Aim

Determining the structure of the research design.

Description

Within the VU University Medical Center each scientific study involving humans needs to undergo an assessment. The assessment of a planned study is undertaken by the Medical Ethics Committee (METc) using a research protocol (see guideline 1.1A-01: Ready to go). A study should contain research questions that have not yet been answered or not answered sufficiently, and which will be addressed by the methodology described in the research protocol. A summary of prescribed rules and guidelines may also constitute a research protocol. Therefore, a research protocol is an ordered description of a scientific study.

Researchers undertaking studies within one of the longitudinal studies (AGGO, LASA, HOORN study) do not have to submit a research protocol to the METc for approval, as in these instances all the data have already been collected and work is only being carried out on (blinded) data. Within longitudinal studies an analysis plan may be viewed as the research protocol.

The following items should be found in the research protocol:

• The names and qualifications of the researcher(s).
• The scientific grounds for the research (support);
• Which questions need to be answered (research questions);
• Which participants may or may not participate in the study (selection criteria);
• How the study will be implemented (procedure, methodology);
• To what extent this differs from standard treatment;
• What the participants will be asked to do (burden);
• What safeguards are going to be in place;
• How the participants will be approached to participate (recruitment and informed consent);
• The medical ethics justification.

The collection of guidelines regarding the writing of research protocols is described in the booklet ‘Moresprudentie, het toetsen van protocollen’ (Moral ethics: testing protocols), which is available on request from the METc. You should also incorporate into the research protocol any advice provided by the Scientific Committee regarding improvements of the research proposal.

The study may start once approval has been obtained from the METc.

The researcher should not deviate from the research protocol approved by the METc. Any changes to a protocol approved by the METc should be re-submitted to the METc for approval.

• Moresprudentie, het toetsen van protocollen’ (Moral ethics: testing protocols)
• METc: Medical Ethics Committee.

METc: Medical Ethics Committee.

V1.1: 1 Jan 2010: Translation into English.
V1.0: 11 Aug 2005: Research covenant removed form text. Addition of corrections from Scientific Committee.