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No investigator may involve a human being as a subject or use their tissue or data in a research activity without obtaining the informed consent of the subject or the subject’s legally authorized representative. There are limited conditions under which this requirement is waived.
The informed consent process involves providing a research subject with adequate information concerning the study, providing ample opportunity for the research subject to consider all options, responding to questions, ensuring that the research subject has comprehended this information, obtaining the voluntary agreement to participate, and continuing to provide information as the research subject or situation requires.
The consent process is one of the most important elements of all research studies involving human subjects. If consent is not properly obtained, then the rights of the individual research subject have been violated.
IRB-recommended consent, permission, and assent form templates are available on the Forms page.These should be used when preparing consent documents. These should be updated and submitted to the IRB as amendments for review and approval when study procedures are changed or when new risks to research subjects are identified.
When and How to Seek Consent
Consent must be sought under circumstances where the subject or representative is given enough time to consider whether to be in the study and that minimize the possibility of coercion or undue influence. Information provided to the subject or representative must be written in simple language, so that all aspects of the research (e.g., purpose, risks, benefits) are clearly stated and a research subject can make a fully informed decision. An assessment of capacity to give consent must be performed in all subjects.
Electronic Signatures for Consent and Approved Online Software
Electronic Signatures may be used in lieu of hand written signatures for consent. If this will be done, then you will need to use DocuSign to officially document the consent process. It is recommended that you use a DocuSign PowerForm, where you can create a standard form signature that you can link to your survey. Additionally, the PI will need to apply to be a DocuSign admin via esignature.gatech.edu. More information can be found on the following websites:
Online consent can also be conducted verbally or passively (e.g., subject clicks "I agree" in survey or verbally responds over the phone or in video conference). If doing this electronically, please use one of the following Georgia Tech approved platforms: Qualtrics, Web Ex, Blue Jeans or Teams. More information can be found on the following OIT websites:
What are the requirements for waiving consent of research subjects?
When consent is waived, research subjects are enrolled in a study without their knowledge. A waiver of consent may only be approved under these two exceptions:
- All of the following conditions must be met:
- The research involves no more than minimal risk to the subjects.
- The waiver or alteration will not adversely affect the rights and welfare of the subjects.
- If an individual was asked to provide broad consent for the storage, maintenance, and secondary research use of identifiable private information or identifiable biospecimens in accordance with the requirements at paragraph (d) of this section, and refused to consent, an IRB cannot waive consent for the storage, maintenance, or secondary research use of the identifiable private information or identifiable biospecimens
- The research could not practicably be carried out without the waiver or alteration.
- Whenever appropriate, subjects will be provided with additional pertinent information after participation.
- The Food and Drug Administration (FDA) permits an exception to the informed consent requirement before the emergency use of a test article under certain conditions. Review the emergency use exemptions in the IRB Policies & Procedures Manual (Section VIII.B.1.) for details.
Note: If the research involves using identifiable private information or identifiable biospecimens, it must be determined that the research could not practicably be carried out without using such information or biospecimens in an identifiable format.
What are the requirements for waiving documentation of informed consent?
Federal regulations allow for waiving documentation of consent (i.e., a signed consent form) if an IRB determines that either:
- The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether he or she wants documentation linking the subject with the research, and the subject’s wishes will govern;
- The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
- If the subjects or legally authorized representatives are members of a distinct cultural group or community in which signing forms is not the norm, that the research presents no more than minimal risk of harm to subjects and provided there is an appropriate alternative mechanism for documenting that informed consent was obtained.
Even if a waiver of documentation of consent is approved, research subjects must be provided sufficient information to make a fully informed decision. Sometimes that information will be delivered verbally, such as over the phone. In other situations, research subjects may be given a written document, like a letter to them, that they do not sign. If research subjects are completing an online survey, the webpage should display the relevant consent information and end with a statement similar to the following:
‘If you ____________________(e.g., complete the attached survey, answer these few questions etc.), it means that you have read (or have had read to you) the information contained in this notice, and you are consenting to be a volunteer in this research study.
What is the difference between consent, permission, and assent?
Consent: Consent is obtained from adult research subjects. In the state of Georgia, the age of majority is 18 years.
Permission: Parental permission is obtained from a parent of subjects 17 years or younger. Minors and children cannot legally consent to being in a study.
Assent: While children and minors cannot lawfully give consent, they should be given information suitable to their ability to understand, and their assent must be obtained in order for them to be in a research study.
How do I obtain consent from non-English speaking subjects?
You must provide such research subjects with the relevant information in a language that is understandable to them. If consent forms will be translated into a foreign language, an affidavit of accurate translation must be provided from a professional translator who is unaffiliated with the study.