Local Ethics Committee Institute for Frontier Areas of Psychology and Mental Health e.V.

 

Rules of procedure

(Version 3 from 02.02.2022)

§1 TasksThe Local Ethics Committee (LEK) of the Institute for Frontier Areas of Psychology and mental health e.V. (IGPP) Freiburg is an independent body that examines and assesses the ethical and legal admissibility of psychological research projects or research projects on humans that are to be carried out at IGPP before they are carried out. The procedure of the LEK-IGPP is based on the model rules of procedure provided by the DGPs.

The LEK-IGPP and its members are independent in the performance of their duties and are not bound by instructions. They are only responsible to their conscience.

The opinion of the LEK does not release the person responsible for the assessed project from the responsibility for carrying out the investigations and complying with ethical guidelines.

§2 Conditions for a statement by the CommissionThe assessment of a research project is carried out at the request of the person responsible for the research project.

 

1. the LEK-IGPP examines in particular whether all precautions have been taken to minimize the risk to the test subjects, whether there is an appropriate balance between the benefits and risks of the project, whether the consent of the test subjects or their legal representatives has been sufficiently documented, and whether the implementation of the project takes into account the relevant legal provisions, in particular the data protection provisions of the GDPR.

2. applications to the LEK-IGPP should contain information about

The aim and plan of the project, the type and number of test subjects as well as criteria for their selection, all steps of the study procedure, burdens and risks for test subjects including possible secondary effects and precautions to avert negative effects. Regulations on informing subjects about the study procedure and on their consent to participate in the study Possibilities for subjects to refuse or withdraw from participation, in the case of subjects with limited decision-making capacity (e.g. children, legally incompetent persons): Regulation of consent to study participation by legal guardians, insurance cover provided if necessary, data storage under the aspect of data anonymization.

§3 The review procedure(1) The documents relevant to the ethics opinion must be submitted by the applicant to the chairperson of the LEK-IGPP.

(2) An application is reviewed by at least 2 members of the LEK-IGPP. The reviewers are selected by the chairperson of the LEK-IGPP. Each reviewer passes his/her vote on to the chairperson of the commission. If the votes are not unanimous, at least 2 further opinions are obtained from members of the LEK-IGPP. If an ethics vote is requested for a research project (with a GDPR-compliant declaration of consent from participants) in which participation does not go beyond everyday experience and is not associated with any harm or adverse consequences for the participants, the Chair of the LEK-IGPP can issue a vote after examining the study documents without additional expert opinions from other LEK-IGPP members.

(3) In the case of several ethics opinions, the Chairperson shall summarize these votes and his/her own assessment for the Commission’s opinion in such a way that the authors of specific votes remain anonymous. If the votes are not compatible, the Chairperson shall submit a draft statement to the members of the Commission for discussion and clarification of the Commission’s opinion. If the votes are still irreconcilable, an oral hearing shall be scheduled if a member of the Commission so requests.

(4) The Chairperson may, after consultation within the Commission, ask one or more additional expert(s) for their vote. In this case, the experts consulted receive the entire application.

(5) As a rule, an application must be decided within one month.

(6) If there are significant objections to an application, the applicant may be required to submit a revised application.

(7) If an application is rejected on ethical grounds, the applicant may present counter-arguments and request a new opinion from the Commission.

(8) Decisions of the Ethics Committee require at least a simple majority of the experts.

(9) If an application is submitted by a member of the LEK-IGPP, this member and every other LEK-IGPP member involved in the research project must abstain from making a statement. In addition, any LEK-IGPP member may abstain from commenting if there is an employment relationship or other relationship of dependence with the applicant or a conflict of interest.

If an ethics application is submitted to the LEK-IGPP in which an applicant is a member of the institute’s management and this constellation would mean that neither the chairperson nor the deputy chairperson of the LEK-IGPP is available to carry out the review process for this ethics application, the review process will be handed over to a person from the LEK-IGPP who is not employed at IGPP and is therefore not dependent on the institute’s management.

§4 Confidentiality of the ethics reviewThe subject matter of the procedure and the opinions of the LEK-IGPP must be treated confidentially. The members of the commission are bound to secrecy.

The first version of the rules of procedure was issued on 25.11.2015 by the then Chairman of the Association and Institute Director of IGPP, Prof. Dr. Dieter Vaitl.

At meetings on April 15, 2021 and February 2, 2022, the LEK IGPP adopted amended rules of procedure in the second and third versions.

signed. PD Dr. Jürgen Kornmeier (Chairman of the LEK IGPP)