Key Information

The regulations require a "Key Information" section to be placed at the top of each consent document. This section should provide a brief overview of the research such that a reasonable person would be able to decide whether to participate. At this time, the Key Information section is only required for informed consent documents 4 pages or more in length.

Key Information should include:

• A statement that the project is research and participation is voluntary;
• A summary of the research including the purpose, duration, and brief list of procedures;
• Reasonable, foreseeable risks or discomforts;
• Reasonable, expected benefits;
• And alternative procedures of courses of treatment, if any.

Basic Elements of Consent

After the key information section, the remaining consent should give a more in depth of the research and what the subject should expect should they choose to participate. The regulations provide a list of basic elements that are required to be in informed consent documents.

• A statement that the study involves research. This includes but is not limited to:
  • An explanation of the purposes of the research;
  • The expected duration of the subject’s participation;
  • A description of the procedures to be followed.
• A description of any foreseeable risks or discomforts to the subject.
• A description of any expected benefits to the subject or to others.
• When applicable, a disclosure of appropriate alternative procedures or courses of treatment that might be advantageous to the subject.
• A statement describing how confidentiality of data will be managed.
• For research involving more than minimal risk:
  • An explanation as to whether any compensation or medical treatments are available if injury occurs. If these exist, what they consist of, or where further information may be obtained.
• A statement that:
  • Participation is voluntary;
  • Refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled;
  • The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
• One of the following statements is required about any research that involves the collection of identifiable private information or identifiable biospecimens:
  • A statement that identifiers might be removed from the identifiable private information or identifiable biospecimens and that, after such removal, the information or biospecimens could be used for future research studies or distributed to another investigator for future research studies without additional informed consent from the subject or the legally authorized representative, if this might be a possibility;
  • A statement that the subject’s information or biospecimens collected as part of the research, even if identifiers are removed, will not be used or distributed for future research studies.
• List of whom to contact with questions about the research, research subjects’ rights, or in the event of a research-related injury to the subject. This includes but is not limited to:
  • Principal Investigator’s contact information;
  • Faculty Advisor’s contact information (if applicable)
  • Contact information for the SBER IRB Office, and a statement about why participants would contact the IRB, instead of the research team:

If you have questions or concerns about your rights as a research participant, or if you would like to discuss the study with someone outside of the research team, contact the Tufts Social Behavioral & Educational Research Institutional Review Board (Tufts SBER IRB). This is a board that oversees research at Tufts.

Tufts SBER IRB Contact Info:
Tufts SBER IRB
75 Kneeland Street, 6th Floor  |  Boston, MA 02111
Telephone: 617-627-8804
Email: sber@tufts.edu
Website

Additional Elements of Consent

In addition to the required elements of informed consent, there are additional elements that may be added to the consent form when necessary. They include:

• A statement that the particular procedure may involve risks to the subject which are currently unforeseeable
• Anticipated circumstances in which the subject’s participation may be terminated by the investigator;
• Any additional costs to the subject that may result from participation in the research;
• The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
• A statement that significant new findings developed during the course of the research will be provided to the subject;
• The approximate number of subjects involved in the study.
• A statement that the subject’s biospecimens (even if identifiers are removed) may be used for commercial profit and whether the subject will or will not share in this commercial profit;
• A statement regarding whether clinically relevant research results, including individual research results, will be disclosed to subjects, and if so, under what conditions;
• For research involving biospecimens, whether the research will (if known) or might include whole genome sequencing (i.e., sequencing of a human germline or somatic specimen with the intent to generate the genome or exome sequence of that specimen).

Standard Written Consent

It is expected that the researchers will obtain the participant’s signatures on the ICF. The participant’s signature is the way that the research team documents the participant’s willingness to consent. This type of consent is expected to be used in face-to-face research. The informed consent template should be used to craft the consent forms for your study. 

Waiver of documentation of informed consent

However, it is not always appropriate to collect a signature from participants. In this case, a research team may request to waive documentation of informed consent. The participants still agree to be in the study, but are not required to sign the consent form. This type of consent might be used for online surveys, interviews done over Webex, or in cases where it might not be culturally appropriate for a participant to sign a consent form. Sometimes, a research team may request to waive the requirement that a participant signs the consent form when the research is greater than minimal risk, and the only document that links the individual to participation is the consent form itself.

The three circumstances under which a research team may request to waive documentation of informed consent are as follows:
• The only record linking the subject and the research would be the informed consent form and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject 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;
• 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. In this case, the research team must explain what alternative means of documenting consent are being employed.

Waiver or Alteration of the Informed Consent Process

Under some circumstances, the research team may request to waive the informed consent process, or waive or alter some of the required elements of informed consent. Researchers will often request to waive the informed consent process when conducting secondary analyses of preexisting data. Whenever possible and appropriate, participants and/or their legally authorized representatives will be provided with additional pertinent information after participation. When studies use deception, a researcher may want to alter the purpose of the research as it is described in the consent form. In this case, the researcher must debrief the participant after the study as to the true nature of the research. The waiver of the consent process, or alteration its elements, may be granted if the following four conditions apply:
• The research involves no more than minimal risk to the subjects;
• The research could not practicably be carried out without the requested waiver or alteration;
• If the research involves using identifiable private information or identifiable biospecimens, the research could not practicably be carried out without using such information or biospecimens in an identifiable format;
• The waiver or alteration will not adversely affect the rights and welfare of the subjects.

Short Form Written Consent

When a participant has limited proficiency in written English, the research team has not previously translated the consent documents, and there is not time to do so (e.g., a participant is fluent in a language that was not expected by the research team), the research team may utilize a shortened, non-English consent document in the language understandable by the participant. Both the participant and a witness to the consent process sign the short-form after oral delivery of the consent information.

Parental Permission and Minor Assent

When minors (under the age of 18) are involved in research, permission must be sought from the parents or guardians. While in most cases, the SBER IRB allows for the consent of just one parent or guardian, in some greater than minimal risk studies, permission may have to be sought from both parents or guardians. For studies involving minors aged 7-17, the SBER IRB expects researchers to seek not only parental permission, but the assent of the minors involved in research as well. While there is not a formal assent process required for children under the age of 7, it is expected that researchers ensure that the minor is willing to participate and has a plan for stopping the research should the child show signs of no longer wishing to participate.

Exempt Research

The Tufts SBER IRB considers it best practice to collect consent even if the research is determined to be exempt. While we expect researchers to obtain consent, there is more flexibility in how the research team may wish to conduct or document consent. Therefore, the consent process and information contained within the consent can be adapted to the research context. The SBER IRB consent form may be used. Alternatively you may use the SBER IRB consent script. If deviating significantly from either the form or script templates, or requesting to substantially alter or eliminate the consent process, provide a rationale in the application. 

• Consent documents should be written in simple, plain language, and should not contain any jargon. For adult participants, IFCs should be written at an 8th grade reading level.
• Plain language includes short paragraphs, with short sentences, that have short words.
• Write in the second person (you) and avoid the first person (I).
• Avoid the passive voice and opt for the active voice. 
• The informed consent should not include any exculpatory language.
• Use 12 point font with 1 inch margins. This will maximize readability and allow the IRB to stamp the consent documents, if necessary.
• If using multiple consents, label each clearly in a footer (e.g., SONA credit, SONA paid) to lessen the likelihood of using the incorrect consent document.