Human Subjects Protection: A Reflection for IRBs

As Member Appreciation Month draws to a close, it is our pleasure to share with you an example of PRIM&R members' many talents. Below, Regina Drake, who was featured in a Member Profile earlier this month, reflects on the importance of human subject protections in a poem.

There are villains,                                       

But few                                                         

In the scheme of things—                         

There is after all,                                         

More honesty                                               

In this world                                                 

Than we recognize.                                    

There are folks                                            

Who are sick,                                               

And want to be well—                                

Folks that are moved                                  

By the suffering of others,                         

By injustice,

Or just by the valiant search                     

For the cure.            

                                               

Here we sit                                                   

“Betwixt and between”—                           

Not as power-brokers                                 

Or nay-sayers,                                             

Not even as the strong arm

Of the law—

As much as we are

Protectors

Of those who consent,

Those who agree

To take the risk.

We sit also

As the reminders

Of those who might

Otherwise make

Honest mistakes

That are costly—

And, yes, we sit

As barriers

To those few villains

Who exist

In every arena.

Ours is to protect

And remind—

To do a honest day’s work

That could just make

The critical difference—

To not fall prey

To routine,

Or complacency,

Underestimating

What we do

Just because we do it

Every day.

For this just might be

The day,

Or tomorrow,

Or the next,

When what we do

Matters

Most. 

If you have a story, a poem, a song, or another piece of work that you would like to see featured, please share it with us!   

Featured Member Profile: Brenda Wright

Welcome to another installment of our featured member interviews where we will continue to introduce you our members—individuals who work to advance ethical research on a daily basis. In honor of Member Appreciation Month, we will be introducing you to a couple of our members each week. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Brenda Wright, institutional review board (IRB) administrator at the Florida Hospital Tampa Bay Division IRB in Tampa, FL.  

When and why did you join the field?
I developed an interest in research while working as a sleep technologist for University Community Hospital, Inc., which is now Florida Hospital Tampa Bay Division. At the time, the sleep lab was exploring the possibility of conducting some sleep related research, and I was very excited about the possibility of being involved. In February of 2008, while exploring career opportunities within the organization, an IRB coordinator position became available. I did not have any prior experience in the field, but was fortunate enough to be hired into the position as a trainee. I love working in this field and plan to finish out my career in this arena.

What is your favorite part of your job?
What I find most interesting and challenging about the job is researching less routine regulatory applications. As of late, our organization has had a lot of affiliated activity, which has presented a lot of new challenges and learning opportunities.

What do you value most in your friends?
One of the attributes I value most in my friends is honesty. Even though it may be difficult, and at times cause hurt feelings, I believe true friendship can weather open and honest discussions.

Why did you join PRIM&R?
During some of my encounters with research professionals, I was asked if I was a member of PRIM&R. These interactions informed me about the benefits of membership, which include educational opportunities, conferences, and certification. My membership in PRIM&R has been a very positive and beneficial experience.  

What is your favorite member benefit?
Though there are many benefits I enjoy, I am especially pleased with the mentoring program. I have been paired with a Certified IRB Professional (CIP®) mentor, Maria Arnold, clinical research manager at South Florida Baptist Hospital. It has been a very rewarding experience, providing yet another tool to help with my IRB education.

What would you say to someone who is considering PRIM&R membership?
I would tell them about the many benefits I have experienced, but I would preface that with the importance of joining right away, and not waiting, as I did. I missed out on a lot of valuable information and opportunities by not joining earlier in my IRB career.

What motivates you to maintain your commitment to advancing ethical research?
I believe research is a critical and exciting aspect of our lives. Ensuring that the rights and welfare of those who participate in research are protected is a challenging and necessary part of this endeavor. It is critical that we never lose sight of the fact that human beings are involved in research, and that there is no greater resource than this. We need to be reminded that those who participate in research often do so at risk to their own lives, and it is important to have people who are willing to advocate for the safe and ethical conduct of research.

Thank you for being part of the membership community and sharing your story, Brenda. We are glad to hear that you have enjoyed working with PRIM&R’s mentoring program!

If you’d like to learn more about becoming a member, please visit our website today.

