You may be familiar with the flyers, perhaps from your college days: NEED EXTRA CASH? ENROLL IN THIS STUDY. You may have even participated and, when you did, you signed a form to give "informed consent" to your participation in the study. Like many legal documents, this form likely contained complicated clauses and statements that purported to explain the risks and benefits of the research study to you.
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| [motherwoman.org] |
The ambiguous and jargon-filled language of study consent forms may, in fact, be due for a makeover. Yesterday, at a Health and Human Services public meeting in Washington D.C., federal informed consent regulations were under the microscope as stakeholders weighed in on how these regulations should be applied to participant-based research studies.
The catalyst for the public meeting? A national premie study with 20 participating research centers that looks at how much supplemental oxygen premies should receive. The HHS Office of Human Research Protections raised a red flag earlier this year when they determined that prominent research centers at Yale, Stanford, Duke, and Emory didn't advise parents that their babies faced potential risks of blindness, neurological damage, or death.
"It would have been appropriate for the consent for to explain that the study involves substantial risks and that by participating in this study, the level of oxygen an infant receives would in many instances be changed from what they would have otherwise received," HHS said.
This public meeting is only the beginning of HHS's evaluation of the informed consent process.
Read more here: http://www.kansascity.com/2013/08/27/4441247/study-of-premature-babies-with.html#storylink=cpy
Read more here: http://www.kansascity.com/2013/08/27/4441247/study-of-premature-babies-with.html#storylink=cpy
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