CEP

I. TECHNICAL NOTE No. 16/2020: Regarding conducting research, scientific and academic studies within the Special Thematic Area – Studies with Indigenous Populations.

II. CNS Resolution No. 466/2012: aIt proves compliance with the guidelines and regulations governing research involving human subjects.

III. CNS Resolution No. 510/2016: This document establishes the applicable standards for research in the Humanities and Social Sciences whose methodological procedures involve the use of data obtained directly from participants or identifiable information, or that may entail greater risks than those existing in everyday life.

IV. CNS Resolution No. 304/2000: Approves the Standards for Research Involving Human Subjects – Area of ​​Indigenous Peoples.

V. Law No. 13.123/2015: It provides for the protection of and access to associated traditional knowledge.

VI. Law No. 14.874/2024: It provides for research involving human subjects and establishes the National System of Ethics in Research with Human Subjects.

VII. Law No. 12.853/2013: It provides for the collective management of copyright.

VIII. Specific legislation that protects image rights (Article 5, Item X, of the Federal Constitution; Article 20 of the Civil Code; and the Law No. 10.406 / 2002).

IX. FUNAI Normative Instruction No. 01/PRES/1995: approves the rules governing entry into Indigenous Lands for the purpose of conducting scientific research.

X. FUNAI Ordinance No. 177/PRES/2006: It protects the copyrights of Indigenous Peoples and their image rights.

I. All research projects conducted on indigenous lands must be processed by the Ethics Committee (CEP), according to their respective areas, and simultaneously by FUNAI and CNPq. These three processes must be carried out simultaneously to expedite the process. It is important to inform each committee about the simultaneous processing.

II. In the protocol to be submitted, it is important to explicitly state who will have access to the indigenous land and data – advisors and students – reinforcing, if applicable, that the student is from the community itself.

III. For the FAEPEX Call for Proposals “Indigenous Researchers: First Projects”, contextualize it in the application (especially for FUNAI), describing the context and highlighting the indigenous student who will carry out the research.

IV. Entry onto indigenous land is only permitted after approvals have been obtained for the presentation of the research and for the meeting with the community. Data collection should only be carried out after approvals from all three bodies (CEP-CONEP, FUNAI, and CNPq), even for students from these bodies.

V. It is essential to obtain the approval of the community and, when applicable, of the collegiate body or association. In the case of the Upper Rio Negro, for example, this would be the Federation of Indigenous Organizations of the Rio Negro (FOIRN).

VI. Research conducted in the urban area of ​​São Gabriel da Cachoeira requires submission to the Ethics Committee (CEP), but not necessarily to the National Ethics Committee (CONEP).

VII. If the research accesses associated traditional knowledge, it is necessary to: (1) obtain prior and informed consent from the indigenous people, different from the TCLE (Law 13.123/2015, Article 9 and Article 12); (2) register in SISGEN, even before collection (Law 13.123/2015, Articles 12–16).

I. Terms of Responsibility for research in the Special Thematic Area – Studies with Indigenous Populations, available here

II. Research Project In Portuguese, containing: background, objectives, rationale, hypotheses, methodology, sampling criteria, inclusion and exclusion criteria for participants, data collection methods and instruments, study location, primary and secondary data sources, expected results, risks and benefits, dissemination of results, research team, and a timeline including the stage for presenting the study/research results to indigenous communities, CONDISI, and DSEI.

III. Agreement Form of the locations where the research will be conducted:

a. The consent of the indigenous people, under the terms of CNS Resolution No. 304/2000, which can be obtained through the minutes of the CONDISI meeting, where it is stated that the research project was presented, discussed and approved; or through approval by the local councilors representing the area covered by the research, and/or the "agreement" of the indigenous leaders, representatives of the community(ies) where the study will take place.

b. Note: Agreement obtained through indigenous organizations and/or representatives/leaders does not replace the individual consent of the participant.

IV. Referral Protocol from the project to FUNAI.

Funai Normative Instruction 01/PRES/1995 It regulates access to Indigenous Lands for both Indigenous and non-Indigenous researchers.

The regional Funai office cannot authorize entry; only the head of the agency has that authority.

Applications for admission to Funai, along with the required documentation, must be submitted exclusively through the system. Digital Protocol, under the terms of SEGES/ME Ordinance No. 10.988/2022.

A Decree 177/PRES/2006 It regulates the administrative procedure for authorization by the National Indian Foundation (FUNAI) for the entry of people into indigenous lands interested in the use, acquisition and/or transfer of copyright and image rights of indigenous people.

If the activities involve entering areas whose preservation, protection, or control is the responsibility of other bodies – federal, state, or municipal – prior authorization will be required so that CNPq and MCTI can issue their opinion.

Ask about SISBIO Authorization – Research Authorization in Federal Conservation Units (UCs).

Based on Law 13.123 / 2015,  The researcher must obtain the prior and informed consent of the indigenous people involved. 