Poster Spotlight: Developing Indicators for Measuring Quality of Exempt and Expedited Reviews

With the Call for Poster Abstracts open for the 2012 Advancing Ethical Research (AER) Conference, I invite you to join me, Avery Avrakotos, PRIM&R’s education and policy coordinator, as I interview poster presenters from past conferences. This week, I will chat with Helen Panageas, associate director at the New York University School of Medicine, and Caryn Diuguid, continuous quality improvement manager.

In 2011, Helen, Caryn, and their colleagues reviewed exempt and expedited protocol submission materials to determine if all regulatory requirements were satisfied. Through this research, the team sought to develop measurable standards that could be used in the evaluation of research protocols.

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference.  How has your research since evolved?
Helen Panageas (HP): We have implemented a process to evaluate the quality of reviews of expedited projects.

We have been having some difficulty transitioning to full-board protocol reviews because not all studies are equal in their level of complexity. Hence, we have decided that the project must evolve in order to capture the complexity of a research protocol, in addition to ensuring that all regulatory requirements have been satisfied.

Adding a rating for complexity will help us stratify the types of protocols we are looking at and what areas of our initial indicators we should focus on. We also used our initial findings to develop training and education sessions for our reviewers.

AA: What challenges have you faced in implementing this research?
Caryn Diuguid (CD): Our challenge lies in identifying a metrics system that we can use to quantify our findings. We are still determining what methodology to use to finalize a specific metric; therefore we have been unable to measure the quality of protocols approved by the institutional review board (IRB). We are considering basing our metrics on scores for each required element and the complexity of a project. If there is anyone out there that thinks they can help us with this… please email us!

AA: What is one principle that has guided you in your research?
HP: Continuous improvement. We ultimately would like to develop a tool that can objectively measure the quality of a research protocol. We hope that this tool can be used to assist research teams and IRB staff training.

Thank you for sharing, Helen and Caryn! We hope that you will consider submitting an abstract for the 2012 AER Conference.

Featured Member Profile: Denette Roulinson

Welcome to another installment of our featured member interviews where we will continue to introduce you to more of our members—individuals who work to advance ethical research on a daily basis. In honor of Member Appreciation Month, we will be introducing you to a couple of our members each week throughout the month of May.

Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Denette Roulinson, institutional review board (IRB) administrator at Decatur Memorial Hospital in Decatur, IL. 

When and why did you join the field?
I joined the field in January 2003 just a few years after I started my family and earned my bachelor's degree in healthcare administration.

What is your favorite part of your job?
On an abstract level, I like the trust that is bestowed upon me by my colleagues, by the researchers, by the IRB members, and by hospital administration. In a more tangible sense, I enjoy the pre-review process, particularly when it comes to the consent forms.

What do you value in your friends?
With my friends, I value the ability to speak freely and honestly. With my colleagues at work, I appreciate that they understand it's not uncommon to catch me talking to myself or perhaps singing.

Why did you join PRIM&R?
[Membership] is practical and it makes sense. The educational opportunities are phenomenal, and there certainly are other benefits to being a member as well.

What is your favorite member benefit?
In today's market, my favorite membership benefits are the discounts given to members for Certified IRB Professional (CIP®) recertification and registration fees for the Advancing Ethical Research (AER) Conference. I also look forward to reading each issue of the Research Ethics Digest.

What would you say to someone who is considering PRIM&R membership?
PRIM&R membership is very much like research. Once you're in, you'll never leave.

What motivates you to maintain your commitment to advancing ethical research?
I love the work we do. It's important. It's specialized. And, when done ethically, it is truly life-changing.

Thank you for being part of the membership community and sharing your story, Denette.
If you’d like to learn more about becoming a member, please visit our website today.

Featured Member Profile: Andria Whited

Welcome to another installment of our featured member profiles, where we will introduce you to some our members—individuals who work to advance ethical research on a daily basis. In honor of Member Appreciation Month, we will be introducing you to a couple of our members each week throughout the month of May.

Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Andria Whited, research monitor and protocol manager at the Research Foundation for Mental Hygiene, Inc.

When and why did you join the field?
I joined the field a little over a year ago. When I graduated from the Columbia School of Social Work, I began working as a project coordinator at the New York State Psychiatric Institute for an investigator involved in bringing mental health awareness to the juvenile justice system. Thus, my interaction with institutional review boards (IRBs) began. Several years later when a position with the IRB at the Research Foundation for Mental Hygiene, Inc. became available, I seized the opportunity. Ethics is a big part of an education in social work, so it made sense for me to transition to the IRB.

