21st century cures act update: research rigor and ...prelim report to full acd second meeting of the...
TRANSCRIPT
21st Century Cures Act Update Research Rigor and Reproducibility
Michael Lauer MD (for the ACD WG)Deputy Director for Extramural Research
National Institutes of Health
114th Meeting of the Advisory Committee to the Director (ACD)National Institutes of Health
Porter Neuroscience Building Building 35 A Rooms 620630 Bethesda Maryland
June 8 2017Disclosures None
1
Statute
2
Section 2039 requires the NIH Director to convene a working group under the ACD to develop and issue recommendations through the ACD for a formal policy which may incorporate or be informed by relevant existing and ongoing activities to enhance rigor and reproducibility of scientific research funded by NIH
ACD Working Group
bull ACDndash Russ Altman (Chair)ndash Mary Sue Colemanndash Lisa Cooperndash Jose Florezndash Linda Griffithndash Peter MacLeish
bull NIHndash Michael Lauerndash Pritty Joshindash Jennifer Plank-Bazinetndash Patricia Valdez
3
4
Pilots
Few Years Ago
5
Pilots
New Biosketch
Notices
More Notices
More Notices
Updated application amp RPPR instructions
Updated review language
(See handout for links to notices)
Moving to Nowhellip
Multi-Stakeholder Approach
6
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
Statute
2
Section 2039 requires the NIH Director to convene a working group under the ACD to develop and issue recommendations through the ACD for a formal policy which may incorporate or be informed by relevant existing and ongoing activities to enhance rigor and reproducibility of scientific research funded by NIH
ACD Working Group
bull ACDndash Russ Altman (Chair)ndash Mary Sue Colemanndash Lisa Cooperndash Jose Florezndash Linda Griffithndash Peter MacLeish
bull NIHndash Michael Lauerndash Pritty Joshindash Jennifer Plank-Bazinetndash Patricia Valdez
3
4
Pilots
Few Years Ago
5
Pilots
New Biosketch
Notices
More Notices
More Notices
Updated application amp RPPR instructions
Updated review language
(See handout for links to notices)
Moving to Nowhellip
Multi-Stakeholder Approach
6
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
ACD Working Group
bull ACDndash Russ Altman (Chair)ndash Mary Sue Colemanndash Lisa Cooperndash Jose Florezndash Linda Griffithndash Peter MacLeish
bull NIHndash Michael Lauerndash Pritty Joshindash Jennifer Plank-Bazinetndash Patricia Valdez
3
4
Pilots
Few Years Ago
5
Pilots
New Biosketch
Notices
More Notices
More Notices
Updated application amp RPPR instructions
Updated review language
(See handout for links to notices)
Moving to Nowhellip
Multi-Stakeholder Approach
6
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
4
Pilots
Few Years Ago
5
Pilots
New Biosketch
Notices
More Notices
More Notices
Updated application amp RPPR instructions
Updated review language
(See handout for links to notices)
Moving to Nowhellip
Multi-Stakeholder Approach
6
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
5
Pilots
New Biosketch
Notices
More Notices
More Notices
Updated application amp RPPR instructions
Updated review language
(See handout for links to notices)
Moving to Nowhellip
Multi-Stakeholder Approach
6
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
Multi-Stakeholder Approach
6
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
7
Co-Sponsored NIH Guidelines for
Preclinical ReportingAAAS
Signed on to NIH Guidelines for
Preclinical ReportingSfN
AACR
Webpages for RampR Resources
SfNAPS
Published Reports with Recs for Enhancing
RigorFASEBASM
ASCB
Hosted SymposiaSessions on
RampRFASEB
APSAAAS
Responded to NIH RFI Inviting Comment on
Reagent-Related Barriers
AAIThe Endocrine Society
Conducted a Member Survey on
ReproducibilityASCB
Multi-Stakeholder Approach
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
8
RPG Application and Review
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
Resources
9
httpsgrantsnihgovreproducibilityindexhtmhttpswwwnigmsnihgovtrainingpagesclearinghouse-for-training-modules-to-enhance-data-reproducibilityaspx
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
10
21st
Century Cures Act
First meeting of the ACD WG
May 25 2017 June 8-9
2017
Prelim report to full ACD
Second meeting of the ACD WG
TBD
Final Report from the ACD WG (TBD)
NIH report to Congress
NIH action on ACD WG recs
TBD(before June 2018)
TBD(before Dec 2018)
Timeline for ACD WG
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
Interim Recommendations
bull Applicationndash Highlight whatrsquos importantndash Section(s) for rigorndash Not just authenticationndash ldquoCONSORT-likerdquo checklistndash Clarifies review priorities
bull Resourcesndash Validated vetted materials
11httpwwwconsort-statementorg
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research
Interim Recommendations
bull Trainingndash Ongoing funded projects (PA-16-060)ndash Incorporate into spectrum of ethics trainingndash NAS ldquodetrimental research practicesrdquo
12
httpswwwnapeducatalog21896fostering-integrity-in-research