Registration is mandatory. National System for the Management of Genetic Heritage and Associated Traditional Knowledge (SISGEN)

For more information, visit [website address]. Genetic Heritage Commission (PATGEN) from the PRP.

According to PO Ordinance 941/2022, The analysis of the scientific merit of research projects to be developed in indigenous areas falls under the responsibility of CNPq. and will support the decision of the National Indian Foundation – FUNAI regarding requests for entry into said areas for the purpose of conducting scientific research, according to FUNAI Normative Instruction No. 01, of November 29, 1995.

Applications must include the following documents:

I - Project research proposal, with information about the area of ​​knowledge in which the research topic primarily falls, according to the CNPq's area of ​​knowledge table, detailing the indigenous land(s) in which you intend to enter;

II - Curriculum Updated Lattes CV of the principal investigator;

III - Curriculum Updated Lattes CV of the advisor/supervisor, in the case of undergraduate research, Master's, Doctoral and Post-Doctoral studies;

IV Letter presentation of the researcher's affiliated institution; and

V Letter Presentation of the advisor/supervisor in undergraduate, master's, doctoral, and post-doctoral research projects.

The request should be sent to the CNPq Customer Service Center (email: atendimento@cnpq.br / telephone: 61 3211-4000).

A Technical Note 16/2020-COGASI/DASI/SESAI/MS This involves conducting research, scientific and academic studies within the Special Thematic Area – Studies with Indigenous Populations.

For information on the ethical review of research involving indigenous populations, please consult the relevant project area:

CEP (Biological, Exact and Technological)

CEP-CHS (Human and Social)

Essential documents

I. Complete project (model Annex I/NT16)

II. Informed Consent Form/Tax Information Form (translated/adapted, if necessary)

III. Statement of Responsibility (Annex II)

IV. Indigenous consent (CONDISI minutes / local leaders / council members)

V. Approval from the DSEI manager (Annex III)

VI. Schedule, budget, resumes, etc.

(I.e. Data collection can only begin after approval from CONEP.

FUNAI – Authorization to Enter Indigenous Land

Required for any entry into Indigenous Territories (both Indigenous and non-Indigenous).

Processing in accordance FUNAI Normative Instruction 01/1995:

I. A letter of introduction from the institution to which the researcher is affiliated and, in the case of undergraduate and graduate students, a letter of introduction from the supervising advisor;

II. Research project in Portuguese, detailing the indigenous land(s) you intend to enter and a timeline;

III. Curriculum vitae of the researcher(s) written in Portuguese;

IV. Certified copy of Identity Card or passport, in the case of foreign nationality;

V. Individual certificate of vaccination against an endemic disease in the area;

VI. Medical certificate stating that the person does not have a contagious disease;

CNPq – Scientific Merit Assessment

Required for any IT research, according to FUNAI Normative Instruction 01/1995.

Documents:

I. Project

II. Researcher's Lattes CV

III. Lattes CV of the advisor

IV. Letter from the Institution

V. letter from the advisor

VI. Forwarding to CNPq (email/central office)

Other Authorizations (when applicable)

I. SISGEN (Law 13.123 / 2015): if there is access to associated traditional knowledge.

II. SISBIO (ICMBio): if the Indigenous Territory overlaps the Conservation Unit.

III. Ordinance 177/2006 (FUNAI): Use of indigenous images, sounds, graphic designs, works and creations.

IV. Foreign participation (CNS Resolution 292/1999).

Complete process (step by step)

1. Preliminary stage

Obtaining Indigenous Consent

2. Simultaneous submissions

The three submissions below must occur simultaneously, as per CONEP and PRP guidelines.

2st. Submission to CEP/CONEP (Brazil Platform)

Includes:

• Project + Informed Consent/Tax Receipt
• Schedule, budget, resumes, etc.

2b. Referral to CNPq – Merit Assessment

Includes:

• Project
• Lattes researcher
• Lattes advisor
• Institutional letters
• IT details

2c. Application for Admission to FUNAI

Via Digital Protocol, with:

• Project
• Indigenous consent
• CNPq merit review
• Additional documents (when access to genetic resources, images, etc. is available)

3. Approvals

CEP Evaluation → AUTOMATIC SUBMISSION to CONEP
Special Thematic Area: Indigenous Peoples.

CNPq Merit Opinion
It is necessary for FUNAI to issue authorization.

Formal authorization from FUNAI
Signed by the president of FUNAI.

(I.e. No data collection can begin before all three approvals are obtained: (1) CONEP, (2) CNPq and (3) FUNAI.

4. Conducting the research

Entry into Indigenous Land
Only with the official decree from FUNAI.

Data collect
Observing:

• Clear and understandable informed consent forms.
• Linguistic adaptations
• Cultural respect
• No conflict generation
• Confidentiality and data protection
• Rules regarding images and sounds (177 / 2006 Ordinance)

5. Completion

Presentation of the results to the community
Mandatory according to Annex I.

Deposit and reporting to institutions (when applicable)

Publication of results
Observing the Terms of Responsibility (Annex II)
No misuse of images, sounds, or cultural materials.