Clarifying alternatives to research participation

Study: Only a third of consent forms had enough info

While federal regulations require that subjects be informed of the possible alternatives to their participation in a clinical trial, often subjects don't learn enough about those alternatives to make an informed decision, says a bioethicist who has studied the issue.

"A reasonable person needs a robust discussion of alternatives to make an intelligent choice to participate," says David Resnik, JD, PhD, who is chairman of the National Institute of Environmental Health Sciences' IRB. "It's like buying a car when you don't know what else is on the market. You can tell everything you want about the car, but you need to know what else is out there."

Resnik and his colleagues set out to look at how well alternatives to participation were spelled out in more than 100 informed consent documents from adult oncology trials.1

They found that while the majority of the documents met the minimum regulatory standards for disclosure of information about alternatives, only a third met a higher "reasonable person" standard, which Resnik describes as the information needed by a reasonable person to make an informed decision.

Nearly a tenth of the documents presented little or no useful information to subjects about alternatives to participation.

"They might say something like: 'There are alternatives to this study; please discuss these with your doctor,' or 'The alternatives to participating in this study are chemotherapy or radiation. Please discuss these with your doctor,'" Resnik says. "It seemed like they were trying to get it in the document but not really putting much effort into it."

Resnik says IRBs reviewing consent documents need to pay careful attention to the alternatives section.

"They should be making sure there's an adequate discussion of alternatives in that section," he says. "Obviously you don't want just a token discussion of alternatives — it needs to be more than that. They need to make sure that they are meeting the regulatory standards, and if they can, go above and beyond those standards."

Resnik says he and his colleagues had examined the same documents earlier for a similar study, which looked at whether subjects were informed that they had the ability to receive commercially available study drugs outside of studies. In that case, fewer than 20% of the documents mentioned the off-study availability of the drugs.

In the more recent analysis, researchers categorized the documents' description of alternatives as follows:

  • 4.8% had a score of zero, meaning that they did not discuss alternatives to participation at all and did not meet the minimum regulatory requirements;
  • Another 4.8% had a score of one, meaning that the document mentioned the existence of alternatives but failed to list them or discuss them further. Resnik says it's questionable whether those documents met the regulatory requirements;
  • 57.7% of documents scored a two, meaning that they listed or described alternatives, fully meeting the minimum federal requirements;
  • 32.7% had a score of three, indicating that the documents not only listed alternatives but gave information that would help the subject make an informed choice. This would meet the higher "reasonable person" standard.

"I would have thought there would have been more threes," Resnik says. "But I have read a lot of consent documents in my life and I know from personal experience of reading the alternatives section that it's often very minimal."

While more than half of the consent documents studied were model consent documents, as opposed to locally produced documents, the local documents more likely to receive higher scores for their discussion of alternatives.

"It was a little bit surprising to us that local forms did better," Resnik says.

While he's not sure what contributed to the higher local scores, he speculates that their drafters may have had more information about the types of alternative treatments available at that local institution. Someone drafting a model document for a multisite study, on the other hand, might not have that kind of information, he says.


  1. Resnik DB, Patrone D, Peddada S. Evaluating the quality of information about alternatives to research participation in oncology consent forms. Contemp Clin Trials. 2009 Nov 6. (Epub).