Informed Consent Process

Obtaining informed consent is more than just a form; it is a process. Informed consent must be obtained prior to any involvement of the participant in a study.

The informed consent process is an interaction between the prospective participant and the Principal Investigator, co- investigator, and/or other designated qualified key personnel. During the process, the research study is explained to the participant so that the participant can make an informed decision about whether or not to participate in the research study. This common sense process involves having a conversation with the prospective participants to ensure that he/she understands the research study and the reasons why the study is being conducted as well as the risks and benefits of the research. The conversation must allow the participant sufficient time to ask questions and to consider whether to participate in the study. This conversation must also take place in a setting that affords a sufficient level of privacy for the participant.

During this conversation, the participants are generally presented with the consent form. All consent forms must include instructions for the participants as to whom to contact regarding research related questions, research related injuries (if applicable) and how to contact the IRB regarding their rights as a research participant.

Participants are considered enrolled at the time of signing the consent form. If applicable, participants must be informed that they may be withdrawn if it is determined that they do not meet inclusion criteria.

Informed consent is an on-going process and the investigator and/or study personnel must keep participants apprised of any developments that may affect their willingness to continue to participate. This is particularly important for longitudinal studies. The PI should be available to answer participants questions at all times. In certain circumstances, it may be appropriate to remind participants of the purpose of the study and to remind them of the study procedures that will take place in the future. For example, longitudinal studies that require completion of multiple assessments over several weeks or several months should be accompanied by a brief informed consent document, not necessarily one that must be signed, to explain the research and the study procedures that must be completed at the point in time the assessment is to be completed.

The informed consent process should also take place in person.

The informed consent form is submitted as part of the IRB application. The consent form must contain a signature and date line for the participant (or the legally authorized representative) and for the person obtaining consent. Unless specifically required by the IRB, witnessing of consent is optional. The IRB may also determine whether assent is required and if so how it shall be obtained and/or documented.

The PI and study personnel are required to use copies of the most recently approved IRB forms when obtaining consent. The participant must be provided with a copy of the IRB approved document. The PI should also keep one copy of the consent form. Investigators are required to keep consent forms on file for 3 years following the completion of the research.

Informed Consent Requirements

As explained in the federal law that governs research with human participants, the informed consent process and document must contain certain required elements. Most of the elements involve basic, common sense information – information that most people would want to know in any situation before deciding to participate.

Except as subsequently noted, informed consent will be sought and documented for each participant choosing to participate in an approved project. Consent will be in lay terms and in a language understandable to the participant. (Preferably native language if the participant is not fluent in English.) Potential participants must be given sufficient time to have questions answered and to decide whether to participate. It must be explained that participation is voluntary and that choosing not to participate has no impact on benefits to which the participant is otherwise entitled. The consent process and document will contain the elements required in 45 CFR 46.116(a)(1-8) and 46.117 and may contain additional elements in 45 CFR 46.116(b)(1-6, and institutional requirements, as applicable. Exculpatory language which releases or appears to release the institution, sponsor or investigator from liability or which makes or appears to make participants waive any legal rights cannot under any circumstance be included in the informed consent document or process.

The informed consent form must include the following:

General

• Study Title
• Investigator(s) are listed as well as affiliation with Boise State (director, professor, student)
• Funding Source(s) (if applicable)

Purpose and Background

• Statement that study involves research
• Nature of the study
• Purpose and Goals of the study
• Brief description of the study pool (e.g., adult participants, Boise State COMM 101 students)

Procedures

• Step-by-step explanation of participation from subject’s point of view
• How data will be collected
• Length and frequency of each study procedure
• Total time commitment
• Where data collection will take place
• Conditions (if applicable)
• Options available (if applicable)

Risks

• All possible risks or discomforts (physical, emotional, social)
• Safeguards in place to minimize risks
• Required language if collecting a combination of demographic data that could make subject identifiable
• Required language if research involves serious psychological stress
• Required language if research involves serious physical risks

Benefits

• • All possible direct or indirect benefits
  • If no benefits, indicate larger societal benefits

  Extent of Anonymity and Confidentiality

  Confidentiality = individual can be identified directly or through identifiers, but the researchers promise not to divulge that information

  Anonymity = individuals cannot be identified by anyone, including the researchers

  • Extent to which subjects will be identifiable
  • Explanation if anonymity or confidentiality is promised
  • Explanation of use of video or audio recordings
  • Who will have access to data
  • When data will be destroyed (must be kept for minimum of 3 years, per federal regulations)
  • Statement if data will be published
  • Explanation of use of direct quotes; if using identifiers or pseudonyms, etc.

  Compensation

  • Statement indicating subject will receive compensation or will not receive compensation
  • Amount of compensation, how it will be received
  • If offering extra/course credit, what equitable alternatives are available?

