Ethics Procedure
3.1. Meetings of the Evaluation and Monitoring Committees
The committees meet at least once a month, except for the month of August, or when so required due to circumstances, to be communicated in advance to all the members of the committee. To have a valid quorum, the meetings must be attended by the Chair and the Technical Secretary of the committee in question, or by members standing in for the Chair and the Technical Secretary, and half of the members of the committee, plus one.
- Ordinary meetings are those scheduled in the work calendar and are convened, through an online app, with at least seven working days' notice, providing specific details on the date, time and place of the meeting. The call to such meetings shall include the agenda, the minutes of the previous meeting, the attached documentation and a list of the RDI activities to evaluate.
- Extraordinary meetings may also be convened, when so required. In such meetings, the agenda only needs to focus on the urgent matter requiring the meeting.
- Meetings have to be held in person. Exceptionally, and at the request of any member(s) of the committee, members can attend remotely through any online platform that allows for their identification.
In any case, the members of the committee can delegate their participation to others or be provisionally replaced (except for the Chair and the Technical Secretary) in order for the minutes to be taken.
The meetings may also be attended by specialist guests and the research staff subject to evaluation, who can be present as consultants. Members with a conflict of interests must abstain from participating in the evaluation at the meeting in question.
The person acting as the committee's technical secretary establishes the committee's work calendar each academic year, which must be approved before the end of the previous academic year and published on the committee's website.
3.2. Evaluation of the Project
Once they have submitted the ethics self-assessment form through the committee's website, the researcher receives information specifying the date of the committee meeting to assess their activity. The committee will decide and issue its findings within three months of the date on which the documentation is submitted.
1. Initially, two members of the committee in question assess the RDI activity, while keeping their identity confidential. Subsequently, the remaining members of the committee complete the review initiated by the two assessing members.
2. The person acting as the technical secretary of the committee is responsible for appointing the members who evaluate the submission and, subsequently, providing the remaining members with all the documentation.
3. The assessment made by the evaluators is presented at the committee meeting called to decide on the matter. If there is no consensus, a vote takes place, which is decided by simple majority. In case of a tie, the vote of the Chair prevails. If necessary, committee members may consult an expert in RDI matters.
4. Within a maximum period of eight days following the committee meeting, the person acting as the technical secretary prepares a report and sends it to all committee members through an online app. This report must be reviewed and ratified within 72 hours of receipt.
5. Once the committee has debated and decided on the ethical questions around the RDI activity, it issues one of the following reports to the requesting investigator:
- Favourable report
- Unresolved report with minor amendments
- Unresolved report with necessary adjustments
- Unfavourable report
6. The committee's report is enclosed with the corresponding minutes of the evaluation meeting, and the person acting as technical secretary sends it to the requesting investigator through the committee's website within ten days.
7. The RDI activity subject to evaluation by the corresponding committee cannot begin until the committee has issued a favourable report.
8. The investigator responsible for the RDI activity subject to evaluation has the right to present a report and to be heard by the committee. In this case, a meeting is scheduled through the person acting as technical secretary, who must include this hearing in the agenda.
3.3. Ethics Checks During the Course of the RDI Activity
All committees have the obligation to ensure adequate monitoring of the RDI activity under way following the issuance of the favourable report. There are two mandatory ethics checks:
- Half-way through the project
- At the end of the project
Research staff have to sign a document undertaking to submit their RDI activity to the pertinent committee whenever there is a significant change to the same compared to the initial favourable report. This statement of compliance is included in the ethics self-assessment form.
Likewise, investigators have the option of making a voluntary oral presentation about their RDI activity in front of a monitoring working group (members of the committees). Alternatively, they may send a report on the activities in question to the committee's technical secretary. The monitoring working group shall meet at least twice a year to hear any investigators who wish to describe the evolution of their work. If the investigator highlights any significant changes in the activity or difficulties encountered, the committee, duly informed, shall consider the relevance of the same and act accordingly.
Upon completing the RDI activity, the investigators have to submit a final report to the technical secretary that describes all of the research activity undertaken. This report shall include a summary of their work and of any publications pertaining to the same.
