Informed Consent

The Belmont University IRB provides investigators with an informed consent template. However, it is important to understand what must be included when gaining informed consent from your participants. Please see the end of this document for elements required for informed consent.

For participants not fluent in English, the consent process and document must be presented in a language (preferably native) understandable to them. If it is expected that participants who do not speak English will be enrolled in a study, translated documents should be made available.

Translation of Documents and Consent

Study related documents (e.g., the informed consent document, the HIPAA authorization,) may be translated by one of two methods. One method is that the document be translated by a professional translation service that will attest to the accuracy of the translation.

The second is the use of back-translation into English. In this scenario, the English version of the document is translated into the foreign language;

1. the name and credentials of the individual who did the translation are provided to the IRB by the investigator;
2. another individual who has not seen the English version of the document translates the foreign language document back into English;
3. this individual provides his/her name, credentials and a statement that s/he has not seen the original English version to the IRB via the investigator;
4. both English versions of the form and the foreign language version are submitted to the IRB for review.

The informed consent process must also be conducted in a language understandable to the participant and may therefore require the use of a translator or sign language interpreter. In most cases, the translator may be a family member or friend of the participant, an employee of the institution or may be hired by the PI. The IRB will determine whether a professional translator is required on a case-by-case basis.

The PI is responsible for covering the cost of the translation. The cost of the translation will not be incurred by the participants.

If one of the two recommended methods is not feasible, the IRB will accept certification from the PI that he/she or a member of the research staff translated the document and that the translation is accurate. This verification must accompany submission of the translated documents.

Signed informed consent is usually required; however, there are a few situations with the IRB can waive documentation of consent or waive consent

"Waiver of Documentation" of Informed Consent (see "What is implied Consent?" section")

A waiver of documentation of informed consent is a request whereby a signed consent document is not required. Examples include implied and verbal consent. Consent will still be obtained from participants; however, they will not be required to sign the consent form. There are only two circumstances when the IRB may waive the requirement to obtain a signed consent form:

• The only record linking the research participant and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality (participant must be asked if he/she want documentation); OR
• The research presents no more than minimal risk of harm to participants and involves no procedure for which written consent is normally required outside of the research context (for example, no risk surveys or interviews) 

 

"Waiver" of Informed Consent? (How is it different from a "waiver of documentation" of informed consent?)

A waiver of informed consent could: (1) alter some or all of the required elements of informed consent or (2) completely waive the requirement to obtain informed consent. The IRB may approve a consent procedure which does not include or alters some or all of the required elements of informed consent provided all of the following are true:

• The research involves no more than minimal risk
• The waiver of informed consent will not adversely affect the rights and welfare of the subjects;
• It is not practicable to conduct the research without the waiver or alteration; or
• Whenever appropriate, participants will be provided with additional pertinent information after their participation.

Examples of types of studies in which some or all elements of consent have been waived include retrospective chart reviews, studies of existing pathology specimens, ethnographic research, studies that require deception or passive (opt-out) consent.

For some research projects, the IRB may approve a request to waive the documentation of informed consent. This means that the research team must provide a subject with the required consent information, but the study team is not required to obtain the subject's signature on the informed consent document. For example, if an investigator is conducting on online survey that has very little risk, by completing the survey, the participant has provided consent to participate in the research. The term "implied" consent is not referenced in the HHS regulations - see https://www.hhs.gov/ohrp/regulations-and-policy/guidance/faq/informed-consent/index.htm.

Even in situations where the IRB may waive the documentation (signature) requirement (e.g., telephone interview, online survey), investigators are expected to present participants with the required key elements of informed consent and with a copy of the written consent document.

A waiver of documentation is permissible when:

• The signature on the informed consent document would be the only record linking the subject to the research and the principal risk of harm to the subject would be a breach of confidentiality.  For example, for research on sensitive topics, such as domestic violence or illegal activities; OR 
• The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.  For example, minimal risk research that invovles surveys/interviews conducted via telephone or online.

• Under the 2018 Common Rule, there is an addtional requirement for the IRB approval of an informed consent documentation waiver request:  Where the participants are members of a cultural group in which signing forms is not a normal/acceptable practice.

Consent forms are legal documents that can only be signed by adults, and assent forms give minors (i.e., children) the opportunity to convey their own independent decision to participate in research. Oral assent is appropriate for children ages 7 to 11 years. Written assent is required for children ages 12 to 15 and must be written in language-level appropriate for children. Assent alone is not sufficient to enroll a child in a study. The permission of a parent or guardian, using a parental permission form, must be obtained as well. The requirements for parental permission forms are very similar to those for consent forms. For children ages 16 and 17, a special consent form designed for both the child and parent to read and sign is required. The special consent form is also an available alternative to the written assent/parental permission option for children ages 12 to 15. A regular consent form should be used for individuals who are 18 years of age and older and have the decision-making capacity to consent. The informed consent form must be written at a language-level appropriate for the potential participants (i.e., about an 8^th grade level). Please see the IRB webpage for templates for consent and child assent.