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Guide to Creating an Informed Consent

General notes on creating a consent form:
Where it is clear that research participants have the capacity (i.e., decision-making capability) to provide informed consent, you must ensure that the information provided to research participants is presented in such a manner as to be easily and comprehensively understood.

The language and terminology used in describing the research must clearly convey the objectives and methodology of the research project, and the risks and benefits to the research participant. It is recommended that consent forms be written for a Grade 8 level of reading comprehension.

Consent forms should be drafted such that the research participant is referred to in the second person (i.e., ‘You are invited....’ ‘You will be asked to ...’). This should be used throughout, with the exception of a signature statement that is in the first person (i.e., ‘I have read this form….), and which is intended to state the in clear terms what the participant is attesting to in signing the form.

When more than one group of participants will be involved, researchers should prepare a separate consent form that describes specifically the kind of involvement of each group.

With complex studies and/or lengthy consent forms, or where the study poses significant risks to participants, it is often advisable to provide a copy of the form to participants in advance of the actual time where consent will be obtained, in order that they may consider it carefully, and perhaps have an opportunity to discuss it with a family member or other trusted person.

CONSENT FORM CHECKLIST

The checklist is provided to help researchers ensure that all the required elements are present in their consent forms. The following format should be used for a standard written consent form that could be used with individuals capable of giving consent for their own participation in research. Suggested headings for each section in the consent form are shown in underlined text, followed by a description of the appropriate content for that section. Examples that can be used as templates can also be found at:
Adult Informed Consent (pdf)
Parent Informed Consent (pdf)
Child Assent (for children 6 to 18 years of age) (pdf)

Consent Form
The top of the page should display the study title in lay language and the words "Consent Form" must appear at the top of the page.

Introduction
The following introductory paragraph is recommended:

We invite you to take part in a research study being conducted by [principal investigator’s name], who is a [professor/student] at Hampshire College, Amherst, MA, as part of his/her [name of research project]. The study, as well as your rights as a participant, are described below.

Description
This section briefly explains the study, its procedures (i.e. what you will ask the participants to do), and what you hope to achieve. It should provide enough information so that the intent of the study is clear, without biasing the participation of the participant. Researchers should avoid the use of coercive language (such as stating that the success of your project relies on the participation of the participant). Terms such as "qualitative study," "open-ended interview," or "participant observation" should not be used, unless they are explained carefully, as they may not be meaningful to participants. If there is to be deception or incomplete disclosure of the purpose of the study for any reason, participants should be told that they will be given additional information about the study after their participation is complete (i.e., a debriefing). This section may also include who is eligible to participate in the study. The language used should be simple and direct: "You may participate in this study if you are..." Any conditions (e.g., being above or below a certain age) that exclude a participant from participation must also be listed here. If any screening activities are planned, these should be described.

Confidentiality
It is your responsibility to safeguard the anonymity of participants and the confidentiality of the information that they provided.

Anonymity: Researchers should indicate the way in which the anonymity of participants will be achieved. Where it is not possible to protect a participant’s anonymity (e.g., where they are part of a focus group) this limitation should be described. Participants should be told that they will not be identified in any reports or publications.

If you will not be able to provide anonymity (i.e. you are using names in the final project or you are recording their participation (visually or auditorily), you should also provide SEPARATE additional signature lines so that consent can be given for specific uses of this information.

Explicit consent must be sought from participants for the following, when applicable:

  1. waiver of confidentiality
  2. audiorecording or videorecording
  3. recontacting for future phases of research or other studies
  4. use of substantial direct quotations

Consent for each of these should be indicated with a separate signature line. It should be clear in the protocol why each of these permissions is being sought. With respect to permission for the use of quotations, the best practice is to confirm explicit permission for this after the interview/focus group is completed so that individuals will have a clearer understanding of what might be contained in quotations.

Confidentiality: Research participants should be informed of who will have access to their information (additionally the IRB application must describe how this data will be collected, where it will be stored, and how it will be kept safe). This should be described clearly and in terms that are easily understood. In addition, any limitations of these safeguards should be stated clearly. Where there are limits to confidentiality that are imposed on researchers due to their legal obligations (i.e., duty to disclose suspected child abuse or neglect, or the abuse or neglect of an adult in need of protection), this must be stated. A simple description of what you will do in such a situation should be provided. This is advisable for research that may, inadvertently, cause such disclosures to be made, and it is imperative for research that specifically deals with issues of sexual or child abuse, domestic violence, or elder abuse.

