Investigating How Consent Forms Have Changed Over Time

Signed consent forms are a necessary part of scientific research that uses human subjects. These consent forms typically inform potential subjects about the purpose of the study, risks and benefits of their involvement, the length of time involved, payment amount (if any), and a description of their rights. Because of problems in the past with regard to adequately informing potential subjects about every aspect of a study, including its potential risks and how the collected data will be used, today consent forms are standardized and guided by strict regulations.

Researchers at the University of Pennsylvania Law School and Columbia University recently conducted a study of how consent forms have changed over a 25-year time period. The researchers specifically looked at consent forms that were used between the years 1978 and 2002. Their study resulted in two main findings. They found that, over time

  • consent forms have become more accurate, and
  • consent forms have grown substantially in length, from just a few paragraphs to over four pages in length.

Though the researchers find it quite heartening that the amount of discrepancies and/or inaccuracies in consent forms have dropped drastically, they find it worrisome that consent form length has increased dramatically. According to the study authors, data suggests that “consent forms longer than 1,000 words (four double-spaced pages) are unlikely to be read, perhaps in part because of the time involved.” Research indicates that consent forms should be limited to 1250 words or less (that is, no more than five pages) and the information should also be presented in other ways, such as through an informational booklet that potential subjects can read on their own time or through video or computer-based disclosures. Research also indicates that consent forms could be shortened by including only the most pertinent information that potential subjects would need to know in deciding whether or not to take part in the research study.

The results of the researchers’ study were reported in the May-June edition of the journal IBS: Ethics & Human Research. Study authors included Ilene Albala, Margaret Doyle, and Paul S. Appelbaum.

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Researchers Recommend Ethics Guidelines for Whole-Genome Research

Earlier last year, an interdisciplinary team of scientists met at a workshop to discuss the ethical issues related to whole-genome sequencing, particularly as it relates to human-genome research. The goal of the workshop was the develop an ethically rigorous and practical guide for scientific investigators and research ethics boards involved with human-genome research projects. At the workshop, the researchers identified four high-priority topics. These topics included:

  • consent
  • withdrawal from research
  • return of research results
  • public data release

There are many legal and ethical obligations related to human-genome research. Often, when participants agree to participate in a study involving sampling their DNA, they may not realize that their sequenced DNA may be involved in research studies beyond the one they signed up for. For example, DNA sequenced for a cancer study may later be used in a completely different study. One “problem” with current human-genome studies is that once an individual’s DNA is sequenced, it is often released into a publicly-accessible database. This information could theoretically be used by health insurance companies to determine whether or not to give you coverage. One of the major recommendations of the workshop attendees was that participants in genome-studies must be able to rescind their consent to participate at any time. At the same time, the researchers recognize that this may in some cases be impossible, given how quickly (and how far-reaching) information is disseminated. It may be necessary to regulate how the sequenced DNA of individuals is used and who exactly has access to the data.

Another ethical issue related to human-genome research is related to the findings that researchers discover from sequencing an individual’s genome. Many times, participants are told that they will not receive any information from the researcher’s about their genetic information. An ethical dilemma arises if there is information in the individual’s genetic information, such as a propensity toward the development of cancer or other disease, that if told to the participant, could have far-reaching consequences on their health and well-being (and possibly the health and well-being of their offspring as well). Researchers recommend that ethics boards develop criteria to determine when a participant should be told about certain aspects of their genetic information gleaned from sequencing their DNA.

A third ethical issue relates to the release of genetic information for use by scientists in publicly-accessible databases. One major problem with this is that once data is released into the public domain, it is basically impossible to rescind the release. Thus, even if a participant later requests to withdraw their genetic information from a study, it may be impossible to delete all their relevant data. Researchers recommend that when procuring a participant’s initial consent, they be informed that their genetic information is likely to be publicly available, and it may be impossible to remove their information from the public domain once it has been released. The workshop participants also recommended that scientists weigh the benefits and drawbacks of releasing participants’ genetic information to publicly-accessible databases with the participants’ privacy.

