New Opportunities in the Field of Ethical Research Oversight

Researchers and institutional review boards often feel they're buried under paperwork. Delia Wolf, of Harvard T.H. Chan School of Public Health, has helped pioneer a new field in which trained IRB experts make the process less burdensome and more effective.

“IRBs are not the most popular kids on the block,” said Delia Wolf, referring to institutional review boards, the oversight groups that approve – and bury under paperwork, depending on whom you ask – clinical research projects involving human participants.

Of course, popularity isn’t everything, but Wolf is helping give the IRB process a makeover, and under her guidance, the process is transforming into one of the cool kids on the block.

As associate dean of regulatory affairs and research compliance at Harvard T.H. Chan School of Public Health, Wolf has gained national attention for streamlining and reforming the IRB process – making it more efficient, less burdensome, and more useful and relevant to clinical researchers in the field.

Trained IRB experts free researches to focus on fieldwork, not paperwork.

What’s more, she’s helping pioneer a new field, one that’s likely to expand in the coming years and create job opportunities for a new group of professionals trained to be IRB specialists.

This is good news for clinical researchers: These highly trained IRB experts will be able to make quicker decisions, shepherd large research projects through the approval process, and serve as a “one-stop-shop,” freeing researchers to focus on fieldwork, not paperwork.

The Complicated World of Ethical Research Has International Reach

Anyone developing a new drug, or exploring the human genome, or even conducting in-person surveys to collect important data and information, must, at some point, engage with human subjects. Such research is critical, but it can also be ethically complex.

Researchers have an obligation to make sure people aren’t manipulated, exploited, coerced, fooled, bribed, or strong-armed into participating and that participants receive proper care, treatment and respect.

These ideals of ethical research can get muddy and complicated when put into practice on real people, in real communities, in diverse countries and cultures around the world.

Wolf, summarizing a brief example, pointed to a project she, herself, was involved in, where researchers traveled to a small, poor village in Asia to collect blood samples for a study on a genetic disease.

For the minimal risk of providing blood samples, participants received a $10 stipend, an appropriately modest amount by U.S. standards. “But in that specific location, in that specific country, ten dollars is a lot of money,” said Wolf. Because people were poor, within a few months researchers had thousands of participants.

Researchers have an obligation to ensure participants receive proper care and respect.

However, the local government felt the research violated villagers’ rights by luring them with money in return for blood samples. It lodged a complaint with the United States government, which was obliged to get involved. The story became the subject of newspaper articles, and it took two years to investigate.

“I was the one who approved the study,” Wolf said. Although it met all U.S. standards for ethical research, given the different cultural norms and economic realities, did the study engage in coercion?

Global Research Requires Global Expertise

Ethical issues can get knotty and tangled, especially when working across cultures.

Take the matter of informed consent, which is “crucial,” Wolf said. In most Western societies, participants in medical studies are comfortable asking tough questions and making an informed decision about their willingness to participate.

In other parts of the world, the mentality is sometimes, “Okay, doctor, whatever you say,” said Wolf. Patients want to obey.

It can even be troublesome to provide full and transparent information to participants. Western patients want to be informed when they have stage 2 cancer. People in some other cultures might prefer to be left in the dark, to spend their days unencumbered by the mental anguish stemming from such a diagnosis. How do you write an informed consent agreement when it’s considered culturally insensitive to disturb a patient’s peace of mind with a dire prognosis?

Ethical issues can get knotty and tangled, especially when working across cultures.

What about standards of care, which differ widely from country to country? If you provide drugs and a Western standard of care to HIV patients in impoverished parts of Africa, are you luring desperate participants with the promise of free medication and hospital time? After the study, do you continue to treat them? If you don’t provide a Western standard of care, are you guilty of exploitation?

The ethics get complicated fast, and there’s not a “one size fits all” solution, Wolf said.

A One-Stop-Shop

Of course, that’s why internal review boards exist in the first place: to make sure ethical issues are thoroughly considered and research is conducted to the highest standards.

Boards want to get it right, so they require lots of information, which in turn can frustrate researchers, who may feel they need to jump through hoops, cut through red tape, and wait months for approvals.

Harvard Medical School, which also falls under Wolf’s domain, has about 1,000 studies going on at any given time, she said. They consist of everything from HIV treatment to surveys. IRB approval is required for almost any study involving humans: drug research, psychological research, asking questions face-to-face. “If you look at their medical record” it’s human research, Wolf said. (It’s a bit more complicated, but she was illustrating a point.)