What is your favorite part of your job?
I feel great satisfaction when investigators thank me for doing my job. Sometimes the relationship between IRBs and investigators can be strained, so when an investigator recognizes my intention to help, I am delighted.

What is your idea of perfect happiness?
Perfect happiness, to me, is feeling contented in my daily life and being grateful for my relationships.

What are you reading? I’m currently reading Charles Dickens’ Great Expectations for my book club.

What's your after-hours guilty pleasure?
My after-hours guilty pleasure is to read romance novels.

Why did you join PRIM&R?
I had the wonderful opportunity to attend the annual PRIM&R conference, so I joined for that reason.

What is your favorite member benefit?
Attending the annual conference was fantastic. I learned a lot. Looking ahead, I want to take advantage of the educational opportunities PRIM&R offers to prepare for Certified IRB Professional (CIP®) certification, as I will sit for that exam next year.

What would you say to someone who is considering PRIM&R membership?
PRIM&R offers a lot of opportunities for learning outside of their annual conferences. I’ve attended a few webinars and found them very helpful. So even if you can’t attend the annual conference one year, membership offers several other ways to continue your education.

What motivates you to maintain your commitment to advancing ethical research?
The field is changing all the time and current thinking advances, so it’s important to stay abreast of what is happening in the field and how others are handling the issues.

What do you believe is a key challenge facing the field of research ethics?
One current challenge is the use of social media in research—how to utilize it wisely while protecting human subjects.

Thank you for being part of the membership community and sharing your story, Andria. We look forward to seeing you at a future conference!

If you’d like to learn more about becoming a member, please visit our website today.

Featured Member Profile: Regina Drake

Welcome to another installment of our featured member profiles where we will continue to introduce you to more of our members—individuals who work to advance ethical research on a daily basis. In honor of Member Appreciation Month, we will be introducing you to a couple of our members each week. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Regina Drake, senior research protocol analyst at Emory Institutional Review Board (IRB) in Atlanta, GA.

When and why did you join the field?
It was really quite by accident. I opted for an early retirement package when my former employer was bought out by another corporation. Doing temporary work at Emory University in Atlanta, I was sent to the Emory IRB. That was in 2007, and I never left. I am currently a senior analyst on the biomedical team, the facilitator for one of six monthly IRB committee meetings, and a community member/liaison to the Morehouse School of Medicine IRB.

What is your favorite part of your job?
I am interested in the consent process within the context of science. The form is important, but the consent process is vital—how an individual is introduced to the research, the timing, where it occurs, who is involved, the information given, and what other things are going on or scheduled that may contribute to or detract from the exchange. I also enjoy the work of the IRB committee.

What are you reading?
I am currently reading The Politics of Jesus by Dr. Obery Hendricks.

Why did you join PRIM&R?
PRIM&R membership is offered by the Emory IRB to everyone in the department and has been a real fringe benefit.

What is your favorite member benefit?
I enjoy the PRIM&R conferences.  Some of the keynote speakers have been exceptional. There are so many workshops with current and pertinent information in areas of interest to me, such as international research, the consent process, community-engaged research, and research on women.

If you were planning our next conference, who would you select as a keynote speaker?
Dr. Ben Carson.

What do you believe is a key challenge facing the field of research ethics?
Ethical research is a measure of our humanity. To allow the reoccurrence of past research atrocities, or to not pay attention to present disparities, puts us all at risk. This understanding and my faith motivate me to advance ethical research.

Thank you for being part of the membership community and sharing your story, Regina. We hope we can help you keep up with all the new regulations here at PRIM&R! If you’d like to learn more about becoming a member, please visit our website today.

Poster Spotlight: Parental Attitudes Regarding the Acceptability of Research Involving their Child

With the Call for Poster Abstracts now open for the 2012 Advancing Ethical Research (AER) Conference now open, I invite you to join me as we revisit the work of Stephen J. Cico, one of the poster presenters from the 2011 AER Conference. 

