Scientific Record Keeping

I. Reasons for data collection and proper record keeping:

II. Keeping useful scientific recrods

Useful databooks explain:

Good databooks:

III. What do scientists recognize as data?

A. Quantitative data: graphs, recorded numbers, instrument output of any type, including photographic materials from which measurements can be made

B. Qualitative data: notes of any type (in any form), some types of instrument output, including photographic media

C. Original samples in unanalyzed form; e.g., biological specimens

D. Research tools: protocols in any form; computer software

IV. Ownership of data: NIH grant-sponsored research

A. Ownership of data can be realistically viewed in terms of who will exert control over the use of data and under what conditions.

B. Useful terms:

C. The U. S. Public Health Service provides guidance. Thus, we operate as though the grantee institution owns the data generated by individual scientists. However, explicit regulations do not exist, a legal foundation for this policy is unclear, and the legal implications for such a policy are in current debate.

D. Retention of records by the grantee institution:

1) three years from date of submission of final expenditure report

2) if the grant is involved in any type of litigation or audit procedure then all data and records must be retained until such process is completed

E. Granting agency may access any records pertinent to any grant; this can be done as long as the records of the grant are retained -- i.e., this right is not limited to the required 3 year period for maintaining records.

F. Individual responsibilities regarding data retention and management

1) if the need arises, the university will contact the principal investigator of a grant to obtain requested data or records

2) record keeping, record maintenance, and record retention are the prime responsibilities of the principal investigator: this responsibility is over co-investigators, trainees, technicians, and any other individuals involved with the conduct of the research

3) faculty who leave the university: at present, most universities treat the situation as though the data belong to the investigators and that these investigators may take their data with them when they leave the university.

 

G. Universities need to develop policies that

V. Record keeping

A. Most granting agencies impose few or no regulations regarding laboratory recordkeeping.

B. Principal investigator responsible for validity and quality of all data, including the orientation of staff and trainees working on the project, setting and enforcing of policies for recording data, record keeping and maintenance, and record retention.

1) data collected and recorded in experimental notebooks according to methods prescribed by the principal investigator

2) all data records are stored in a manner that provides comprehensible access to other investigators.

3) the principal investigator should meet regularly with lab personnel to review experimental data, research notebooks, and related records. Weekly meetings on a one-to-one basis are desirable. An indication of the PI's review of the most recent data is also desirable; e.g., initial and date the most recent page of the experimental notebook.

C. Data notebooks

1) Bound notebooks with consecutively numbered pages vs. looseleaf binders

2) Organizational aspects

-table of contents (in bound notebooks, reserve the first several pages for the table of contents)

-write in permanent ink

-making copies of all data is recommended; store separately

-use an experiment-identification number scheme; this facilitates cross- indexing

-use plastic sleeves for organizing data output like photographs, autoradiograms (do not use plastic sleeves for photocopies or laser printed material - over time image will transfer to plastic)

-where possible, attach data output in a permanent fashion

-some kinds of data must be stored separately; set up appropriate storage scheme but keep records of such storage organization in your data notebook (e.g., oversize photographic or autoradiographic materials, negatives, computer disks, microscope slides, etc.)

3) Witnessing of data by a knowledgeable colleague

4) The master laboratory log.

5) Methodology notebooks.

D. Format of recording experiments and experimental results

1) Purpose: begin each experiment with a brief but instructive statement of the purpose of the experiment no matter how routine you think it is

2) Materials and methods: include any deviations from procedures of lab manual. If a new method (e.g., from a research paper) detail each step in your lab manual; you can refer to this experiment as a reference for this procedure until such time that the method appears in the lab methodology manual (cite primary reference and or other published lab manuals as appropriate). Carefully document materials being used; lot numbers, specific activities, manufacturer's specifications, information on cell lines, animals, etc. Equipment calibration and standardization should be part of you record keeping.

3) Observations and results: record all data as soon as it becomes available, during the experiment. ALWAYS record your results directly into your notebook. Don't rely on memory or loose sheets of paper to capture data. Include and explain all calculations. Use tables and graphs; label extensively indicating what the results represent. Be concise and honest. All raw data should be part of the experimental results section where possible.

4) Discussion. Include your impressions, interpretations and conclusions. Describe plans for future experiments, need to duplicate results, and any other related issues. Remember, your data book should include all of your mental as well as physical activities related to your research. Be sure to include any references that were used in the design and/or execution of the experiment.

5) Other considerations:

---identify mistakes and errors and explain them: Mistakes made in the laboratory notebook should be crossed out with a single line and a full explanation of the error provided. Striking out of material in the laboratory notebook should be done in a way that does not obscure the original data entry.

---use standard terms rather than abbreviations and write legibly

---organization should be such that someone not familiar with the specific experiment can retrieve all the pertinent details, including the hypothesis being tested, materials and methods used, the complete collection of the primary data, its statistical analysis and its organization into the data sets that appeared in the publication reporting the work

---log experiments and all other activities chronologically

---special attention should be taken in writing about the interpretation of experiments. More often than not, this language can be very important in the preparation of manuscripts for publication.

---avoid statements that may be misinterpreted at a later time; e.g., "the experiment was unsuccessful". A failed experiment may provide evidence of diligence or of a correct conception.

---mark through or cross out any unused pages or portions of pages; use wide margins to discourage making notes after the fact; if you are making notes or further commenting on your data do so chronologically in your notebook, referring back to the appropriate data by page and experiment number

---important correspondence from colleagues or collaborators should be included in your data book

---keep record books and all data secure and safe; duplicate records should not be stored together

Sample databook pages

VI. Sharing data :   check out the NIH Draft Statement on Sharing Research Data at:

                  http://grants.nih.gov/grants/policy/data_sharing/index.htm

Federal Freedom of Information Act (FOIA):  

The federal FOIA applies to documents held by agencies in the executive branch of the federal government. Citizens can request that such documents be made available to them (or have them published, so they are in the public domain). Your request must describe the records being sought (or your request may be rejected). Your letter must say that you are making a request under the FOIA, it must request the records or documents you are seeking, and you must provide your name and address. There may be fees associated with your request. Reasons for denying access for an federal FOIA request: classified material, internal personnel rules and practices, exempt info under other laws, confidential business info, internal government communications, personal privacy, law enforcement, financial institutions, geological information. Most states have their own FOI Laws.

Grant records in possession of the grantee are not subject to FOIA requests; however, records which are in possession of or under the control of the granting agency are subject to the FOIA although exemptions that deny or limit public access can be applied

Common exemptions to mandatory disclosure under the FOIA include: 1) data which are deemed intrinsically valuable; 2) data used to support a patent application or to seek FDA approval; 3)data which if released before publication would be likely to harm the competitive position of the scientist who has conducted the research

 

Check out the following site for scientific record keeping guidelines:

NIH Grants Policy Statement
http://grants.nih.gov/grants/policy/nihgps_2001/nihgps_2001.pdf

National Science Foundation General Grant Conditions
http://www.nsf.gov/home/grants/gc102.pdf

University of Florida
http://rgp.ufl.edu/otl/goodrecords.html

Fox Chase Cancer Center
http://www.fccc.edu/ethics/RecordKeeping.html

The NIH Freedom of Information Office
http://www.nih.gov/icd/od/foia/

An informative WEB site on Freedom of Information may be found at:
http://www.missouri.edu/~foiwww

OMB Circular A-100  Uniform Administrative Requirements for Grants and Agreements With Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations
http://www.whitehouse.gov/omb/circulars/a110/a110.html

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Last modified: 09/10/02