Funeka Sihlali, RN, CRC

[Editor's note -- As readers of this Newsletter are aware, the Bureau adopted a program of research quality assurance in the summer of 1999. The Coordinator of the research QA program, Funeka Sihlali, has prepared the following fictional (but not far from the truth) cautionary tale from her experience so far in auditing our research projects.

The tale is presented below. Please read it and ask yourself how this project might have been handled better, and how it might deviate from either good research practice or research regulations. Below you will find a discussion of the problems this study poses and the lessons to be learned from it.]

Dr. Chicago (an attending physician) is listed as the Principal Investigator, and Dr Michigan (a resident) is listed as the co-investigator on project Lake, which will study an Investigational New Drug (IND). Everything is fine, with ten subjects enrolled into the study.

Dr. Michigan leaves the institution 4 months after the beginning of the project. Drs La Salle and State (also residents) take over Michigan's responsibilities and start obtaining consents from subjects.

Because St. Elsewhere Hospital has a few of their copiers broken, the residents ask the subjects to sign three different copies of the consent form which are distributed as follows: 1) filed in the subject's medical chart; 2) inserted in the investigator's binder; 3) sent to Pharmacy Services.

Dr. Chicago received new correspondence from the sponsor informing him of new risks recently uncovered: this drug may damage the kidneys if the subjects do not drink 8-10 glasses of water a day. Dr Chicago shares this new risk with the residents, who in turn write in this added risk on the consent with a ballpoint pen. When Drs La Salle and State enroll new subjects they emphasize the importance of drinking water.

Once a week Dr Chicago reviews the consents of the new recruits enrolled by the residents and signs the forms as the Principal Investigator.

The first ten subjects were pleasantly surprised when at the sixth month visit they were awarded a $75 Jewel coupon and $25 worth of CTA tokens. The information about payment was not
included in the protocol or in the consent form.

Mrs Shift, a participant in the study, faints at a family reunion. Her out-of town daughter, who is a Physicians Assistant, knows that her mom is on research medication, but she does not know who to contact because her mother does not have a copy of the consent form at home.

PROBLEMS WITH THIS STUDY:

The IRB was not informed when Dr. Michigan left the institution. The IRB is not aware of the new members of the research team, their qualifications and their level of understanding of the project.

Participants were not given copies of the consent to take home or to discuss their options with their families. Not having a consent form on hand hampers ongoing review by the participants and their families.

Lack of a consent form at home gave Mrs. Shift's daughter no quick way to respond to what could be an emergency related to the investigational drug.

Shouldn't the IRB have the opportunity to review new information about the risks and decide if the risks and the benefits are still appropriate?

Shouldn't the already enrolled participants have a chance to make a decision based on the new information?

If Dr. Chicago signs the consent forms, doesn't that imply that he was present for the informed consent discussion? If he signs -- but was not present -- doesn't this cast doubt on the validity of the consent form as documentation of that discussion?

The payment of subjects is not mentioned in the consent form -- hence the surprise. Can participants trust that the investigators will do what they promised they would do or will there be other surprises? Would the IRB members have considered payments coercive if they had known about the amount to be paid out to the participants ?

LESSONS LEARNT FROM THIS TALE

There must be ongoing communication between the Investigators and the IRB. Whenever there is change in personnel among those listed as investigators in the original application to the IRB, the IRB must be informed.

The P.I. must take full responsibility for all study personnel, give full orientation to the new residents and also inform the IRB of all the changes in personnel.

The consent form exists as documentation of a verbal explanation and discussion. Signatures on the form attest that this interaction took place. Persons who cannot attest to this fact should not sign the form.

Participants are not always aware of their rights, or of the information and time they are entitled to.
Without their own copy of the consent, participants may not know about or remember these rights , the risks of participating, or whom to call in case there is a problem.

Changes in the known risks and benefits must be submitted to the IRB for evaluation. It may be necessary to reconsent previously enrolled participants.

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