NHLBI Guidelines for Consent Forms in Multicenter Clinical Studies

National Heart, Lung, and Blood Institute
National Institutes of Health

August, 2004

Background

In multicenter clinical studies, all clinical sites are required to follow the same study protocol. Therefore, certain basic features in each consent form should be identical, or nearly so. While recognizing the respective roles of the DHHS Office for Human Research Protections (OHRP) and the institutional Review Boards (IRBs), it is ultimately the responsibility of the NHLBI to ensure that a process is followed to assure that consent forms meet the expectations expressed above and described in more detail below. There may be many ways to accomplish the goals set out in the Consent Form Template and Content section of this document.

The following statements are an integral part of the guidelines:

  • The quality of the consent process and associated form(s) is the primary responsibility of the study investigators and their Institutional Review Boards (IRBs)
  • The NHLBI expects all clinical researchers to have received training in the ethical conduct of research
  • Clinical researchers understand both the ethical basis for consent and the proper procedures to use in informing prospective study participants about clinical studies, including the associated risks, and obtaining truly voluntary consent
  • Each IRB is appropriately constituted and conducts a careful and thorough review of all proposed consent processes and form(s)

Consent Form Template and Content

  • The study governance for each clinical study that includes more than one clinical site following the same protocol must develop a consent form template.
  • The template will constitute the basis for the development of each of the individual site consent forms. Sites are strongly encouraged to use the template unchanged.
  • Although sites are allowed to reword or add to the template, in line with local needs and IRB preferences, all key elements must be included. All changes must be clearly identified to aide those who review the forms.
  • The consent forms must include the general basic elements that must appear in all consent forms and any items, such as possible adverse events, that are specific to the intervention being tested or procedure being conducted.

Consent Form Review Process

  • NHLBI staff will monitor the development and review of consent form(s).
  • The following table outlines one process that could be used. Another approach to accomplishing the goals of steps 4, 5, and 7, for example, would have investigators indicate any changes as a result of the IRB review.

Step

Action

1

 Study group investigators develop a consent form template

2

 The template is reviewed and approved by the DSMB, OSMB, or if neither exists, an expert or group (e.g., the data coordinating center IRB) appointed by the NHLBI or the investigator).

3

 Each site prepares a template-based consent form(s) for submission to its IRB

4

 A subcommittee of the investigator group or appropriate data coordinating center staff develops a checklist, used to review each site's consent form(s) to assure that the forms meet the criteria described in the Consent Form Template and Content section of this document.

5

Using the checklist, the group that developed it reviews the consent forms:

  • Forms will be returned to the investigator for revision if:
    • they do not satisfy the requirements on the checklist
    • they misstate a point (e.g., underplay a potential adverse event)
  • After forms are revised, they are re-reviewed before proceeding to step 6

6

 Each site submits consent forms to its IRB

7

IRB-approved consent forms are reviewed as in Step 5, to assure that none of the key elements have been removed by the IRB review process:

  • Forms will be returned to the investigator for revision for the same reasons listed in Step 5
  • When forms are resubmitted to the IRB, changes must be discussed with the IRB
  • If forms are acceptable, go to Step 8

8

 Notification that the consent forms contain the necessary elements that were in the template and that a site has obtained IRB approval of acceptable forms is sent to the NHLBI