Research protocols

Aim

To write a clear research protocol and submit it to the METc for ethical approval.

 

Requirements

  • Submission of the research protocol to the METc, when the study involves humans;
  • Any changes to the approved protocol should be re-submitted to the METc using an amendment, for approval.

 

Documentation

A clear research protocol containing:
  • 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.

 

Responsibilities

Executing researcher:
  • To write the research proposal which includes all statements described under Documentation;
  • To write down any changes to the protocol in an amendment and to submit these to the METc.
Project leaders:
  • To review the research protocol written by the executing researcher and discuss these points with him/her;
  • To ensure the project is registered at the CBP;
  • To ensure that the research proposal is submitted to the METc;
  • To ensure that the study does not start before consent was given by the METc;
  • To ensure that any changes to the protocol are sent to the METc using an amendment.
Research assistant: N.a.

 

How To

Within the VU University Medical Center each scientific study involving humans needs to undergo an ethical assessment. The Medical Ethics Committee (METc) considers the research protocol of the planned study. If research does not include the Medical Research Involving Human Subjects Act (WMO), the Committee can be asked for a declaration of non-WMO. Since November 2014, researchers are required to register their project to the Dutch data protection authority (College Bescherming Persoonsgegevens; CBP) before they are able to submit their research protocol to the METc. Here all the information how to apply for medical ethical approval can be found. This intranet page provides additional information and leads to the CBP. More information can be found in the guideline CBP registration.
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. 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 items that should be found in the research protocol can be found under Documentation.
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 should be re-submitted to the METc using an amendment for approval. In case of research not under the remit of the WMO (niet-WMO plichtig onderzoek), the METc still strongly advises to inform them about any changes in data collection, informed consent procedure, burden to participants and/or design of the study.

 

Audit questions

  1. Was this study registered to the CBP?
    1. If not, why not?
  2. Did the METc approve the research protocol prior to data collection?
  3. Are there any amendments in the research protocol which were approved by the METc?
  4. Did all participants sign an informed consent?

 

V3.0: 16 Dec 2016: Revision guideline
V2.0: 12 May 2015: Revision format
V1.1: 1 Jan 2010: Translation into English
V1.0: 11 Aug 2005: Research covenant removed form text. Addition of corrections from Scientific Committee