Informed Consent

 

A research participant should be able to make an informed decision concerning participation, free of explicit or perceived coercion. Potential risks and procedures to minimize such risks must be stated in detail in clear, precise language. The form must give a clear and concise explanation of the research to be conducted and the procedures to be employed. The statement should be written clearly enough for the potential participant to understand what involvement in the study entails, so that they may make a reasonable, intelligent, and informed decision. The language should be kept simple, and the sentences short, and concise. Language should be understandable at the eighth-grade reading level for studies using adult populations.

 

Each statement should address only one topic for consent.  A statement should provide a way for the participant to declare them self fully informed and agreeing to participate on a purely voluntary basis. Finally, the participant should be given a copy of the consent form, and/or any information sheets that is required to read. A model consent form is available below.

 

Accessibility Note: The form must be written in language appropriate for the targeted participant population (e.g., English and Spanish versions should be written for a multi-cultural study). The typeface should be large enough so that participants with impaired vision can read it.

 

Elements of an Informed Consent Form

The elements below must be included in an informed consent form.

  • A statement that this is a consent to participate in research.
  • An explanation of the purposes of the research and the expected duration of the participants' involvement
  • A description of the procedures to be followed, and identification of any procedures which are experimental. If the purpose of the research cannot be fully revealed to participants, describe exactly what participants will be told, the justification for any deception, and plans to debrief participants after their participation in the research.
  • A description of any reasonably foreseeable risks or discomforts (both physical and mental) that could reasonably be anticipated. This includes any potential financial risks or burdens that could ensue such as who has responsibility for any costs or expenses that might arise from the study.
  • A description of any benefits to the participants or to others that may reasonably be expected from the research. In most research, expected results are tenuous, at best. If no direct benefits due to participation are foreseen, it is appropriate to state this.

■   A statement that participation is voluntary, refusal to participate in any part of the study or to withdraw entirely will involve no penalty or loss of benefits to which the participant is otherwise entitled, and the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.

  • A statement describing how anonymity and confidentiality will be maintained as well as the extent, if any, to which confidentiality of records identifying the participant will be maintained which should include how records will be kept confidential, (e.g., encrypted and password protected hard-drive, locked cabinet, erasing of tapes, etc.). If audiotaping is to occur, indicate who will hear the tapes, where they will be stored, and how and when they will be disposed of. If videotaping is to occur, indicate to whom the tapes are to be shown and where they will be stored.
  • The Principal Investigator(s) name(s) and affiliation(s).
  • Contact information for the HSRC chair and an explanation of whom to contact for answers to pertinent questions about the research and research participant’s rights, and whom to contact in the event of research-related injury to the participant. The informed consent form should include a phrase such as: If you have any questions regarding this research, you can call the IRB administrator XXXX  at (area code) TELEPHONE and email address. 
  • The informed consent form must have a line for the participants and researcher's signatures, and the date of consent. If the participation must be anonymous and the form is to be signed with an X, then the signature of a witness must also be obtained. The Investigator should retain a copy of the signed consent form and provide a copy to the participant.

 

Informed Consent with Minors as Participants

Participants under age 18 are considered legally unable to give informed consent. As human subjects, children are especially vulnerable. The following definitions are important for research with minors: (a) “Children” are persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted, (b) “Assent” means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent, (c) “Permission” means the agreement of parent(s) or guardian to the participation of their child or ward in research, (d) “Parent” means a child's biological or adoptive parent, (e) “Guardian” means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. The HSRC has decided that written assent should be obtained from children aged 12 and older; verbal assent should be obtained from children under 12 years of age. Assent from a child should be requested only after the child's parents or guardians have agreed that the child may participate. In most cases, the signature of one parent or guardian is sufficient. However, in studies involving greater than minimal risk, signatures from both parents or guardians may be required. Information provided during the procedure to obtain consent or assent from children should be presented in a form understandable by the children selected for the study. We encourage researchers to consider alternatives to the conventional consent form used with adults. Appropriate alternatives include: a checklist, pictures, role playing and audiovisual methods (slides, videos, cassettes). The basic information about procedures, purpose, selection, risks, benefits, and willingness of the researcher to answer questions should be provided to children serving as research participants.

 

Oral Consent

In certain cases, the Principal Investigator may determine that oral consent is more appropriate and more adequately safeguards the participant. Oral consent shall consist of a written consent document presented orally to the participant (or his/her legally authorized representative). The HSRC shall approve the written text of what is said to the participant or representatives. A copy of the information that is read to the participant should be given to them or the representative to keep. There should be a witness to the oral presentation who can attest that the information was given as stated.