Given the vast number of questions scientists have about the human genome, the need for participants remains as high as ever. However, as more people become involved in these studies, there more there needs to be standards and guidelines to deal with the ethical issues that arise from genetic research. The workshop participants hope that their recommendations can serve as a starting point, though more empirical evidence and analysis is needed. As noted in an article about their recommendations, the researchers note that “the door must remain open for further reflection on these and other social concerns.”

Recommendations arising from the workshop were published online in the March 25, 2008 edition of the open-access journal PLoS Biology .

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The Ethics of Sequencing an Individual’s Genome

On May 21, 2008, President George W. Bush signed H.R. 493, the Genetic Information Nondiscrimination Act of 2008. The purpose of the Genetic Information Nondiscrimination Act (GINA) is to protect Americans against discrimination when applying for health insurance or employment based on the results of genetic testing.

The bill passed in the U.S. Senate by a unanimous vote and passed in the U.S. House by a vote of 414 to 1. Prior to the bills passage in early May, the topic had been under debate in Congress for 13 years. One of the hopes of the sponsors of the bill is that it will allow Americans the ability to undergo genetic testing without fear that the results will affect future health insurance coverage or employment, letting them pursue individualized medical treatments.

The U.S. Human Genome Project was started in 1990. Two of the main goals of the project were to identify and determine the sequences of the 3 billion base pairs that make up the human genome. Scientists hoped to complete the project within a span of 15 years. However, technological advances allowed them to finish early, and they completed the human genome sequence in 2003.

One of the unique aspects of the U.S. Human Genome Project was that funds were set aside by the U.S. Department of Energy (DOE) and the National Institutes of Health (NIH) to study the ethical, legal, and social issues associated with the availability of genetic information. According to information gathered by the DOE and NIH, some of the ethical issues related to genetic testing include:

  • Fairness in the use of genetic information
  • Privacy and confidentially of genetic information
  • Psychological impact of genetic test results
  • Reproductive rights and genetic testing
  • Standards related to genetic testing
  • Uncertainty related to genetic testing results
  • Free-will versus genetic determinism (i.e., how much control does an individual have over their genetic fate?)
  • Ownership of information related to genome sequences and genetic tests

Although the technology now exists for individuals to get their genome sequenced, many scientists caution against doing so.

“From a basic science perspective, the advances being made in genomics are important discoveries, but its unrealistic for individuals to believe those advances can yield meaningful information that will improve their health,” said Dr. James P. Evans, a professor of genetics and medicine at the University of North Carolina-Chapel Hill School of Medicine. “And even saying It’s not there yet is too optimistic. It’s going to be a long time before the potential is realized.”

Several companies now offer individuals the opportunity to be genetically tested, usually for a fee between $1000 and $3000. Those individuals who seek genetic screening are often interested in finding out their potential to develop conditions such as Alzheimer’s or heart disease. The results of such a screening has interesting ethical implications. If an individual finds out that they do have the genes that may lead to a life-threatening disease, what do they do with that information? How does it affect their outlook on life? If the genetic tests come back negative, does that mean the patient should be completely worry-free? Perhaps an even bigger question is whether or not most doctors are equipped with the knowledge to adequately interpret a patients genetic test results.

Most physicians, by their own admission, are not geneticists and wont know what to do with the information, Evans said. Many who do understand the technology and how it is generated don’t know what to do with it. So there’s huge potential for patient harm—either for patients to be lulled into a false sense of security by this new genetic information or, in the opposite extreme, to have unnecessarily increased anxiety.

The field of genomics is constantly evolving. Many medical advancements have been made since the human genome sequence was first made available in 2003. The study of human genomics continues to be a bit of an ethical minefield. However, it is hoped that some day in the near future scientists will be able to use their discoveries to aid human health and help treat and/or prevent genetic diseases from developing.

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A New Meaning to Smart Dresser

Garment-integrated electronic technology — that is, smart tools in your clothes — is much more appealing than implanting a computer chip under your skin. It may be possible in the near future to fill your closet with smart T-shirts or smart suits or whatever the seasons fashion is! But how confidential can your health record be when your garments are smart enough to monitor and report your vital statistics and activity? This and other bioethical questions must be considered in light of a new smart garment system that uses Bluetooth wireless technology to transmit information.

