Needed: Stronger partnerships between researchers and IRBs

Recently, I am across an op-ed piece about breaches of conduct in medical research that, I’m sure, you will find as disturbing as I did. As the former chair of an institutional review board (IRB), I was sickened to learn that, despite federal mandates that universities adhere to the Belmont Report principle to do no harm, violations of those regulations continue to occur.

When I was an IRB chair, we routinely reviewed clinical trials that were supervised by a data and safety monitoring board (DSMB), as well as other studies exempt from DSMB oversight. Then, as now, I was concerned that universities, relying on the honor code, have depended on principal investigators to report irregularities that occur while conducting research studies.

In pursuing scientific discovery, academic and scientific communities rely heavily on human volunteers when conducting research. However, it has become evident in some instances that publishing novel findings has taken priority over protecting human subjects. Belmont Report “do no harm” guidelines notwithstanding, some researchers are failing to show allegiance to this principle.

Nurses and other health care providers are well positioned to advocate for the highest ethical treatment of human volunteers. The challenge is how to structure this advocacy in a systematic manner that safeguards against potential abuses. In my view, academic centers do not have adequate resources to monitor research protocols. Consequently, investigators are left to grapple with ethical issues that, if not addressed properly, may result in unintentional harm to research subjects.

Advocating on behalf of human volunteers in research studies is tantamount to the advocacy nurses provide patients. Far too often, the consent forms used in conducting research are too complex for volunteers to comprehend, particularly as they relate to potential risks and benefits of a research study, as well as its method and design. Hence, it is incumbent upon investigators to do due diligence in creating forms that are clear and comprehensible.

Additionally, I propose that institutional review boards charged with overseeing research studies: 1) increase the frequency of their monitoring, and 2) that they deploy sufficient personnel to provide necessary oversight while avoiding unnecessary interference with execution of research studies. In other words, a partnership that benefits both investigators and research participants is needed.

From personal experience, I know it is easy for some investigators to regard the IRB as an adversary rather than the quality-assurance arm of their studies. But to ensure that protection of research volunteers is more than just a philosophical principle and that all volunteers who participate in research are well protected, I propose that stronger partnerships be forged between investigators and the institutional review boards to which they are accountable.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.

Addressing men's health

It’s the time of year when we focus on men’s health. (June is Men’s Health Month in the United States.) Far too many men fail to seek early detection and treatment of disease. For them, it is much easier to ignore a potential health problem than to address it. Lack of media attention on men’s health only exacerbates the problem.

I am not alone in grappling with how best to motivate men to abandon notions that keep them from seeking out health care. I am confident many of you have male family members and friends who are adept at disregarding your attempts to put them in touch with primary health care providers. So what is the best strategy to use to increase men’s compliance with having yearly physical exams?

Coercion and fear not the answer
It is best to avoid coercive tactics, because they don’t work. And don’t use fear as a motivator, because, for some, fear is the very reason they don’t seek out a primary-care provider in the first place. Using these types of messages only defeats the purpose.

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I have found that an effective strategy is a pragmatic approach, such as making this time of year an annual celebration of health. For example, in conversations I’ve had with various male audiences, I’ve learned they are more likely to go to a doctor if making an appointment becomes routine, or if a buddy encourages them to nip any potential health problem in the bud.

Like women, men care about their health and want long and prosperous lives, but the challenge is to get past the fear of finding that something is wrong, which, in their minds, translates to, “I won’t be able to provide for my family or take care of myself.” Whether such a negative prospect is real or perceived, it’s important to recognize that this belief is very real to them, and should not be disregarded.

Men helping men
One strategy is to meet men where they are. For example, a great way to spark dialogue is to hold health fairs in health clubs, churches, and barbershops. The objective is to keep the conversation light, but substantive. Another helpful tactic for recruiting men to dialogue about their health is to engage the help of male leaders in the community.

Men talking to men—either one on one or in a group—can be a powerful way to encourage discourse about health issues. To be effective, the messages need to be appropriately tailored to the audience. For example, college-age men need to learn about the importance of screening for testicular cancer and how to conduct self-examinations, because this age group is at the highest risk for this health problem. Again, it’s prudent to educate and then deploy college-age males to host health parties where they can discuss how critical it is to pursue early detection.

