The Informed Consent Process in Research

Research patients subjects are entitled to informed consent.

Informed consent is both an ethical directive as well as a law. This understanding is vital carrying out a successful clinical trial because understanding informed consent provides the necessity for obtaining it. According to Pozgar, (2011), informed consent is a:

Legal concept that provides that a patient has the right to know the potential risks, benefits, and alternatives of a proposed procedure prior to undergoing a particular course of treatment. Informed consent implies that a patient understands a particular procedure or treatment, including the risks, benefits, and alternatives; is capable of making a decision; and gives consent voluntarily.

From a legal perspective, patients who are not provided proper information concerning procedures, have the right to seek legal remedy. Under the law, the patient must provide consent and must understand what she is consenting to having performed. This should be done in writing as well as verbally in many instances.

This legal requirement is upheld in Section 4.8 of the International Congress of Harmonization (ICH) Guideline for Good Clinical Practice E6(R1) (Department of Health and Human Services, 2011). Furthermore, the ICH requires that prior to a trial, the investigator should receive written approval that shows consent of the written informed consent form as well as other information provided to the subjects (Department of Health and Human Services, 2011).

There are several key elements the must be covered in order to obtain legal informed consent. According to the American Medical Association (1998) informed consent includes making the patient aware of:

· The diagnosis, if known
· The nature and purpose of a proposed treatment or procedure
· The risks and benefits of proposed treatment or procedures
· Alternatives (regardless of costs or extent covered by insurance)
· The risks and benefits of alternatives
· The risks and benefits of not receiving treatments or undergoing procedures (Temple Health, 2014).

Informed consent is important to many different stakeholders in research for both ethical and legal reasons. Most importantly, informed consent provides a clear intention and communication of procedures and the risks involved. Patients must be given enough information to be fully informed before deciding to undergo a major treatment, and this informed consent must be documented in writing. In this way, both patient and provider are clear on what needs to be performed. Healthcare organizations are also impacted by informed consent due to the way that it is practiced within the organizations. This is to say that organizations that have strong practices for obtaining informed consent can reduce the risk of litigation and loss of patient (consumer) value.

References

Pozgar, G. (2011). Legal Aspects of Health Care Administration [VitalSouce bookshelf version]. Retrieved from http://devry.vitalsource.com/books/9781449643850/id/gloss_24

Temple Health (2014) A Practical Guide to Informed Consent Background: Requirements for Informed Consent Retrieved from http://www.templehealth.org/ICTOOLKIT/html/ictoolkitpage5.h

Department of Health and Human Services (2011) Good Clinical Practice Resource Guide Retrieved from http://www.niaid.nih.gov/labsandresources/resources/dmidclinrsrch/documents/handbook.pdf

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