University of South Australia students Aaron Toney and Wynard Marais, under the direction of Professor Bruce Thomas, developed smart garment management technology. When clothes are placed on electronic hangers in a computerized closet, they can download the data they have monitored to a computer via a wireless network and recharge the clothing for another wearing. The computerized system will keep track of the same type of data gathered from different items of clothes. For example, a person can monitor heart rate throughout the week using a different smart shirt every day.

In the future, a doctor may use this clothing to monitor a patient released from the hospital or to keep track of a patient with Alzheimer’s disease. These clothes could even tell if the wearer has fallen and needs help.While this technology has many benefits, it also has risks. Consumers who use the system need to know who can access the monitored data. Another concern is the security of very private information over a wireless network. These issues must be addressed before many people will feel comfortable in their smart clothes.

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Extra Embryos: Destroy or Donate to Research?

One of the hottest debates in bioethics has been the use of human embryos in stem cell research. Infertility patients find themselves in the middle of this debate. Patients that use in vitro fertilization often have many frozen embryos in storage and must decide what to do with the embryos once they are done having children.

New research from Anne Lyerly of the Duke University Medical Center and Ruth Faden of the Johns Hopkins Berman Institute of Bioethics indicates that patients see destroying their embryos or donating them to other infertile couples as unacceptable options. The patients find it especially uncomfortable to think of their genetic embryo developing into another couples child. However, these patients widely support donating their excess embryos to research, including developing embryonic stem cell lines.

Other studies have shown that 66 percent of the American public supports donating embryos for stem cell research. This support runs across all religious, political, and socioeconomic lines. The percentage of infertility patients that support donating of their frozen embryos for medical research or stem cell research is about the same.

In 2001, President George W. Bush restricted federally-funded embryonic stem cell research in the United States to 20 preexisting stem cell lines. No new embryonic stem cell lines can be produced using federal research funds. However, the limited cell lines have prompted concern from the scientific community that there just aren’t enough cell lines for safe, effective research. The frozen embryos remaining from infertility treatments are not created for research purposes and could potentially get around the federal funding restrictions. They may also solve a moral dilemma in the debate over how stem cells are made for research.

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Scandal over Falsified Results Roils the Stem Cell Research Community

In May of 2005, a paper by Dr. Woo Suk Hwang published in the prestigious journal Science reported that he and his team of South Korean scientists had successfully created eleven patient-specific stem cell lines cloned from the patient’s skin cells. Hwang was already a hero in South Korea for reportedly cloning human embryos a year earlier using somatic cell nuclear transfer (SCNT). As described in Science, this breakthrough suggested that stem cells could be successfully harvested from cloned embryos. In just two years, Hwang had become a world leader in the field of stem cell research. His research suggested that science was one major step closer to tailor-made stem cells for any human.

But all was not well. First came the news that female workers at Hwang’s own lab had supplied the embryos used to make the clones, a serious breach of professional ethics. Then came news that Hwang’s success in producing stem cells from eleven stem cell lines may have been too good to be true. By December of 2005, after members of Hwang’s own research team asserted that he falsified results, a panel set up by Seoul National University found that at least nine of the eleven stem cell lines Hwang claimed to have made did not exist. A month later, in January of 2006, the panel concluded that Hwang had not produced a single stem cell line at any time, prompting Science to retract Hwang’s articles from both 2004 and 2005.

Hwang made a tearful apology on live television in South Korea for the shame he had brought upon himself, his university, and the nation. But despite admitting that his results were fraudulent, he placed blame on the researchers who were responsible for creating the stem cell lines from the 101 cloned embryos that he says had been produced using SCNT. Hwang claimed that it was they who had cheated, and that he had been tricked into believing their results.

In May of 2006, Hwang and several other members of his research team were indicted for fraud, for breach of South Korean bioethics laws, and also for embezzling $3 million in funding.

The fall-out of the scandal not only shook the science community but the community of reviewers and writers who report on science. Science created its own panel to examine how its editorial process had failed to catch inaccuracies in Hwang’s paper. Science reporters, whom ordinary people rely on to read journals and translate technical articles into everyday language, vowed to pay closer attention to these journals and take more time to review results before publicizing science news in mainstream media.

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