Authors

  1. Miracle, Vickie A. EdD, RN, CCRN, CCNS, CCRC, Editor, DCCN

Article Content

As many of you know, from time to time, I "roast" some of my nursing colleagues, always in jest. These articles get the most feedback from the readers and it has always been positive. I totally believe we need more humor in our lives. So after all the serious and important articles in this journal, I hope to provide you with an opportunity to laugh (or least chuckle a little).

 

I worked as a nurse research coordinator for 9 years in my nearly 30-year career in critical care nursing. The role as a research coordinator, on more than one occasion, caused a temporary loss of sanity (okay, maybe more than temporary). However, I learned much about research, the nurse's role in research, and how to conduct clinical trials. I also learned that many issues arise in research that are not expected and the coordinator must learn to adapt quickly and have a good sense of humor.

 

So while this is a lighthearted look at the role of the nurse research coordinator, it is also a tribute to the great work these professionals do everyday. They are often unsung heroes. So set back and read about some of my less-than-scholarly efforts as a nurse research coordinator. Feel free to laugh. I can look back now and laugh, even though I found no humor at the time when these issues were happening.

 

1. You want me to write the informed consent again? This was the sixth rewrite. Each time there was a change made by one of the members of the Institutional Review Board. By the time the informed consent was accepted, it looked remarkably like the first draft I submitted.

 

2. Working with a physician who may be the principal investigator (PI) but does not know the protocol.

 

3. Working as the coordinator of a clinical trial in which one of the physicians was the PI and his partner hated the protocol. It was an experimental medication protocol. Each weekend the partner was on call, he would stop the protocol and change all the orders necessary for the protocol. I would have to go back to the hospital several times a day to restart the drug and rewrite the necessary orders.

 

4. Be awakened at 3 AM on Thanksgiving and asked to come in and assist with a patient who wanted to participate in a clinical trial involving a new equipment. I repeatedly asked the PI if he had the patient's consent. He replied in the affirmative. After all, I was expecting several people over for Thanksgiving and I was doing all the cooking. I got up and drove to the hospital only to find out the physician had not discussed the protocol with the patient. He and I then explained the procedure to the patient who refused to participate in the study. The PI and I then had a long discussion about when it is appropriate to call the research coordinator in the middle of the night.

 

5. Getting into hand-to-hand combat with a physician who wanted to use an investigational stent but was not a member of the investigational team. I am not joking. He went into the locked cabinet where the stents were stored and just took the investigational one. One of the nurses called me immediately. He and I literally were trying to pull the stent away from each other. He eventually let go and saw reason.

 

6. Arguing with a PI about the importance of informed consent. He wanted me to enroll his patient, perform the protocol, and then obtain consent. He said the patient was a relative of his and would agree to anything. I refused and we engaged in a lively discussion of the necessity of obtaining informed consent before starting a procedure.

 

7. I love the statement: You want it by when? This is usually followed by much laughter.

 

8. All research takes at least 3 times longer to do than expected.

 

9. As a coordinator, I had the opportunity to attend many meetings about certain protocols. Most of them were very informative and nice to attend. One, however, still bothers me to this day. The nurse coordinators were sent to a meeting in a city located in the Midwest. We were flown in that Saturday morning and met from noon until 10 PM, with only a break for dinner. We spent the night at a nice hotel and started the meeting again Sunday at 7 AM. The meeting was over at noon. At that time, we went to the airport and flew home. The physicians were treated to a 4-day weekend at a beautiful golf resort located in the southwestern United States. They played golf in the morning and attended a 2-hour session concerning the protocol in the afternoon. They were then treated to a lovely dinner. This lasted 4 days and then the physicians were flown home. Needless to say, I did not spend a lot of time and effort to recruit patients for that study. Don't the companies realize that the majority of work is done by the nurse coordinator?

 

10. Tracking patients after discharge from the hospital for a follow-up visit can be a challenge. In many cases, the patient has moved or changed his or her phone number or do not have a phone. When this occurs, a registered letter is sent, but sometimes to no avail. Patients have the option to withdraw from a study. However, this requires a lot of paperwork and is very difficult to explain to a research auditor.

 

11. Once I had a PI who went to the pharmacy and took an experimental drug to a patient (underage) at another hospital. He believed the patient needed the drug. Now the protocol said the subjects had to be older than 18 and had to be a patient at our facility. He broke 2 rules. He administered the drug to a 14-year-old in another facility. The research company was extremely angry. In the PI's defense, the drug did work, thankfully.

 

12. Finding out a patient enrolled in your study is actually already enrolled in another study. In most clinical trials, patients can only be enrolled in one study at a time. When I asked this patient if he was enrolled in any other study, he replied "no." I asked again and got the same answer. I found out 3 months later that he was in a drug study at another institution. This invalidated all data I had collected. Now we provide patients with a card they should carry in their wallet informing them of the study, but there is no guarantee that patients will do this.

 

 

Do not get me wrong. I loved being a nurse research coordinator. The good times fared outweighed the bad. I learned much and was involved in many clinical trials that so many other nurses would never be, such as the use of investigational stents, new medications, new treatments for heart disease, and adult respiratory distress syndrome, among others. Overall, it was a very satisfying experience. I encourage all nurses to become involved in clinical research whenever possible. You can conduct your own trial or assist others. Data collection is critical and this is one way staff nurses can play a crucial role. Nurse research coordinators need your help. Become involved in research and you may find it is a rewarding career, especially when you are not tearing your hair out or having a nervous breakdown.

 

Vickie A. Miracle, EdD, RN, CCRN, CCNS, CCRC, Editor, DCCN

 

Lecturer, Bellarmine University School of Nursing, Louisville, KY