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From the article: EPA is proposing to eliminate consideration of scientific studies unless the raw study data are made publicly available — possibly including

by mhneu 8y ago

From the article: EPA is proposing to eliminate consideration of scientific studies unless the raw study data are made publicly available — possibly including participants’ personal, confidential, and private information — data that may be subject to legal, ethical, and human subject research protections. This requirement would eliminate human health studies that use integral medical, lifestyle, and geographic data, as well as studies that include confidential business information, such as information from studies conducted by industry to demonstrate safety of a pesticide or other toxic chemical. It could also eliminate consideration of older studies for which data are no longer available or accessible, even if the data have been reanalyzed and the studies have been validated, replicated, reproduced, and undergone rigorous and independent peer review. Far from using the best available science for EPA decision-making, the proposal would severely limit the studies and scientific evidence the agency would use to fulfill is statutory mission to protect human health and the environment. This is not a new idea. It is the result of a decades-long campaign to undercut reliance on groundbreaking research...

deleted 8y ago
[deleted]
refurb 8y ago
Instead of quoting the article, how about we quote the actual proposed regulation? The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.[1] Seem eminently reasonable to me. And seems aligned with the "open science" movement to me. And in terms of privacy... EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government. Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. [1] https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science https://www.federalregister.gov/documents/2018/04/30/2018-09...
- Retric 8y ago
  Changing the rules after the fact is generally a terrible idea. Suppose zero studies that satisfy that criteria study lead. Should the EPA suddenly say lead must be safe in any concentration?
  - refurb 8y ago
    These standards are no different than any reputable scientific journal. Try and publish a paper in Nature and tell them “I can’t share the data”.
  - smsm42 8y ago
    Why would there be zero studies that study lead and have source data? What happened to those that studied lead - did they destroy their data for some reason? Are the data about lead somehow unique so that, unlike any other data, they can't be published? Did some weird catastrophe occur which erased all data regarding to lead studies, and nobody knows about it? What would be the reason that basic scientific norms would not be preserved in this case? I guess if it happened, we'd need to conduct new studies - and find people who screwed up the old ones and make sure they are not responsible for any new studies ever again, to avoid future screwups.
    - Retric 8y ago
      Science is old. Good luck tracking down data from ~50 year old studies published in 1970. Further, their is little point in replicating old studies so often that's all we got.
      - smsm42 8y ago
        1970 is not a Stone Age, and civilization didn't collapse since then. Why would it impossible to have data? Also, does it mean if a study in 1970 made a mistake, we're now doomed to carry on with this mistake forever? And if not, how would we discover it if not by trying to replicate/re-analyze data?
- ouid 8y ago
swebs 8y ago
From the actual document: >With this notice, EPA is soliciting public comment on a proposed regulation designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests. >The proposal takes comment on how to ensure that, over time, more of the data and models underlying the science that informs regulatory decisions (over and above the dose response data and models underlying “pivotal regulatory science”) is available to the public for validation [13] in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification. >EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government.[16] Nothing in the proposed rule compels Start Printed Page 18771the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines.[17] The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that “Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach.” [18] More recently, both the National Academies and the Bipartisan Commission on Evidence Based Policy [19] have discussed the challenges and opportunities for facilitating to secure access to confidential data for non-government analysts. >Considering the breadth of dose response data and models used in the development of significant EPA regulations, the requirements for availability may differ. These mechanisms may range from deposition in public data repositories, consistent with requirements for many scientific journals,[20] to, for certain types of information, controlled access in federal research data centers that facilitate secondary research use by the public.[21] EPA should collaborate with other federal agencies to identify strategies to protect confidential and private information in any circumstance in which it is making information publicly available. These strategies should be cost-effective and may also include: Requiring applications for access; restricting access to data for the purposes of replication, validation, and sensitivity evaluation; establishing physical controls on data storage; online training for researchers; and nondisclosure agreements.[22] https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science https://www.federalregister.gov/documents/2018/04/30/2018-09...
nine_k 8y ago
It sounds as if the requirement is to make the data available for anyone to reproduce the analysis. It's not a bad goal, though making data public is always a bit tricky when data collected from human beings is involved.
smsm42 8y ago
It's fascinating. EPA says "we won't consider your research unless it's done in open and reproducible fashion so that other people can verify your results and reproduce the conclusions" and people hear "we hate science and want to undercut research". Amazing.

by mhneu 8y ago

deleted 8y ago

[deleted]

refurb 8y ago

Instead of quoting the article, how about we quote the actual proposed regulation? The proposed regulation provides that when EPA develops regulations, including regulations for which the public is likely to bear the cost of compliance, with regard to those scientific studies that are pivotal to the action being taken, EPA should ensure that the data underlying those are publicly available in a manner sufficient for independent validation.[1] Seem eminently reasonable to me. And seems aligned with the "open science" movement to me. And in terms of privacy... EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government. Nothing in the proposed rule compels the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. [1] https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science https://www.federalregister.gov/documents/2018/04/30/2018-09...