In my experience, utilizing men to engage other men in discussing health issues is a powerful approach that usually results in behavior change. When designing men’s health campaigns, we need to involve men in our efforts. Unfortunately, some men’s health programs focus too much on potential adverse outcomes rather than communicating effective prevention strategies. 

Do you have an effective approach?
Consider how you might engage men for participation in early detection and annual screenings. Clearly, ignoring one’s health only leads to higher health care costs, costs that early detection can largely prevent.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.

Healing after tragedy

Like so many Americans, I was outraged by events that took place this past week in Baltimore, Maryland, USA. While I do not assert to have all the facts, it is clear something went terribly wrong. In 2003, as a student in the Master’s in Public Health program at Johns Hopkins University in Baltimore, it was also clear to my classmates and me that economic disparity in the community was ubiquitous.

As the situation unfolded this past week, I found myself transfixed by the media coverage, but also disappointed in the outlets that focused on the few who decided to express their frustrations through destructive means rather than the vast majority of citizens who, to bring attention to a long-standing problem, protested peacefully. As I listened to a number of young people being interviewed, either in a school setting or on the street, I heard the chilling perceptions they communicated, of feeling left to fend for themselves and that their lives do not matter. Whether perceived or real, these beliefs, formed by their lived experience, demand an effective response by community leaders, as well as the federal government. Imagine believing your life does not matter! It is almost impossible to comprehend.

Like all wounds, this chasm is going to take time to heal. However, this is also an opportunity for health professionals to help bring healing to a community in pain. It is truly going to take a village to address the enormity of the deep-seated issues the community has long endured. Through this transformational event, we have all been reminded that economics and race still divide us, producing a narrative that creates misplaced fear about the very people who need our help the most.

Health care providers have a critical role to assume as Baltimore begins to move forward. So many of the youth and adults feel left behind. Hence, we need to provide not only advocacy, but also innovative vision that opens a way forward toward health and economic prosperity.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.

Daring to confront

Have you ever felt guilty for taking a stand against challenging behavior? If you have, you’re not alone. It’s certainly easier to delay confrontation than it is to decide, “Enough is enough,” and take action. Far too often, we allow wrong behavior to continue until an eruption occurs that could have been avoided had we dared to confront.

In an earlier post, I told you about confronting, as a nursing student, a physician who used finger-snapping as a means of communicating with nurses. Well, guess what? Years later, history repeated itself. By that time, I was a charge nurse, and I couldn’t believe I was, once again, witnessing a physician snap his fingers to get the attention of nurses. It was déjà vu all over again.

I still recall the outrage of the nurses. “He shows no respect for nursing staff,” some of them complained, but no one dared confront the physician about his behavior. The situation was delicate. After all, he was a surgeon who commanded power in that hospital. Colleagues said, “Never cross him. You’ll get fired!”

It was déjà vu all over again! 

— Photo by Ingram Publishing/Thinkstock   

Hearing those comments gave me pause, but I didn’t want to see nurses treated with disrespect. Usually, I didn’t have contact with this surgeon unless he wanted to complain that a nurse wasn’t moving fast enough. Another issue was that he would take all the charts, thereby creating problems for nurses who were trying to complete their charting in a timely manner.

Because politics and institutional power were involved, confronting this physician would not be easy, but I knew my nurse colleagues, who were fed up with his behavior and were losing morale, expected me to take action. After pondering what to do, I came up with a plan. The intervention would be simple. To force the physician to interact with me, all the other nurses would be with patients in their rooms.

Like clockwork, he came to the floor the next day to complete his rounds, this time accompanied by residents, and, as usual, the finger-snapping began. I intentionally ignored him. The snapping continued, but I remained silent. Growing frustrated, he finally blurted out, “Don’t you hear me talking to you?” He was speaking loud enough that the other nurses came out of the patients’ rooms, and the residents stood aghast. This was my opportunity.

