Informed consent is one of the primary ethical considerations underlying research with human subjects. “Informed” means that the subjects know what they are being asked to do and why, and that they are aware of the potential consequences of their participation in the research. Thus, potential subjects need to be provided information about the purpose of the study, what will happen during the study, and any possible risks, benefits, or outcomes they may experience as a result of participation. Investigators are responsible for presenting this information in a way that potential subjects can understand, with no technical jargon or significant omissions. Merely reading the consent form to potential subjects is not a substitute for ensuring that they understand the information in it. Potential subjects should be given the opportunity to ask questions to clear up any confusion or uncertainty before providing consent.  

In most cases, federal regulations require that informed consent be documented on paper. It should be reiterated, however, that the consent document does not substitute for discussion and clarification. Ideally, the specifics of the research study will be explained to the potential subject verbally with the paper forms as a guide. Verbal or nonverbal agreement to participate in a study (also known as assent) is insufficient; the informed consent form should be signed by all subjects.

Certain circumstances may require adaptation of the above guidelines:

• Research involving children or other people for whom cognitive or physical or mental health status may prevent informed consent (e.g., people with dementia or intellectual disability) requires consent from a parent, guardian, or other authorized representative. Assent should be provided by the potential subject and noted on the consent form; however, assent is not equivalent to or an appropriate substitute for informed consent.
• Researchers collecting data remotely, such as through telephone calls or online or mailed surveys, may not be able to discuss the study details as thoroughly as they would for in-person research. However, the researcher is still responsible for providing potential subjects the necessary information they need to make an informed decision about their participation. In these cases, any description of the study, whether written or oral, must be sufficiently detailed and understandable, and opportunities to refuse participation or ask questions should be provided. If the study methodology does not produce official documentation of informed consent, a Waiver of Documentation of Consent form (see below) is required.  

Waiver of Consent or Documentation of Consent

The methodology of certain research projects does not allow for fully informed consent.  For example, researchers wanting to study conformity may present the study as an examination of perceptual processes such as color vision, because telling the subjects the study is about conformity may influence behavior.  In this case, fully informed consent is impossible, and for studies of this nature, deception or lack of detail may be allowable in the consent forms.  However, it must be determined by the IRB that this deception or lack of detail is necessary and is unlikely to harm the subjects. For these studies, a Waiver of Consent form must be completed and submitted along with the IRB application. Additionally, subjects in these types of studies should receive a debriefing after their participation explaining the true purpose of the study and the reasons for the deception or lack of detail.  

As mentioned previously, written documentation of informed consent is typically required. However, some research projects, such as surveys administered over the telephone, may not provide for the documentation of informed consent.  In these situations, a Waiver of Documentation of Consent form should be completed and submitted along with the other documents in the review application. Again, it must be determined by the IRB that obtaining tangible evidence of informed consent would be impractical and that failing to document informed consent is unlikely to harm the subjects. It should be noted that research sponsored by the Food and Drug Administration does not allow for this type of waiver, and informed consent for these projects must be documented. 

Broad Consent

Broad consent was added to the 2018 federal guidelines to address the use, storage, and maintenance of data and secondary research with identifiable private information or biospecimens.  If researchers anticipate or decide to use identifiable private information or biospecimens for research studies that are unrelated to the one for which approval has been obtained, they must get broad consent from those subjects.  Broad consent can be obtained either along with initial consent for the primary research or at the time that the secondary research is proposed.  If included as part of initial consent for the primary research, the researcher must decide whether giving broad consent is required for participation in the primary study.

The word “identifiable” is important here. If potentially identifiable details have been removed from human subjects information, then broad consent is not required to use those data for other studies.  

Confidentiality Limitations

The term “confidentiality” in a research context means that subjects cannot and will not be individually identified through their responses, either directly or indirectly, without their permission. The most pertinent example of direct linkage is publishing the names of individual subjects.  Indirect linkage could include, for example, publishing the name of a group whose members could be identified (e.g., “Dr. Smith’s ENGL 1101 class”, “the members of the International Student Association”) or providing demographic information that is so specific as to apply to a very limited group of people.  Researchers should ensure that their data collection, particularly related to demographic data, does not inadvertently create situations that violate the confidentiality of their subjects.  If identification of a group (such as a class or members of a particular organization) is considered a relevant part of the research aims and the group will be identified in any resulting publications or presentations, then the consent form should state this.

