Informed Consent

Obtaining Informed Consent

There are three methods to obtain informed consent:

Through a signed consent form: This is the norm for most research conducted in the United States. See a sample consent form.

*Researchers may obtain electronic signatures signifying consent to participate, but must ensure that research subjects receive a full consent form before an electronic signature is accepted.

Through implied consent: When the researcher employs a survey, they may include at the beginning of the survey a full explanation of the nature of the research. If the subject proceeds to answer the survey questions, consent is implied. The implied consent text must include all components of informed consent listed below, and must specifically ask RSs to print or download a copy of the consent text that they can keep for their records.
Through verbal consent: This may be used when . . .

The researcher conducts low-risk research in which RSs are members of a distinct cultural group or community in which signing forms is not the norm.
The principal risks to a research subject would result from a breach of confidentiality about their participation in the research (e.g., studies on potentially sensitive topics such as illegal drug use, other illegal conduct, or sexual behavior), and the consent document is the only record linking the subject to the research.

In obtaining verbal consent, the researcher must:

--Put in place a procedure for ensuring and documenting that informed consent was obtained from each research subject, even in the absence of a signature (and even if identifying data has been removed)

--Provide a printed copy of the verbal consent script, or an information sheet about the research, to subjects who agree to participate in the study, so that they can refer to it later if they have any questions or would like to contact the researcher or the IRB. If this is declined, provide a business card or written contact information.

How to Write Consent Forms, Texts, and Scripts

As per the revised Common Rule (introduced in January 2019), information needs to be presented in sufficient detail and organized and presented in a way that facilitates an understanding of why one might, or might not, want to participate. There is a new requirement that key information about the study must be provided at the beginning, so follow the order of the components presented below (and on our informed consent template). Because consent forms can be very long, the aim is to put the really important information up front. This “key information” includes components 1-9, below, although other information is also required. The IRB will review consent forms and texts to ensure that information is presented in a concise and focused manner that will help people process the complicated information they have been given and aid in decision-making. Take into account that . . .

Consent forms/texts/scripts must be clearly written in plain language (typically at an 8th-grade reading level) so participants can fully understand the implications of participating.
Scientific, medical, and technical terms should be avoided if possible or, if they must be included, clearly defined in simple language.
If research is to be conducted in a language other than English, copies of the forms/texts/scripts should be provided in that language and English.

Components of Consent Forms, Texts, and Scripts

All consent forms, text, and scripts must include the following, federally mandated, information:

The names, titles, and departmental and institutional affiliations of all researchers, along with contact information. If the researcher is a student, the faculty mentor’s name, title, and departmental and institutional affiliation should also be given, along with contact information
The fact that consent is being sought for research, and mention of the prospective written end product [such as a book, article, report, senior thesis, etc.]
A statement that participation is voluntary and that the research subject can decline to participate and can refuse to answer a question or do anything asked of him/her. (S)he can also withdraw from the study at any time without penalty.
An easy to understand explanation of the purpose of the study
A simple description of the procedures to be followed
A clear overview of how the research will be scheduled and the time it will take to participate
A description of any reasonably foreseeable risks or discomforts to the subject. These include not only physical injury, but also possible psychological, social or economic harm, discomfort or inconvenience.
A description of any benefits to the subject or to others which may reasonably be expected from the research. If there is no direct benefit, this should be stated. Please note that payment is not considered a benefit.
A description of the extent, if any, to which anonymity or confidentiality of records will be guaranteed (anonymity means that no identifying information will be recorded, while confidentiality means that identifying information will be kept in the researcher’s private records, but names or identifiers will not be revealed in publications or presentations)
If identifying information is included in the researcher’s records (“confidential” research): a statement that information or biospecimens collected for the research might be stripped of identifiers and used in other research in the future, or that this will not happen.
A statement concerning compensation to the subject, if any, and the terms under which such compensation may be withheld.
An invitation to use the contact information listed above if the research subject has further questions about the research
An invitation to contact the Gettysburg College IRB (at irb@gettysburg.edu) if the research subject has questions about their rights as research subjects.
If applicable, whom to contact in the event of a research-related injury or emotional trauma to the subject (for example, counseling centers).
Information about what organization is funding the study
Information about access to the results of the research.
If applicable: a request for consent to video or audio record the interview
If deception is involved in an Exempt study: an indication that the research cannot be fully described at this time, but that at the end of the subject's participation an explanation will be provided
The participant's signature, as well as their printed name and the date. Electronic signatures are accepted. The signature can be withheld if the IRB has approved this, provided the researcher has a way to ensure and document that consent was obtained from all research participants whose data is collected

Verbal consent with no signature can be used a) When conducting low-risk research in which RSs are members of a distinct cultural group or community in which signing forms is not the norm, or b) when the only record linking the subject and the research would be the consent form and potential harm would result from a breach of confidentiality.

