Records Management Program

Informed Consent Retention

While the standard practice is clearly to keep original informed consent documents, here is what is said in our policy plus the FDA and DHHS policies and regulations. The period of record retention is dictated by either sponsor regulations or the FDA as appropriate. Federal grant regulations require retention for generally 3 years after a study is completed. In privately funded studies, it is contract dependent. In cases of FDA clinical trials, records must be kept for 2 years after a marketing application is approved or 2 years after the suspension of the trial (where no application will be submitted).

UI IRB Investigators Manual

F. Record keeping

Every principal investigator is required by University and federal regulations to maintain records of all correspondence relating to the use of human subjects in research. Copies of the application for approval, notice of final approval and notice of continuing review must be maintained in the investigator's records. All records of human subject research are subject to inspection by federal authorities. Copies of all research records must be kept for three years after the close of the study. Studies that involve drugs or devices seeking FDA approval must be kept for three years after the FDA has taken final action on the marketing application.

The Human Subjects Office maintains records of all protocols. These records include copies of the ongoing research, minutes, voting records and correspondence regarding every study that has been submitted for review.

From the FDA "IRB Operations and Clinical Investigation Requirements"

An investigator may retain records either in their original form or by means of microfilm, microfiche, photocopies, or other accurate reproductions of the original records. If copies are used, however, they must be legible and the investigator is required to assure that such reproductions are true and accurate copies of the original. When reproduction techniques (e.g., microfilming) are used, a reader and photocopying equipment should be readily available. If written notes, erasure marks, or other changes are not apparent on the reproduction, a notation of this fact should be clear on the reproduction of the record, and the original record should be retained for the time required.

DHHS IRB Regulations 45 CFR § 46.117 Documentation of informed consent

  1. Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the IRB, and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.

  2. Except as provided in paragraph (c) of this section, the consent form may be either of the following:

    1. A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator should give either the subject or the representative adequate opportunity to read it before it is signed.

    2. A short form written consent document, stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form itself is to be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person actually obtaining consent shall sign a copy of the summary. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

  3. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either:

    1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or

    2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context.

In cases, in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Note the FDA 21 CFR Part 50 says essentially the same thing as 45 CFR Part 46 cited above.

Source: Email from David Wynes to Andrew Ives on 17 July 1998

 

 

Records Management is a part of Financial Managment and Budget within the Finance and Operations organization