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HUMAN SUBJECTS
Developing a Consent Agreement
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An important aspect of human subject research is developing an appropriate consent agreement, unless the requirement for a consent protocol has been waived by the UHSRC under federal guideline 45 CFR 46, 116 (d).

A good consent agreement not only provides human subjects with a wealth of information not necessarily available to them elsewhere, but also informs the UHSRC that the subjects’ interests are well protected by the researcher.

Although EMU does not have a specific consent agreement that is universally recommended, due to the wide variety of human subjects research, there are certain items that are required by the federal government in institutions approved to carry out research using human subjects.

In appropriate research circumstances the consent agreement required by the UHSRC should include statements that:
  • Provide information on confidentiality of the subject and explain the purpose of the study

  • Explain risks and benefits to the participant

  • Estimate time needed to complete the proposed study

  • Explain rights and privileges of subjects

  • Explain that no rights may be denied to the subjects while participating to gain agreement to research

  • Provide that the information regarding procedures has been thoroughly explained and subjects are free to suspend or conclude their participation at any time

  • Explain how and when the collected information provided will be distributed, disseminated, published, protected, or destroyed

  • Provide a form that includes the P. I’s name(s) and contact phone number(s)

  • Provide the name(s) and contact number(s) of the EMU Human Subjects Committee Co-Chairs for any questions regarding the consent agreement and research protocol approval procedures

  • Include verbal consent assurances if participants are below the age of consent in the State of Michigan (18) and an approval to participate signed by their parents or guardians

  • Provide minors a separate developmentally appropriate oral or written consent (i. e., when non-literate) protocol to be witnessed by an adult. For upper elementary, middle school, and high school students, a consent form written in developmentally appropriate language should be signed by the minor

  • Include approval to use facilities and involvement of researchers or organizations other than Eastern Michigan University

  • Provide a copy of the informed consent so the subjects will have complete information with phone numbers of the researchers in their possession

  • And, if the potential for any harm to the subject exists, a list of potential agents to offer physical, emotional, psychological, or medical services

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One electronic and one paper copy of the following should be provided to the UHSRC for review: (1) consent agreement; (2) research questions to be asked of the subjects; (3) "Request for Approval of Research Involving Human Subjects" form.

All request forms will be provided an expedited review by a minimum of two faculty members of the UHSRC and will be approved following this review. If questions arise during this process, one of the UHSRC co-chairs will contact the researcher to clarify or ask for additions/ recommended changes.

Only a request that is surveying a federally protected population (e. g., minors, pregnant females, incarcerated, or infirm) and places these or other subjects in a research situation beyond minimal risk will necessitate a full board review. Approval to conduct research will be conveyed by the administrative co-chair via email to be followed up with a formal letter of approval following approval by the full UHSRC.

Doctoral students receiving a formal approval letter in response to a human subjects request should place a copy of this Consent Agreement and approval letter in an appendix to the final copy of the dissertation to be provided to the Graduate School.

The following are sample paragraphs taken directly from consent agreements that cover these issues that have been approved by the UHSRC. These are provided as templates to guide the development of the Consent Agreement.

  • "I understand that information that I give will be held in the strictest confidence and that my responses will be kept separate from my identifying information. All information will be kept in a locked file in the locked office of the Principal Investigator."

  • "While there should not be risk to you in participating in this study, there is the possibility that as you respond to the images (or questions) you may feel some distress through identifying painful experiences from your own past. If you feel any such discomfort, you have the right to stop at any time and seek assistance. Additionally, if such distress is felt after the interview has been conducted, you may contact the person in charge. As a licensed professional counselor, I will be able to provide a space for you to discuss your feelings, or alternatively refer you to someone who is qualified to do so."

  • "You can help us in this project by filling out two questionnaires. It should take 20-40 minutes to complete. Participation in this project is strictly voluntary, and if you choose not to participate, this will in no way affect any interactions with ***** or Eastern Michigan University. You are free to withdraw your participation at any time. If you do choose to participate, you will be paid $10. 00 when you return the complete set of questionnaires."

  • "I fully understand that I may withdraw from this research project at any time without prejudice or effect on my standing with Eastern Michigan University. I also understand that I am free to ask questions about any techniques to be used or procedures to be undertaken."

  • "It is my right to withdraw at any time from completion of the study without penalty. I have read all of the above information regarding this study. The procedures and requirements have been explained to me, and I understand them. I freely and voluntarily consent to be a participant. For my records, I have been provided with a copy of this consent form."

  • "The interview will be tape-recorded to enhance accuracy. Later, when the interview is transcribed, your name will not be attached to the transcript, and I will be asking you to choose a pseudonym by which your interview will be identified, protecting your identity in any transcripts of the interview. The interview tapes themselves will be erased immediately after transcription (or destroyed following completion of this study). This informed consent form, with your real name, will not be matched with the data, and your participation will be kept confidential."

  • "This study is being conducted by researchers in EMU’s **** department and the (other agency) to better understand students’ experiences while taking a typical class. In this questionnaire, we would like you to provide some information related to your background and respond to statements about your motivation-related beliefs and attitudes, the ways that you study, and your perceptions of your class and teacher. In addition, if you participate, your instructor will receive feedback on students’ learning skills and motivation that will help him/her improve his/her teaching. Later in the term, we will ask that you complete another questionnaire in class about those same topics. We also ask for your permission to obtain your final grade in the course."

  • "Please note that this is NOT A TEST. THERE ARE NO RIGHT OR WRONG ANSWERS to this questionnaire. We only ask that you answer each question as honestly and accurately as possible about your experiences in this **** class."

  • "In the unlikely event of a physical injury resulting from research procedures, I understand that medical treatment will be arranged, but the costs of the treatment will be my responsibility since Eastern Michigan University will not provide financial compensation."
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Content Posted 09/24/2013 | Design Posted 04/17/2012