A related issue is that confidentiality cannot be maintained under certain conditions, such as when researchers find evidence of child abuse or neglect or potential Title IX violations. Researchers whose data collection methods or research goals could reasonably be anticipated to yield information of this nature should include this information in the “Confidentiality” section of their consent form.  If questions arise, the appropriate parties (e.g., GSW’s Title IX Coordinator, Department of Family and Children Services) should be contacted.

Elements of a Consent Form

Consent forms must be written in such a way that they facilitate the potential subject’s understanding of the research and the reasons why someone may or may not want to participate.  To some extent, the specific circumstances of a research study will dictate the content of a consent form.  However, federal guidelines require certain elements.  

2018 Federal Guidelines stipulate the following:

• Informed consent must begin with a concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
• Informed consent as a whole must present information in sufficient detail relating to the research, and must be organized and presented in a way that does not merely provide lists of isolated facts, but rather facilitates the prospective subject's or legally authorized representative's understanding of the reasons why one might or might not want to participate. 

At a minimum, an appropriate consent form should include the following information, in lay language at the 8^th-grade reading level or below:

• The study title (if not in lay language, then any technical terminology should be explained)
• A description of the purpose of the study, to include:
  •   What question the research is intended to answer
  •   Why answering this question is important (i.e., how the research will contribute to knowledge or practices to improve the lives of others) 
• A description of what participation in the study will involve, including:
  •   Duration and location of the participation
  •   Procedures that will be followed, and what the subject will be asked to do
  •   Potential risks to the subject and what will be done to address them
  •   Potential benefits to the subject, including any compensation or services
• A description of how confidentiality will be maintained, including:
  •   The circumstances under which confidentiality cannot be guaranteed, as applicable 
  •   An explanation of whether or not identifiable private information or biospecimens obtained from this study might be used in future studies, even with identifiers removed, without additional consent obtained from the subject
• A description of the subject’s legal rights, including:
  •   The right to refuse and/or withdraw participation at any time with no penalty
  •   Acknowledgement that participation is voluntary and involves no loss of legal rights to which the subject would otherwise be entitled
• Contact information for the primary investigator and IRB chair

Other information (e.g., alternative treatments or procedures, possible commercial profit, whether subjects will receive clinically relevant research results) may be required depending on the nature and purpose of the study. The Department of Health and Human Services Informed Consent FAQ and 45 CFR 46.116 web pages provide further clarification on this issue.  Investigators are strongly encouraged to review the information on these web pages before submitting their consent forms for IRB review.  Inadequate consent forms that require significant revision and clarification can interfere with timely review and approval of the research.

Consent forms should include space for signatures of both the subject and either the researcher or a member of the project staff.  If the potential subject cannot provide a signature due to issues such as age or cognitive ability, then their parent, guardian, or authorized representative should sign the form, and this person’s relationship to the subject should be noted (see “Consent for Special Populations” section). Additionally, there should be a space at the bottom of each page for potential subjects to provide their initials to document that they understand the information on that page.  

Subjects should have the opportunity to keep a copy of the consent form.  Consent forms for online studies should be in a format that allows the consent form to be printed.  For telephone-based research, investigators should offer to send the subject a copy of the consent form.

When IRB approval is granted, the investigator will receive a copy of the consent form stamped with the approval date. Copies of this stamped consent form must be used with study subjects.  If this is not feasible due to the method of data collection and/or consent form administration, then the date of IRB approval must be noted elsewhere on the consent form. 

Coercion and Consent for Special Populations

Coercion can occur when potential subjects feel compelled to participate because they do not understand the study or their rights or because they fear negative repercussions if they refuse.  Coercion can also occur if there is a power differential between the investigator and subject or if the potential benefits of participating are so great that they would be difficult to refuse.  Whether the investigator intends to produce this coercion is irrelevant.  If potential subjects do not feel that they have the ability to refuse participation or enough knowledge to understand the study, then coercion is occurring.

