Scientific Record Keeping Alan L. Goldin, M.D./Ph.D.

Laboratory Notebooks Bound, serially numbered pages All entries should be dated Permanent ink Table of contents Include the actual data, such as photographs, negatives, autoradiograms and printouts

Data in Laboratory Notebooks Original data should be included Photographs, negatives and similar can be glued or taped Other materials can be inserted in plastic sleeves (including CD or DVD) Oversize material and magnetic media should be stored, with the location and coding scheme included in the lab book

Laboratory Notebook Requirements Can be More Detailed Data book paper should be acid-free Bindings should be sewn or glued  Plastic comb, wire spiral, or ring binders are considered unacceptable Data books may be inventoried  Master data book log  This policy applies in industry

Policies in Industry Only bound laboratory notebooks are acceptable Entries must be countersigned weekly or more often The rules are stricter because the notebooks may be used as evidence to gain patent protection

Electronic Record Keeping ELN – Electronic Laboratory Notebook  Database software  Generic electronic notebooks  Scientific electronic notebooks CENSA – Collaborative Electronic Notebook Systems Association

How long to keep notebooks? NIH policy mandates 3 years after the end of the project (grant funding period) FDA policy mandates 10 years after use Patent policy mandates 23 years after issue of the patent

How long to keep notebooks? The organization with the longest policy has priority State law usually overrides federal laws  Virginia mandates that data by state agencies must be retained for 5 years  Investigators in Virginia at state-supported universities must follow that policy

Who owns the notebooks & data? When NIH awards a research grant to a university, any and all data collected as part of that funded project are owned by the grantee institution Data books of all investigators (PI, postdocs, grad students, technicians) are the property of the institution

Who owns the notebooks and data? The principal investigator is the steward If the PI resigns or moves to another institution:  Equipment and all data belong to the initial institution  Permission can be obtained to transfer the award, equipment and data

Public Access to Data The Office of Management and Budget (OMB) revised the regulations regarding public access to experimental data in 1999  Circular A-110 included the revisions  The public can obtain access to experimental data through the Freedom of Information Act (FOIA)

Applicability Data produced with Federal support that are cited publicly and officially Data collected by institutions of higher education, hospitals, and non-profit institutions  Does not apply to commercial organizations  Does not apply to state and local governments Applies to new and competing awards made after the effective date of the amendment (11/8/1999)

Research Data Recorded, factual material commonly accepted in the scientific community as necessary to validate research findings Published  Peer-reviewed scientific or technical journal  Cited by a Federal agency publicly and officially

Research Data Do Not Include: Preliminary analyses Drafts of papers Plans for future research Peer reviews Physical objects (samples, tapes) Trade secrets or commercial information

FOIA Request Must Include: Specific regulation or order citing the data Publication cited Grant number Description of the data being sought A statement that the data are being requested under the amendment to Circular A-110

What happens if the PI has moved? Research grants are award to institutions, not individuals The FOIA office will send the request to the institution Both the FOIA office and the institution will try to locate the PI and fulfill the request for data

What happens if the PI refuses to comply with the request? This would be viewed as a material failure to comply with the terms and conditions of the award NIH would initiate appropriate enforcement action  This could include withholding future support to the institution

What if the data are in an abstract cited in a Federal regulation? If the abstract is based on preliminary analyses, then the data would be excluded If the abstract is not based on preliminary analyses and is cited by a Federal agency in a regulation, then the data may be accessible

Additional Sources of Information Responsible Conduct of Research Education Consortium (RCREC) Web Site Responsible Conduct of Research Education Consortium (RCREC) Web Site Office of Management & Budget Circular A-100 (section 36) Office of Management & Budget Circular A-100 NIH Working Group Report on Research Tools NIH Working Group Report on Research Tools