Front image
direct edit

 

EMU Research

Developing a Consent Form

 

The information on this page reflects information in the revised human subjects regulations, effective January 21, 2019, and the European Union General Data Protection Regulation (EU GDPR), effective May 25, 2018. Research that  may  enroll subjects located in EU countries (e.g.,  all online survey research ) must be compliant with EU GDPR Requirements (see below).

 

Obtaining informed consent before involving human subjects in research is required. Consent must be obtained in such a way that the prospective subject has the opportunity to ask questions, discuss the study, and consider whether or not to participate. In addition, the prospective subject must not be coerced or otherwise unduly influenced to participate. 

 

An important aspect of human subject research is developing an appropriate consent form. The consent form is only a small part of an overall consent process. Even if an investigator plans to obtain verbal consent, a form should still be used as a script for the researcher and as a reference document for the subject.  A good consent form not only provides human subjects with detailed information about the research project, but also informs the University Human Subjects Review Committee (UHSRC) that the subjects' interests are well protected by the researcher. 

 

EMU provides a consent template and sample forms, accessible using the links below. Federal regulations dictate the format and content of the consent form. The template is compliant with regulatory requirements. 

 

The consent form must be presented in language that is understandable to the subject. The prospective subject must be given information that a reasonable person would want to have in order to make an informed decision about participating and an opportunity to discuss the information. The consent form must provide sufficient detail and be organized in a way that makes it easier for a potential subject to understand the information provided.

 

 

Regulatory Consent Requirements

 

 

Consent forms must contain the  following information, in this order:

  • Consent forms must begin with a brief, focused presentation of key information that is most likely to assist the prospective subject in understanding why they may or may not want to participate. This information must be presented in an easily comprehensible manner.
  • A statement that the study involves research, an explanation of the purpose of the research, a description of study procedures, information about the duration of a subject's participation, and an indication of experimental study procedures
  • A description of potential risks to participation
  • A description of potential benefits from participation. Note that benefits are measurable improvements in physical or psychological health or quality of life. Compensation, course credit, and learning more about oneself from completing questionnaires are not benefits.
  • If applicable, an explanation of alternative procedures or treatments. If subjects are earning course credit for participation, alternative ways of earning this credit must be listed.
  • An explanation of the procedures in place to protect confidentiality. This includes whether data will be identifiable, coded, or anonymous, and how data will be stored and disseminated.
  • If applicable, an explanation of whether medical treatment will be available in case of injury and, if so, how additional information can be obtained.
  • Contact information for the principal investigator. If the principal investigator is a student, the advisor's contact information must also be provided.
  • The following sentence: "For information about your rights as a participant in research, you can contact the Eastern Michigan University Office of Research Compliance at 734-487-3090 or [email protected].
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the participant is otherwise entitled, and that the participant may discontinue participation at any time without penalty or loss of benefits to which the participant is otherwise entitled.
  • If data are identifiable: a statement that data might be stripped of identifiers and used for future research or shared with other investigators without additional consent; or a statement that data will never be used for future research or shared with other investigators even if identifiers are stripped.

The following information must be in the consent form, as applicable:

  • A statement that there may be currently unforeseeable risks.
  • An explanation of circumstances under which participation may be terminated without regard to the subject's consent.
  • Any costs to the subject that may result from participation.
  • The consequences of a subject's decision to withdraw from the research and termination procedures.
  • A statement that significant new findings developed during the course of the research which may affect the subject's willingness to continue participation will be provided.
  • The number of subjects involved in the study.
  • For research with biological samples or specimens: a statement that the biological specimens, even if identifiers are removed, might be used for commercial profit and whether the subject will or will not share in this profit.
  • A statement regarding whether or not clinically relevant research results, including individual results, will be provided to subjects.
  • For research with biological samples or specimens: a statement indicating whether or not the research will or might include whole genome sequencing.

 

The consent form must be uploaded for review with the application package. 
Please note that exculpatory language is not allowed and "I understand" language is not recommended. 


If you have questions or would like assistance in developing a consent form, contact
the Research Compliance Officer, Sonia Chawla, at 734-487-3090 or [email protected].

 

 

EU GDPR Requirements

 

 

The EU GDPR requires a lawful basis for collecting and processing personal data. In research, that lawful basis is consent. In order to be compliant with the EU GDPR, the following requirements must be adopted into the consent procedures and consent form:

 

  • Consent records, including time and date of consent, must be maintained for each subject. In the case of verbal, online, or any other type of undocumented consent, the Principal Investigator is responsible for maintaining a consent log indicating each subject (either by name or study ID number) and the date and time that they provided consent.
  • Consent must be explicit. If the consent form or consent script serves multiple purposes (e.g., a consent form that is also the recruitment email), then the request for consent must be clearly distinguishable within the document.
  • Each subject has a right to withdraw consent, at any time. Each subject must be informed of this right prior to giving consent. Withdrawal of consent must be as easy as giving consent.
  • Consent must be an affirmative action. This means that opt-out procedures or pre-checked boxes indicating consent are not permitted.
  • Consent information must be provided in clear and plain language in an intelligible and easily accessible format. Consent forms using excessive jargon or that do not have separate sections with section headings will be returned for revision.
  • Consent must be freely-given. Individuals in a position of authority cannot obtain consent, nor can consent be coerced. This means that faculty members or teachers cannot obtain consent from their own students.
  • Consent forms must contain the following information:
    • The identity of the Principal Investigator;
    • The purpose of data collection;
    • The types of data collected, including listing of special categories:
      • Racial or ethnic origin;
      • Political opinions;
      • Religious or philosophical beliefs;
      • Trade union membership;
      • Processing of genetic data;
      • Biometric data for the purposes of unique identification;
      • Health data; and/or
      • Sex life or sexual orientation information;
    • The right to withdraw from the research and the mechanism for withdrawal;
    • Who will have access to the data;
    • Information regarding automated processing of data for decision making about the individual, including profiling;
    • Information regarding data security, including storage and transfer of data;
    • How long data will be stored (this can be indefinite);
    • Whether and under what conditions data may be used for future research, either related or unrelated to the purpose of the current study.

The EU GDPR requirements are to be implemented in addition to the Regulatory Consent Requirements listed above. 

 

 


Consent Templates and Examples:

 

* Please do not use these templates for classroom assignments. They are to be used for research purposes only.

 

 

Elevating Communities, Inspiring Generations

EMU Research, 200 Boone Phone: 734.487.3090 mail [email protected]

Eastern Michigan University, Education First

Ypsilanti, MI, USA 48197 | 734.487.1849

Non-Discrimination Statement | Report a Title IX incident | Accessibility
Privacy Statement | Copyright © 2024

  • facebook
  • twitter
  • youtube
  • linked in
  • Blog EMU