79C3C34C52B45572883A05D425EB0F82

Guide for Ethics Committees

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This file was generated: 2020-12-01 09:06:03

Indicators in focus are typically shown highlighted in yellow; Peer Indicators (that share the same Vulnerability association) are shown highlighted in pink; "Outside" Indicators (those that do NOT share the same Vulnerability association) are shown highlighted in green; Trigger Words/Phrases are shown highlighted in gray.

Link to Orphaned Trigger Words (Appendix (Indicator List, Indicator Peers, Trigger Words, Type/Vulnerability/Indicator Overlay)


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalvulnerablevulnerable1
HealthDrug Usagedrug4
HealthDrug Usageinfluence1
HealthMotherhood/Familyfamily3
SocialAccess to Social Goodsaccess2
SocialAccess to informationaccess to information1
SocialAgeage2
SocialIncarceratedrestricted1
SocialProperty Ownershipproperty1
SocialReligionreligious1
Socialgendergender2
General/OtherRelationship to Authorityauthority6
General/Otherbelmontbelmont1
General/Othercioms guidelinescioms1
General/Otherdeclaration of helsinkihelsinki1

Political / vulnerable

Searching for indicator vulnerable:

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p.(None): Resume of the research team.
p.(None): Research protocol: The aspects that imply the technical quality of the research protocol should be evaluated.
p.(None): research, as well as its subsequent development within the research site.
p.(None): We must take into account aspects such as: the socialization of the study, access barriers, factors
p.(None): economic factors that may affect the research participant, the randomization method,
p.(None): blinding, confidentiality of information, statistical method and the feasibility of the project of the
p.(None): research (possibility of reaching the expected conclusions, benefit / risk balance and
p.(None): inconveniences for participants, financing and necessary resources) among other documents. Inside of the
p.(None): protocol is also necessary to review the mechanisms (if any) with which it is intended to compensate or reward the
p.(None): Participation of the subjects.
p.(None): Informed Consent: This document should evaluate aspects such as materials and methods that will
p.(None): be used to obtain the informed consent of the participants in the study. It must also be obtained
p.(None): an informed consent freely given of each subject, prior to their participation in the study, which
p.(None): find in clear, readable letter, suitable for the sociocultural level where it will be applied, with a volume
p.(None): adequate, complete, that does not have ambiguities, that the coverage of the attention of events is explained
p.(None): adverse, information relevant to research, considerations regarding vulnerable populations,
p.(None): budgeted time for informed consent, people who should be witnesses and everything
p.(None): contemplated in Resolution 8430 of 1993.
p.(None): It is important to keep in mind that the participation of minors must follow the guidelines established in the
p.(None): Resolution 8430 of 1993.
p.(None): Likewise, informed consent must be evaluated for genetic samples, in which the sponsor
p.(None): specify the use of these samples, the retention time and the handling of the confidentiality of this
p.(None): information.
p.(None): Recruitment announcements and materials delivered to participants: These documents and their equivalents are
p.(None): They should always analyze thinking about the well-being and confidentiality of the research subject.
p.(None): Study Budget: The Ethics Committee must verify in the budget that will be considered
p.(None): for the realization of the protocol, that all the expenses that have to do with the project of
p.(None): research are covered by the same budget of the study and that the own resources of the study will not be used
p.(None): research participant, contemplating the budget for food and transportation for the participant
p.(None): of the study, if applicable.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 10 of 12
p.(None): Insurance policy for participants: The committee must verify that the policy is in force, which
...

Health / Drug Usage

Searching for indicator drug:

