can be reached if the subject has questions.
A copy of the cover letter or any other approved form of informed consent, including written description of verbal instructions, questionnaire, survey outline (written or verbal) and any other documentation, is to be submitted with the application.
6. Contents of A Written Informed Consent Document
- The Informed Consent Form must be written in a language easily understood by the subject; therefore it will be necessary to avoid technical terms or to explain them thoroughly when you need to use them. The form is intended to show that the subject or participant has a reasonable comprehension of the basic elements.
- The following items should be included in an informed consent document:
- Name of responsible investigator, title of the project, and identification of the project as research. The title should be identical with the project title filed with the IRB. If the title is revised, the Investigator must promptly advise the IRB administrator or peer review committee.
- Purpose or objectives of the research. Describe the justification for the research. If appropriate, indicate the number of subjects involved and why the subject is included.
- Description of procedures to be followed. Describe the subject’s participation and identify those aspects of participation which are experimental. Indicate the expected duration of the subject’s participation and the experimental procedures to be followed. As clearly as possible, explain exactly what the subject will do or what will be done to the subject. If the subjects are students, patients, clients or employees, advise that nonparticipation or withdrawal from the study will not affect their grade, treatment, care, or employment status, as appropriate.
- Foreseeable risks or discomforts – physical, psychological or sociological. Any foreseeable risks or discomforts are to be explained and described – a description of any foreseeable risks or discomforts to the subject or a statement of the absence of risks. Not only should you outline risks that might be greater than those encountered in everyday life of the type of potential subject but you should note any discomforts the subject may encounter, explaining their significance.
- Alternative procedures available. Describe any alternative procedures available in language the subject can understand, or indicate there are no feasible alternative procedures available for the study.
- Benefits to subject, similar subjects, and/or society. Describe the benefits of participants, or lack of benefits, to the individual subject as well as to society. (In most research projects, the subject receives no direct benefits. Increased knowledge or the development of improved treatments, therapies, or services are more common benefits of research. These benefits should be consistent with the stated purposes of the research and should be explained to the subject in the consent document.)
- How privacy will be protected, and confidentiality maintained. Indicate specifically how the investigator will keep the names of the subjects confidential, the use of subject codes, how this information will be secured, and who will have access to the confidential information. The subject should be advised whether or not anonymity or confidentiality will be maintained, and what dispositions will be made of identifying documents, data, or recordings. “Confidentiality will be maintained” is not acceptable. If there is a master list which includes subject name and subject code for collecting data, the master list must be kept under lock and key apart from any data collected.
- Treatment to be anticipated in case of injury. If more than minimal risk of foreseeable injury is anticipated, describe the facilities, medical treatment or services which will be made available in the event of an injury or illness to a subject. Description may include on- and off-campus services. If the research will not involve more than minimal risk, briefly explain how or why the investigator determined that the subject would be exposed to no more than minimal risk.
- Compensation to be expected in the event of injury. If compensation is to be provided to subject, include amount of compensation, method of payment, and schedule for payment, including whether payment will be made in increments or in one lump sum. If compensation is not to be provided to subject, inform the subject there will be no compensation for participation.
- Who to contact regarding questions related to the project. The standard paragraph recommended by the IRB is:
“I have been informed that any questions I have concerning the research study or my participation in it, before or after my consent, will be answered by (name of individual), (address), and (telephone number). [This refers to the principal investigator. In the event the investigator is a student, the name of the thesis advisor (responsible faculty member) must be included.]
- Who to contact with questions related to participants’ rights or risks. The standard paragraph recommended by the IRB is:
“(I understand that in case of injury,) if I have questions about my rights as a subject/participant in this research, or if I feel I have been placed at risk, I can contact the Chair of the Institutional Review Board, through the IRB administrator at (660) 785-XXXX” [This information must be included in all consent forms. If “no foreseeable risk or discomfort” has been indicated then the first phrase (in parentheses) should be omitted.]
- Participation is voluntary and participants can withdraw without penalty. The standard paragraph recommended by the IRB is:
“I have read the above informed consent. The nature, demands, risk, and benefits of the project have been explained to me. I knowingly assume the risks involved, and understand that I may withdraw my consent and discontinue participation at any time without penalty or loss of benefit to myself. In signing this consent form, I am not waiving any legal claims, rights or remedies. A copy of this consent form will be given (offered) to me.”