Retric 8y ago
Changing the rules after the fact is generally a terrible idea. Suppose zero studies that satisfy that criteria study lead. Should the EPA suddenly say lead must be safe in any concentration?
- refurb 8y ago
  These standards are no different than any reputable scientific journal. Try and publish a paper in Nature and tell them “I can’t share the data”.
- smsm42 8y ago
  Why would there be zero studies that study lead and have source data? What happened to those that studied lead - did they destroy their data for some reason? Are the data about lead somehow unique so that, unlike any other data, they can't be published? Did some weird catastrophe occur which erased all data regarding to lead studies, and nobody knows about it? What would be the reason that basic scientific norms would not be preserved in this case? I guess if it happened, we'd need to conduct new studies - and find people who screwed up the old ones and make sure they are not responsible for any new studies ever again, to avoid future screwups.
  - Retric 8y ago
    Science is old. Good luck tracking down data from ~50 year old studies published in 1970. Further, their is little point in replicating old studies so often that's all we got.
    - smsm42 8y ago
      1970 is not a Stone Age, and civilization didn't collapse since then. Why would it impossible to have data? Also, does it mean if a study in 1970 made a mistake, we're now doomed to carry on with this mistake forever? And if not, how would we discover it if not by trying to replicate/re-analyze data?
ouid 8y ago

swebs 8y ago

From the actual document: >With this notice, EPA is soliciting public comment on a proposed regulation designed to provide a mechanism to increase access to dose response data and models underlying pivotal regulatory science in a manner consistent with statutory requirements for protection of privacy and confidentiality of research participants, protection of proprietary data and confidential business information, and other compelling interests. >The proposal takes comment on how to ensure that, over time, more of the data and models underlying the science that informs regulatory decisions (over and above the dose response data and models underlying “pivotal regulatory science”) is available to the public for validation [13] in a manner that honors legal and ethical obligations to reduce the risks of unauthorized disclosure and re-identification. >EPA believes that concerns about access to confidential or private information can, in many cases, be addressed through the application of solutions commonly in use across some parts of the Federal government.[16] Nothing in the proposed rule compels Start Printed Page 18771the disclosure of any confidential or private information in a manner that violates applicable legal and ethical protections. Other federal agencies have developed tools and methods to de-identify private information for a variety of disciplines.[17] The National Academies have noted that simple data masking, coding, and de-identification techniques have been developed over the last half century and that “Nothing in the past suggests that increasing access to research data without damage to privacy and confidentiality rights is beyond scientific reach.” [18] More recently, both the National Academies and the Bipartisan Commission on Evidence Based Policy [19] have discussed the challenges and opportunities for facilitating to secure access to confidential data for non-government analysts. >Considering the breadth of dose response data and models used in the development of significant EPA regulations, the requirements for availability may differ. These mechanisms may range from deposition in public data repositories, consistent with requirements for many scientific journals,[20] to, for certain types of information, controlled access in federal research data centers that facilitate secondary research use by the public.[21] EPA should collaborate with other federal agencies to identify strategies to protect confidential and private information in any circumstance in which it is making information publicly available. These strategies should be cost-effective and may also include: Requiring applications for access; restricting access to data for the purposes of replication, validation, and sensitivity evaluation; establishing physical controls on data storage; online training for researchers; and nondisclosure agreements.[22] https://www.federalregister.gov/documents/2018/04/30/2018-09078/strengthening-transparency-in-regulatory-science https://www.federalregister.gov/documents/2018/04/30/2018-09...

nine_k 8y ago

It sounds as if the requirement is to make the data available for anyone to reproduce the analysis. It's not a bad goal, though making data public is always a bit tricky when data collected from human beings is involved.

smsm42 8y ago

It's fascinating. EPA says "we won't consider your research unless it's done in open and reproducible fashion so that other people can verify your results and reproduce the conclusions" and people hear "we hate science and want to undercut research". Amazing.