21st century cures act update: research rigor and ...prelim report to full acd second meeting of the...

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