For biomedical research, consent must include the following, federally mandated, information:

If applicable: appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the prospective subject (this is considered “key information” that must be listed early on the consent form, as item #10)
If biospecimens may be used for commercial pro¿t: inform the research subject of this possibility and whether they will or will not share in this commercial pro¿t (even if identi¿ers are removed).
If there will be clinically relevant research results: state whether clinically relevant research results, including individual research results, will be disclosed to subjects
If the research project might include whole genome sequencing: state whether researchers will sequence any human germlines or somatic specimens with the intent to generate the genome or exome sequence of that specimen

Broad Consent in Addition to Informed Consent

If an investigator foresees that identifiable data or biospecimens collected for their project may be used for future research, the researcher should obtain broad consent from their research subjects at the same time that they obtain standard consent for the present study. The researcher will have to submit a separate form to the IRB (they would use the application for Exempt status, and this would fall under Exempt Category #7). The researcher should use a separate broad consent document in addition to the informed consent document, so that the research subject does not confuse the two consent processes.

When Consent is Not Required

As per the revised Common Rule (January 2019), researchers do not need to obtain informed consent when accessing data or biospecimens for the purpose of screening, recruiting, or determining the eligibility of individuals to be included in a research project.
Exempt Category #4 does not mandate informed consent since it involves secondary data.

Consent for Projects Involving Children (under the age of 18) and Mentally Incapacitated Individuals

Children and mentally incapacitated individuals cannot legally provide informed consent, so assent should be obtained from the research subject, while full informed consent should be obtained from their legal guardian.

1) Assent from research subject: The individual should be told about the research, including an explanation of the procedures to be used, the risk of discomfort and inconvenience, and the purpose of the research, in language appropriate to their age, maturity, experience, and condition. They should then be asked if they wish to participate. They must say "yes." An individual’s failure to say "no" does not constitute assent. It must be made clear to the prospective research subject that no one will be upset with them if they decline to participate. If the child is old enough, an assent form may also be used.

In the protocol, the investigator should indicate the following:

How assent will be obtained (including a script of what the investigator will say to the child and whether or not the child's parent(s) or guardian(s) will be present);
How assent will be documented.

2) Consent from the research subject’s legal guardian: Even if the research subject ASSENTS, his or her legal guardian(s) must still CONSENT in order for the child to participate. The mechanism for obtaining consent must be the same as that described above, except that forms/texts/scripts are modified as appropriate (e.g., use "you/your child" phrases and change the signature line to include the research subject’s name and the legal guardian’s relationship to him/her).

Consent in Research that Involves Deception or Withholding of Key Information

The employment of deception or the withholding of key information by an investigator(s) for the purpose of securing subject participation and/or to prevent potentially biased reporting of data/information by the subject is permissible in Exempt and Expedited studies, provided all of the following conditions exist:

For Exempt: the research subject is told in advance (on the consent script and verbally) that this will take place but not given any details; for Expedited: the research subject is not told in advance, because full deception is necessary due to the lack of alternative procedures for data collection not involving deception;
The deceptive procedures will not place subjects at significant financial, physical, legal, psychological, or social risk;
The data collection/experiment will be followed by careful debriefing sessions whereby the subjects are fully informed of the nature and purpose of the deception; and
The procedures for deception meet the guidelines established by the discipline of the investigator through its professional code of ethics.

Debriefing Participants: If you anticipate using deception in your research, debriefing is an essential part of the informed consent process. It provides participants with a full explanation of the hypothesis being tested, procedures to deceive participants and the reason(s) why it was necessary to deceive them. It should also include other relevant background information pertaining to the study. When debriefing is required, researchers must submit a Debriefing Script to the IRB along with their application:

Sample Debriefing Script (download and edit to fit your research project)

Elements to Include in Debriefing:

The study title
The PI name and contact information
A statement thanking participants for completing the study
A full explanation of what was being studied (i.e., the purposes, hypotheses, aims, etc.). Use lay terms and avoid jargon
An explanation of how participants were deceived
An explanation of why deception was necessary
An explanation of how the results of the deception will be evaluated

Consent for Photographs and Videotapes to Be Published or Disseminated Publicly

Sample Photo or Video Release Form (download and edit to fit your research project)

Subjects must sign a photo or video release form if the goal of one’s research is to create a film, video art, or webpage, or if published work (book, articles, or reports) will contain research subjects’ images. The photo or video release form is separate from the consent form or script. To be clear, the researcher must obtain consent from the research subject to be video-taped or photographed in the general consent form/script before research begins. In addition, a specific photo or video image release form should be signed by the participant either directly before photographing or video recording begins or, if more suitable, when the researcher is organizing visual images/footage for presentation.