There was a small party in September at Jewish Hospital to celebrate the one-year anniversary of the surgery that replaced Tom Christerson’s failing heart with an artificial one. The guest of honor, of course, was Christerson.

The surprise guest? Well, that was Christerson too. At least, that’s what he says.

The 71-year-old retired tire dealer, who since April has been living back at his home in Central City, Ky., is the first to tell you that he did not expect to be alive one full year after his landmark surgery.

“I thought it would give me another six months,” he admits.

Christerson, who was suffering from what doctors call “end-stage heart failure,” was thought to have less than 30 days to live when he became the world’s second recipient of the AbioCor Total Implantable Heart on Sept. 13, 2001.

Developed by Abiomed Inc. of Massachusetts, the AbioCor--a grapefruit-sized pump made of titanium and plastic--is the first artificial heart to be fully implanted in a recipient with no wires or parts protruding from the body. It has been called the most complex medical device ever developed for use inside the body.

Before the implant, Christerson was so weak that he could hardly walk. Now, he is able to walk every morning from the parking lot to his favorite breakfast spot to drink coffee and chat with friends. He recently met his first great-grandchild, and in October he and his wife celebrated their 55th wedding anniversary.

“I’m no hero,” he says. “I just wanted to live.”

Christerson encourages other people with severe heart failure to get the AbioCor.

“It’s so much easier to live, breathe,” he says. “I’m looking forward to doing great things in life.”

Christerson’s remarkable progress represents the top of the mountain during 15 months of emotional peaks and valleys for his doctors, U of L surgeons Laman Gray and Robert Dowling. It also has been a time of unprecedented medical discovery.

The duo first made history in July 2001 when they performed the first successful AbioCor implantation in 59-year-old Robert Tools. The feisty ex-Marine lived for more than five months on the device, visiting local restaurants and even finding the energy to go fishing a time or two.

“I’m surprised, I’m thankful, I’m grateful and nobody can tell me anything different than it works,” Tools said during a TV interview late last year.

“The only guarantee was, if you have the surgery, it might work,” he continued. “If you don’t have the surgery, you don’t have a chance at all. And I took a chance.”

Tools died in December due to complications following a stroke.

“We asked before we got into this ÔWhat are our realistic goals?’ “ Dowling says. “If we put this artificial heart into patients who are so sick that they’re not going to live 30 days, one of our realistic goals was to have one of the patients survive 60 days.

“This is unprecedented. No one has ever gone home with an artificial heart before.”

“We are treating a patient who is living with a device that has never been implanted before,” Gray explains. “We’ve adjusted some of our early educated presumptions as we’ve learned from our patients. It has been quite a privilege to be a part of this learning process.”

THE HUMAN ELEMENT

“Adjusting educated presumptions ...” “Learning from their patients ...” “Being a part of a learning process ...”

Gray and Dowling not only are skilled surgeons but also determined investigators engaged in groundbreaking research using human subjects. Their work not only demonstrates the endless potential of research, but the earnest responsibility they have to subjects ... to people ... like Robert Tools and Tom Christerson.

“Every time you go to a doctor’s office, you are the beneficiary of medical research,” says Nancy Martin, vice president for research at U of L. “People who participate as research subjects are brave because it involves risk. But you hope that it also involves benefit to the individual participating. When that’s not possible, you hope that it benefits society long-term.

“It’s important to have integrity in research in everything you do, but there’s a much more heightened awareness when human beings are involved.”

A BALANCING ACT

You just received a letter in the mail inviting you to take part in a study aimed at developing a new flu vaccine.

Sounds interesting, you think, but will it be safe?

If the study involves at least one U of L faculty member, student or research assistant, you can count on it having been through a rigorous review process designed to protect the research subjects.

Four human studies committees evaluate all U of L-connected medical, social and behavioral research projects and any drug or device tests that propose to use people as subjects. New projects must clear a committee before any research can begin. Existing studies must go before a committee at least once a year for review.

Before any research proposal goes to committee, it is “triaged” by staff in the human studies office, a full-time university office set up by Martin to support the review process.

The university follows a comprehensive set of research ethics guidelines and regulations, says Richard Miller, a dentistry professor who has chaired all four of U of L’s human studies committees for six years. Some of the rules are handed down from the federal government. Others are created internally.

“In some cases, our standards are higher than those imposed by the federal government,” Miller says.

Why use people as subjects in research at all when the practice can pose risks?

“Because the new knowledge gained can outweigh the possibility of harm,” Miller says. “We have to balance the interests of society as a whole with the ethical protection of an individual’s welfare and privacy.”

What’s more, he adds, the data yielded from research projects using human subjects is nearly always more useful than that obtained from animal models or computers.

Evaluating the safety of people who take part in research nearly always means balancing the risks against the benefits.

“For example, if a study calls for the use of an invasive medical technique such as surgery, reviewers have to decide whether the potential payoff is likely to outweigh the risk to those who undergo the surgery while it is still in an experimental stage,” Miller says.

Informed consent is another important factor in the ethical treatment of people who take part in research. It’s essential to explain to people up front exactly what the risks are so that they can make an informed decision about whether they want to be involved. That applies to social and behavioral research as well as medical research, Miller says.