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p.(None): approval and constant monitoring of the research project, amendments, informed consent of the
p.(None): Study participants, among other related documents.
p.(None): This evaluation should always be focused on the integrity of the study participant, above the
p.(None): feasibility that involves conducting a research study in a Center or IPS.
p.(None): For this reason the Ethics Committee is the highest authority within the Research Center in what has to do with
p.(None): maintaining the integrity of the research participant.
p.(None): 5. PROCEDURES OF THE ETHICS COMMITTEE
p.(None): The Ethics Committee must have a document (guide, statute, etc.), which includes all procedures
p.(None): what you should do in the investigation. These procedures must be in constant updating and socialization of
p.(None): according to the advances in the field of Good Clinical Practices.
p.(None): The minimum responsibilities to be met by an Ethics Committee must be defined, according to the
p.(None): national regulations in force and supported by international regulations.
p.(None): 6. RESPONSIBILITIES
p.(None): All research carried out in human beings must be evaluated and approved by the Ethics Committee. The Committee must
p.(None): evaluate the research project, the researcher's competencies and the competencies of his team of
p.(None): investigation; the informed consent form, the known information about the drug
p.(None): (including reports of unexpected and expected adverse events) and all potential publicity
p.(None): planned to obtain possible participants, in addition to any change in the protocol, however insignificant this
p.(None): be.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 2 of 12
p.(None): Research projects of institutions that do not have an Institutional Ethics Committee must be
p.(None): approved by an Ethics Committee of another institution that has been evaluated and certified in the
p.(None): compliance with Good Clinical Practices, document issued by the National Surveillance Institute of
p.(None): Medications and Foods - INVIMA.
p.(None): The national and international guidelines of Good Clinical Practices should be accepted and the ethical framework should
p.(None): be based on the principles contemplated among others, in the Nuremberg Code of Ethics, the Declaration of Helsinki,
p.(None): the Belmont Report and international ethical guidelines for biomedical research in humans
p.(None): (CIOMS).
p.(None): Every Ethics Committee must define its code of conduct, its conflict of interest management policy and its
...

p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 5 of 12
p.(None): The rule specifies that “there must be at least one member that is independent of the
p.(None): institution / site where the study will be carried out ”. Therefore, it should be taken into account that
p.(None): This statement must maintain the independence of the committee, avoiding any labor subordination.
p.(None): In addition to the characteristics described in the multidisciplinarity of the Committee, it is clear that the
p.(None): following competences for the evaluation and monitoring of a Research Project.
p.(None): A member who has training in bioethics, to have a more precise criterion in the evaluation of a
p.(None): Research Project in this aspect.
p.(None): A member who has training in research methodology, to have a more precise criterion in the
p.(None): evaluation of the protocol in terms of its technical characteristics.
p.(None): A member who has training in epidemiology or some other specialty focused on research, with
p.(None): experience in clinical research, topic review and database analysis; tools that are
p.(None): Very useful in the evaluation of a research project.
p.(None): A member of the branch of law, to advise the Ethics Committee in all aspects
p.(None): legal that may arise in the evaluation of a research project.
p.(None): A member who is a pharmaceutical chemist, to advise on the evaluation of the part
p.(None): pharmacological research project and evaluation of adverse events in what has to do with the
p.(None): drug interactions
p.(None): With respect to community representatives, it must be ensured that these personnel also have a criterion
p.(None): analytical but always focused on the point of view of the research participant and the research project.
p.(None): It would be appropriate if you have previously been a participant in any research study.
p.(None): All the members described above, with the exception of the community representative, may be
p.(None): convened under the figure of external advisors or consultants and it will depend on each committee if these external advisors
p.(None): They have voice or vote.
p.(None): Within the members of the Ethics Committee there may be researchers from the projects of
p.(None): Research being evaluated or other members of the research team. However, a researcher has the
p.(None): restriction to be a member of the committee when:
p.(None): He is the Chairman of the Committee
p.(None): You have conflicts of interest because you participate in the development of studies evaluated by the Committee, or because your
p.(None): affiliations or relationships imply bias for the development of the evaluation by the Committee. I know
p.(None): you should keep in mind that if it is the only IP or IS of the majority of studies that the Committee is following,
p.(None): it would not be appropriate to lose a member of the committee due to permanent impediments.
p.(None): Have any interest from the labor, personal, family, economic, social, religious and / or academic point of view with
p.(None): the sponsor of the study that is carrying out the protocol.
p.(None): It does not timely inform if there is a conflict of interest in the exercise as a member of the Committee.
...

