Informed Consent

Informed consent is a process for ensuring that participation in human subject research is truly voluntary.

Definition

There are two parts to informed consent:

• provide information to prospective subjects

• document that the process took place and that the subject agreed to participate

Information that must be provided to prospective subjects includes:

• a statement that this is research
• an explanation of the research project's goals and duration
• a description of any incentives offered
• all involved experimental procedures must be specifically identified
• all reasonably foreseeable risks and reasonably expected benefits must be specifically described
• any appropriate alternative procedures must be disclosed
• a statement about the confidentiality of information, and any limits on that confidentiality
• for research involving more than minimal risk, information must be provided regarding treatments and compensation for those injuries
• an explanation of any relevant contacts
• a statement that participation is voluntary, that refusal is without penalty, and that participation can be discontinued
• consequences of discontinuing participation, including the compensation policies for such cases
  • exculpatory language is disallowed

There may also be specifications about the handling of PII.

All recruitment materials, including ads and messaging, are subject to similar restrictions. They cannot unduly influence the decision to participate.

Child Assent

Children cannot give informed consent. Instead, one or both (if possible) parents are required to give informed consent on their behalf. In addition, a child assent process must be constructed as appropriate for each age group involved.

Generally, one parent's informed consent is allowable for research with non-to-minimal risk, or with greater than minimal risk and prospect of direct benefit. The IRB still has the ability to determine both (if possible) parents' informed consent is necessary.

Broad Consent

Broad consent is an alternative to informed consent. It involves a subset of the components from informed consent, and an IRB cannot waive any requirements. A general description of the research that may be conducted is still required.

Exemptions

The informed consent process can be modified by waiving some or all components if five criteria are met.

1. Research involves none-to-minimal risk
2. The research could not be conducted without the modifications to informed consent
   • e.g. research reliant on deception or covert observation

3. The research could not be conducted without the collected PII

4. The modifications to informed consent will not adversely impact the rights and welfare of subjects
5. Information is provided after participation

Informed consent can also be waived on the collection of information for screening and recruitment purposes if that information is collected verbally or in writing, or accessed from records.

By the same criteria, parental consent can also be waived.

Importantly, the requirement to document informed consent can also be waived in circumstances. For example, if such is the only PII then keeping to the requirement would increase risk for subjects.

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