Articles on Law, Science, and Engineering

Scientific Misconduct: Part 3 - Standards for Scientific Record Keeping (cont'd)

The Hearsay Rule

The use of records in court is governed by the hearsay rule. As with other rules of evidence, the objective of the hearsay rule is to assure that the best possible evidence is presented to a jury. Subject to several exceptions, the hearsay rule prevents one person from testifying about the truth of what another person said. Usually, witnesses can testify only as to what they heard, not whether what they heard is true. For example, a laboratory technician could testify that she heard Dr. Smith say, "I am writing this data in my notebook." The jury would be told that they could accept this as evidence of what Dr. Smith said, but not as evidence that Dr. Smith actually wrote the data in the notebook. On the other hand, if Dr. Smith spontaneously exclaims, "This data just does not fit, I am going to throw it out", an exception to the hearsay rule might apply if the judge believes the statement was made spontaneously and, if true, would be against Dr. Smith's interests. Then, the jury would be told that they could accept the technician's testimony, not only as evidence of what Dr. Smith said, but also as evidence that Dr. Smith actually discarded data.

The hearsay rule assures that witnesses and authors of documents can be cross-examined to determine their truthfulness. If a statement made out of court is accepted as evidence, the person making that statement can be questioned (cross-examined) about the truthfulness of the statement. Thus, evidentiary rules require that the person who actually made the statement be brought into the courtroom, placed under oath, and asked to repeat the statement.

Without an exception to the hearsay rule, laboratory notebooks and other written records could be used as evidence only if everyone who made an entry was available for cross examination. Even if the persons making the records were available, they would have to be prepared to testify as to which entries they made, why they made them, and what information they based these entries upon. Putting aside the practical problems in finding persons who might have left a laboratory years before, it would be unreasonable to expect anyone to remember the specific circumstances of notebook entries made years in the past. Because of these difficulties, there is another exception to the hearsay rule called the "business records exception". This exception allows documents that meet certain standards admitted into evidence without requiring that the persons who actually made the entries be available for cross-examination.

To qualify for the business records exception, a record must meet four basic tests: 1) it must be made in the regular course of business; 2) the entries in the record must be made by a person with personal knowledge of the act, event, or condition that is being recorded; 3) the record must be made at or near the time that the recorded act, event, or condition occurred, or reasonably soon thereafter; and 4) the records must be kept in a consistent manner, according to a set procedure.

The usual practice of the research profession for keeping laboratory notebooks conforms with these criteria for the business records exception to the hearsay rule. If a scientist fails to keep a notebook in the usual manner required by his or her profession, one possible legal consequence of such improper record-keeping is that the researcher breached of the usual standard of care in practicing the profession (i.e., malpractice).

Entry in the Regular Course of Business

The first requirement is that the entry be made in the regular course of business. For laboratory workers, the regular course of business includes all work associated with their research and other laboratory activities. The laboratory record will be admissible to prove the truth of these activities. Entries in the laboratory record that do not deal with research or laboratory activities will not be considered to have been made in the regular course of business. These could include personal comments about other researchers, or about political aspects of laboratory activities.

Entry by One with First-Hand Knowledge

The second requirement is that the entry be made by someone who has personal knowledge of the event being recorded, or that the information be transmitted directly to the person making the entry from someone who has personal knowledge. While this legal rule allows notes to be dictated to a secretary for transcription into the record, the usual practice is for the researcher who is conducting the experiment to enter the record himself.

Contemporaneous Entry

The third requirement is that the entry be made at or near the time of the event described. While the legal rule permits some delay in entry, it is standard practice for the researcher who is conducting the experiment to enter the record immediately.

This requirement is frequently ignored in practice. We expect the courts will deal with breaches strictly, using legal torts such as malpractice or fraud, or both. Entries cannot be backdated. Progress notes and other daily memorandum must be made on the day to which they pertain.

Consistent Method of Entry

The fourth requirement is that there be a standard procedure for making the entry. While there is considerable flexibility in the professional standard for research as to what procedures may be used in making laboratory notebook entries, the standard practice is clearly that the researcher enter the record according to some consistent method. The basis for both the legal and professional requirements that entries be recorded in a consistent manner in the ordinary course of professional activities contemporaneously by the individual with first-hand knowledge is to ensure the accuracy of the records. It is assumed that an enterprise has an incentive to maintain accurate records of its routine activities. However, once the business' activities are under question, it is assumed that there is some incentive to slant the entries. If it is found that records have been altered, perhaps after a question has arisen about their content, this alteration undermines the credibility of the record itself.

The use of interim notes is a dangerous practice, both professionally and legally. Poor organization, combined with illegible handwriting, leads some researchers to use temporary notes to record data so it can be "properly" entered into the lab book when the researcher is not pressed with the details of his or her experiment. Given the added dimension of hindsight, it is impossible to avoid bias, unconscious or otherwise, that slants entries to reflect what should have happened, as opposed to what did happen. This is as dangerous legally as it is professionally because it is difficult to maintain consistency in entries that are biased by hindsight. In complex experiments, it is impossible. If interim notes are made, they should be glued into the notebook with a brief explanation written in ink in the permanent pages of the notebook. They should never be copied and then discarded.

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