“The IRB wants to do a good job,” she said. “Sometimes they do too good a job.”

The traditional IRB process begins with a lower level review. Research projects are then passed around to different groups. Even with an expedited review pathway, proposed research often gets sent to the full board for approval, and boards typically meet just once a month.

It takes a long time, and that can hinder important research. When Wolf started at Harvard Medical School, “the turnaround time was four months,” she said.

She helped institute a new “one-stop-shop” system, which relies on hiring high-level IRB specialists, all of whom are experienced enough to be IRB chairs in their own right.

Each of these specialists is assigned to a different department. Thus, epidemiology has just one specialist it deals with; immunology has its own specialist, and so on. That one specialist is able to decide, quickly, if a research project is eligible for expedited review or if it needs to go to the full board. If a full board meeting is required, the specialist prepares paperwork, sits through meetings, maintains records and helps shepherd the project through the process.

The ethics get complicated fast, and there’s not a “one size fits all” solution, Wolf said.

At Harvard Medical School, as a result of this one-stop-shop model, “Our turnaround time is way shorter than the national average,” Wolf said. Her team now handles Harvard Chan School, Harvard Medical School and Harvard Dental School. “We’ve doubled our workload, we’ve doubled our staff,” Wolf said.

Less Red Tape Means More Compliance

It may seem counterintuitive, but in Wolf’s experience, lessening the regulatory burden on researchers often leads to greater compliance with ethical regulations.

For one thing, researchers want to conduct their research in an ethical manner, but what they need is practical guidance, not piles of documents written in legalese.

For instance, instead of handing researchers a 10-page document filled with regulations, it’s easier and more effective to give them a one-page checklist.

Cutting out unnecessary paperwork is another goal. Take another example: In order to make sure researchers are qualified, IRBs often ask for their CVs, but in Wolf’s experience, institutional review boards rarely look at the CVs. So why ask for them?

“Stick to a minimum,” Wolf said. However, this requires IRB specialists with a “great deal of expertise” to properly guide the process.

A Burgeoning Career Path

Institutions around the country are beginning to explore the one-stop-shop model, Wolf said.

Because the model requires experienced IRB liaisons – people with intense training and a specific set of knowledge in medicine, research and regulations – Wolf thinks it’s a burgeoning career path.

It’s one that Wolf, herself, has pursued to the hilt. After receiving her medical degree in her native China, she worked in the United States as a clinical researcher in breast cancer research, and she conducted trials on FDA-regulated devices. In that capacity she gained exposure to the IRB process, admitting, in an interview with Public Responsibility in Medicine and Research, “I felt my chance of getting IRB approval was hit-or-miss.”

The process interested her so much that she acquired a master’s degree in clinical investigation, and she was tapped to be an IRB chair at Massachusetts General Hospital and Brigham and Women’s Hospital, both in Boston. She developed a passion for human research protections, and she ultimately took a research management position at Partners HealthCare. Meanwhile, she pursued a one-year fellowship in medical ethics at Harvard Medical School and, over the course of four years, taking classes at night, acquired a law degree from Suffolk University. In 2008, she came to Harvard Chan School, where she also directs the school’s “Ethical Issues in Global Health Research” course at the Center for Executive and Continuing Professional Education.

Developing an Online Certification Program

It’s not feasible to require a medical degree, law degree and master’s degree from everyone who oversees research, particularly in less affluent parts of the world.

Lessening the regulatory burden often leads to greater compliance with ethical regulations.

That’s why one of Wolf’s current projects is developing a 12-month online certification program for people around the world. She’s seeking grant funding to provide scholarships for students from low- and middle-income countries, where the need for such training is greatest. Ultimately, she hopes to open the program to tuition-based students, which will make the program self-sustaining.

At the moment, the focus of the program is in Nigeria, Bangladesh and India, she said, but it aims to expand.

Another feature is that the program involves hands-on training in students’ home communities. It’s one thing to teach the ethics of research from the comfort of Harvard, it’s another thing to apply those principles in real life halfway around the world, Wolf said.

The program involves 15 credits and 5 didactic courses taught by “renowned ethicists” who provide “culturally specific, hands-on” training, she said. A major component is a practicum, where students work in their home countries and are mentored by faculty. “We focus on the end results,” she said. After completing the course, graduates serve as mentors for their colleagues.

“We want people to bring home the tools so they can use them,” Wolf said.

Dr. Wolf directs Ethical Issues in Global Health Research at Harvard T.H. Chan School of Public Health.