  Participation is Voluntary

  • Statement that subjects are free to withdraw from study at any time without penalty
  • If compensation is involved, statement explaining subjects will be compensation for their portion of the study.
  • Statement that subjects are free to skip any question they do not feel comfortable answering without penalty.

  Questions

  • Contact information for PI (and faculty sponsor for students)
  • Contact information for the IRB office

  Consent Documentation

  • Statement of consent
  • Signature lines (participant and person obtaining consent)

  Other

  • Language is free of scientific jargon
  • Text is readable and appropriate for the age and population
  • Free of exculpatory language in which the subject is made to waive or appear to waive any rights
  • Free of grammatical and typographical errors

  Who May Obtain Consent

  The PI or a qualified individual authorized by the PI on the IRB application may obtain informed consent. The individual who obtains consent must possess an in-depth knowledge of the protocol and be able to answer all questions posed by the participant. The individual obtaining consent must disclose their role in the study to the participant (e.g., PI, co-investigator, study coordinator, research assistant, etc.). It is strongly recommended that the individual obtaining consent has completed training in the protection of human participants in research (Link to CITI Training).

  Documentation of Consent

  The informed consent process is most often documented by use of an IRB approved consent form. Consent must be obtained from individuals who are at least 18 years old and who are competent to give informed consent. The PI must make a practical assessment of the participant’s capacity to understand the research, weigh the risks and benefits and make an informed decision about whether to participate. For example, the PI can facilitate this process by asking the participant open-ended questions that ask for explanations such as: “Please tell me in your own words what we’re going to ask you to do?”

  Consent will most often be documented using a standard, signed consent form that lists the required elements of consent. The participant (or the participant’s legally authorized representative) and person obtaining the consent (PI or delegate) must sign and date the form prior to study participation. The PI must provide the participant (or the participant’s legally authorized representative) with a copy of the document.

  When it is feasible, the PI or his/her delegate must sign and date the form in the presence of the participant. Written consent may not be necessary or appropriate in certain studies, such as surveys, interviews and other minimal risk research or in research where the participants are to remain anonymous. In these cases, the investigator should prepare an information sheet or cover letter appropriate for the study. An information sheet is similar to a consent form; it contains the same required elements but omits the signature section.

  The templates should be used; however, the IRB will consider alternative formats (e.g. letter format). The templates also provide guidance and suggested language that may be used to inform participants about the research study, the requirements for participation and the participants’ rights and responsibilities.

  The consent document must be written with language that is understandable. It should include plain conversational language, at an 8th grade reading level (or lower where appropriate), similar to the level used in popular magazines and newspapers to the participant population. Jargon and field specific terms should be avoided or if unavoidable must be defined. It must also be written in the second person (e.g., “You are invited to participate,” “Your child will be assigned,” etc.). If you need help with this, Microsoft Word has a tool to assess readability. The consent document should be prepared with a font that is easy to read such as Times Roman, Arial, or Garamond and use a font size no smaller than 11 point.

  Waiving or Altering Consent

  In some circumstances, the IRB may waive or alter the elements of informed consent. A complete waiver of consent is most often granted for research studies that involve the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens (45 CFR 46.101(b)) or those studies that are conducted by or subject to the approval of state or local government officials such as an evaluation of Medicare programs (45 CFR 46.101(b)(5)). When a complete waiver of consent is granted, the PI does not prepare a Consent Form or Information sheet and the participant is not told that his/her information is being used in a research study. To request a waiver of consent, the PI must complete the appropriate section of the protocol application. The PI must explain why the research could not practically be carried out without the waiver.

  In certain circumstances, the IRB may grant a partial waiver or alteration of certain required elements of the informed consent process. The two most frequent examples of when such waivers or alterations are granted are when the research involves use of deception or use of “implied consent,” for example, via the return of completed, frequently anonymous, surveys. In cases where deception is used, potential participants should be advised in the consent form that the information they are given is not complete and that they will be debriefed after the research procedures are completed. In cases where consent is implied, an information sheet must be provided to participants.

  In all cases the IRB is required to find and document justification for any alteration to the requirements of consent. Therefore, you must submit a “Request to Alter or Waive Consent” form with your IRB protocol application.

  Informed Consent Requirements When Using Deception

  The use of deception in research (e.g., participants are initially misinformed deliberately for purposes of the study) raises special issues. One consideration is whether the deception is necessary. A PI proposing to use deception must justify its use in the procedures section of the protocol application. Federal regulations prohibit the use of deceptive techniques that place participants at greater than minimal risk. The IRB may modify the informed consent process for research involving deception when participants are not placed at risk.

  The debriefing should include a detailed description of the ways in which deception was used and the reason why deception was necessary in order to carry out the research. The investigator is responsible for ensuring that the participant leaves the research setting with an accurate understanding of the purpose of the research and why deception was used. The debriefing process, including any written materials, should be provided to the IRB as a part of submitted protocols.

