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Informed Consent

Informed Consent

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General Federal Regulations

The Department of Health and Human Services requires researchers to comply with federal laws defining informed consent for individuals wishing to participate in a research study. These laws cover the general rules for informed consent, and now also include rules specific to genetic research. According to the HHS (Heath and Human Services) Policy for Protection of Human Research Subjects, studies are obligated to provide information in a way that will “minimize the possibility of coercion or undue influence.” An informed consent document must give information about a particular study and the potential risks and benefits of participation in it and cannot be a blanket statement that lacks specific detail. The law requires that consent information be written in an appropriate way, so that it is comprehensible for an average individual. For example, researchers cannot use language that is too technical for an individual to understand and then consider the individual “informed.” Any language used cannot excuse the liability for wrongdoing or negligence from the “investigator, the sponsor, the institution or its agents” and must not “waive or appear to waive” an individual’s legal rights.

 

Further requirements of informed consent:

1. The purpose of the research must be explained. The time commitment and total duration of participation, as well as the steps that will be taken, must be described. The researchers must also give information on the steps that are “experimental,” if any.

2. The participant must be told of any expected “risks or discomforts” involved.

3. The participant must understand the benefits to themselves and others that are expected to come from the research.

4. Researchers must provide information on alternatives to their study that could provide the person with other advantageous procedures, if any exist.

5. There must be a statement that describes how the information that traces back to the person’s identity will be handled and maintained after the study.

6. In a case where there is “more than minimal risk,” researchers must disclose any available compensation for harm done. Furthermore, they must give information about therapies that might be used to treat the adverse outcome, if there are any, and where the individual can get more information on the subject.

7. The study must have a specific individual that participants can contact with questions or to report “research-related injury”.

8. Individuals must understand that participation is voluntary, meaning there cannot be any punishment, including the loss of benefits already received, for choosing, at any time, to withdraw from the study.

 

Other sections of the law are specific to certain studies. If they apply, the informed consent documents must disclose:

1. If part of the procedure involves a risk to an embryo or fetus that is “currently unforeseeable”

2. If there are expected reasons for a person’s participation to be ended by the researchers, regardless of the person’s consent

3. Any additional costs to the subject

4. The steps a participant can take to withdraw from the study in an “orderly” way

5. If incidental findings are discovered during the research related to the person’s “willingness to continue participation,” that the person will be informed

6. How many other people are involved

 

Specific Rules for Genetic Research

When considering genetic research, several issues must be specifically addressed. Language is an important element in any agreement, and researchers must strike a balance between accurate information and language that can be understood by the subject. Therefore, as a guide, the language should be specific but not technical.

Purpose:

A participant is entitled to know who is sponsoring the study as well as details about its design, the diseases or conditions being studied, and the “immediate and long-term goals.” A person must be able to understand why a study is being conducted and the role a person’s participation plays in it.

Description of Procedures:

A research team should disclose everything that will happen to the participants before they begin. This includes what will happen to the patient’s samples, such as blood and genetic information. If researchers expect any data derived from a patient’s genetic information to be used in the future, the sharing and storing mechanisms should be described. Furthermore, it should establish a mode of future contact and duration of storage.

Confidentiality:

A person should be well aware of whether their samples will be attached to their identities or not. In the consent form there may be Certificates of Confidentiality. These documents make it legal for researchers to refuse to give information about their participants in “any civil, criminal, administrative, legislative, or other proceeding, whether at the federal, state, or local level.” These are very helpful for both researchers and participants in studies that might affect participant’s lives financially, or concerning insurance, employment, and reputation.

CLICK HERE to learn about informed consent and incidental findings
CLICK HERE for a case study exploring the limitations of informed consent

 

REFERENCES

“Code of Federal Regulations.” United States Department of Health and Human Services. N.p., n.d. Web. 03 Nov. 2012. <http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html>.

“Elements of Informed Consent Described in Federal Regulations.” Elements of Informed Consent Described in Federal Regulations. N.p., n.d. Web. 03 Nov. 2012. <http://www.genome.gov/27526659>.

“Elements Tailored to Genomics Research.” Elements Tailored to Genomics Research. N.p., n.d. Web. 03 Nov. 2012. <http://www.genome.gov/27026589>.