- Waivers to Obtaining Written Informed Consent
- Waivers to Obtaining Informed Consent and Alternatives
- From Whom Does the Investigator Obtain Informed Consent?
- Retaining and Storing Signed Informed Consent Documents
The informed consent process constitutes an invitation to volunteer to participate in a research project. Every researcher (faculty, staff, or student) at Prairie View A&M University must obtain the informed consent of any human subject participating in research. Sample informed consent documents are included in IRB Forms.
Obtaining Informed Consent:
The investigator must ensure that the circumstances under which consent is sought will provide the subject (or his/her representative) with sufficient opportunity to consider whether or not to participate. The circumstances must also minimize the possibility of coercion or undue influence that might be experienced by the subjects. Often the situation of the subjects may be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, 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 choices in consenting to participate in a research project.
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 the research, and the freedom to decline to participate without jeopardy. If applicable, 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 before signing. The informed consent document will provide contact information for the primary investigator and the IRB Chair to enable the subject to ask questions after the consent form has been signed. The expiration date of the informed consent document will be the approximate date of completion of data collection for the subject. The date may be different for each subject, depending upon the timetable for the research. The subject should receive a copy of the informed consent.
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 consent form stating that the basic consent form elements have been orally presented. Both the consent form and the outline of the oral presentation must be approved by the IRB. A witness must also be present for this presentation and must sign both the consent form and a written summary of the oral presentation.
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 the assent form to be used should be included with other materials submitted to the IRB for approval. For those subjects who are too young to read an assent form, but who would be capable of understanding oral explanation of the procedures, a copy of the outline of the oral explanation to be given must accompany the request for IRB approval. The age, maturity, and emotional state of the subjects must be taken into account by the principal investigator when creating an assent form or an outline of the oral presentation to obtain oral assent from such subjects.
The IRB may waive the written consent requirement if 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 breech of confidentiality; or 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. (45CFR 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 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 to enable preservation of anonymity. The subject must 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 non-participation or withdrawal from the study will not affect their grade, treatment, care, or employment status, etc.
Under certain circumstances, the use of written consent documents may be waived. All waivers must be approved by the IRB, and requests for waiver must be fully justified by the research 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. In survey based research, the answering of the survey and passing or mailing in of said survey instrument is evidence of consent and often preferable because the subject’s name is never linked to the research data.
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 three sets of conditions. In each case, the researcher must request a waiver with a full justification of the request. The sets of conditions are as follows: Benefit and service programs, biased results and sole identity. For more details on the criteria for each of these three sets of conditions, read the Rules & Procedures Manual.
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 18 years of age or older. 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 one cannot predict every possible variation from the norm, there are certain requirements for each age group and for other types of subjects such as prisoners, wards of the state, individuals with mental disabilities, fetuses, pregnant women, and other special populations. For more details on the requirements for each of these and other groups, read the Rules & Procedures Manual.
Notable Risk Project:
When research involves greater than minimal risk, the subject needs a reasonable enumeration of the risk 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 protective measures used to lower the risk potential or to ensure safety while the subject encounters the risk(s). 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 subjects of research have special features or circumstances that might alter their 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.
Many types of survey research 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.) With anonymous questionnaires, the researcher may fulfill the requirements of informed consent by providing the subject with a cover letter or set of instructions that includes the following items, as applicable: An explanation of the research project, its purpose and duration of participation time; an offer to answer questions concerning the project and information on how to contact the investigator; a statement indicating anonymity or confidentiality; and an indication that the return of the questionnaire will constitute the subject’s consent to participate (a statement of voluntariness must be included).
Signed informed consent forms are legal documents, and the researcher has the legal responsibilities in handling them. They should be stored in a secure location that is accessible to the University in the event that an inquiry should require their examination. Access to these documents should be limited to those persons who have a right 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 three 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.
The Progress Report requires an account of the exact location, the method of storage, and the names or titles of individuals (other than University and federal officials) having access to the consent documents. A copy of the informed consent document is to be submitted with the Progress Report if subjects are still being recruited. The IRB cannot approve the continuation of projects that omit this information.
An investigator who leaves the University prior to the end of the three-year retention period for consent forms should notify the IRB of this fact, specifying the new location of the consent documents. Signed consent documents must be turned over to the responsible faculty member after data collection is completed if a student or research assistant maintained the consent documents. A change of location within the University that results in a new storage place for consent forms should also be reported to the IRB.
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