- The researcher/investigator is expected to explain the project to participants and answer their questions. The standard paragraph recommended by the Human Subjects IRB is:
“I certify that I have explained to the above individual the nature and purpose, the potential benefits and possible risks associated with participation in this research study, have answered any questions that have been raised, and have witnessed the above signature.”
- Participants are to receive a copy of the Informed Consent Form. The standard paragraph recommended by the IRB is:
“I have provided (offered) the subject/participant a copy of this signed consent document,” or, if research study does not exceed minimal risk, a Letter of Consent may be appropriate
7. Waivers to Obtaining Informed Consent and Alternatives
- Under certain circumstances, the use of written consent documents may be waived. All waivers must be approved by the IRB, or the Peer Review body if there is no more than minimal risk involved, and requests for waiver must be fully justified by the researcher when submitting an application to the IRB. A waiver includes both those cases in which the researcher desires not to use written consent documents and those cases in which the researcher desires to alter the consent form or to omit some elements of informed consent.
- The IRB may approve a consent procedure that does not include, or that alters, some of the elements of informed consent. The IRB may also waive the requirement for obtaining written informed consent under the following sets of conditions. In each case, the researcher must request a waiver with a full justification of the request.
- Biased Results: The IRB may waive part or all of the normal consent requirements if: a)the research involves no more than minimal risk to the subjects; b) the waiver or alteration of normal consent procedures will not affect adversely the rights and welfare of the subjects; c) the research could not be carried out practicably without the waiver or alteration; and d) whenever appropriate, the subjects will be provided with additional pertinent information after participation (CFR 46.116) This category of waiver includes those cases in which an investigator desires to withhold from the subject some information about the project that, if known by the subject, would bias the results of the study. Ordinarily, the investigator will plan a debriefing session after completion of the subject’s participation in order to provide the subject with the missing information, and give the subject the option of including his/her data in the study or having it destroyed. In no case should an investigator seek to withhold information about the research or the subject’s role in it solely to reduce the chances of refusal to participate by potential subjects.
- Sole identity: The IRB may waive the requirement for written consent if it finds that: a) 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 b) the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context. This type of waiver applies especially to anonymous interviews (including face-to-face and telephone interviews) wherein the investigator’s sole knowledge of the identity of the interviewee would come from the consent document. (45 CFR 46.117) Waiver of written consent procedures does not imply waiver of the researcher’s responsibility to obtain consent from the subject. In all cases, the researcher must provide the subject with a statement of the research that includes all relevant elements of informed consent. It is the recommendation of the Truman State IRB that, wherever practicable, when an informed Consent Form is waived, a cover letter be submitted to subjects which outlines the purpose and procedures of the project with a statement such as “completion of the survey and/or return of the questionnaire indicates consent to participate in the study.”This procedure is applicable when subjects are not at risk and enables preservation of anonymity. This process is recommended for projects which do not require Full Board review, both to preserve anonymity and to eliminate the need for maintaining and storing consent forms for three years following completion of the project. The subject must also be given a clear and free choice to accept the invitation to participate or to refuse without prejudice or penalty. If subjects are students, patients or employees of an institution in which research is being conducted, they must be informed that nonparticipation or withdrawal from the study will not affect their grade, treatment, care or employment status, etc.
8. Retaining and Storing Signed Informed Consent Documents
- Signed informed consent forms are legal documents, and the researcher has legal responsibilities in handling them. They should be stored in a secure location which is accessible to the University in the event that an inquiry should require an examination of them. Access to these documents should be limited to those persons who have a need to know their contents, ordinarily the investigator (and co-investigators), a representative of the IRB (usually the chair), the IRB administrator on behalf of the University, and authorized federal officials. In compliance with federal regulations, consent documents must be retained for a period of five years following the completion of the research.
- Consent documents become part of the IRB file of a project and, as such, are subject to federal audit. Therefore, the IRB will review carefully both the content of and the storage provisions for all consent forms.
- An investigator who leaves the University prior to the end of the five-year retention period for consent forms should notify the IRB of this fact, specifying the new location of the consent documents. For projects which are reviewed by a peer committee, consent documents should be stored in a central location within the division along with the application and other documents relating to the project. If consent documents are maintained by a graduate student or research assistant, they must be turned over to the responsible faculty member after data collection is completed. A change of location within the University that results in a new storage place for consent forms should also be reported to the IRB.
