Institutional Review Board for Research - Takiwasi Center

The Institutional Review Board for Research of the Takiwasi Center ensures ethical standards for research involving human participants through the formulation, recommendation, and supervision of policies and procedures for conducting research with human participants. The privilege of conducting research with human participants is granted on the basis of the responsibility to participate in ethical research, respecting the rights of the participants and acting in a way consistent with the values of the Institution.

The Board is in charge of the ethical, scientific and regulatory compliance of all the investigations that take place at the Center for Rehabilitation of Drug Addicts and Research on Traditional Medicines - Takiwasi.

The Board protects the rights, safety, and well-being of human research participants by performing the following functions:
- Review the protocols for the planned research studies to ensure that all research meet the established criteria.
- Confirm that research plans do not expose participants to unreasonable risks.
- Conduct an ongoing review of approved research at intervals established according to the risk level of the study, but not less than once a year, to ensure that the protection of human participants remains in effect.
- Consider adverse events, interim findings, and any recent literature that may be relevant to the research.
- Evaluate alleged violations of the protocol, complaints expressed by the participants in the investigation or violations of Institutional policies.


TABLE OF CONTENTS

I. Approval of the research by the Institutional Review Board for Research
II. Principles of the Institutional Review Board for Research
III. Forms and procedures to submit research proposals
IV. Members of the Institutional Review Board for Research


I. APPROVAL OF THE RESEARCH BY THE INSTITUTIONAL REVIEW BOARD FOR RESEARCH

1.1 Research approval is valid for one year from the original approval date. Data collection that does not start within one year will require to submit a new request for approval to the Board.


1.2 Once submitted, the Committee will consider that each proposal falls into one of the following categories:

- a) Full review: studies with the participation of human subjects involved in any type of therapeutic treatment in Takiwasi (collection of clinical data). Projects that are already underway at the date of approval of this document are exempt (for example, the Ayahuasca Treatment Outcome Project - ATOP). For studies that only include the analysis of pre-existing clinical data from the clinical data management system of Takiwasi (Plus System), reference is made to the specific procedure for accessing data (see Multiple Memorandum No. 001-2019-Takiwasi/PE). For this category of cases, the proposals have to be fully reviewed by the Board.

- b) Expedited review: studies that does not include human subjects involved in therapeutic treatments (for example, if the study involves only therapists). These proposals will be reviewed by a minimum of two members of the Board to speed up the decision-making process. The Board is responsible for granting the final decision based on the report of the members who analyzed the proposal. There is always the possibility for any member of the Board to access the complete documentation and request a full review by the Board according to their consideration.

- c) Exempt: It does not require a review by the Board due to the fact that the research does not include human subjects (for example, bibliographic review, production of herbarium, among others). In this case, the researcher's Curriculum Vitae, their Health Declaration (Annex 1) and Presentation/Motivation Letter (Annex 2) are required, which will be evaluated by the Takiwasi Center Management according to a pre-existing protocol, together with the following documents: Annex 3, Annex 4, and Annex 5. The Committee is responsible for granting exemptions (Annex 8).


1.3 The Board's decision may be:

- a) Approved: the researcher can start his/her project upon receiving approval.

- b) Conditionally Approved: the researcher will have to resubmit the complete application together with the changes required by the Board. Once these requirements are fully met and approved by the Board, research approval will be granted. No investigation can be conducted until all reviews are approved and final approval is granted.

- c) Return to investigator: there are important errors or questions in the application that need clarification from the investigator. No vote for approval is made, the application is returned for further amendments prior to the Board’s review. The investigator must complete a new application that answers the questions proposed.

- d) Disapproved: the investigation cannot be carried out. There is a significant risk of harm or ethical considerations. No person can reverse the disapproval decision made by the Board.


1.4 Record keeping:

- a) The minutes will be recorded at each meeting.

- b) Feedback to the investigator must be clear and timely, including written reasons for the Board's decisions.

- c) The Chairman of the Board must provide regular updates to a designated person (President of the Institution).

- d) Records must be kept for a specific period of time not to exceed 3 years.


II. PRINCIPLES OF THE INSTITUTIONAL REVIEW BOARD FOR RESEARCH

2.1 The Board is responsible for reviewing, approving and monitoring all research involving human participants conducted at the Takiwasi Center.


2.2 The Board ensures that the researcher takes adequate measures to protect the participants while minimizing any potential risk. The potential risks should be weighed against the potential benefit to the participants and the importance of the knowledge gained through the study should also be considered.


2.3 In accordance with an ethical approach, the Board reserves the right to suspend research activities if scientific misconduct is evident within the study. Scientific misconduct refers to fabrication, falsification, or plagiarism in proposing, conducting, or reporting research.


III. FORMS AND PROCEDURES TO SUBMIT RESEARCH PROPOSALS

3.1 Instructions for research review

3.1.1 Researchers and others will recognize that conducting research with human participants is not a right, but a privilege. This privilege is granted to researchers who, after close scrutiny by the Board, can demonstrate that they intend to conduct high-quality, meaningful research that provides adequate protection to human participants.

