Information on Bioethics

>>>Information on Bioethics
Information on Bioethics 2019-06-20T17:41:59+00:00

Institutional Ethics Committee of the Institut Pasteur of Montevideo

Guide for the presentation of projects to the CEI

1- Documents to submit:

  1. a) Letter from the Service Director endorsing the study.
  2. b) The project to be presented at the CEI should include:
  • Introduction.
  • Hypothesis.
  • Overall objective.
  • Specific objectives.
  • Methodology: should include selection of the population to be studied with calculation of n, inclusion and exclusion criteria, place and method of selection: detailed description of the intervention to be performed specifying types of analysis or studies or administration of treatments: in obtaining biological samples must specify the procedure for obtaining samples, conditions of transport and storage of samples, you must specify all studies or analyzes to be performed on the samples, the approximate storage time specifying whether they will be included in a biobank or in otherwise, the method of destroying them. Biosecurity measures with which the biological material will be handled.
  • Algorithm or chronogram of project phases.
  • Expected results.
  • Communication of the results to the participant.
  • Ethical aspects.

Annexes:

  • All questionnaire, score or test that is done to patients must be attached.
  • Participant insurance
  • MSP registration of the medicine to be evaluated.
  • Informed Consent Form. It must include clear information about the objective of the project and all the interventions involved in participating in the project, in other words, so that the person can decide to participate or not in an autonomous way. It must also include 3 essential items:
  1. Participation in the present study is voluntary and your decision to participate was made freely after having been informed of the objectives and the requirements you must perform for it. You can withdraw from the study at any time until the publication of the results, without having to give any explanation and without this determining any change in the medical assistance you receive.
  2. Participation in this study will not represent any economic cost, as well as no economic benefit of any kind for participating.

iii. The data obtained will be treated confidentially and at all times the anonymity of the participant will be preserved, as stipulated in the LAW OF HABEAS DATA n° 18.331 and the LAW of the CODE OF ETHICAL MEDICINE n°19.286.

2- Deadlines.

The CEI should be informed if there are deadlines for the evaluation, such as deadlines for funding agencies, etc. in order to organize the work.

3-Response to information requests from the CEI.

Bear in mind that the response time of the researchers to requests for complementary information or modifications required by the CEI, will be directly reflected in the total project evaluation time.