Researchers who may wish to take personal data outside of the U.S. or to share it with colleagues outside of Hampshire College must seek consent for this from participants.

Risks and Benefits
This should include all possible adverse events or side effects, along with estimated probability of occurrence (if known) of risks of the study that participants will be involved in. This refers both to discomfort associated with physical procedures (e.g., stress tests) as well as the possibility of emotional or psychological distress caused by interviews or survey contributions. Where there is a possibility of economic repercussions, damage to relationships, or loss of privacy, these should be described. The steps that you will take to minimize these risks should be stated. In some instances, risks may exist for communities associated with the study (stigmatization, community discord). These should also be discussed.

Researchers should not categorically state that there is "no risk" associated with a study. This suggests a guarantee that is not possible, given the inherent uncertainty involved in research. Where the harms or discomforts are no greater than those that are related to common experiences of everyday life, they may be described as "minimal."

Describe any potential benefits that the participants may derive from their participation in the study. Where there are no anticipated direct personal benefits to participants, this should be explicitly stated. More altruistic benefits (e.g., contribution to knowledge) should be realistically assessed (i.e., not overstated); the text should not imply that these benefits are guaranteed. If participants are to be compensated for their participation, the full extent of this compensation and how it will be provided should be described. If participants are to be reimbursed for expenses incurred in relation to their participation (e.g., parking, transportation costs) this should be stated. Upper limits of reimbursement available (per person) should be stated also, so as not to create inappropriate expectations on the part of research participants. If participants are not being compensated, this should be stated also.

Freedom to Withdraw or Refuse Participation
It is critical to make clear to participants that they are under no obligation to participate in your research and that they can stop participating at any time. This is particularly important when there are power differences between the researcher and participant or where personal/economic/or other relationships exist between the researcher and participant. It must be made clear that their participation will in no way affect these relationships. Awareness of this right should be created during the consent process; it should be re-affirmed throughout the study if/when expectations or circumstances change, if/when the researcher perceives the participant may no longer feel comfortable participating, or at any other time the researcher feels appropriate.

Grievance Procedure
It is necessary to inform participants of whom they may contact if they have any questions or concerns about how the research was conducted. Therefore the following statement must be included at the end of every consent form:

Grievance Procedure: If I have any concerns or am dissatisfied with any aspect of this study, I may report my grievances anonymously if desired to the Human Subjects Institutional Review Board, c/o Dean of Faculty Office, Hampshire College, Amherst, MA 01002, 413.559.5479.

Participants who live at a distance from Amherst may be told that it is acceptable to call collect.

Questions
Participants must be provided with a means of having their questions about the study addressed. Ideally, a 24-hour local telephone contact should be available (this number can be included in the following section).

Principal Investigator
This section should identify the names and roles of the various people who will be involved in the research. This would include the principal investigator (student researcher and/or faculty), and any technical assistants that the research participant may be dealing with (e.g., translators) or others who may have access to the data (e.g., transcribers).

Summary (optional)
If the protocol is a complicated one, a simple summary might be helpful. Participants should also be told that they will receive a copy of the consent form for their records and information at the outset of the study.

Informed Consent Statement
The consent form should be signed and dated by the research participant or by the person authorized to sign on behalf of the research participant (e.g., a parent or care-giver). In the latter instance, the participant’s name must also be clearly indicated. The following statement can be used:

I, ______________, agree to participate in the research project entitled, “[title of project].” The study has been explained to me and my questions answered to my satisfaction. I understand my right to withdraw from participating or refuse to participate will be respected and that my responses and identity will be kept confidential unless indicated otherwise above. I give this consent voluntarily.

It should be clear from the format of the page that "I" refers to the research participant.

A signature and date line should also be provided for the person who is obtaining consent (usually, but not always, the researcher). This should be completed at the time when the consent form is signed by the participant. A witness signature, however, is not generally required.

 
 

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