 

When it Might be Appropriate to Omit Use of Consent Form

As a general rule, the HSRC believes informed consent should be obtained from all research participants. However, if the Principal Investigator believes that obtaining a signed consent form would be inappropriate, such a request must be justified according to the following criteria:

  1. The only record linking the participant and the research would be the consent form and the principal risk would be potential harm resulting from a breach of confidentiality.
  2. The research presents no more than minimal risk and involves no procedures for which written consent is normally required outside the research context. For example, in a sample survey of volunteers, investigators would describe the nature of the interview to the participants. Rather than seek written approval, participation here is regarded as de facto consent.
  3. Tacit Consent. When participation entails only the completion of anonymous written questionnaires, consent may be considered to be tacit. Provided that responses can in no way be used to identify participants, written consent is not necessary. (To ensure that participation is voluntary, the investigator should not be present when participants are filling out the instruments and participants must not be required to hand back their responses directly to the investigator.)

 

Example Informed Consent Outline 

  1. Purpose & Procedures: A fair explanation of the study’s purpose and procedures.
  2. Risks: A description of any possible discomforts and risk reasonably expected.
  3. Voluntary: Clear instructions that the subject is free to withdraw or discontinue participation at anytime without prejudice or penalty. Subjects must receive any promised compensation even if they discontinue their participation.
  4. Questions: An offer to answer any inquiries concerning the goals of the research or the research procedures and to provide a summary of results upon a request. A contact person and phone number should be provided.
  5. Confidential: A statement that the data collected is confidential and that the subject will not be identified by name in writing or orally.
  6. Data Management: Provide itemized explanation of how the data will be managed, stored, and protected.
  7. Video and/or Audio: When utilizing video and/or audio recordings, clearly receive confirmation from participant, explain how the researcher will use session video and/or audio recordings, who will have access to the recordings, and length of time stored.
  8. Participant Compensation: Explain that there will be no compensation or if compensation is given, explain that the participant may voluntarily withdraw with compensation promised.
  9. Researcher’s contact information.
  10. Confirmation that the subject is over 18.
  11. Restatement of voluntary participation.

 

Example Informed Consent Form (Not intended to be copied and pasted.  The example below is ONLY AND EXAMPLE each study requires a customized consent form.) 

Please acknowledge that you have read and agree to each paragraph by initialing each statement. 

 

Study Purpose (Create a clear and specific description of the study purpose and procedure)

___ I consent to participate in this study concerning the relationship between life events and journal writing. I understand that I will be expected to write in a journal three times, as well as complete some tasks on the computer. I understand that there are three phases to this study, two of which require my presence at the laboratory. Sessions at the laboratory will not exceed sixty minutes and my commitment outside of the lab will be limited to a fifteen-minute period.

 

Risk Mitigation - (Describe any risks to participants and include community-based services available to support participants)

___I understand that aspects of the study may ask me to reflect on life events that might elicit negative feelings initially, but that these feelings should dissipate over time. If these feelings do not dissipate, I understand that there are services available to assist me and I can contact these services if I feel I need assistance. I am aware that if I would like to utilize the services of a mental health expert, I can contact the Counseling Center at (XXX) XXX-XXXX or the Mental Health Center at (XXX) XXX-XXXX. I also understand that I will be given a list of contact numbers for these services.

 

Voluntary Participation

____I understand that I may stop my involvement in the study for any reason without penalty or loss of compensation.

 

____I understand that I may decline to answer any question asked of me, and that by doing so I will not be required to terminate my involvement in the study.

 

Questions

___ I understand that the researcher is willing to answer any questions I might have after I have participated in the study. The researcher reserves the right to answer questions regarding the findings of the study until after the project has been completed.

 

Confidentiality

___ I understand that no individual data will be reported and that the researcher will not share my individual results with me either during or after the project.

__ I permit publication of the results of the study with the agreement that appropriate steps are taken to maintain participant confidentiality.

 

Data Management

___I understand that data from this study will be kept no longer than five years after the study is complete.

___ I understand that data may be collected in written or digital form and the data will be stored under password protection.

___I understand that data collected in this study belong to the researcher.

___ I understand I may request to review the interview transcript and offer additional comments after the interview is complete.

 

Recording

___ I understand that the researcher will be utilizing (audio and/or video) to record the session(s). The recordings will only be used for (purpose). Only (researcher & other assistants names) will have access to the recordings. The recordings will be kept for (time range) in accordance with the study's Data Management agreement.

 

Compensation

___ I understand there will be no compensation for participation in this study. OR I understand that if I withdraw for any reason, I will not lose compensation for my participation.

 

Contact Information

___ I understand that matters relating to this study can be directed to (researcher) at (phone and email), or the faculty advisor at (phone and email). If I have additional questions or concerns about this study, I can contact The Evergreen State College  Human Subjects Research Committee at irb@evergreen.edu

Age to Consent

___ I acknowledge that I am eighteen years of age or older and that I have read and understand the above explanations.

 

Voluntary

____ Again, I understand that my participation in this study is voluntary and that I have the ability to withdraw at any point without penalty or loss of compensation

 

 

Participant’s Name (Print)             Participant’s Signature                  Date

 

I have presented this information to the participant and obtained his/her voluntary consent.

 

Researcher’s Signature                                                                  Date