It’s what you say that could create liability

Consent forms shouldn’t waive rights

Federal laws governing research on human beings prohibit research institutions and sponsors from requiring subjects to sign documents that waive or appear to waive any of their legal rights. However, researchers are also required to inform potential participants whether the sponsors intend to pay for medical care in the event a subject is injured as a result of participation.

In some cases, legal experts warn, sponsors’ efforts to inform subjects about payment policies are crossing the line and may actually be interpreted as the waivers that the Common Rule prohibits.

"What you see, almost constantly, are sponsors, investigators and institutions attempting to inject into the consent document language that supports a particular view," explains Thomas K. Dalglish, JD, PhD, former director of the Office of Research Integrity at the University of Louisville (KY). "They will try to push the envelope. You see phrases like, I specifically understand that the sponsor is not liable for any . . .’ or We will pay only for medical expenses related to the research study.’"

Such phrases attempt to make subjects believe that their options, in the event that injury occurs, are limited by the policies of the respective research sponsors when that, by law, is not the case, he says.

For example, injured subjects can sue if they believe they were injured as a result of an investigator’s negligence. Subjects also may have rights to the information collected about them during the course of the trial.

Language in the consent form should inform subjects of things that the sponsor will provide (e.g., payments for medical care), but be careful not to imply that consent or acceptance of the terms limits the subjects’ options at a later time.

"The point is, you should not write language that serves as a discouragement or disincentive — We will only pay,’ for example, or I understand that I will only be entitled to . . .,’" Dalglish explains. "Those statements are not true. No matter what the policy of the institution or sponsor, subjects should be under no illusion and the sponsors should be under no illusion, that such policies limit what is available under the law."

What the rules say

Section 45 CFR Section 46.116 covers informed consent (as does similar language in the regulations of the U.S. Food and Drug Administration at 21 CFR Sections 50.20 and 50.25), says Janet M. Lis, Esq., a health care attorney practicing in Media, PA.

The introductory paragraphs of Section 46.116 state:

"No informed consent, whether oral or written, may include any exculpatory language through which the subject or the representative is made to waive or appear to waive any of the subject’s legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence."

Section (a)(6) then states:

"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 injury occurs and, if so, what they consist of or where further information may be obtained."

This can be fulfilled by stating what the sponsor on institution does plan to pay for or has set funds aside for should injuries occur, Lis says.

"The issue becomes that of stating what will or will not be provided clearly, and not stating or implying that rights have been given up [as prohibited by the introductory section noted above]. These statements should not make the subject think that he is releasing anyone involved in the research from liability for negligence or giving up rights that would otherwise exist," says Lis.

The federal Office for Human Research Protections (OHRP) has provided guidance as to what language they think is and is not appropriate, she adds.

Assumption of risk does not apply

An argument often made is that, by signing the consent forms, subjects have assumed responsibility for the risks of the research, says Dalglish.

However, this is a legal concept that applies under contracts between specific individual parties that have equal power in their interaction, he explains.

"The relationship between investigators and subjects is inherently one of unequal power," he says. "Individual subjects cannot write individualized or customized consent documents. There is a certain rigidity in the posture that investigators bring to subjects — they screen them in, they have set exclusion criteria, and they tell all of the subjects the same thing, etc. The assumption of risk is not an appropriate doctrine in this context because it is in the nature of the activity that there are an enormous amount of risks that are unknown. You are not going to get a court to say that the person with the lesser power agreed to assume all of the risks in all of the experimental treatment — that is just not ethical."

A research protocol is not individualized treatment that can be varied according to treatment needs; it is a set protocol where changes are limited to those within the protocol itself, agrees Lis.

"A potential subject is faced with wanting to participate in a clinical trial but finds that some of the pieces of the trial which may be negotiable, such as payment for injuries sustained, may not be to his liking," she continues. "As a research subject, he may feel that he has little bargaining position. Even if this is not true, and the sponsor would be open to negotiation with regard to the terms outside of the protocol itself, the unequal bargaining position (i.e., being presented with a form consent with set terms) is likely to make the subject feel that this is not the case. And, of course, if the information regarding what will or will not be paid for is not clearly stated in the consent, the subject does not even know what he could be paying for."

What should be said?

Dalglish believes researchers should include statements in informed consent documents that thoroughly explain what policies the sponsor or institution has regarding potential injuries to participants during trials. But, he says, they should also clearly state that the subject also might have other rights and include language informing them where they can go to find more information.

"You don’t have to go into an exhaustive discourse, but you can say, You may have rights for damages allowable under the laws of this state.’ And, I think it would be a good idea to say, Call X number,’ which could be the human subjects’ office, which would then be duty-bound to be straight about it."

Above all, informed consents documents must be truthful, adds Lis.

"So consent documents should include the things that will be covered, such as where the sponsor offers to pay for study-related injuries. This is often very finely parsed out; i.e., payment for medical treatment vs. emergency medical treatment, so it is important to make it clear to subjects," she says. "Also, even where payment is offered by a sponsor, it may be difficult to determine whether the injury is study-related or not."

If costs for medical care for injuries are not covered by anyone related to the study, she adds, it also seems fair to state how they will be billed. According to Lis, consent language could be something such as:

"Medical care for injuries related to the study is available. [Sponsor/Institution] has set aside funds to reimburse you for costs for medical or other injuries related to the study. This will be determined by [state how determined and by whom]. Costs for medical care for any injury not deemed study-related will be billed as usual. For more information, and if you think you have been injured, call [name and local telephone number].

"Nothing in this consent is meant to limit any of your legal rights" or

"Medical care for injuries related to the study is available. However, no funds have been set aside, and there are no plans to pay you for costs for any injuries related to the study. Costs for medical care for study-related injuries will be billed as usual. For more information and if you think you have been injured call [name and local telephone number].

"Nothing in this consent is meant to limit any of your legal rights."

It’s also important to note that most people will think of injuries in terms of physical injury, but this is not necessarily the case. Participants may legally pursue compensation for other non-physical injuries and this should also be reflected in the informed consent.