Walking over to him, I said, “Hello, Doctor. My name is Chris. I am the charge nurse, and I have a simple request. Do not feel you need to snap your fingers to get my attention. I prefer that you address me as Chris. Also, I was wondering if we could agree on a time for you to chart so my nurses could have the charts back in time to complete their documentation?”

To my surprise, he responded, “No problem, Chris. We certainly do not want to increase the hospital’s budget,” and he chuckled. The residents stood with their mouths open. From that day forward, he never tried to get a nurse’s attention on that unit by snapping his fingers, and, yes, we were able to arrange for a suitable time for him to review charts.

Every nurse asked me, “How did you do that? I cannot believe his response.” The only insight I had to share was that, as a student, I had learned to assert myself and not allow a physician to treat me as an object—to objectify me—and my refusal to let him do so disrupted his improper behavior. Nurses do have power when we affirm our role and identity.

I knew that both the physician and I shared a desire for our patients to heal, and, to make that happen, we needed to function as a team. From that time forward, he would say, “Chris, how are my patients doing today?” I realize that communication challenges are complex, and confronting doesn’t always turn out as well as this encounter did, but the surgeon and I both discovered that a simple introduction that began with “Hi, my name is Chris” can stop disrespectful communication in its tracks and lead to positive outcomes.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.

My mother got it right!

I grew up with five brothers, so I am acquainted with the nature of competition. My brothers excelled at every sport and set school records, and, like a typical younger brother, I tried to be like them. I tried playing basketball and football. It was not a pretty sight. But there was one sport I excelled in, and that was track and field. I was named the fastest sprinter and won awards.

It was during that time of my life that I learned other kids were breaking the rules in a variety of ways to win—to be the best at any cost. My mother taught me, however, that it was important to discover my talent; even if it meant finding I did not excel in a particular sport, musical instrument, or school subject. Her point was, we cannot be good at everything, and we are better off not cutting corners just to prove a point.

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My mother got it right! Envying the talents of peers can lead to poor decisions that prevent us from discovering our own talents and intellectual gifts. I have heard stories of athletes who pursued esteemed titles at any cost only to be disqualified and lose the title in the end.

As children, many of us were taught that “cheaters never prosper,” and we’ve seen this to be true. Whether we are students, administrators, or scientists, we should never compromise our integrity for fame or notoriety. No amount of recognition is worth that cost. Pursue your dreams and goals with integrity.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.

This season, give of yourself!

Can you believe the holidays are upon us? I am amazed at how quickly the time has passed. As we celebrate with family and friends, we need to remain cognizant not only about our mental health, but others as well. While the holidays are a happy time for many of us, they are not for some. This season can be a time of sadness for those who have experienced loss or are alone.

This year, as I saw the holidays approaching, I challenged myself and friends to make an effort to reach out to those who may be estranged from their families or find themselves struggling to get through the holidays—perhaps by inviting them to dinner or making ourselves available. It is so easy to be consumed by our own happiness that we fail to look beyond our own comfort and joy.

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During this season, let’s reach out, bearing in mind that bringing joy to others is the greatest gift of all.

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those that promote products or services will not be posted.

I am a nurse

Like many of you, I have been following the Ebola situation, both here and abroad. Listening to media reports is reminiscent of the early days of the AIDS epidemic when we were all trying to find our way through endless speculation about viral transmission. As I watched the two infected nurses from Texas brought out of obscurity and thrust into the limelight—a place I am certain they never imagined they would find themselves—I was pleased to hear so many commentators mentioning the important role nurses have within the health care system.

One physician observed, “It is important we do not demonize nurses, as they are brave professionals who are on the front lines, saving patients’ lives.” Despite the intense political debates currently taking place, nurses are still the most trusted of health care professionals, and patients look to us when searching for answers in these uncertain times. No matter what the threat is to public health, nurses will be there to provide guidance, as we have for centuries, with these comforting words: “It’s going to be OK. I am a nurse.”

For Reflections on Nursing Leadership (RNL), published by the Honor Society of Nursing, Sigma Theta Tau International. Comments are moderated. Those the promote products or services will not be posted.