Question

Discuss the elements of informed consent and provide a clinical example about what can happen when some elements are not adhered to.

Answer 1

Informed consent is an ethical and legal requirement for any research or procedure involving human participants. In it the participant is informed about all aspects of the trial which makes them capable of, taking any decision. After understanding all aspects of the trial the participant voluntarily confirms his or her willingness to participate in a particular procedure or clinical trial for the stated purpose.

Informed consent is a necessity and which is inevitable prior to every research involving a human being as subjects for study.

According to DHHS/FDA, there are eight basic elements of informed consent. They are required to be provided in the course of the consent process.

Elements of written informed consent documents

1. A detailed statement that the study involves research: which explains

• the purposes of the research
• the expected duration of the subject's participation
• description of the procedures to be followed
• identification of any procedures which are experimental

2. description of any foreseeable risks or discomforts to the subject:

- estimate of their likelihood and the description of steps taken to prevent or minimize them

3. A description of any benefits to the subject or to others which may reasonably be expected from the research, but monetary compensation is not considered as a benefit

4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject

5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained

6. For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if the injury occurs and, if so, what they consist of, or where further information may be obtained

7. An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject

8. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled

Additional elements:

Additional Elements of IC –DHHS/FDA

1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable

2. Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent

3. Any additional costs to the subject that may result from participation in the research

4. The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject

5. A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject

6. The approximate number of subjects involved in the study.

         

Example of Violation of the first element of informed consent

A patient having severed abdominal pain and bleeding, and her OB/GYN has determined that she has fibroid tumours that must be removed. The staff had obtained the consent for fibroid removal, but there is no mention on the form of a hysterectomy. During surgery the surgeon determines that a hysterectomy is necessary, he has no consent for the procedure.

The performance of the procedure without explicit consent exposes the doctor, and the hospital, to serious liability if something goes wrong or if the patient is upset because she may have chosen an alternative treatment. If the physician decides not to proceed with the surgery patient may get exposed to the additional risks of another major surgery.

The well organized informed consent regarding the could have been made everything legal and easy if the staff discussed the possibility of needing to do a hysterectomy with the patient as well as the potential risks and alternatives beforehand. A possibility of both the procedures could have been included on the consent form for Emily’s signature.

References:

• HRPP website: http://www.yale.edu/hrpp/
• http://www.yale.edu/hrpp/policies/index.html
• http://www.yale.edu/hrpp/responsibility/compliance.html
• OHRP website: http://www.hhs.gov/ohrp/
• FDA website: http//www.fda.gov/
• https://www.fda.gov/downloads/regulatoryinformation/guidances/ucm405006.pdf