Informed Consent for Research (Ruthann Russo)

Medical research is often a controversial topic, however there are many regulations in place to protect patients rights.

Providers must follow specific requirements of informed consent
for research purposes. There is widespread agreement that informed consent for research must contain three basic elements: (1) the physician researcher must provide information to the patient, (2) the patient participant must understand the information, and (3) the patient must voluntarily participate in the study.

There are several additional guidelines for obtaining informed consent
for research purposes. These include:

The consent must contain a statement that the participant can ask questions and withdraw from the experiment at any time.
The researcher must reveal information about the study that “a reasonable volunteer” would wish to know to make a decision.
A special problem arises when informing participants of some aspect of the research that may affect the validity of the study. Here, it is sufficient to let the participant know that some features of the research will not be revealed until the research is over.
Researchers must present information to participants in an organized manner, giving participants sufficient time to review and consider all of the issues.
Researchers must present information using language participants can understand. Researchers cannot offer participants excessive or improper “rewards,” as this would influence participants’ ability to participate voluntarily.
Researchers in a position of authority, or who have commanding influence, over a potential participant should not ask the person to be in a study. This also can influence their ability to participate voluntarily. This can apply to patients asked by their regular doctor to participate in one of her studies. In these cases, outside physicians should be asked to obtain informed consent from the patient-participants.