The U-M is far advanced over most other American institutions when it comes to protecting human research participants and has been for some time, said national bioethics expert and former U-M president Harold Shapiro at a recent lecture on campus.
But, he argued during Waggoner Lecture on Ethics and Values in Medicine, the current level of protection at the U-M and elsewhere needs even more improvement. In fact, he said, dramatic changes to the national system should be made to shield volunteers in clinical trials and other studies from exploitation and harm, while enabling researchers to pursue their work with the least interference.
Human subjects research is part of a great humanitarian effort to take us to a better place, Shapiro said. But to use human beings in any type of research is a special privilege that carries with it special ethical considerations and responsibilities.
Shapiro recently completed an assignment from former president Bill Clinton to chair the National Bioethics Advisory Commission and assess issues such as research involving humans. His talk, before an overflow audience of Health System researchers and others from around campus, was sponsored by the Department of Psychiatry and the Historical Center for the Health Sciences. It was the latest in a series held in memory of former psychiatry chair and ethics researcher Raymond W. Waggoner.
Before laying out his proposed changes to the nations system for research involving human participants, Shapiro reviewed the history of the field, from early experiments on slaves, orphans and prisoners through the post-World War II reform movement and on to the patchwork of national regulations and institutional reviews that exist today.
The tension between the push to advance science and the need to protect human participants has existed as long as such research has been done, he explained, and the process of balancing the two demands is an evolving one. These two ethical drives often move in opposite directionswhat weight to give to the science that may be achieved, and to human health and welfare, he explained. And, who decides?
In the last 35 years, and especially in the last decade, the United States has improved its system significantly, Shapiro stated. Today, the so-called common rule providing for independent review of research proposals and voluntary informed consent by participants applies to all government-funded research, and to all work at the U-M.
Todays federal and institutional requirements may seem cumbersome and inefficient to researchers, Shapiro said, but they represent a great advance.
We may not like them, and we may want to change them, but we do have to respect them.
Still, Shapiro said, more changes would make the system both consistent and intelligent for the entire nation. In order to improve protections without hindering discoveries, he argued, the nation will need to extend the reach and consolidate the power of the federal governments oversight, increase the capability and accountability of the research review process, strengthen the informed consent process and mandate training for all members of each research team. Failure to do so could lead to a decline in public support for human research altogether.
Theres no reason why every human subject, no matter who is financing the study, should not be covered, by federal protections, he said. This is not the case now, and it is the single most important change needed. An independent government office, with jurisdiction over research funded by government, industry or any other source, would help overcome the current hole-filled system.
The Institutional Review Boards (IRBs) that assess and rules on research protocol proposals at institutions also should receive help, Shapiro said. Currently, IRBs are enormously overburdened and under-resourced, leading members to focus on regulatory details and not substantive issues.
When IRBs are overworked, substantive protection goes by the wayside, and this has serious ethical implications for our commitment to human subjects, he said. More inclusion of people from outside medicine and the local institution on IRBs, and a system of random audits and annual reports would increase the boards accountability and credibility, he added. Many study protocols need little review and could be triaged more effectively to allow substantive review of other, more risky studies.
Better education for researchers, research team members, IRB members, IRB staff and others also is crucial, Shapiro argued. The current decentralized system, which has great strength, depends critically on the education and understanding of those at the local level, he explained. Before anyone can be on a research grant, they should get education and certification in that area.
As for informed consent, Shapiro suggested that researchers must always remember that its a process, not a moment. The voluntary agreement by research participants is more than a signature on a formit must continue throughout the course of the research.
Even those whose historical medical records or tissue samples are being sought for use in new studies should be approached for renewed consent, even if a blanket consent was obtained initially, he said. More protection also is needed for those potential participants who might be considered vulnerable. However, Shapiro argues that vulnerability should be assessed on an individual level, not group, for each study depending on the potential for risk and benefit.
A lot of money and effort will be needed to improve the human research system further, Shapiro concluded. But the outcome will be worth it.
It is in the self-interest of all those working in this great endeavor to show how much respect they have for those who participate, especially in risky experiments, he stated. Noting that physicians have long been viewed as heroes, Shapiro said, I think its now time to return the favor and treat those who participate in research as heroes, and give them the respect that heroes get.