In a commentary published in the February 20 issue of the New England Journal of Medicine, a group of bioethicist, led by Ruth Faden, director of the Berman Institute of Bioethics at Johns Hopkins, and Nancy Kass, the Berman Institute’s deputy director for public health, advocate for a more nuanced approach to patient consent. It is their opinion that some cases “a time-consuming consent process is unnecessary for patient protection and could actually impede improvements in patient care.
Comparative effectiveness research is designed to inform health-care decisions by providing evidence on their effectiveness, pros, cons and the different options available. This evidence is determined by research studies that compare effectiveness of drugs, treatments, devices or even ways to deliver healthcare to patients.
According to the report, there are two ways that this evidence is found:
- Researchers look at all of the available evidence about the benefits and harms of each choice for different groups of people from existing clinical trials, clinical studies, and other research. These are called research reviews, because they are systematic reviews of existing evidence.
- Researchers conduct studies that generate new evidence of effectiveness or comparative effectiveness of a test, treatment, procedure, or health-care service.
Common questions asked about comparative effectiveness research explain just why this kind of research is important for patients, according to the Agency for Healthcare Research and Quality website, a sub agency with the U.S. Department of Health & Human Services.
Q: Why is comparative effectiveness research needed? What problem is it trying to solve?
- If you don’t get the best possible information about your treatment choices, you might not make an informed decision on what treatment is best for you.
- When you shop for a new car, phone or camera, you have lots of information about your choices. But when it comes to choosing the right medicine or the best health-care treatment, clear and dependable information can be very hard to find.
- It’s true that some treatments may not work for everyone, and that some treatments may work better for some people than others. This research can help identify the treatments that may work best for you.
Q: What are the practical benefits of comparative effectiveness research?
- You deserve the best and most objective information about treating your sickness or condition. With this research in hand, you and your doctor can work together to make the best possible treatment choices.
- For example, someone with high blood pressure might have more than a dozen medicines to choose from. Someone with heart disease might need to choose between having heart surgery or taking medicine to open a clogged artery. Reports on these topics and others include the pros and cons of all the options so that you and your doctor can make the best possible treatment decision for you or someone in your family.
- Every patient is different — different circumstances, different medical history, different values. These reports don’t tell you and your doctor which treatment to choose. Instead, they offer an important tool to help you and your doctor understand the facts about different treatments
The HHS legally requires informed consent as it provides protection of human subjects in research, albeit there are some exceptions.
The HHS regulations at 45 CFR part 46 for the protection of human subjects in research require that an investigator obtain the legally effective informed consent of the subject or the subject’s legally authorized representative, unless (1) the research is exempt under 45 CFR 46.101(b); (2) the IRB finds and documents that informed consent can be waived (45 CFR 46.116(c) or (d)); or (3) the IRB finds and documents that the research meets the requirements of the HHS Secretarial waiver under 45 CFR 46.101(i) that permits a waiver of the general requirements for obtaining informed consent in a limited class of research in emergency settings.
The informed consent process involves three key features: (1) disclosing to potential research subjects information needed to make an informed decision; (2) facilitating the understanding of what has been disclosed; and (3) promoting the voluntariness of the decision about whether or not to participate in the research. Informed consent must be legally effective and prospectively obtained.
The views of the bioethicists is nuanced break from principles that have guided research ethics and regulation for decades. Faden et al contend, “in a mature learning health care system with ethically robust oversight policies and practices, some randomized comparative-effectiveness research studies may justifiably proceed with a streamlined consent process and others may not require patient consent at all.”
Scott Kim, MD, PhD, and Franklin Miller, PhD, of the National Institutes of Health Clinical Center in Bethesda, Md., raise concerns that by forgoing patients’ rights to know, the medical providers are unjustifiably undertaking a paternalistic role that could easily be perceived as physicians actively concealing information thereby eroding the trust and credibility they might hold in the public’s eyes.
They, instead, propose something called “integrated consent.”
For comparative trials of commonly used treatments that have been validated in clinical trials, the integrated consent strategy would just incorporate the mention of randomization into the usual clinical discussion about treatment.
For example, with two blood pressure drugs, a physician might explain both are approved and commonly used, and add:
“But honestly, we doctors really don’t know if one is better than the other. So our hospital is doing a study by randomly (like a flip of a coin, so that we can obtain an unbiased answer) giving patients one or the other drug and then comparing results over a period of 1 year. … So unless you have a preference for drug A or B, I’d like to include you in the study.”
After the discussion, a physician would document the interaction as usual, mentioning that the patient agreed to randomization after discussion of rationale and risks and benefits of both options.
This strategy wouldn’t fulfill the regulatory requirement for explicit statements about voluntariness and confidentiality, but meets all requirements for altering informed consent (no more than minimal risk, not adversely affect rights or welfare, cannot “practicably” be carried out otherwise, pertinent information could be disclosed afterward), they wrote.
Additional Resources:
- You have a genetic disorder: Should your family be told they might carry the mutation?, Genetic Literacy Project
- Comparative Studies: No Informed Consent Needed?, MedPage Today
- Patient consent to research not always necessary, leading bioethicists say, Hub John Hopkins News Network
