[Replace letterhead with appropriate

logo from the PI’s department.]

DU IRB Approval Date:Valid for Use Through:

University of Denver

Consent Form for Participation in Research

Title of Research Study: Title

Researcher(s): Name, Credentials, Institutional Affiliation (e.g., Jane Doe, PhD, University of Denver)

(If student investigator, include faculty sponsor and their credentials)

Study Site: Location where study will take place if off campus or in specific laboratory

Purpose

You are being asked to participate in a research study. The purpose of this research is to[details regarding the study aim or purpose of the investigation].

Procedures

If you participate in this research study, you will be invited to [details about the procedures and duration of participation].

Voluntary Participation

Participating in this research study is completely voluntary. Even if you decide to participate now, you may change your mind and stop at any time. You may choose not to [details: e.g., answer any survey question, continue with the interview, etc.] for any reason without penalty or other benefits to which you are entitled.

Risks or Discomforts

Potential risks and/or discomforts of participation may include [explicitly identify reasonably foreseeable risks of participation. Consider risks other than physical harms or injury, such as criminal or civil liability, damage to participants’ financial standing, employability, reputation, or insurability, emotional distress, embarrassment, and/or loss of privacy].

Benefits

Possible benefits of participation include [details about direct benefits to subjects participating or benefits to society or the scientific community. Reimbursement/compensation is NOT considered a benefit.].

Incentives to participate

You will receive [describe any compensation, reimbursement, or incentives being offered for participation] for participating in this research project.

Note: Incentives/compensation include cash payments, extra credit for class, gift cards, or other goods (i.e., iPads, T-shirts, etc.) provided for participation. Include specific method of payment, schedule of payment, information regarding any prorated payment if study includes multiple sessions or if withdrawing excludes participant from payment. Note that participants are entitled to payment for time invested in the project, even if they withdraw early.

Study Costs (if applicable)

You will be expected to pay for [description of any costs that might be incurred by participants during the study (e.g., your own transportation, parking, child care, etc.)] if needed. If this does not apply, delete this section.

Alternatives (if applicable)

Describe appropriate alternative procedures or courses of treatment that might be advantageous to the research participant. If this does not apply, delete this section.

Confidentiality

The researcher will [details to protect privacy/confidentiality of subjects] to keep your information safe throughout this study. Your individual identity will be kept private when information is presented or published about this study.

Note: Include information regarding anyone who will receive identifiable data (e.g., through subcontracts or other agreements) and describe how data will retained/stored throughout the study. If audio/video recordings or photographs will be used, explain the purpose, who will have access, and when they will be destroyed.

However, should any information contained in this study be the subject of a court order or lawful subpoena, the University of Denver might not be able to avoid compliance with the order or subpoena.The research information may be shared with federal agencies or local committees who are responsible for protecting research participants, including individuals on behalf of[study sponsor, if applicable].

Questions

If you have any questions about this project or your participation, please feel free to ask questions now or contact [Researcher Name]at [phone number and/or email address]at any time.Include Faculty Sponsor’s name and contact information if applicable.

If you have any questions or concerns about your research participation or rights as a participant, you may contact the DU Human Research Protections Program by emailing or calling (303) 871-2121 to speak to someone other than the researchers.

If your study will include optional parts to which participants can agree or disagree, but can still participate in the overall study, it may be appropriate to include a section for participants to indicate their choices in that regard.
Options for Participation
Please initial your choice for the options below:
___The researchers may audio/video record or photograph me during this study.
___The researchers may NOT audio/video record or photograph me during this study.
Use this section if signed documentation of consent will be obtained.
Please take all the time you need to read through this document and decide whether you would like to participate in this research study.
If you agree to participate in this research study, please sign below. You will be given a copy of this form for your records.
______
Participant Signature Date
Use this section if signed consent will not be obtained and waiver of documentation of consent will be requested. Be sure to remove the signature section above.
Please take all the time you need to read through this document and decide whether you would like to participate in this research study.
If you decide to participate, your completion of the research procedures indicates your consent. Please keep this form for your records.

See below for instructions and additional language to be used if applicable.

Instructions for completion

This template is for use with Expedited or Full Board Review research projects. The gray textis template wording that may be used. Feel free to customize the information or language for your particular project or subject population.

Suggested guidelines when completing this consent template:

  • Student researchers must include contact information of your Faculty Sponsor/Advisor.
  • Use simplified language that is understandable to your subjects and avoid technical terminology, scientific jargon, and legalese.
  • Avoid using first person language from the perspective of the participant (e.g, “I understand…” or “I agree to…”). Such language can be considered suggestive or unduly influencing participants.
  • Only use one of the suggested signature boxes but not both.
  • Delete all instructions (blueand redtext) in the template and make the font and color of text the same throughout before submitting for review.
  • Update the version date in the footer and letterhead in the header before submitting for review.

Additional required elements of consent,when appropriate, are required for research studies:

(1) A statement that the study may involve risks to participants that are currently unforeseeable.

(2) A statement that the study may involve risks to the embryo or fetus, if the subjects is or may become pregnant, that are currently unforeseeable.

(3) Anticipated circumstances under which a subject’s participation may be terminated by the researcher without regard to the participant’s consent.

(4) The consequences of a participant’s decision to withdraw early.

(5) Significant new findings developed during the course of the study, which may relate to the participants willingness to continue participation, will be provided to the participant.

(6) The approximate number of subjects in the study (if for example, this might affect confidentiality of information provided or the privacy of participants).

As appropriate, the IRB/HRPP may require additional language or information for the protection of human subjects. Please include the following information, if applicable to your study.

IF APPLICABLE, the following details should be included within the consent form:

All records of this research project may be inspected by the Food and Drug Administration (FDA). [Note: Include only if the study is FDA-regulated (i.e. investigational drugs or devices)]

The University of Denver has not provided for any payment to you or for your treatment if you are harmed or injured as a result of taking part in this study. [Note: Include if the study is physical in nature or includes reasonably foreseeable risks of injury. If externally funded, describe any arrangement provided by the sponsor for medical care for research-related injury. If the sponsor will not pay for research-related injury, you may add the sponsor’s name after University of Denver in the statement above (e.g., “The University of Denver and NIH have not provided...”]

Some things we cannot keep private and must report to proper authorities. If you disclose information about child abuse or neglect or that you are going to harm yourself of others, we have to report that to the [state agency or other agency]as required by law.[Note: If the project involves situations that may reasonably elicit a response indicating the existence of child abuse/neglect, suicide ideation, or threatened violence against another specific person, that information must be reported and the following state has to be included in the consent form.]

SONA/Psychology Research Participation (PRP) System Studies: The following information should be included for studies utilizing SONA/PRP.

Your name and identifying information will not be connected in any way to your responses in this study. The online system will grant you credit when you submit your responses by separately submitting your Identity Code to the system while your responses are sent to a different database for retrieval by the researcher.

Online Survey Studies:The following language is recommended as appropriate for studies where data are collected through online systems such as Qualtrics, RedCap, and mTurk.

Before you begin, please note that the data you provide may be collected and used by [Online System]as per its privacy agreement. This research is only for U.S. residents over the age of 18. Please be mindful to respond in private and through a secured Internet connection for your privacy. Your confidentiality will be maintained to the degree permitted by the technology used. Specifically, no guarantees can be made regarding the interception of data sent via the Internet by any third parties.

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