Vicki Hammen, Vice Chair, IRBIRB Brown Bag

February 9, 2009

The Code of Federal Regulations (CFR) addresses the process separately from documentation◦ 45 CFR 46.116 and 21 CFR 50.20, 50.23, 50.24 &

50.25 covers the process◦ 45 CFR 46.117 and 21 CFR 50.27 deals with

documentation

“Except as provided elsewhere in this policy, no investigator may involve a human being as a subject in research covered by this policy unless the investigator has obtained the legally effective informed consent of the subject or the subject’s legally authorized representative.”

According to the Belmont Report, informed consent falls under the principle of ‘Respect for Persons’◦ “…requires that individuals, to the degree that

they are capable, be given the opportunity to choose what shall or shall not happen to them.”

It has been stated that a signed document without an effective informed consent process is not worth the paper it is written on (Cohen, J. , personal communication, 2008)

The three important elements that must be address in the informed consent process are:◦ Information about the research study

Full disclosure of the nature of the research and the subject’s participation

◦ Comprehension Does the potential participant fully understand the

information presented to him/her?◦ Voluntariness

Process must be free from any form of coercion or undue influence

Tampa Tribune article, March 2000◦ A lawsuit accusing USF doctors of experimenting

on pregnant women without their consent is settled for 3.8 million dollars The experiment was not considered risky and no

adverse events were recorded◦ The failure of the physicians to obtain informed

consent from the pregnant women cost their hospital

Women were given a 3 page, densely written document to read

Document was given while women were in active labor

None of the women thought they were participating in a research study

There were no benefits to participation for the mothers or their babies

A law firm specializing in clinical research problems filed suit on behalf of the unwitting participants

Information about the Research Project◦ Purpose: Why are you conducting this research?◦ Duration: How long will you need the subject?◦ Experimental: If the procedure is experimental

are there any other approved methods of choice? Usually only necessary in biomedical or

pharmaceutical clinical studies

Information, con’t◦ Procedures: Method to convey the information

may vary depending on the type of research, the complexity, and prospective participant Must be thorough but avoid MEGO (My Eyes Glaze

Over) Sometimes too much information is worse than too little

Consider using pictures, demonstrations, or videos

Risks◦ Are there any risks to participating?

What are the reasonably foreseeable risks—not all possible

How likely are the risks? Benefits

◦ Do not feel that you have to provide substantial benefits for the subjects

◦ Payment for participation is not a benefit

Alternatives to participating◦ Typically included in biomedical studies

Confidentiality◦ Very rare to be able to guarantee complete

confidentiality, even with anonymous Internet surveys

◦ Address how you will protect the confidentiality of the subject’s data during the project, if they wish to withdraw, and

following

Compensation for Injury◦ Not typically required, only for studies with

greater than minimal risk◦ May need to address how any reactions will be

handled Contact information

◦ Who to contact with addition questions or concerns

Right to refuse or withdraw◦ Need to explain what will happen to the individual

if they decide to withdraw participation during the experimental session or afterwards

◦ Will there be any consequences?

Informed consent is not valid unless the prospective subject understands the information that has been presented

It is the investigator’s responsibility to insure comprehension

Simply stating that the subject is to ask questions if they do not understand is not sufficient

Most subjects will not ask questions so as not to appear unintelligent or that they were not listening

The researcher needs to insure the potential subject has the answers to who, what when, where, and how as they pertain to the research study

Informed Consent Evaluation Feedback Tool◦ A list of 10 questions posed to the subject◦ Provides information about subject’s level of

understanding◦ Subject is given the questions to review at the

start of the informed consent interview◦ Question address: Purpose, benefits, risks, other

options, costs, alternatives, withdrawal, voluntariness, record review, questions for the researcher

The provision of consent must be free from any form of coercion or undue influence◦ Particular concern when seeking students as

research participants A faculty member cannot recruit subjects from

students in their classes or advisees◦ Implied authority

Individual obtaining consent in a medical setting wearing a lab coat

Only legally competent adults can give consent◦ Minors can give assent, not consent◦ Incompetent adults cannot give consent, but their

legally authorized representative can Must be sensitive to more subtle forms of

coercion ◦ Social pressure

Especially from vulnerable populations: children, prisoners

◦ Request from authority figures◦ Undue incentives for participation

The subject gives their ‘knowledable agreement’ to participate

Must have sufficient capacity to understand what is happening and feels free to express his/her wishes◦ Children above age 7 must provide assent◦ Can be a very simplified description

If they object this can veto parental or guardian consent

Informed consent is a process in which the outcome is an informed choice regarding the voluntary participation in a research project.

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