“Let’s say a psychologist wants you to complete a detailed questionnaire about your interaction with your life partner,” he says. “You deserve an explanation of how that information is going to be used, whether it’s going to be kept confidential, and if not, who’s going to see it.”

Besides protecting human research subjects, the university’s internal review process also protects the researchers themselves.

“If institutions don’t provide the proper infrastructure to support clinical research, they face investigations and sometimes penalties by federal agencies such as the Office of Human Protections in Research,” Miller says. “This has happened at several universities around the country. It’s our job to make sure it doesn’t happen here.”

Each human studies committee is required to have a minimum of five members including at least one scientist, one non-scientist and one community member, although the committees typically have 10 to 12 members. If a committee lacks the expertise to assess a particular research project, it brings in a consultant.

Research proposals generally include complex forms, detailed protocols and sophisticated terminology, and they can measure up to several inches thick. It may take hours just to read through one and even longer to make sure it complies with the appropriate rules and regulations.

Phenomenal growth in U of L’s volume of research over the past several years is making the committees’ task a lot more challenging.

Six years ago, the committees were reviewing about 200 new projects and 400 continuing projects a year. In 2001, they reviewed 960 new projects and nearly 1,200 continuing projects. In the same time, the human studies office staff has grown from one full-time person to five.

Miller stepped down as chair of the human studies committees Sept. 1. Ed Leist, director of pharmacy at Norton Healthcare and associate clinical faculty member in U of L’s Department of Pediatrics, took his place.

“The job is not getting smaller,” says Leist, who has been actively involved in the human studies review process for several years, acting as chair in Miller’s absence and recently chairing the behavioral research committee. “But in spite of the volume, we are just as diligent with every proposal.”

Ensuring the integrity of research and protecting the rights of research subjects has never been more important, he adds.

“It’s a labor of love. There are dedicated people (on the committees) who are putting forth a great deal of time and effort to uphold these values.”

TRUST AND CONFIDENCE

The huge growth in research at U of L along with some highly publicized and tragic problems at other universities inspired Martin and her colleagues to take a closer look at the university’s research processes two years ago.

They concluded that the university did not then have the infrastructure in place to make it easy for researchers to be aware of several key ethical issues that other universities around the world were facing. Also, the federal government was instituting several new policy and procedural requirements regarding a variety of ethical issues that arise during research.

Martin decided that U of L needed to have a central office that handled research compliance and research integrity.

“I really didn’t want only a compliance program,” she says. “To me, compliance means that you do things a certain way because of external requirements, that you comply. The fact is, if we do research with integrity, we will comply.

“So the emphasis is not on only compliance, but on really doing a great job with how we do research.”

Last year, U of L established the Office of Research Integrity to be responsible for maintaining a broad oversight and knowledge of all integrity and compliance issues relating to the conduct of research at the university.

Tom Dalglish, an attorney with a Ph.D. and a vast background in ethical, legal and administrative issues involved in the conduct of research, was hired to direct the new office in the summer of 2001.

“I have always been interested in the issues relating to the politics of science--the values embedded in the organized search for new knowledge,” says Dalglish, whose graduate work at Berkeley focused on the management, organization and governance of research at universities, and rules protecting human subjects.

“There’s an incredible amount of creative tension between the actual conduct of research and the regulation of those research activities. Every time a researcher engages in a research activity, he or she may be interacting with the environment, human subjects, or animals, or otherwise encountering issues that people care a great deal about.

“I believe that knowing about society’s ethical expectations and honoring them is every bit as important as the purpose of the research activity engaged in. Otherwise, public trust in science gets undermined.”

The Office of Research Integrity not only coordinates all of the research compliance activities but also promotes and coordinates training--from the proper treatment of human and animal subjects and correct disposal of hazardous waste from labs to how researchers manage grants and avoid conflict of interest issues.

The office also is engaged in a massive effort involving about 100 faculty members who are looking at all aspects of research integrity at the university. Dubbed the “Task Force Project,” the endeavor has seven task forces: animal welfare; award administration; biological and environmental safety; conflict of interest; human studies; monitoring, auditing and response; and research standards and training.

Each task force examines, makes recommendations and devises standards and rules in these specific areas. The research integrity office, with two oversight committees, coordinates to make sure that the final work product is uniform, fair and readily accessible to U of L researchers through handbooks, the Web and elsewhere.

“We make sure the policies are integrated with each other,” Dalglish says. “Is there a synchronicity between the efforts of the investigators who are conducting research and the public’s expectations those policies reflect?”

Martin says the Task Force Project is a “living, breathing process whereby we look at all of these issues with a large group of faculty because you want to make sure that every discipline is served. We define what role everyone plays in making sure research integrity is maintained at the university. And we monitor to see how we’re doing and change things as they need to be tweaked.

“I believe most people at the university and everywhere else want to do the right thing but can inadvertently do the wrong thing if they don’t have the proper training to know what the right thing is.”

The overall hope here, according to Dalglish, is to establish an integrated program of administrative mechanisms that instills trust and confidence in the way research at U of L is conducted and in the outcomes of that research.

“It’s up to the scientists to do good science,” he says. “And it’s up to the scientists and the university to provide the infrastructure and the systems for ensuring that all these important values are reflected in the work they do.

“People need to confidently know that not only is the science good, but it’s getting done in the right way by an institution that cares and is well-organized to do it in the right way.

“And that’s what we’re committed to.”