p.(None): the Administrative Secretary with a technical profile for file and correspondence management, who
p.(None): It has no voice or vote, functions that must be defined for each case.
p.(None): Active member.
p.(None): It must fulfill the functions assigned to it by the Chairman of the Ethics Committee within the Committee, such as
p.(None): the functions within the evaluation of the study.
p.(None): H. Quorum requirements for session and deliberation: The number of required members must be established
p.(None): to meet and the minimum number, disciplines and qualifications for quorum compliance. These guidelines
p.(None): They must be defined by the Chairman of the Committee.
p.(None): The minimum quorum could be established as follows: It must be half plus one (1)
p.(None): Be a minimum of five members.
p.(None): The President must be
p.(None): There must be at least one medical member There must be at least one non-scientific member The Representative must be
p.(None): of the community.
p.(None): Considerations:
p.(None): It is not recommended to session a new research project with the minimum quorum or any other
p.(None): submission where the evaluation suspects damage to the research participant.
p.(None): In the absence of the Chairman of the Committee, there must be a chairman in charge who assumes the functions of
p.(None): charge for that session.
p.(None): I. Description of the training or training that the members of the Committee must have.
p.(None): There should be a continuous training program in research topics such as: Research methodology
p.(None): Research bioethics Database analysis Informed Consent
p.(None): Update on Good Clinical Practices Normative in Research
p.(None): Drug Interactions
p.(None): Adverse events in research projects.
p.(None): II. Code of Conduct, Conflict of Interest Policy and Confidentiality Policy
p.(None): There are situations that may generate a potential conflict of interest by the members of the Committee and by
p.(None): both skew the ideal development of its functions. These situations must be declared and
p.(None): communicate in a timely manner in order to generate relevant actions, such as abstention
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 8 of 12
p.(None): of evaluation and monitoring of specific studies. In turn, the Committee must establish and document how to handle the
p.(None): situation.
p.(None): Some circumstances that generate conflict of interest for the members of the Committee are mentioned below:
p.(None): Labor links with the sponsor such as consulting or advisory agreements, simultaneous participation as
p.(None): evaluation member of the Committee and as a researcher of research studies, owned by securities of
p.(None): signatures involved in studies submitted to the Committee's evaluation, familiar family relationship with
p.(None): participants and responsible for the study under evaluation, business relationship with participants and managers of the
p.(None): study under evaluation, past or present relationship with participants and responsible for the study under evaluation,
p.(None): relationships such as friendship, personal, close or enmity that could affect the judgment of the evaluator, among others.
...

p.(None): You must include a list of the minimum documents to be submitted.
p.(None): You must have a tool (checklist, logbook, etc.) that allows you to evaluate all the documents of the
p.(None): investigation project. This tool should have a checklist that meets the evaluation criteria
p.(None): of the documents and have a space that is mandatory filling in where the evaluating member exposes their
p.(None): points of view. It is recommended to have one of these separate tools for each of the documents.
p.(None): D. Minimum documents to be evaluated for each research project
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 9 of 12
p.(None): Researcher's Manual: The general purpose of this document is to provide the researcher with a
p.(None): clear knowledge of possible risks and adverse reactions, as well as specific tests,
p.(None): observations and precautions that may be necessary in a clinical trial.
p.(None): This document must contain all available information on safety data,
p.(None): pharmacodynamics, pharmacokinetics, toxicity, teratogenicity, physical and chemical properties, etc. of the molecule in
p.(None): research, in addition to reliable information from preclinical studies (pharmacological and not
p.(None): pharmacological) and previous clinicians that justify the use of the molecule in humans. It must also capture the
p.(None): information from phase I, II, III clinical studies (if any, as appropriate), drug interactions,
p.(None): side effects, adverse reactions, all focused on the protection of the participant.
p.(None): Resume of the research team.
p.(None): Research protocol: The aspects that imply the technical quality of the research protocol should be evaluated.
p.(None): research, as well as its subsequent development within the research site.
p.(None): We must take into account aspects such as: the socialization of the study, access barriers, factors
p.(None): economic factors that may affect the research participant, the randomization method,
p.(None): blinding, confidentiality of information, statistical method and the feasibility of the project of the
p.(None): research (possibility of reaching the expected conclusions, benefit / risk balance and
p.(None): inconveniences for participants, financing and necessary resources) among other documents. Inside of the
p.(None): protocol is also necessary to review the mechanisms (if any) with which it is intended to compensate or reward the
p.(None): Participation of the subjects.
p.(None): Informed Consent: This document should evaluate aspects such as materials and methods that will
p.(None): be used to obtain the informed consent of the participants in the study. It must also be obtained
p.(None): an informed consent freely given of each subject, prior to their participation in the study, which
p.(None): find in clear, readable letter, suitable for the sociocultural level where it will be applied, with a volume
p.(None): adequate, complete, that does not have ambiguities, that the coverage of the attention of events is explained
...

