How Well Do Drugmakers Understand Informed Consent?

How Well Do Drugmakers Understand Informed Consent?

June 3rd, 2013 // 2:56 pm @

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Mark Hochhauser, who is a community member on the North Memorial Medical Center IRB in Robbinsdale, MN, provides some details about problems that he sees with informed consent forms:

#1 Be Sure to Proofread Your Consent

Many consent forms come into IRBs that have not been carefully proofread. IRBs can be accused of revising the consents too much. But they do that because the writers of the forms do such a poor job of writing clearly in a way that a subject could understand. Sometimes the form is so confusing, not even the IRB members understand it. So obviously, the subjects aren’t going to understand the consent form.  This can be very frustrating, Hochhauser said, if the IRB  sees identical writing issues from the same sponsor in several submissions.

A big issue is that some writers of consent forms are not good in American English. This is an issue with sponsors that are not located in the US. Some consent forms may refer to an ‘independent review board,’ or an ‘ethics review board,’ and not an ‘institutional review board.’ There also are a lot of spelling errors that can’t be picked up by a word processor’s spell checker.

If you were a clinical trial patient, how much faith would you have in the trial if the consent form is full of errors?

 #2 Be Familiar With US Regulations

Some investigators can come to the IRB meeting and say that the sponsor wants no changes to the consent form at all. This is not acceptable, says Hochhauser. FDA guidance for IRBs states that IRBs do have the final authority for making sure that the information ont the informed consent form is accurate. The IRB of record has the final say on all content of all consent forms.

You should not insult your IRB by telling it that they can’t make changes to your consent. The IRB can and if they think that the consent does not protect the rights of patients, the IRB will order that changes be made.

Some consent forms will mandate that the subject has to initial each page, as if it is a contract. But FDA regulations state that these forms are NOT contracts. There are problems with making the subjects initial the pages:

  • It slows their reading flow
  • It does not indicate that the subject read and comprehended the information
  • It can make for liability problems if some forms were not initialed

FDA Office of Good Clinical Practice has said in the past that the sponsor or IRB CAN require subject initials on each page, but the FDA can then cite the investigator in a 483 for not complying with the investigational plan if the subject does not initial each page. According to Hochhauser, he does not think that having the patients initial each page makes sense, if it is not an FDA or IRB requirement. It just sets up liability concerns and does not in any way guarantee that the patient understands the form.

 #3 Do Not Leave Out Required Information

FDA is very clear in its rules about the 10 required elements that have to be in each form. Some IRBs use a checklist for the elements to make sure that the consent form has each one. Still, IRBs will find forms that are missing critical, required information!

#4 Leave Off The Bill of Rights

Some consent forms will come into an IRB with a Subject’s Bill of Rights. It’s not part of FDA regulations, and it is not required in most states. It could be that the consent form writers are just copying and pasting contents from another state’s consent forms. For most states, this Bill of Rights is irrelevant and misleading.

#5 Time Is Money

Sponsors can be slow in responding to IRB change requests. This response can be a bit of a non response, and then more information is required, sometimes even two or three times. Sponsors can take months to make minor changes to the forms. Imagine how much revenue can be lost with these delays! Three extra months of sales as a drug goes off patent could mean many millions more in revenue. Why should a drug company surrender all that money at the end of a drug’s life because a study was delayed due to improper consent forms?

IRBs know the federal laws for informed consent, and they assume that sponsors and CIs do too, but often the consent forms lead one to believe that they do NOT understand the laws.


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