Informed Consents

The contents of this page has been updated.
Information contained within a red box has been added or modified in accordance with the 2018 Revised Common Rule. To view additional updates, please click the "IMPORTANT UPDATES" link above.

IRB Informed Consent Process

Informed consent is the process of informing potential volunteers about the key facts of a research study. The human subjects in your study should be willing to participate in the research after receiving information about the study. Voluntary participation means that subjects have enough information to give true informed consent. Consent documents and study recruitment materials must be clearly written and understandable to subjects.

Informed Consent Forms (ICFs) may not include language that appears to waive subjects' legal rights or appears to release the investigator or anyone else involved in the study from liability or negligence. The language must be non-technical (comparable to the language in a newspaper or general circulation magazine). Plainly defined scientific, technical, and medical terms are necessary. The same applies to the assent forms for minors.

If the human subjects in your study are part of a vulnerable population, such as prisoners or children, special protections are required. For more information on vulnerable populations, please contact the Office of Research Compliance.

One of the most common reasons for delay of IRB approval is an inadequate informed consent agreement.

The downloadable consent forms available on this page include a cover sheet with instructions for completing the template. It is recommended that you fully read these instructions and follow their guidelines to ensure the document is created correctly. DO NOT INCLUDE THE INSTRUCTIONAL COVER PAGE WHEN YOU SUBMIT THE FINAL DOCUMENT.

Use the links below to quickly locate specific documents or information regarding the use of an Informed Consent Form:

Clinical Trial Informed Consent

This form is to be used for obtaining the informed consent of human subjects participating in clinical research studies. Clinical Research Investigators submitting this form for IRB review must also download and complete a Statement for Payments to Human Subject Participants form available on the Informational Items page.

Related Forms:

The following items, if applicable, must be included when submitting this form.

  • Request for Waiver or Alteration of HIPAA Authorization (view section)

NEW FINAL RULE REQUIREMENTS:

In accordance with the 2018 Revised Common Rule, a copy of an IRB-approved version of the consent form used for enrollment purposes must be posted to ClinicalTrials.gov for all federally-sponsored clinical trials conducted through Mercer University.
  • Consent forms must be posted after the trial is closed to recruitment and NO LATER THAN 60 days after the last study visit by any subject (as required by the protocol).
  • The redaction of proprietary or institutionally sensitive information of portions of consent forms is allowed.
  • Only one unsigned version (not necessarily the final) of the consent form for each clinical trial must be posted on the federal website. In accordance with the new "single IRB review" requirement, only one posting is required for each multi-institution study.

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Mercer Informed Consent of Adults

These forms are to be used for obtaining the informed consent of adult human subject populations (over the age of 18). If your study involves monetary incentives to participate, please download and complete a Statement for Payments to Human Subject Participants

Related Forms:
The following items, if applicable, must be included when submitting this form.

  • Statement for Payments to Human Subject Participants (Informational Items) – this form must be included when providing monetary incentives to participate.

Deceptive ICFs

Using methods of deliberate deception, investigators may omit or falsify information to obtain the consent of human subjects when participants being fully informed would compromise the results (e.g., behavioral and psychological studies). When using a deceptive ICF, investigators MUST provide a debriefing statement using the form below.

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Anonymous Informed Consent

These forms are used to obtain the informed consent of human subjects participating in research that does not require a signature or other identifying information (e.g., the completion of a survey)

Subject Information Sheet

The subject information sheet is used when there is a request for a waiver of written informed consent in situations other than records review or if collecting the participants’ signature is the only link to the participant and could pose harm to the participant if they are linked back to the research.

Related Forms:
The following items, if applicable, must be included when submitting this form.

  • Statement for Payments to Human Subject Participants (Informational Items) – this form must be included when providing monetary incentives to participate.

Online Web Consent and Recruitment

To conduct Online Survey Research, a web consent and recruitment letter must be completed and approved. If our SurveyMonkey services are to be used, the stamped web consent must be included with the survey questions when a new survey request is sent to the ORC.

The Recruitment Email template MUST be used for all emails distributed to recruit subjects for online survey research.

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Informed Assent of Minors

These forms are to be used for obtaining the informed assent of minors (participants under the age of 18) who are not legally able to provide their own informed consent. Use the assent form(s) appropriate to the age range of the targeted subject population.

Parental Consent Forms

When obtaining the informed assent of minor human subject populations, the Principal Investigator must also obtain the parental informed consent of the participant’s parent or legal guardian.

Related Forms (NEW):
As required by the Health Insurance Portability and Accountability Act (HIPAA), Investigators intending to use and disclose protected health information of minors participating in research MUST obtain parent or guardian authorization.  

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Waiver or Alteration of HIPAA Authorization (NEW)

This form is to be used for requesting a waiver, partial waiver, or alteration of Authorization to use and/or disclose protected health information (PHI).

To request a Waiver of Signed Informed Consent when HIPAA does not apply, please download and submit a Subject Information Sheet with your completed research application.

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