University of Dubuque

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Informed Consent


Institutional Review Board

Informed Consent

AVAILABLE FORMS:

Informed Consent Form Template

Informed Assent Form Template (for minors, or for adults not capable of  giving informed consent)

Letter of Permission from Study/Recruitment Site (template)  (To be used when investigator wishes to recruit or study human subjects at, or gather data from, another organization. E.g., graduate students doing research for COM 689 should use this form as a model.)

EXPLANATION OF INFORMED CONSENT: The informed consent process constitutes an invitation to volunteer to participate in a research project. Every researcher (whether faculty, staff, student, or visitor) at the University of Dubuque must obtain the informed consent of any human subject participating in research. For research that requires expedited or full board review, the IRB must approve all informed consent forms to be used. Data collection may not begin until such approval is obtained. (As on the templates above, a line must be provided for the IRB Chair's signature. The researcher may then photocopy the approved/signed form for distribution to research subjects.)

Obtaining Informed ConsentThe 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, their age, associations with certain groups, their mental or physical capacities, or due to confinement in a mental hospital 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 (see next section).

Broadly, the informed consent document communicates to the prospective research subject the purpose, procedures including time commitment of the subject, risks and benefits of the study, a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained, 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 consent form 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 informed consent document is valid for one year. The subject should receive a copy of the informed consent.

In the informed consent document, the description of how confidentiality will be maintained should include an explanation of how identifying data will be securely stored and when they will be destroyed, particularly if the study involves greater than minimal risk to subjects. Studies in which subjects are interviewed, including oral history and ethnography studies, may utilize electronic voice/video recordings. Although these studies generally involve no more than minimal risk to subjects, the use of recording as part of the research procedure and the plans for storage and destruction of the recorded interviews and their associated identifiers should be disclosed in the informed consent document.

Notable Risk: 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.

Obtaining Oral ConsentIf 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.

Obtaining Minors' AssentParents or legal representatives typically sign consent forms permitting minors or adults incapable of giving adult informed consent to participate in research projects. If the subject is a minor or an adult incapable of giving informed consent, the IRB may require him/her to sign an "assent" form if it has been determined that the subject is able to read and understand a simplified version of the adult consent form. Language must be simplified as appropriate for the age group or mental capacity of subjects. A copy of the assent form to be used should be included with other materials submitted to the IRB for approval.

Informed Consent and Special Populations

Every potential subject who is a physically and mentally able adult (defined as anyone age 18 or over) 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. Minors or special adult populations who are being recruited as research subjects may be compromised in their ability to provide truly informed and voluntary consent and therefore require special safeguards to ensure that their rights are protected in the informed consent process. Special/vulnerable populations include such groups as:

  • Minors (anyone under the age of 18)
  • Prisoners
  • Persons with addictions
  • Individuals with mental or emotional disabilities/illness
  • Victims of physical and/or sexual assault
  • Pregnant women
  • Fetuses
  • Racial minorities
  • Elderly persons
  • Individuals who are very ill
  • HIV-infected individuals
  • Economically disadvantaged persons

Alteration or Waiver of Informed Consent

An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirement to obtain informed consent provided the IRB finds and documents that:

A.  The research is to be conducted by or subject to the approval of state or local government officials as follows:

  1. It is designed to study, evaluate, or otherwise examine (1) public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payments for benefits or services under those programs; AND
  2. The research could not practicably be carried out without the waiver or alteration

OR

B.   The research involves no more than minimal risk to the subjects, AND all the following apply:

  1. The waiver or alteration will not adversely affect the rights and welfare of the subjects;
  2. The research could not practicably be carried out without the waiver or alteration;
  3. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

An alteration of the consent procedure may be considered if the research meets all the criteria under A or B.

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either

C.   That the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality

OR

D.   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 the research context.