ethics area

President
Gabriel Arrue (Professor of Philosophy)

Secretariat
Technical Support Staff
Daniela De Franco (Lawyer)

Coordinator
María Silvia Cortese (Social Worker)

Vocal
Bioq. Alicia Delgado Caffé (Biochemistry)
Dra. Florencia Iveli (Child and Adolescent Psychiatry Esp)
Bioq. Daniel Vogliolo (Biochemistry)
Sra. Elba Nievas (Community Representative)

Scientific Area

Dr. Juan C. Iannicelli
Dra. Alicia Rositto
Lic. María Apezteguia
Dr. Luis Guimarey
Dra. Silvia Gonzalez Ayala
Dr. Fernando Rentería
Dr. Pablo Castellani
Dra. María Angélica García

CONSULTANTS

Dra. María Rosa Agosti
Dr. Fernando Whichmann
Dra. Virginia D`alessandro
Dra. Analía Morin
Dr. Luis Gambarotta
Dra. Teresita Gonzalez
Lic. Isabel Bosco
Mgr. Silvina Sanchez
Dr. Ricardo Drut
Dr. Leonora Kozubsky

MISSION AND AIMS
REGULATIONS

The activities and functions of the Institutional Review Board for Research Protocolswill be ruled by provisions of Law 11.044, governing clinical research, regimentation and future modifications in the Province of Buenos Aires, and by legislation in force concerning the legal regimen of the public administration, with jurisdiction in the Province of Buenos Aires and field of application with respect to all research developed at the Children´s Hospital.
Third party services will be offered within the province of Buenos Aires due to the importance granted to regional participation by the provincial law.

MEMBERS

The Committee will be formed by professionals from different disciplines, working or not in the hospital. The involvement of a member from the community will be favored, and he/she will represent the interests of patients, as possible subjects of research. To evaluate research projects, such members should have no interests on the study being analyzed.
All members will have the responsibility to verify that the security, integrity and rights of people involved in the study protocol are protected. Likewise, the general ethics of the study and the agreement between the methodological aims of the protocol and the cost-benefit of its implementation should be considered. With these elements, the ethical analysis publicly assures its security.
The Committee will be chaired by a president or coordinator, with competence in clinical research and knowledge of ethical matters, and the board, called vocals.

DESIGNATION, TERMINATION AND RENEWAL OF MEMBERS

New members will be democratically appointed by all stable members of the committee. The President of the committee will inform IDIP´s Director about the election process results. The committee will be renewed every five years in accordance with provincial legislation (Law 11044) so that its accreditation is in force with the regulatory authorities of the Health Ministry.

ROLE

• Evaluate and issue reports about research protocols involving studies in human beings, namely, research with personal information or biological human samples, animal research with further application in human beings or use of biological agents or genetically modified organisms.
• Assess the importance of any research protocol that may affect fundamental human rights, welfare of research animals and the defense and protection of the environment.
• Ensure the compliance with good research practices in relation with the rights and interests mentioned.

OPERATION

The Board will hold weekly plenary sessions to evaluate research protocols (9 - 12 a.m.)
At least 6 members must be present to have quorum. Members cannot delegate their functions or be substituted during the sessions. Delegate votes will not be permitted. The Board´s decisions will be adopted by simple majority, indicating the number of members in favor, against and abstentions in the Minute Book. Members of the Board will ensure the confidentiality of debates and reports.

Members of the board should not evaluate procedures affecting projects in which they are involved as researchers o whenever there may be a conflict of interests.
The board may consult external experts when necessary, subject to the principle of confidentiality.
The board may ask researchers involved in a project under evaluation to provide additional information as deemed necessary. The board may form sub-boards to study projects concerned with human research, animals and biosecurity whenever necessary because of the amount, deadlines or kind of protocol presented.

REGULATIONS FOR THE SUBMISSION OF RESEARCH PROJECTS

Researchers should be familiar with the research protocol submitted for ethical analysis. They should know international rules governing research activities with human beings, the Informed Consent and Assent forms, the manual for researchers in force and all sources of information provided by the sponsor. If necessary, researchers should be aware of the adequate use of research products and of products used for the treatment of the pathology to investigate. All information must be submitted in English and Spanish. The Informed Consent and Assent forms for patients between 8 and 21 years of age must be furnished in Spanish. The resumé of researchers must be submitted in Spanish. The President or Coordinator of the Board will verify that the necessary antecedents for project evaluation have been submitted and will acknowledge receipt of said antecedents.  The schedule for project evaluation is set in 45 days from the presentation of all the documentation. The proposal will be approved or rejected according to scientific, technical and ethical judgement. All reports should be in writing. Amendments to research protocols, research manuals and adverse effects should be sent to the Board and considered as original protocols in plenary sessions. Results will be notified within 30 days.

EVALUATION OF RESEARCH PROJECTS

A review body may approve, request amendment of, or reject a research proposal on ethical grounds.

• APRPROVED: Positive evaluation of all bioethical aspects involved in the research protocol.
• REQUEST AMENDMENTS: Positive evaluation, but formal aspects should be corrected or additional documentation presented.
• APPROVED WITH FOLLOW-UP:  Certain implementation stages of the protocol should be controlled.
• PENDING: Relevant information for the positive or negative evaluation of the protocol is missing and should be submitted within 30 days. Once received, the protocol will be evaluated again.
• REJECTED: The decision should be based on solid grounds and sent to the principal researcher as well as to the Provincial Program of Health Research for its record, according to Regulation 11.044.
• DISCONTINUED:  When ethical concerns are reported by the Board or by researchers involved in the proposal. The information will be sent to the Provincial Program of Health Research

FILING AND DOCUMENTATION SYSTEM

Files are private and secret. They will be under the custody of the president and/or coordinator who will only show them to authorities regulating ethical aspects of health research within the province. The files include the Minute Book, copies of the reports issued, all documents used during the process of protocol evaluation, and bibliography supporting the board´s tasks. Each document will be allocated an identification number.

COMPENSATION

The Committee follows the funding criteria of IDIP for the acceptance of research protocols from the pharmaceutical industry for their scientific and ethical evaluation. The corresponding fees will be solely used for training. Genuine research protocols will have no fee. Members of the Committee who belong to the hospital´s permanent staff will have no salary. External members should have a salary to ensure their continuous participation. Salaries will be agreed on with IDIP´s Director.