IRBs handle religious, ethical conflicts
Wording changes can meet everyone’s needs
As human subjects research moves into the direction of genetic, umbilical cord, and stem cell arenas, IRBs representing religious institutions may increasingly face ethical dilemmas that require special considerations. For example, will the religious institution permit research that requires umbilical cord storage by a company that also stores sperm samples? What types of genetic research would not be permissible? These IRBs also must find ways to reword informed consent forms that involve studies in which human subjects must avoid procreation for safety reasons. All of these are issues that IRBs representing religious institutions might encounter. What’s more, solutions to the problems can even vary within a particular religion.
Religion’s role in informed consent
While some IRBs might include in an informed consent document a religious statement that reminds Catholic participants of the church’s prohibition of contraception, others may not, says Patrick J. McCruden, vice president of mission and ethics for the St. Joseph’s Mercy Health Center in Hot Springs, AR. "We recognize that we’re serving a diverse population in Arkansas, and we’re only 4% to 5% Catholic; so most of the people who would be in a clinical trial here would not be Catholic," McCruden says. "So that’s why we would not use a consent document to teach people about the Catholic faith."
However, the IRB representing St. Joseph’s will request that investigators change their informed consent forms to eliminate any detailed references to contraception, McCruden says. "The [U.S.] Food and Drug Administration guidelines on that matter say that it’s a personal choice between the person and their physician," he says. "How a person chooses to [not get pregnant] should be up to the person."
Decisions regarding these issues are made in a health care and research environment that includes mergers of hospitals of different philosophical bents and of the growing use of community IRBs to handle the review of human subjects protection for studies done at a variety of research institutions. For instance, the Peoria (IL) Community IRB represents a Catholic hospital, a medical school, and two nonreligious hospitals, says Frank L. Gold, MD, CIP, associate dean for organizational ethics at the University of Illinois College of Medicine in Peoria and co-chair of the IRB.
The IRB handles the occasional research proposal that might conflict with the Catholic hospital’s ethical philosophy in the same manner. The organization convenes a specialist IRB for research protocols that cannot be performed at the Catholic institution. The specialist IRB will meet after the community IRB meeting, and the IRB members who are representatives of the Catholic hospital will not attend the specialist IRB meeting, Gold explains. "So we address the issue in a sense by ducking it, and it works," Gold says. "It was a very satisfactory solution, and it allowed us in 1994 to combine the resources of all of our medical school and hospitals into one IRB."
Troublesome policy eliminated
Previously, researchers would have to present their protocols to four different IRBs, which was inefficient and time-consuming, he says. Typically, if there is a protocol that would be a problem for the religious institution, Gold would show it to the hospital’s corporate ethicist, who is on the general IRB, and see if it should be referred to the specialist IRB, he says. "So the investigator won’t recruit any patients at that hospital or perform research at that Catholic hospital, and then we don’t have a problem of offending the Catholic IRB members’ sensibilities by discussing those protocols," Gold adds.
A similar situation arose when the TriHealth IRB was formed in 1996 to represent Bethesda and Good Samaritan Hospitals in Cincinnati. Bethesda is a Methodist institution, and Good Samaritan is a Catholic institution; and while both have a religious perspective, the Catholic institution takes a more conservative approach to certain research and consent-wording issues, says Holly Silva, CIP, IRB coordinator. The IRB’s membership includes a cross-section of specialties from both hospitals, as well as researchers, corporate counsel, administrators, and a Catholic priest.
Since pharmaceutical and other research often requires an informed consent document that instructs participants to avoid pregnancy during the study, the IRB carefully devised a way to word this instruction so that both religious institutions are satisfied. "We had certain people designated to review parts of our verbatim statement, and we had a priest and Methodist minister review it, as well," Silva says.
Within a couple of months, the IRB devised a statement that takes the more conservative approach, but clearly satisfies the research sponsor’s need to inform participants about the importance of avoiding pregnancy during the trial. The statement essentially reads: "If I am a woman able to have children, I understand that I must not be pregnant when I enter the study. I also must not become pregnant during the study. This study could seriously harm my fetus if I am pregnant or become pregnant. I understand I must use a birth regulation method or abstain from sexual relations throughout the study and one week after completing the study. These methods should be used by both female participants of childbearing potential and by males who are partners of such females.
"I understand that only abstinence is 100% effective in preventing pregnancy. If I enter the study and then think I might be pregnant, I will tell my doctor right away. I also understand that there might be risks to a fetus if I become pregnant after the study is done. These risks are unknown. If I do want to become pregnant when the study is done, I will talk about it with my doctor."
There occasionally are research protocols that are more specific about birth control, and when these arise the researcher is given the option of using only Bethesda Hospital as a study site, Silva says. "We’ve had sponsors who’ve disagreed with our verbiage, but if they want our patient population, and we’re willing to work with them, then when it comes to that informed consent piece there’s no room to bend," Silva says. "We have to tell them it’s either this way, or the Catholic hospital can’t participate."
Silva says she has not encountered any study sponsors who were willing to decline using the hospitals because of the informed consent statement, but there have been two instances where studies where birth control was mentioned, and the studies were done only at Bethesda Hospital.
The St. John Medical Center IRB in Tulsa, OK, has been instructed by the hospital’s sisters to not permit these words in the informed consent documents: "contraception," "birth control," "condom," or "fetus," says Dedee Boss, protocol coordinator for the IRB. "We try to make the informed consent as strong as we can, and we have a paragraph that we use that has been approved by the sisters that control this hospital and by our legal department," Boss says. "We’ve very seldom had problems with sponsors or drug companies using this instead of their standard statement, although there have been times we’ve been asked to highlight or underline certain words."
The statement reads: "If you are pregnant or plan to become pregnant, you cannot take part in this study. You will take a urine test to see if you are pregnant before you start treatment. If you are sexually active, your physician strongly recommends that you take precautions to avoid becoming pregnant or fathering a child for one to two months after discontinuing study medications because it is not known how these drugs could affect an unborn child. Should pregnancy occur while you are receiving study medications, you must tell your physician immediately."
The IRB does not approve any Phase I studies and is selective about Phase II studies, so religious ethical conflicts rarely arise other than the consent statement, Boss says. "We have started to see genetic studies coming through now and tissue banking, and we have developed a standard statement of confidentiality for those consents," Boss says. "Most of our genetic and tissue-banking issues have dealt with cancer tissue and tumors, and the board has no problems with that research." Protocols involving the use of umbilical cord research have not come before the board, Boss adds.
St. Joseph’s Mercy Health Center has not yet encountered any tissue bank, umbilical cord, or stem cell research protocols, McCruden says. However, if the hospital were to be involved with research that includes tissue storage by a private firm that also had an unrelated sperm banking service, then it probably would not be an issue for the hospital and its IRB, McCruden says, in answer to the hypothetical question about whether this relationship between the hospital and tissue storage company would pose a religious and ethical conflict.
"You’re always in partnerships with companies and individuals who may not completely share your viewpoint or ethics or morals," McCruden says. "For example, we all work with insurance companies and Medicare and Medicaid, and those companies might pay for acts that we would consider immoral, such as sterilization or abortions, but that doesn’t mean we don’t do business with them."
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