Jennifer Lahl (National Director of CBCNetwork): As it relates to informed consent-can only a doctor give informed consent?

Pauls: Only the patient or research subject (or there lawfully appointed guardian) can give informed consent to a procedure. It is the duty of the doctor or researcher to initiate the process by educating the patient or subject about the procedure, the risks, the benefits, and the alternatives that are available to the patient. In addition, the physician should be honest and straightforward with his or her experience with the procedure. If there are any conflicts of interest or financial interests that may come from the research or procedure these also should be spelled out such that the patient clearly understands what is going on. This is becoming more of an issue with the development of biological products like cell lines or genetic testing which are patented and are being developed for commercial interests.

Lahl: What is the fiduciary responsibility to a young girl who comes in to sell her eggs for an infertile couple?

Pauls: The fiduciary responsibility of the physician in egg donation is the same as it is with any medical procedure. The physician should inform the patient about what is involved with the donation process. This includes the risks of the donation procedure. In a situation like this where there usually is payment for services, the consent process should spell out clearly what each party will be responsible for when it comes to costs, coverage for complications, and other potential financial or personal interests that may influence the decision being made.

Lahl: What is necessary to be told to a young girl for informed consent to have integrity?

Pauls: There is debate on what constitutes adequate informed consent. This is one common allegation in medical malpractice cases i.e., lack of informed consent. The patient claims that if he or she had known that the injury suffered was a potential complication of the procedure, then they wouldn’t have gone through with it.

Informed consent requires several things. First, the proposed treatment or procedure must be explained in such a way that the patient understands it. Second, the patient must also be aware of alternative methods for treatment and the advantages and disadvantages of these. Third, the risks of the procedure must be explained in an understandable fashion. A major controversy is which risks need to be discussed, as there is always the possibility of something totally unexpected could occur. For example, should I explain the risk of the surgical light falling from the ceiling and striking the patient in the face causing a closed head injury? Probably not. Generally, the courts have maintained that the risks discussed would be the ones that a “common person” would want to know about. This is quite vague and certainly open to interpretation. Generally, complications that occur on a regular basis, such as bleeding or infection for surgery should be discussed. In addition, special risks associated with certain procedures; particularly if they have potentially serious consequences should also be shared. This is an area where there are no bright lines delineating what should be discussed and what can be dismissed.

There have been serious concerns raised about long term effects of hyperstimulation and repeat egg donation. There is scant, if any, good information on the long-term effects on general health as well as fertility. This is an issue that needs further evaluation. In addition, patients should be informed that there is uncertainty regarding the long term effects on egg donation.

Lahl: When we turn to scenario of the young girl selling her eggs for cloning research does informed consent apply?

Pauls: Certainly so. The fact that the young woman is entering into a financial transaction with remuneration for services doesn’t mean that informed consent isn’t necessary. The researcher still has a duty to make sure the young girl is aware of how the procedure is performed as well as the risks involved. Offering payment doesn’t abrogate that responsibility. This is spelled out at length in regulations regarding research on human subjects.

Part 2:

Jennifer Lahl (National Director of CBCNetwork): Isn’t egg harvesting for research a breach in the Declaration of Helsinki as the risk to benefit relationship is all risk and no benefit?

Pauls: One could make this case, but the difficulty is defining what is considered to be a benefit for the person donating. Number 4 under Sections 1, the basic principles, states that “Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.” The problem one runs into in this situation is defining the importance of the objective. Certainly the risks are fairly quantifiable in this situation, but the benefits are much more difficult. With the lack of agreed upon standards for measuring benefits, the discussion degenerates into personal preferences.

Lahl: In the case of cloning research and egg selling, is part of informed consent the requirement to be informed that the eggs will lead to profit (patent development) for companies?

Pauls: I certainly believe that financial interests that may not be apparent should be spelled out up front. This has been an area of legal action in the past few years as patients are finding out that tissue obtained from them is being used in a for profit fashion. There are already regulations covering some situations where a doctor may have a financial interest in a facility or company. As a surgeon, I have to disclose to my patients if I have an ownership interest in the hospital or surgical center that I’m referring them to for their operation. Likewise, there are extensive federal regulations in place for physicians regarding self-referral to laboratories or radiology facilities which they may have ownership.

Lahl: Since the cloning/embryo research is still in its infancy, is it appropriate to use human subjects in the research?

Pauls: In my opinion, I believe that extensive research should first be performed in animal models if possible before human research is attempted. The underlying problem that is faced in embryonic and cloning research gets back to the basic fundamental understanding of what constitutes a human person. The last fifty years has seen the rise of alternative definitions of personhood, which makes this issue so difficult to resolve. The problem faced today is that there are many people who do not see the embryo as a person, therefore entitling the embryo to special protection from an ethical and legal standpoint. Most of the courts have handled embryos as property, which is a very different status. This gives the impression that embryos are just like my lawn mower, which can be manipulated, adjusted, and disposed of in whatever fashion. Since the embryo is now seen by many as a nonperson, then it can be used in whatever fashion is deemed necessary. It’s only when the embryo, or the clone for that matter, is being used to create or is allowed to mature into a full term infant that everyone draws the line, because in that case most would agree that it is a person or is becoming a person.

Lahl: Is it a violation to use young women for basic research?

Pauls: I would not consider it to be an a priori violation to use young women for basic research, meaning that the use of young women or young men for that matter is a violation of protocol in and of itself. However, the situations where it would be acc

eptable are quite limited. As I mentioned before, the risks of the situation have to be carefully delineated and extensive research should be done prior to using young women in order to determine those risks. As the Helsinki Declaration states, “Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable.” It also states that “Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others.” In situations like this, the project should be thoroughly reviewed by an independent Institutional Review Board to carefully vet the risks and benefits. If there are alternative methods that don’t involve human subjects, then those should be explored first before proceeding to human experimentation.

David Pauls is General Surgeon on staff at Mercy Health Center in Wichita, KS and is Board Chair of the CBCNetwork.