Searching for indicator influence:

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p.(None): Investigators should be informed about the sanctions that cause non-compliance with this
p.(None): numeral.
p.(None): The Ethics Committee, due to its constitution, cannot take judicial measures of a sanitary nature against the Center for
p.(None): Investigation, neither against the Investigator or the study sponsor, but it can impose
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 12 of 12
p.(None): sanctions when in defense of the protection of the welfare of research participants, what
p.(None): consider necessary. These sanctions can be among others:
p.(None): Warning call Warning
p.(None): Suspension of the approval of the research project, a measure that immediately generates remission or
p.(None): report to the regulatory entity (INVIMA) and the sponsor.
p.(None): 9. CONSIDERATIONS ABOUT THE ETHICS COMMITTEE
p.(None): Among the considerations about the Ethics Committee, the following should be established:
p.(None): The Ethics Committee is the highest authority in relation to the safety of the participant of
p.(None): investigation; therefore, it will not be subject to any external influence and all actors (sponsor, center
p.(None): of investigation, research group) must comply with the decisions and / or measures that are generated from it.
p.(None): In case such decisions are not followed, the Committee will have the support and obligation to report said decisions.
p.(None): irregularities to INVIMA. The Committee, by virtue of its composition and competence, can refute the analyzes, decisions
p.(None): and changes in the research project, which according to its criteria affect the safety of the participant in the
p.(None): center that is endorsing. According to the above, the Committee may define the qualification of an adverse event not
p.(None): serious to a serious adverse event above the investigator's criteria, as long as this decision
p.(None): Affect the participant.
p.(None): In case of deviations or violations committed by the principal investigator, the Ethics Committee establishes
p.(None): If this report is adequate, according to the provisions of the protocol and the security of the
p.(None): competitor.
p.(None): The Committee must have a budget with its own resources, either generated by the research center to which
p.(None): find attached, or by resources derived from its services. This budget must be handled sovereignly by
p.(None): the Committee, which can be made public and must have items intended for operation
p.(None): routine, stationery, office maintenance, human resources, file management, training and,
p.(None): if it is contemplated, the payment of fees of its members.
p.(None): The ethics committee should not receive the sponsor's budget directly, it must be managed by the
p.(None): certified institution whereby the contract between the Ethics Committee and the institution must be specified as
...

Health / Motherhood/Family

Searching for indicator family:

