Modifying an Approved Human Subjects Application

The process for modifying (or amending) an existing Human Subjects Application varies depending on the nature of the desired modification. Some modifications are routine, and can be reviewed and approved administratively. Others are substantive, and must be reviewed either by a subcommittee of the appropriate Human Subjects Review Committee, or by the full Committee.

In all cases, however, modifications must be reviewed and approved before they can be implemented.

An application may be modified with respect to one or more of the following:

• funding: a grant application can be added to one or more human subjects applications
• personnel: investigators, including principal investigator, may change, as may other authorized personnel, or such relevant information as an investigator's contact telephone number;
• population: the size of the study population may change, or a new population may be included;
• procedures: approach and recruitment, selection criteria, interventions, or other approved procedures, instruments or forms;
• purpose: involving, for example, changes in the time over which the study is conducted, or secondary uses made of study data.

A useful rule of thumb is that a change in any one of the above (and minor ancillary adjustments in the others) may be reviewed administratively; a change in any two may or may not require more than administrative review, and a change in three or more, or any change in substantive risk to subjects, will very likely require review by a full Committee, and perhaps even submission of a new application.

The reviewing Committee may, at its discretion, request a full new application whenever repeated modifications have made it hard for reviewers to discern the current activities and procedures involved in the study.

It is very helpful to use the Modification Form, since that form asks for all necessary information, thus eliminating time that might be spent getting that information before the modification can be reviewed. The form should be used as a cover sheet; a memorandum providing any necessary additional information should be attached to each of the three copies of the modification form. After July 1, 2001, no modification will be reviewed if it is not submitted on a current Modification Form.

Submitting a Modification

Procedure: Submit a modification form in triplicate (a signed original and two copies) and (if necessary) a memorandum (also in triplicate, collated with the modification form), collated with three (3) copies of all revised or additional materials - consent forms, instruments, advertisements, recruitment flyers, and so on. When adding a grant, contract, dissertation or other proposal, also submit one (1) copy of the complete funding proposal. The modification form should be signed by the principal investigator or someone authorized to sign for the principal investigator; any such authorization must be clearly documented in the file, or the modification proposal cannot be considered.

Explanation: The Human Subjects Division must keep two file copies of all material relevant to each Application (they are sent to the reviewers at the time of regular renewal review); the third copy is returned to the investigator for the investigator's records. Since the Human Subjects Division is asked to certify that what has been approved in a Human Subjects Application is what is being proposed in a grant, contract, dissertation or other proposal, it is necessary to be able to compare one with the other in order to be able to issue the certification.

The modification proposal must be signed by the principal investigator or other authorized person to document that it is in fact an authorized modification. Since the principal investigator is responsible for the activities of other investigators and staff, and for their compliance with relevant regulations, it is important that modifications to approved procedures be authorized by the PI.

Special Points

• Do not, unless, specifically asked to do so, submit a revised Human Subjects Application form as part of a modification. This may cause the modification to be treated as a new application, resulting in delays until the confusion thus created is fully resolved. If in doubt, call the Human Subjects Division and speak with the Coordinator of the Committee that reviewed the application you wish to modify.
• Check the relevant boxes, and answer any questions in the space provided. The questions on the form are there to elicit information necessary to understand whether the proposed modification may be approved. If questions are not answered, information necessary to understand the proposed modifications may not be provided, and the modification may not be approved.
• Consent form text should not be used in any form that has not been reviewed and approved. Consent forms should not be used with such ad hoc modifications as strike-outs, hand written additions, or other informal adjustments. If modifications have been reviewed and approved, the consent form should be re-typed to incorporate the modifications. If an alteration has not been reviewed and approved, it should not be used.
• Changes in investigators who will have direct contact with subjects should be reflected in a change in the investigators listed at the beginning of the consent form.
• Adding an investigator simply adds personnel; if the investigator will be doing something other than what is already approved in the application, this should be set out in the appropriate sections of the modification form. If the investigators will be conducting their own projects, the modification should state the human subjects application under which the projects have been reviewed and approved, or, if appropriate, add the project as a sub-study to the existing application. It is generally best to check with Committee staff to determine whether such a modification is appropriate before submitting it for review.
• The fact that someone is authorized by the principal investigator to sign and submit modifications does not authorize that person to sign and submit a Status Report. The Status Report is not a modification; it is an extension of the application itself. Just as the principal investigator must sign the application form as principal investigator, so also the principal investigator must sign the Status Report.
• The principal investigator on an application will not be changed without a signed letter from the current principal investigator assigning the application to a new principal investigator. In cases where a principal investigator has died, this letter of assignment may be signed by the chair of the department, or the dean of the school, and should include an explanation of the circumstances justifying the procedure. Changes of principal investigator should be submitted, like any other modification, in triplicate.
• Any significant change to the number of subjects from that originally approved should be submitted as a modification for approval.
• No procedures, instruments or forms are approved in general or at large: they are approved only in the context of a specific Human Subjects Application. Only materials that have actually (a) been submitted for review in connection with a specific application, (b) been reviewed in connection with that application and (c) approved in connection with that application, are actually approved for use in connection with the study covered by that application - and only in connection with that application. Materials that are not provided cannot be reviewed, and cannot be considered approved. Use of such unapproved materials can constitute a breach of the terms of approval of a Human Subjects Application.
• The Committees may approve the use of procedures, instruments or forms only in the context of a specific Human Subjects Application. Procedures or instruments are not given blanket approval, nor can approval of an instrument in the context of one application be extrapolated to assume that it must be approved in the context of any other application, proposed or approved.

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