The U.S. Department of Health and Human Services, alongside 15 other federal agencies, issued Jan. 18 a final rule updating regulations to safeguard individuals participating in research.
According to the final rule, consent forms are to include concise explanations at the beginning of the document, stating key information most relevant to people considering participating in a certain study. These explanations include the study's purpose, the benefits and risks involved, and alternative treatments that a prospective subject may find beneficial.
Consent, however, will no longer be required should samples be used for other studies. This means that researchers will not be required to obtain written consent before using blood, DNA, cell, and tumor samples, as well as other "biospecimens" acquired in medical procedures, even when these samples have no identifying information, like the subject's name, or were from an earlier study a person participated in.
Scientists welcomed this provision in the final rule as they said being required to track down donors each time a sample is to be used would stifle research. For one, the act of tracking down a donor would be costly, in terms of both money and time.
"This is a big win for science and therefore a big win for patients," said Holly Fernandez Lynch, a bioethicist from Harvard Law School.
To protect the interests of patients while facilitating research, the final rule will set up a single central ethics committee to oversee studies.
"The bottom line is the trial has to be conducted the same way across all those sites to be scientifically valid," said Jerry Menikoff, M.D., head of HHS's Office of Human Research Protections.
Concerns About The Final Rule
The initial proposal that required researchers to obtain consent before using samples was an effort to avoid what happened to Henrietta Lacks. An African-American tobacco farmer, Lacks died of cervical cancer in 1951, and some of her cancer cells were kept alive, some used for research and others for commercial purposes without her or her family knowing.
With consent no longer required for further research, bioethicists like Johns Hopkins University's Debra Matthews are raising concern over trust, citing it is a critical factor for those seeking to participate in research. For the public to work with the scientific community, the latter has to show it is trustworthy, and a big part of that is asking for permission, she said.
The final rule is set to be published in the Federal Register.
The Common Rule
In place since 1991, the Common Rule refers to current regulations meant to ensure federally funded medical research is done ethically. Back then, studies were predominantly carried out in medical institutions and universities, with each study usually taking place at one site. Research involving human participants has grown over the years, expanding in scope and subjects, so the HHS and other concerned federal agencies released a Notice of Proposed Rulemaking in September 2015. This drew over 2,100 comments and it was from these comments that the final rule was based from. This is the first time the Common Rule was updated in 26 years.