Certain groups of people are considered to be particularly vulnerable to coercion due to age, cognitive status, or group membership. These groups include but are not limited to: 

• Children
• Pregnant women, fetuses, and neonates
• People with cognitive impairments (e.g., dementia, intellectual disability, mental illness)
• Prisoners
• Hospital patients or nursing home residents
• Students

If subsections of the federal code address this specific population, hyperlinks are provided above.  Some of this information, and the rationale for considering these groups as vulnerable populations, is provided below.

Children and people with cognitive impairment may have difficulty understanding the nature and purpose of the study.  Relatedly, individuals under the age of 18 or who have been declared incompetent in a court of law cannot legally provide informed consent.  In the case of research involving children or fetuses (including studies of pregnant women), consent from both parents must be obtained if possible.  In the case of research involving people with cognitive impairment, consent must be provided by a guardian or other authorized representative, such as a family caregiver. 

Prisoners, hospital patients, or nursing home residents may need extra reassurance that their decision about participating and the data they provide will not affect aspects of their life such as the quality of the care they receive, their potential release/discharge date, or their ability to accept or refuse other treatment. 

Students may also feel that they cannot refuse to participate in research, especially if the investigator is a faculty member.  If participation is tied to any type of course credit, whether extra credit or a required part of the course grade, an alternative assignment should be provided to allow students to earn this credit without being forced to participate in research.  When conducting research with student subjects, faculty are encouraged to remove themselves from the data collection process as much as possible to reduce the potential for coercion.  Strategies for this include but are not limited to online surveys, group administration of surveys during which the faculty investigator leaves the room, and use of research assistants.

Sample Consent Forms

Included here are samples of appropriate consent forms. The specific details in the forms should be changed to reflect the study at hand as well as current contact information for the researcher and IRB chair.  Investigators are encouraged to review each example to determine the appropriate format and amount and type of information to include.

Please note that these samples are not exhaustive or absolute.  Certain types of studies may require more or different details than are provided in these samples.  Investigators are responsible for providing their potential subjects with relevant and understandable information to obtain informed consent. 

A. Standard Consent Form: This is a prototype of the consent form layout and content appropriate for much human subjects research.  The “initials” blank should appear at the bottom of each page except for the page with the subject’s signature and should be used to indicate the potential subject’s acknowledgement of the information on those pages. This form is also appropriate for research conducted through the mail.

B. Consent Form for Group Administration: This form is identical to the standard consent form except that it also includes an “opt-out” box intended to reduce social pressure in group settings.  Potential subjects may not want to participate, but may also not want to stand out from the rest of the group by refusing. By checking the “opt-out” box, these subjects can maintain the appearance of conformity but not actually participate in the research. Investigators should discard any data collected from subjects for whom this “opt-out” box is checked.

C. Research Conducted Over the Telephone: Obtaining consent for these types of studies is done through a script read by the researcher.  The researcher should still explain the study and information on the consent form to the potential subjects, and potential subjects should still receive the opportunity to ask questions about the study prior to starting their participation.  If there is an option to participate in a different way, such as by completing an in-person survey, that option should be offered.  As mentioned elsewhere, a Waiver of Consent form is required for this type of research along with the consent script.

D. Research Conducted Online: The main feature of this consent form is the “Yes” box on the last page, which is used in lieu of a signature in online settings.  Consent may be inferred through subject behavior such as checking the box and completing the survey.   Additionally, there are no “initials” blanks at the bottom of each page.   

E. Research Involving Children or Other Persons Unable to Provide Informed Consent: This consent form is intended to be completed by the parent, guardian, or authorized representative of a person who is unable to provide informed consent due to age or cognitive ability.  Although the potential subject cannot legally provide consent, their assent should be obtained.  The form should include a section indicating either that the subject assents to participate or that assent was waived due to the subject’s age, maturity, or psychological state.   If assent cannot be obtained, it should be noted on the form.  The subject’s parent, guardian, or authorized representative can choose to deny or withdraw participation if the subject’s assent is not provided or is withdrawn during the course of the research. Investigators studying vulnerable populations should include a passage in the consent form stating that any abuse or maltreatment witnessed by or described to the research staff will be reported to the proper authorities. 

F. Broad Consent: This is a section of a consent form in which broad consent is obtained to use identifiable information in future research. This section should be incorporated into the consent form appropriate for the type of study in question.