Waiver or Alteration of Elements of Informed Consent

There are two components to the informed consent process: information and documentation. The first occurs when you convey pertinent information to potential subjects so they can make an informed decision about whether they want to participate. The second refers to documenting that the exchange of information and consent took place (usually via a signed consent form).

Sometimes it is inappropriate for researchers to include certain elements of consent, or even the documentation of that consent. Federal guidelines allow the IRB to waive or alter certain elements of consent. The waivers may be used for adult consent and parental permission for children to participate in research. Our policy is as follows:

Four findings must be determined by the IRB before any or all of the elements may be waived.

The research involves no more than minimal risk to the subjects.
The waiver will not adversely affect the rights and welfare of the subject.
The research could not be practicably carried out without a waiver or alteration.
When appropriate, subjects will be provided with pertinent information after participation.
The research could not practicably be carried out without such information or biospecimens in identifiable format.

Information is provided below about how to interpret and apply the findings. See guide on documentation.

Finding No. 1

The research involves no more than minimal risk to the subjects.

No more than minimal risk means that a subject will experience no more discomfort or distress than in the course of normal daily life, or routine physical or psychological test.

In social and behavioral sciences, the greatest risk to participating in research is usually a breach of confidentiality. An inadvertent disclosure about a subject might put the reputation, employment or insurance of the subject at risk, damage the subject’s relationships with their family or community, or put them at risk of civil or criminal prosecution. If the risk of a breach of confidentiality is managed, a study can be considered to pose no more than minimal risk.

Risk is time and situation specific. For example, older children may be much more sensitive to questions about their family life than would very young children. Questions about marijuana use in one’s youth would carry very different risks for a confidential study of the grown up “flower power” children of Marin County than it would for a presidential candidate.

Finding No. 2

The waiver will not adversely affect the rights and welfare of the subject.

The researcher and the IRB must consider the rights and welfare of the subject separate from the question of risk.

There is not always consensus about what constitutes the rights of the individual. More than likely, we all agree that individuals are entitled to respect, even if they are not fully consented. Most of us agree that individuals also have a right to privacy. Privacy is defined as having control over the extent, timing, and circumstances of sharing oneself or one's data with others. The definition of privacy is ever evolving, and we know that it is not always clear what is private and what is not.

Finding No. 3

The research could not practicably be carried out without a waiver or alteration.

This doesn’t mean that it would be time consuming or inconvenient for the researcher. It means that the research could not be conducted at all if all elements of informed consent were required.

Elements of consent are most often waived when the research methodology involves deception. The IRB must determine that the use of deception does not violate the rights or welfare of subjects.

Finding No. 4

When appropriate, subjects will be provided with pertinent information after participation.

This debriefing process is most frequently used for studies involving deception; however, it would not be required if the debriefing itself put subjects at risk.

Finding No. 5

The research could not practicably be carried out without such information or biospecimens in identifiable format.

The collection of participants’ identifiable information increases the risk of a breach in confidentiality. Researchers should not collect identifiable information unless it is absolutely necessary. If the research can be carried out using only non-identifiable information, the IRB will request you to do so.

In cases in which the collection of identifiable information or biospecimens is necessary, the IRB must determine that the research could not practicably be carried out without using the information or biospecimens in an identifiable form.