Medical Research Summit Welcome and Introduction

Medical Research Summit Michele Russell-Einhorn Robert “Skip” Nelson Tom Puglisi We have a terrific line-up of plenary sessions and workshops ahead of us . But I wanted to take a few minutes to share with you some thoughts about the IRB process.

The job of the IRB is to be ever vigilant. That’s not always easy. We know what the regulatory requirements but sometimes we see things that tell us that the investigator or the research team maybe needs a little bit more education…

Investigators will obtain the fully informed consent of the subject . But we realize that’s not necessarily going to happen when we read in the protocol that…

Investigators will obtain the fully informed consent of the subject Informed consent will be obtained shortly after the anesthetic has been administered.

Subject May Withdraw Freely at Any Time But we realize that subjects may not feel this is true when they are told that

Subjects May withdraw Freely at Any Time The device that has been implanted in you is set to explode if you decide to withdraw from this research.

There are alternatives to participating in this research But alternatives can be phrased in such a way as to discourage the subject from viewing the standard treatment as a truly viable option…

There are alternatives to participating in this research The alternative is not to participate in this research and get the standard of care treatment which is 10% effective with an 8% remission rate for successful responders after three months.

Do not make any subject waive or appear to waive any of their rights And of course we are all familiar with the prohibition on exculpatory language—but sometimes it creeps up on us like this one..

Do not make any subject waive or appear to waive any of their rights You do not give up any legal rights by participating in this research except that you give up ownership of every blood, tissue or other sample now or forever after linked to this research and any commercialization thereof…

The Benefits of the Research Should not be Overstated So is it an understatement to say that the benefits have been overstated when we see the following

The Benefits of the Research Should not be Overstated The benefit of participating in this research is that you will be cured.

Subjects Should not be Coerced to Participate in the Research IRBs are supposed to make sure that subjects are not coered to participate in the research but when the investigator represents the following it ought to raise some eyebrows…

Subjects Should not be Coerced to Participate in the Research It is anticipated that 98% of the population recruited will agree to participate in the research.

Anonymous means that there are no identifiers maintained We all also know that there is considerable confusion about what anonymous means..and we would likely find that confusion in the following statement…

Anonymous means that there are no identifiers maintained This research is anonymous because only my research team will know the names of the subjects.

Compensation to Subjects should be reasonable and non-coercive Compensation should be parcelled out evenly in the event that someone withdraws early from the research and should not be set up to be coercive.

Compensation to Subjects should be reasonable and non-coercive You will receive $5 for each of the four visits and $1000 if you complete the entire research protocol.

Unanticipated Problems Involving Risks to Subjects and Others Now what about this funny category called unanticipated problems involving risks to subjects and others? A lot of people don’t really understand what this means so here are a few examples…

Unanticipated Problems involving risks to subjects and others The dog ate my data and is suffering toxic shock from chemicals on the paper. The lab technician drank the experimental alcohol compound instead of the orange juice on the counter. The subject revealed that his father is in the federal government’s witness protection program.

Medical Research Summit 2003 Alright, lets move into the meat of this conference. Thanks again for joining us here and we now begin with our first panel on research in times of bioterrorism.