The recently updated Federal Policy for the Protection of Human Subjects, also called the Common Rule, is changing informed consent practices in two important ways, says Celia B. Fisher, PhD, Marie Ward Doty University Chair in ethics and director of Fordham University’s Center for Ethics Education in Bronx, NY. “Although both have the potential to increase the informational rights of participants, critical ethical questions remain,” she says.

The following are the two relevant changes:

1. Investigators now are permitted to obtain broad consent from participants for future use of identifiable biospecimens by the original investigator or other investigators.

“This will increase the ability of scientists to combine large data sets to explore important medical questions,” says Fisher. This may be done without the participant’s knowledge or consent, as long as an IRB determines that the future studies are within the parameters of the broad consent.

“It is unclear whether hacking or the use of the identifiable information by government officials or others with access to the data will pose a social or economic risk to participants,” adds Fisher.

It also is unclear whether the perspective of research participants will be taken into consideration as to how their data are later used. “This latter concern may be particularly problematic if identifiable data is used to inform policies that promote medical discrimination of already vulnerable groups,” says Fisher. For example, there’s the possibility that insurance companies will access data on individuals with pre-existing conditions.

2. Investigators now are required to give prospective participants a brief summary of “key points” that a reasonable person would want to know to make an informed choice.

“Done well, this can be an advantage over the current risk-averse legal language in informed consent materials,” says Fisher. These often are difficult to understand, and lead to misconceptions and uninformed choices.

“However, one question that remains is: Who will decide what those key points are?” says Fisher. Investigators and IRB members might have very different ideas from participants about what constitutes important information.

Katrina A. Bramstedt, PhD, senior ethics officer at Philips Research and adjunct professor at Bond University School of Medicine in Queensland, Australia, says information must be presented in a way that that truly helps people make informed decisions, rather than simply words on paper.

Costs will be incurred due to the need to update procedures, study templates and checklists, and train IRB members on the new rules. “However, the net result should be a more effective consent process that better informs participants about research studies.”

The posting of clinical trial consent forms on a public website raises issues of confidentiality and intellectual property for research teams. “New product development, as well as patents and technology transfers, are potential revenue streams, and intellectual property considerations are vital,” says Bramstedt.

This is especially true for commercial entities that often partner with federal agencies such as the Veterans Administration during research projects, notes Bramstedt.

The ability to redact these consent forms before public posting is an ethical issue addressed in the revised Common Rule. “But the redaction process is still vague at this point in time, and not yet tested, as even the consent form posting website is still an unknown,” says Bramstedt.

Overall, Bramstedt expects to see fewer hurdles, and faster approvals, for the secondary use of research data. The new rules guide researchers to writing better consent forms that prospectively account for future research and sharing of research data. “Data is the lifeblood of research,” says Bramstedt. “The new regulations appear to make the path of use simpler for research teams.”

SOURCES

  • Katrina A. Bramstedt, PhD, Bioethicist, Senior Ethics Officer, Philips Research/Adjunct Professor, Bond University School of Medicine, Queensland, Australia. Email: katrina.bramstedt@philips.com.
  • Celia B. Fisher, PhD, Marie Ward Doty University Chair in Ethics/Director, Center for Ethics Education, Fordham University, Bronx, NY. Phone: (718) 817-3793. Fax: (718) 817-0731. Email: fisher@fordham.edu.