When does an ERC need to assess the methodology proposed in the research plan? Video presentation: Ethical Research

Assessment is required for all theses with a research phase including:

1. the participation of human beings;
2. the use of biological or biographical material from human beings (such as collecting data from a register, or conducting surveys);
3. the use of animals (animal testing);
4. the use of biological agents or genetically modified organisms.

If in doubt over the need for assessment, please consult the website of the University of Alcalá’s Research Ethics Committee (UAH-REC) (https://www.uah.es/es/investigacion/servicios-para-el-investigador/comite-de-etica-de-investigacion-y-experimentacion-animal/), which includes an FAQs section. As a last resort, please send your query by email to the REC secretariat (comite.etica@uah.es). The REC secretariat will decide whether the project requires assessment. Application forms and other information of interest regarding the UAH-REC may be consulted on the same site.

Who performs the assessment?

The University of Alcalá's Research and Animal Experimentation Ethics Committee (UAH-REC) or some other accredited committee may be asked to evaluate the research project (although in the latter case it will probably be required to go through the UAH-REC, which will most likely uphold the decision made without carrying out a new evaluation, although this will be studied on a case-by-case basis). In research projects involving medicines or medical devices (e.g. clinical trials with medicines, or post-authorisation studies) the assessment has to be carried out by specially accredited RECs, known as RECms, which are usually based in hospitals (e.g. in any of the 4 hospitals associated with the UAH). Projects that are obliged to be presented before a RECm need not be submitted for evaluation to the UAH-REC.

How are the research plan approval and REC assessment coordinated?

It is important to bear in mind that the REC only evaluate project proposals, in no case studies that have been carried out or are in the process of being carried out. For this reason, if necessary, the evaluation should be requested from the Ethics Committee once the research plan has been drawn up and approved by the thesis supervisor(s) and before it is sent for approval to the Academic Committee for the corresponding programme. Once the evaluation has been requested from the Committee and before it has been decided, in order not to suffer undue delay doctoral students may/should present their Research Plan to the Academic Committee, attaching proof of the request.

However, even if the Academic Committee approves the Research Plan, doctoral students may not carry out the part of the research for which they require the approval of the Ethics Committee until they receive a favourable report from the Committee. Once doctoral students have received a favourable report, they will send it to the Academic Committee for it to be recorded and included in their files and sent to the Doctoral School. If the Ethics Committee's report is negative, doctoral students must present a new Research Plan proposal to the Academic Committee with the changes that this would entail with respect to their initial proposal.

Inclusion of ERC report when requesting permission to defend the doctoral thesis

Compliance with the requirement of obtaining a favourable report from the REC where necessary will be checked by the Academic Committee when applying to defend the thesis. This must be reflected in the report that the Academic Committee draws up when authorising the defence.

This requirement will be compulsory for students admitted into doctoral studies from academic year 2020-2021 (inclusive) onwards.

Within six months from the date of enrolment, both full-time and part-time PhD students must submit their Research Plan and Personal Training Plan (hereinafter PIyPFP) on the DATRES platform in the format that can be downloaded from the same application. The PIyPFP must have been previously agreed with the tutor and director, in which case it will be endorsed by them after its submission in DATRES. Once endorsed by the director and tutor, and only then, it will be evaluated by the Academic Committee. The fact of submitting the PIyPFP in the aforementioned platform without the endorsements of the director and tutor does not imply the interruption of the established deadlines, which appear in this section.

If IRB approval is required, the application to the IRB  will have been made before sending the Research Plan and Personal Training Plan to the academic committee of the doctoral programme, so that a copy of this application will be attached to the Research Plan and Personal Training Plan.

Subsequently, the academic committees will have a period of two months to issue the corresponding evaluation report. 

If the report is negative, the student may only resubmit another plan for assessment within a maximum period of one and a half months in order to make the improvements requested and submit them to the Commission for assessment.

If the evaluation of this second plan is negative, you will not be able to submit another one and you will be informed of the closure of your doctoral studies record, as well as the impossibility of applying again for admission to this doctoral programme again.

The Research Plan and Personal Training Plan can be improved and fleshed out throughout the student’s residence on the programme. When significant changes occur (affecting, for example, the title or subject matter), an updated version of the plan must be  submitted through the DATRES platform, always before the thesis is deposited.