In 2011, Stephen and his colleagues shared their work collecting quantitative data on the willingness of parents to enroll their child in research. Through a survey analysis, the team demonstrated that reluctance on the part of parents to enroll their children in research create barriers for recruiting populations as mandated by the National Institutes of Health . To read Stephen’s full abstract, please visit our website.

Avery Avrakotos (AA): It’s been a year since you presented this abstract at the 2011 AER Conference.  How has your research since evolved?
Stephen Cico (SC): I met people during my poster session with whom I am now collaborating.  It was a great opportunity for me to meet people from across the country, but also locally, who share my same research interests.

AA: What challenges have you faced in implementing this research?
SC: Time is always the biggest challenge for all of us.

AA: What is one principle that has guided you in your research?
SC: Do what’s best for patients.  This is a difficult principle to follow, because what is right for one patient may be completely different from the next patient.  Clear and open communications is so important.

Thank you for sharing, Stephen! We hope that you will consider submitting an abstract for the 2012 AER Conference.

Featured Member Profile: Jeanelle Graham

Welcome to another installment of our featured member profiles where we will continue to introduce you to more of our members—individuals who work to advance ethical research on a daily basis.

In honor of Member Appreciation Month, we will be introducing you to a couple of our members each week. Please read on to learn more about their professional experiences, how membership helps connect them to a larger community, and what goes on behind-the-scenes in their lives!

Today we’d like to introduce you to Jeanelle Graham, research compliance specialist at the University of Alabama in Tuscaloosa, AL.

When and why did you join the field?

I joined the field of research compliance in 2006.  When I noticed a job posting for a research compliance specialist, I saw it as an opportunity to expand my knowledge of research in a different way. Previously, I had been involved with participant recruitment and retention.

What is your favorite part of your job?
My favorite part of my job is helping to relieve some of the anguish students feel when they have to develop an institutional review board application for the first time. When they find out the process is not as bad as expected, they are relieved.

What are you reading?
Silver Sparrow, by Tayari Jones

Why did you join PRIM&R?
Membership was recommended by my colleagues when I joined the field.

What is your favorite member benefit?
Networking at the annual Advancing Ethical Research (AER) Conference.  

If you were planning our next conference, who would you select as a keynote speaker?
Regina Benjamin, MD, MBA, Surgeon General of the United States

What do you believe is a key challenge facing the field of research ethics?
I believe the push to publish is a key challenge facing the field of research ethics. Publishing research findings is important; however, ensuring that the information being disclosed was obtained in an ethical manner is of the utmost importance.

Thank you for being part of the membership community and sharing your story, Jeanelle.
If you’d like to learn more about becoming a member, please visit our website today.

"Science Times" synthesis

The presidential race has taken off, and the intersection of healthcare and policy seems to be a topic on the mind of all involved. This week’s installment of the “Science Times” synthesis features articles that emerge from the world of research from childhood obesity to environmental concerns.

Week of April 23

Fly and human mothers share a milk enzyme: An enzyme called sphingomyelinase, important in mammalian lactation, has been found in a milk-like substance fed by mother tsetse flies to their larvae. This discovery may help researchers to study issues in human lactation, as well learn more about sleeping sickness, a parasitic disease spread by the tsetse.

The neurological roots of lingering regret: Researchers in Germany have just published a new study that demonstrates how the brain adapts to feelings of regret as we age and mature. These fascinating results may have a profound impact on the way we understand and treat adults with emotional disorders.

Study of fighters shows brain changes are seen before symptoms: For the first time, researchers have used MRI technology to detect physical changes in the brains of boxers before symptoms of cognitive decline are observed. Neurologists believe this may have implications for understanding, diagnosing, and treating a broad range of degenerative brain disorders, including Alzheimer’s.


Week of April 30

Obesity-linked diabetes in children resists treatment: A new study comparing several different treatments for diabetes that results from obesity in children has found that the disease may be more resistant to treatment than researchers had expected.

Of geese and fleece: Leading scientific organizations have announced plans to issue an annual award to honor seemingly frivolous research that has gone on to produce big dividends. The award, called the Golden Goose Award, was created in response to the Golden Fleece Award, given by William Proxmire during his tenure in the US Senate to lampoon scientific projects for supposedly wasting taxpayer dollars. 

May is Member Appreciation Month at PRIM&R!