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p.(None): legal that may arise in the evaluation of a research project.
p.(None): A member who is a pharmaceutical chemist, to advise on the evaluation of the part
p.(None): pharmacological research project and evaluation of adverse events in what has to do with the
p.(None): drug interactions
p.(None): With respect to community representatives, it must be ensured that these personnel also have a criterion
p.(None): analytical but always focused on the point of view of the research participant and the research project.
p.(None): It would be appropriate if you have previously been a participant in any research study.
p.(None): All the members described above, with the exception of the community representative, may be
p.(None): convened under the figure of external advisors or consultants and it will depend on each committee if these external advisors
p.(None): They have voice or vote.
p.(None): Within the members of the Ethics Committee there may be researchers from the projects of
p.(None): Research being evaluated or other members of the research team. However, a researcher has the
p.(None): restriction to be a member of the committee when:
p.(None): He is the Chairman of the Committee
p.(None): You have conflicts of interest because you participate in the development of studies evaluated by the Committee, or because your
p.(None): affiliations or relationships imply bias for the development of the evaluation by the Committee. I know
p.(None): you should keep in mind that if it is the only IP or IS of the majority of studies that the Committee is following,
p.(None): it would not be appropriate to lose a member of the committee due to permanent impediments.
p.(None): Have any interest from the labor, personal, family, economic, social, religious and / or academic point of view with
p.(None): the sponsor of the study that is carrying out the protocol.
p.(None): It does not timely inform if there is a conflict of interest in the exercise as a member of the Committee.
p.(None): D. On the participation of consultants (when applicable): The participation of external consultants is given by the
p.(None): specific training of these in subjects where there is no profile within the members of the
p.(None): Committee to perform the analysis of a research proposal that requires a specialized concept in
p.(None): any area
p.(None): The independence of external consultants should be ensured in relation to sponsors or any other
p.(None): entity that generates conflicts of interest.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 6 of 12
p.(None): E. Requirements and processes for the selection of members in terms of the following aspects: The person (s)
p.(None): in charge of selecting the members of the Committee must be absolutely independent of the persons
p.(None): responsible for reviewing the convenience and feasibility of the research project within the center of
p.(None): investigation.
p.(None): In general, it is better that this appointment be proper to the Ethics Committee and that there is a consensus
p.(None): General for the evaluation of the new member. It is essential that there are several candidates.
p.(None): It is necessary to define what are the conflicts of interest and disabilities that will be in
p.(None): account to define the candidate. Some of them are listed below:
p.(None): Be part of an entity or be a direct actor in the research project (Sponsor, Researcher or
p.(None): research center) or any other entity that has an economic interest in the research project.
p.(None): That there is a labor, contractual, family or advisory relationship with entities that have economic interests in
p.(None): the research projects to evaluate.
p.(None): F. Conditions for the appointment of committee members:
p.(None): Agree to make some personal information public for legal purposes.
p.(None): Have established for each member, the general functions and those that must be fulfilled during the evaluation of each
p.(None): study and support of acceptance thereof.
p.(None): Agree to register and have available information regarding payments and refunds
p.(None): received for their work as members of the Committee (if any).
p.(None): Sign a confidentiality agreement by each of the members of the Committee on all the topics discussed
p.(None): in each session and in the general information of the Committee.
p.(None): Register knowledge of conflict of interest policy and code of conduct of the Committee.
p.(None): G. Membership terms: A period of appointment must be contemplated within the statutes, which may be of
p.(None): two (2) years extendable according to the policies defined within each Ethics Committee.
p.(None): Within the Committee's procedures, policies on the
p.(None): disqualification, replacement of Committee members and resignation, which must include among other factors:
p.(None): conflicts of interest, the inability to violate them, as well as events that may affect the participation of
p.(None): a member within the Committee (disabilities, workload, training, etc.).
p.(None): The records of the declaration of conflicts of interest of the members of the Committee, as well as the
p.(None): generated actions.
p.(None): In addition, responsibilities and functions must be defined according to the position held within the Committee:
p.(None): President.
p.(None): Preside over the meetings and will be the spokesperson for the socialization committee.
...

p.(None): There should be a continuous training program in research topics such as: Research methodology
p.(None): Research bioethics Database analysis Informed Consent
p.(None): Update on Good Clinical Practices Normative in Research
p.(None): Drug Interactions
p.(None): Adverse events in research projects.
p.(None): II. Code of Conduct, Conflict of Interest Policy and Confidentiality Policy
p.(None): There are situations that may generate a potential conflict of interest by the members of the Committee and by
p.(None): both skew the ideal development of its functions. These situations must be declared and
p.(None): communicate in a timely manner in order to generate relevant actions, such as abstention
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 8 of 12
p.(None): of evaluation and monitoring of specific studies. In turn, the Committee must establish and document how to handle the
p.(None): situation.
p.(None): Some circumstances that generate conflict of interest for the members of the Committee are mentioned below:
p.(None): Labor links with the sponsor such as consulting or advisory agreements, simultaneous participation as
p.(None): evaluation member of the Committee and as a researcher of research studies, owned by securities of
p.(None): signatures involved in studies submitted to the Committee's evaluation, familiar family relationship with
p.(None): participants and responsible for the study under evaluation, business relationship with participants and managers of the
p.(None): study under evaluation, past or present relationship with participants and responsible for the study under evaluation,
p.(None): relationships such as friendship, personal, close or enmity that could affect the judgment of the evaluator, among others.
p.(None): Membership in the Committee allows access to information with publication restrictions, which should be considered as a
p.(None): confidentiality policy that prevents the use of reserved information.
p.(None): 8. PROCEDURE
p.(None): A. Institutional authority under which the Committee is established
p.(None): It must be defined under what authority within the Research Center (Institution) you are
p.(None): constituted the Research Ethics Committee.
p.(None): To define the subordination it is necessary to clarify that the Ethics Committee is the highest authority in the center of
p.(None): research in what has to do with maintaining the safety of the research participant.
p.(None): Therefore, the Committee must always be on the process map of those in charge of
p.(None): approve, review and define the financial feasibility within the institution, such as: the researcher, office
p.(None): financial, clinical or scientific management (if these two offices have this function).
p.(None): He must be as an advisory body to the legal representative but never subordinate him.
...