3.1.2 The research is considered to be participant-centered. This means that the research cannot be conducted according to the convenience of the researcher, instead the well-being of the participant is considered to be crucial. Therefore, when requesting permission for an investigation, the researcher should bear in mind that the participants must be treated with respect for their right to be well informed before the beginning of the study about what will happen to them and what behaviors are required of them. They must be aware of the risks involved in the study and then freely allowed to decide to participate or not. The option to opt out or terminate participation at any time must be clearly explained. Participants must also be guaranteed the confidentiality of any information they provide and any information about themselves. It is also important, in terms of maintaining the goodwill of our participants’ population, to make arrangements to inform participants about the purpose of the study and the importance of their role in it.


3.2 Research Review Forms for Studies Involving Human Participants - Human Participants Research Request

The investigator must provide the following documentation for review:

- a) Summary / Curriculum Vitae in English and/or Spanish and/or French (depending on the project, a basic or advanced knowledge of Spanish may be required);

- b) Health Form (Annex 1) and Letter of Presentation/Motivation (Annex 2);

- c) Inter-institutional Research Collaboration Agreement (according to the standard model, see Annex 3). This should also indicate that the researcher is responsible for presenting to the Board an annual progress report or, in the case of a stay of less than one year, a brief report on the progress of the research halfway through the time foreseen for the development of the research project. The researcher also declares to adhere to the policies and procedures established by the Board, to have knowledge of the fact that he/she has the ultimate responsibility for his/her research, and to possess own resources for the development of the research (laptop or audio recorder, for example) and to be independent in daily life (accommodation, food, transportation, extra expenses).

- d) Confirmation of being aware of the basic rules of the Center (Annex 4): being primarily a Therapeutic Community with patients in residential treatment for addiction, there are well-defined and strict rules of behavior, which could be not compatible with the researcher's requirements.

- e) Agreement to pay $ 200 dollars a month to cover operating expenses, mandatory in case the research project has on specific funding (Annex 5).

- f) A description of the Research Project that eventually includes the questionnaire that the researcher will use to collect data from human subjects during the research (Annex 6);

- g) A copy of the Informed Consent Form that the researcher will use to obtain authorization from the human subjects involved in the research, where guarantees are offered on the possibility of requesting the privacy and confidentiality of the participants' data, and appropriate safeguards to protect participants from any potential risk or harm. This should also include the researcher's comments to the participants or the material that he/she intends to use during an information session (Annex 7).


3.3 Review procedure

a. Upon receiving the researcher's proposal, the Board evaluates its formal integrity (presence of all signed and dated annexes).

b. Once it is determined that the proposal is complete, the Board will inform the researcher within a period of 3 weeks from the moment of receipt of the proposal of an indicative date for the final result of the review process, be it expedited or complete review. Incomplete proposals will be returned to the investigator.

c. The Board will review all full proposals and make a decision as soon as possible regarding the project: Approved, Conditionally Approved, Return to Investigator or Disapproved.

d. Once the Board has made a decision on the project proposal, the researcher will receive a notification (Annex 8).

e. Those individuals with approved proposals can begin research upon receiving approval.

f. Those who are granted conditional approval must comply with the terms and conditions outlined in the written notice and will receive a final approval notice from the Board prior to initiating the investigation.

g. Proposals that are rejected cannot be started. No person can reverse the decision of the Board regarding the disapproval of the research proposal.

h. If the investigator's proposal is approved, they will be asked to submit a Progress Report to the Board on their activity at the end of their study, or on the first anniversary of the granting of approval by the Board. Failure to complete the Progress Report may result in disciplinary actions that include the revocation of the agreement to the investigation and consequently the suspension of the investigation.

j. The Board will conduct audits of randomly selected research projects.

The approval of the research by the Board does not exempt the researcher from the responsibility of participating in the research according to general principles of ethics in scientific research respecting the rights of the participants (see for example the Declaration of Helsinki, the Code of Ethics of the International Society of Ethnobiology (ISE) and other relevant international standards).


IV. MEMBERS OF THE INSTITUTIONAL REVIEW BOARD FOR RESEARCH

4.1 The Chairman of the Board oversees the operation of the Board and provides feedback to researchers and the institution's board of directors, as appropriate.

The Chairman of the Board is:

Jaime Torres Romero
Executive Director
jaime_torres@takiwasi.com


4.2 The Board is made up of the following area managers of the institution:
1. President – Jacques Mabit
2. Director – Jaime Torres
3. Research – Matteo Politi
4. Laboratory/ATOP – Fernando Mendive
5. Therapy – Veronika Kavenská
6. Plus System – Gary Saucedo
7. Communications – Fabio Friso


4.3 Qualified professionals and especially psychologists who are members of the therapeutic team may be asked to review requests and/or attend meetings in order to provide additional knowledge in certain areas of expertise.


4.4 Fabio Friso, communications manager of Takiwasi, is appointed as secretary in charge of the Board's Minutes Book.


4.5 The composition of the Board will be confirmed or renewed on an annual basis, through a dedicated meeting, or at the extraordinary request of a member of the Board in the event one of them decides to retire from office.