  Witness Signature

  The IRB may require that the entire consent process be witnessed by a research participant advocate, a representative of the IRB, research study personnel, a primary caregiver or other appropriate individual. A witness to the informed consent process may also be required for certain vulnerable populations (i.e. educationally disadvantaged, illiterate or non-English speaking individuals or when the study is complex in nature. The informed consent may, for example, be presented orally to the research subject, and signature will be obtained from the witness.

  Informed Consent with Special Populations

  The PI should discuss with the participant whether any special provisions will be needed for the consent process to take place. For example, hearing impaired individuals may want a sign language interpreter present or individuals with dyslexia may prefer to have the document read to them.

  For participants not fluent in English, the consent process, consent document, and all study related documents (e.g., survey instrument, medical release forms) must be presented in a language (preferably native) understandable to them. If it is expected that participants who do not speak English will be enrolled in a study, translated documents should be made available. The IRB must review and approve all foreign language versions of the consent documents. The informed consent process must also be conducted in a language understandable to the participant and may therefore require the use of a translator or sign language interpreter. In most cases, the translator may be a family member or friend of the participant, an employee of the institution or may be hired by the PI.

  For illiterate participants, at the onset of the consent process, the PI or designated individual authorized to obtain consent must ask the participant if any special provisions are required by them for the consent process, including having the consent document read to them. A witness to the process is required when obtaining consent from illiterate participants. An illiterate participant may make their mark on the consent form to indicate a willingness to participate.

  Assent from Children or Decisionally Impaired Individuals

  In the State of Idaho, only individuals who are 18 years old or older may legally consent to participate in research. This legal authority may be withheld from some classes of individuals with limited decision-making or cognitive ability.

  Assent is a knowledgeable agreement to participate in the project. It differs from “consent” which is recognized as being granted from an individual with the legal authority to do so. Children cannot legally give consent; however, they can provide assent. Adequate provisions should be made for soliciting the independent, non-coerced assent from children or cognitively impaired persons who are capable of a knowledgeable agreement. In cases where assent is obtained from a child or cognitively impaired participant, permission must also be obtained from parents or legally authorized representatives. In accordance with the ethical principal of respect for persons, if the person from whom assent is sought refuses, the person should not be enrolled, even if the parents or legally authorized representatives give permission. Alternatively, if the person from whom assent is sought agrees to participate, the person may not be enrolled if the parents or legally authorized representatives do not give permission. In rare circumstances, depending on the nature of the study and the age and circumstances of the child or decisionally impaired person, the IRB may waive the requirement for permission from parents or legally authorized representatives.

  The IRB will determine whether one or both parents must sign a parental permission form. The IRB may find that permission from one parent (or legally authorized representative) is sufficient for research involving no greater than minimal risk or for research involving greater than minimal risk but holding out the prospect of direct benefit to the participant.
  As a general guideline, if the participant is 11 years of age or older, the child signs and dates an assent signature line on the parental permission form and a parent or guardian signs the same form. In certain circumstances, the PI may propose or the IRB may require that a separate assent statement is necessary. For example, the PI may wish to reinforce the voluntary nature of participation and the nature of the study with minor participants in studies taking place at a school where the parents have already given permission of the minor participant to participate in the study.

  If a separate assent form is required, both the form and the assent discussion with the participant should be in a language especially tailored for participant, i.e., age appropriate. It should briefly explain in basic terms:

  • They are being asked to participate in a research study;
  • The purposes of the research study;
  • An estimate of how much time is involved in participating;
  • What will happen to them if they agree to participate (e.g. “answer some questions”);
  • The foreseeable risks or discomforts they may experience (immediate risks/discomforts rather than future or theoretical possibilities);
  • The benefits which may reasonably be expected from the research;
  • That they should ask their parents or the researcher any questions they have about participating;
  • That their research is voluntary (up to them), and they may stop at any time;
  • That their parent/guardian knows they have been asked to be a part of the study.

  The assent form should be limited to one page. Illustrations might be helpful and larger type makes it easier for some individuals to read. In studies involving older children or adolescents it may be possible for the child to read and indicate their written assent on the assent form.

  If the child is less than 11 years of age, the parent or guardian signs the parental permission form, the participant signs nothing. No written assent statement is required; however, the PI should provide a script that will be followed to describe the study to participants. However, the PI or person obtaining consent must document in the study record that the child was willing to participate.

  Informed Consent in International Research

  Field research done outside of the United States, especially in non-western societies or places where the participants do not speak English, can pose some problems in obtaining written documentation of informed consent. In these situations, it is sometimes impossible, for a variety of reasons, to obtain written consent. If that is the case, the PI must provide the IRB with a statement of the reasons why it should waive written consent, and also provide an acceptable alternative method of obtaining oral consent, which is appropriate to both the participants and their culture.

  If the participants may be economically or educationally disadvantaged, the investigator should pay particular attention to these issues and ensure that appropriate safeguards have been implemented.