Informed Consent and Waiver of Consent

Informed Consent

Informed consent procedures should be conducted in the context of Justice and Beneficence that manifest profound respect for human dignity.
Informed consent needs to provide key information and promote autonomy by ensuring prospective subjects receive the information needed to make an informed decision.
Informed consent is not a single event or just a form to be signed; it is an interactive educational process that takes place between an investigator and a prospective subject beginning with recruitment and continuing throughout the subject's involvement in the research.

What a Subject Should Consider when Considering being in a study:

Are You Thinking About Being in a Research Study? Everything you should know before becoming a research subject. CITI Program, www.citiprogram.org, ©2017 Biomedical Research Alliance of New York LLC. CITI Program is a division of BRANY

General Consent Requirements

informed consent must give prospective subjects the information that a reasonable person would want to have in order to make an informed decision
key information such as the study's purpose, risks, benefits, and alternatives, must be provided at the beginning of the consent form
information must be presented in a way that facilitates an understanding of why one might, or might not, want to participate
the informed consent form should not simply list isolated facts, but instead should help people process complicated information

Documentation of Informed Consent

Documenting informed consent occurs after explaining the research and assessing participant comprehension. At a minimum, it involves obtaining the signature of the participant (or the legally-authorized representative or parent(s) as well as the person obtaining consent. The person obtaining consent indicates they have explained the research to the participant, ensured that the participant understands the research and that the subject freely consents to participate.

In most cases, the federal regulations require that informed consent be documented, but they also provide some important exceptions.

Waiver or Alteration of Consent

Investigators may make a case for the waiver or alteration of the process and/or documentation of informed consent. Consult Waiver or Alteration of Informed Consent for more information. The IRB will consider a waiver or alteration for reasons outlined in [45CFR46.116(c-d)].

When Is a Waiver of Signed Consent Allowed?

Federal regulations allow the IRB to waive the requirement for obtaining signed consent if it finds 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.
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 of the research context. (Note: Only #2 applies to FDA-regulated studies.)

The IRB can also waive signed consent in studies that meet the requirements for waiving all consent.

A waiver of documented consent does not mean that you are relieved of your duty to carry out an informed consent procedure. Generally, when the IRB approves a waiver of signed consent, verbal consent (often with the use of an information sheet) or electronic consent will still be required. In limited cases, implied consent may be allowed.

Assent

In research where the subjects are children or some other protected subject groups, there may need to be an assent process as part of the informed consent process. Capacity to consent is the ability to perform the following four tasks:

1. Understand the information provided
2. Understand the consequences of a decision
3. Make the decision
4. Communicate the decision

Capacity is task dependent. A subject can have the capacity to consent to have blood drawn for a research study and lack capacity to consent to take part in a randomized placebo-controlled clinical trial. Therefore, the best way to assess capacity to consent to a particular protocol is to discuss the research with the potential subject and see whether they can perform the above four tasks. If not, they lack the capacity to consent. Assessment of capacity should be part of the consent process.

Age, maturity and psychological state need to be taken into account when determining whether to ask for assent (45 CFR 46.408(a)). Out of respect for developing persons, it is important to involve children in the decision-making process whenever possible. Though they may not be able to give legal consent, they have the ability to assent or to dissent. It is important to keep in mind that a child's failure to object to participation should not automatically be construed as assent. Assent implies the affirmative, explicit agreement of the child.

Usually, children who are age seven and older may be asked to provide verbal assent or, in some cases, sign an assent form, which is stated or written in language appropriate to the ages and conditions of study subjects. The assent should include a description of the study and describe any inconveniences and discomforts subjects may experience.

The assent form/script should briefly explain in basic terms:

that they are being asked to participate in a research study;
the purpose of the study;
an estimate of how much time is involved in participating;
what will happen to them if they agree to participate (e.g., “answer some questions”);
the foreseeable risks and/or discomfort and any benefits they may experience (immediate risks and/or discomfort and benefits, rather than future or theoretical possibilities);
that they should ask their parents or researcher any questions they have about participating;
that their participation is voluntary (up to them), and that they may stop at any time;
that their father/mother/guardian knows they have been asked to be a part of the study.

Retention

Consent forms must be maintained for three years following the completion of the study. Consent forms must be available for inspection by authorized officials of the Kenyon College administration, the Kenyon College IRB, regulatory agencies, and sponsors.

Anonymous or Confidential?

An anonymous study means there is NO WAY ANYONE can tell if a person was a participant in the study and they cannot be identified by the information they give, (including by the investigator). Even if data is coded, it can be decoded and become identifiable.

A confidential study means that while the subject's identity potentially could be determined from the information they give, steps will be taken to ensure that they will not be identified. Be sure to describe to participants the steps used to preserve confidentiality.

If confidentiality or anonymity cannot be ensured, clearly state this under the "risk" section of the consent form.

Designing a Consent Form

Please consult the following Informed Consent /Assent templates, samples, and wizards for help in developing consent/assent procedures that provide potential research subjects the information they need to make an "informed" decision about participating in your research. The basics of informed consent include:

Purpose of the research
Description of procedures
Description of risk
Description of benefit (there may be no personal benefit to the subject)
Extent confidentiality will be maintained
Contact for research, subjects' rights, and adverse-event issues
Participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and
The subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

PLEASE keep your subjects in mind when designing the consent form. Readability is paramount.

***The informed consent procedures and documents that you include in/with your IRB application should be exactly what you intend to use in both content and format.*** The IRB will consider both.

These are templates and examples only and must be edited to your specific research project. You should design your consent process with your subjects in mind. Not all elements of consent will apply to all studies, but be sure to include all required elements.

Online Consent

The Kenyon IRB likes to see the following in an online survey:

The consent information is presented first. The survey is not served if the subject does not consent.
If the PI claims the subject does not have to answer anything they don't want to, the survey has to be able to move forward without a question being answered. Another way to do that is to have a "I prefer not to answer" choice for each question.
When the subject gets to the last response page of a survey, they should be given a last chance to decide if they still want to submit their information. One way of doing this is to present two buttons 1) this is the end, submit your response 2) quit without submitting your responses.
The submission should be acknowledged. A thank you will suffice, but a debriefing or other information text may be appropriate and respectful. It is a good idea to repeat the PI and IRB contact information.