Michelle N. Meyer
Advances in Methods and Practices in Psychological Science
Volume: 1 issue: 1, page(s): 131-144
Abstract
This Tutorial provides practical dos and don’ts for sharing research data in ways that are effective, ethical, and compliant with the federal Common Rule. I first consider best practices for prospectively incorporating data-sharing plans into research, discussing what to say—and what not to say—in consent forms and institutional review board applications, tools for data de-identification and how to think about the risks of re-identification, and what to consider when selecting a data repository. Turning to data that have already been collected, I discuss the ethical and regulatory issues raised by sharing data when the consent form either was silent about data sharing or explicitly promised participants that the data would not be shared. Finally, I discuss ethical issues in sharing “public” data.
The article is here.
Showing posts with label Common Rule. Show all posts
Showing posts with label Common Rule. Show all posts
Thursday, April 26, 2018
Tuesday, June 6, 2017
Some Social Scientists Are Tired of Asking for Permission
Kate Murphy
The New York Times
Originally published May 22, 2017
Who gets to decide whether the experimental protocol — what subjects are asked to do and disclose — is appropriate and ethical? That question has been roiling the academic community since the Department of Health and Human Services’s Office for Human Research Protections revised its rules in January.
The revision exempts from oversight studies involving “benign behavioral interventions.” This was welcome news to economists, psychologists and sociologists who have long complained that they need not receive as much scrutiny as, say, a medical researcher.
The change received little notice until a March opinion article in The Chronicle of Higher Education went viral. The authors of the article, a professor of human development and a professor of psychology, interpreted the revision as a license to conduct research without submitting it for approval by an institutional review board.
That is, social science researchers ought to be able to decide on their own whether or not their studies are harmful to human subjects.
The Federal Policy for the Protection of Human Subjects (known as the Common Rule) was published in 1991 after a long history of exploitation of human subjects in federally funded research — notably, the Tuskegee syphilis study and a series of radiation experiments that took place over three decades after World War II.
The remedial policy mandated that all institutions, academic or otherwise, establish a review board to ensure that federally funded researchers conducted ethical studies.
The article is here.
The New York Times
Originally published May 22, 2017
Who gets to decide whether the experimental protocol — what subjects are asked to do and disclose — is appropriate and ethical? That question has been roiling the academic community since the Department of Health and Human Services’s Office for Human Research Protections revised its rules in January.
The revision exempts from oversight studies involving “benign behavioral interventions.” This was welcome news to economists, psychologists and sociologists who have long complained that they need not receive as much scrutiny as, say, a medical researcher.
The change received little notice until a March opinion article in The Chronicle of Higher Education went viral. The authors of the article, a professor of human development and a professor of psychology, interpreted the revision as a license to conduct research without submitting it for approval by an institutional review board.
That is, social science researchers ought to be able to decide on their own whether or not their studies are harmful to human subjects.
The Federal Policy for the Protection of Human Subjects (known as the Common Rule) was published in 1991 after a long history of exploitation of human subjects in federally funded research — notably, the Tuskegee syphilis study and a series of radiation experiments that took place over three decades after World War II.
The remedial policy mandated that all institutions, academic or otherwise, establish a review board to ensure that federally funded researchers conducted ethical studies.
The article is here.
Sunday, March 19, 2017
Revamping the US Federal Common Rule: Modernizing Human Participant Research Regulations
James G. Hodge Jr. and Lawrence O. Gostin
JAMA. Published online February 22, 2017
On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).1 Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.
Research enterprises now encompass vast multicenter trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.
The article is here.
JAMA. Published online February 22, 2017
On January 19, 2017, the Office for Human Research Protections (OHRP), Department of Health and Human Services, and 15 federal agencies published a final rule to modernize the Federal Policy for the Protection of Human Subjects (known as the “Common Rule”).1 Initially introduced more than a quarter century ago, the Common Rule predated modern scientific methods and findings, notably human genome research.
Research enterprises now encompass vast multicenter trials in both academia and the private sector. The volume, types, and availability of public/private data and biospecimens have increased exponentially. Federal agencies demanded more accountability, research investigators sought more flexibility, and human participants desired more control over research. Most rule changes become effective in 2018, giving institutions time for implementation.
The article is here.
Tuesday, January 12, 2016
Your Cells. Their Research. Your Permission?
By Rebecca Skloot
The New York Times
Originally posted December 30, 2015
Here are two excerpts:
What’s riding on this? Maybe the future of human health. We’re in the era of precision medicine, which relies on genetic and other personal information to develop individualized treatments. Those advances depend on scientists working with vast amounts of human tissue and DNA. Dr. Francis S. Collins, director of the National Institutes of Health, believes involving donors in this process gives scientists more useful information, and can be life-changing for donors. In announcing plans for the $215 million Precision Medicine Initiative, which he sees as a model for other future research, Dr. Collins said, “Participants will be partners in research, not subjects.” But people can be partners only if they know they’re participating.
(cut)
People have told me by the thousands, and numerous public opinion studies find the same: They want to know if their biospecimens are used in research, and they want to be asked first. Most will probably say yes, because they understand it’s important. They just don’t want to find out later. That damages their trust in science and doctors. It makes them wonder, what else are you hiding from me?
People tell me this because I wrote a book about Henrietta Lacks, a black tobacco farmer whose cancer cells, taken without her knowledge in 1951, are still alive in laboratories worldwide. Those cells, code-named HeLa, were the first such cells grown and one of the most important advances in medicine. But they came with troubling consequences: Her children were later used in research, their medical information was published, and the HeLa genome — including personal information about Mrs. Lacks and potentially her descendants — was sequenced and posted online. All without the family’s knowledge.
The article is here.
The New York Times
Originally posted December 30, 2015
Here are two excerpts:
What’s riding on this? Maybe the future of human health. We’re in the era of precision medicine, which relies on genetic and other personal information to develop individualized treatments. Those advances depend on scientists working with vast amounts of human tissue and DNA. Dr. Francis S. Collins, director of the National Institutes of Health, believes involving donors in this process gives scientists more useful information, and can be life-changing for donors. In announcing plans for the $215 million Precision Medicine Initiative, which he sees as a model for other future research, Dr. Collins said, “Participants will be partners in research, not subjects.” But people can be partners only if they know they’re participating.
(cut)
People have told me by the thousands, and numerous public opinion studies find the same: They want to know if their biospecimens are used in research, and they want to be asked first. Most will probably say yes, because they understand it’s important. They just don’t want to find out later. That damages their trust in science and doctors. It makes them wonder, what else are you hiding from me?
People tell me this because I wrote a book about Henrietta Lacks, a black tobacco farmer whose cancer cells, taken without her knowledge in 1951, are still alive in laboratories worldwide. Those cells, code-named HeLa, were the first such cells grown and one of the most important advances in medicine. But they came with troubling consequences: Her children were later used in research, their medical information was published, and the HeLa genome — including personal information about Mrs. Lacks and potentially her descendants — was sequenced and posted online. All without the family’s knowledge.
The article is here.
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