9. From Whom Do I Obtain Informed Consent?
- Every potential subject who is a physically and mentally able adult must provide consent to participate in research prior to the conduct of any activities that constitute the research encounter. This is the most general case and applies to all research. Regulations define an adult as anyone at least 18 years old. The ideas of mental and physical normalcy revolve around the ability of the subject to provide truly informed and voluntary consent. Variations from this norm may be a function of age or the circumstances of the subject. Although every possible variation from the norm cannot be predicted, the following are some typical cases in which informed consent is necessary.
- Children: Obtaining permission to conduct research involving children – that is, persons under 18 years old – requires special attention to the child’s age, his/her ability to understand what is asked of him/her, and his/her relationship to parents or guardians. In all cases, the investigator must demonstrate respect for the rights of the subject within the proposed consent procedures, which should be developmentally appropriate to the age and circumstances of the subject. A sample child assent form is found in the application packet.
- Parental Consent: Parental permission or consent in writing is generally required for all minors, under the age of 18, who participate in research.
- Adolescent’s Written Assent: From about junior high or middle school onward, a child’s written assent is needed (in addition to parental consent), because children in this age group usually can read and comprehend a well-constructed assent form. However, the investigator should use supplementary verbal explanations wherever needed.
- Child’s Assent: For elementary school age children, the investigator should obtain (in addition to parental consent) the child’s assent to participate. The explanation to the child should contain elements of consent expressed in a form the child can understand. A conversational question-and-answer setting is often necessary to achieve this goal. In addition, the child’s assent should be positive, that is, not merely a lack of dissent. If the child is old enough to render a signature, investigators are required to obtain a signed assent form.
- Very Young Children: For children below school age (e.g., infants, toddlers, and preschoolers) the investigator should give explanations that match the level of understanding. In many instances, the children’s nonresistant behavior may be interpreted as assent, but the investigator must use special care to discontinue the participation of children who appear to experience undue stress from the research procedures. A verbal script must be submitted as part of the protocol.
- Children who are wards of the state may participate in research only under very limited circumstances with the appointment of an advocate for the child for the duration of the research.
- Other Special Types of Subjects: Besides children, numerous other types of subjects require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential subject. The Belmont Report, which is included in the appendices, contains an important section on the application of its standards to informed consent. Every investigator should carefully examine this material.
- Among the types of subjects for which the researcher should have special concern in obtaining informed consent are the following:
- Prisoners: Obtaining the informed consent of prisoners to participate in research requires attention to their circumstances. The research should not provide the prisoners with advantages that would outweigh their ability to weigh the risks involved in the research. Moreover, the consent form should make it clear to prisoners that participation will have no effect upon their parole or treatment.
- Mentally Disabled: Although the federal government has not yet finalized regulations applying specifically to those institutionalized as mentally disabled, certain directions of additional protection are clear. The use of patient advocates appointed or approved by the IRB is necessary to guard patient interests.
- Fetuses, pregnant women, and human in vitro fertilization: Regulations require additional safeguards for the conduct of research involving fetuses, pregnant women, and human in vitro fertilization. Among the recommendations are systems for monitoring the acquisition of informed consent as well as other aspects of the research.
- Other Groups: Vulnerable and special populations include those subjects who, as outlined in federal regulations, must be provided extra protection, such as minors, prisoners, fetuses and pregnant women, and the mentally infirm.Other groups, such as racial minorities, the elderly, the economically disadvantaged, the very sick, and the institutionalized are described as vulnerable populations by the Belmont Report and are therefore provided similar protection when used as research subjects.
- Notable Risk Project: When research involves greater than minimal risk, the subject needs a reasonable enumeration of the risks in order to decide whether or not to participate. The list should not be constructed either to minimize real risks or to overstate them. Projects with risks should also list protection measures used to lower the risk potential or to ensure safety while the subject encounters the risks. If a project presents one or more risks, an injury clause needs to be included in the consent document.
- Although the regulations specifically mention only these special categories of subjects, the overall intent is clear. Whenever the potential research project has special features or circumstances that might alter the subject’s ability to render informed and voluntary consent to participate in research, the researcher has special responsibilities. There is no way to anticipate every situation. Therefore, researchers must use extreme care to respect the rights of potential subjects in developing the means of obtaining their informed consent.
- Oral history and ethnography provide good examples of interview methods holding generally minimal risk, but which also may make use of audiotapes that will not be erased at the conclusion of the immediate research project. It is necessary to use a separate release form for the audiotape advising the subject that his/her identity will be associated with the information he/she provides.