Social / Access to Social Goods

Searching for indicator access:

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p.(None): This has to be done whenever any document or change to the research project is received.
p.(None): The responsibilities of this process fall primarily to the chairman of the Ethics Committee.
p.(None): B. Evaluate and approve or disapprove, before its start, the proposed investigations: For evaluation and subsequent
p.(None): approval or disapproval of the proposed investigations, the Ethics Committee must define the
p.(None): methodology, tools and procedures previously agreed to comply with this
p.(None): responsibility.
p.(None): First: The Committee must establish the criteria that it will take into account for the evaluation of the different documents
p.(None): Let them be analyzed.
p.(None): Second: Define according to the competencies of the members, their functions with respect to the evaluation of
p.(None): The aspects of the project.
p.(None): Third: Standardize procedures for the socialization of the results of the evaluation, monitoring and
p.(None): monitoring of recommendations to research projects, within the times established according to the
p.(None): regulations and the characteristics of the research project.
p.(None): Fourth: Define the measures that will be taken in case of non-compliance with their decisions. Fifth: The Committee must
p.(None): specify criteria to express potential conflicts of interest of its members, define and record the measures
p.(None): generated.
p.(None): C. Obtain and maintain the required documentation of each study put to your consideration: The Committee of
p.(None): Ethics must have a restricted access file with the appropriate security and confidentiality conditions.
p.(None): Therefore, it is essential that there is an infrastructure that ensures compliance with this
p.(None): responsibility, complying with the current document archiving standards.
p.(None): The minimum custody time of the documentation must be established and defined in the contract signed with the
p.(None): research Center.
p.(None): Have a qualified staff for custody and file management, with these specific functions.
p.(None): The Ethics Committee may have a magnetic file, as long as it meets the safety criteria and
p.(None): confidentiality of the information, which cannot be modified later and that
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 3 of 12
p.(None): they are also aligned with the quality management system of the Institution to which the Committee
p.(None): belong.
p.(None): D. Consider the competence of researchers: Establish the minimum criteria that the team must meet
p.(None): researcher who will develop the research project.
p.(None): These evaluation criteria must take into account the following:
p.(None): The evaluation of the resumes and the corresponding supports of the entire research team (researcher
p.(None): principal (IP), co-investigator or secondary researcher (IS), study coordinator, technical staff - (yes
p.(None): there will be) -, bacteriologist and pharmaceutical chemist).
p.(None): Professional degrees (diploma with their respective degree certificate) and a document certifying that the IPS has
...

p.(None): D. Minimum documents to be evaluated for each research project
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 9 of 12
p.(None): Researcher's Manual: The general purpose of this document is to provide the researcher with a
p.(None): clear knowledge of possible risks and adverse reactions, as well as specific tests,
p.(None): observations and precautions that may be necessary in a clinical trial.
p.(None): This document must contain all available information on safety data,
p.(None): pharmacodynamics, pharmacokinetics, toxicity, teratogenicity, physical and chemical properties, etc. of the molecule in
p.(None): research, in addition to reliable information from preclinical studies (pharmacological and not
p.(None): pharmacological) and previous clinicians that justify the use of the molecule in humans. It must also capture the
p.(None): information from phase I, II, III clinical studies (if any, as appropriate), drug interactions,
p.(None): side effects, adverse reactions, all focused on the protection of the participant.
p.(None): Resume of the research team.
p.(None): Research protocol: The aspects that imply the technical quality of the research protocol should be evaluated.
p.(None): research, as well as its subsequent development within the research site.
p.(None): We must take into account aspects such as: the socialization of the study, access barriers, factors
p.(None): economic factors that may affect the research participant, the randomization method,
p.(None): blinding, confidentiality of information, statistical method and the feasibility of the project of the
p.(None): research (possibility of reaching the expected conclusions, benefit / risk balance and
p.(None): inconveniences for participants, financing and necessary resources) among other documents. Inside of the
p.(None): protocol is also necessary to review the mechanisms (if any) with which it is intended to compensate or reward the
p.(None): Participation of the subjects.
p.(None): Informed Consent: This document should evaluate aspects such as materials and methods that will
p.(None): be used to obtain the informed consent of the participants in the study. It must also be obtained
p.(None): an informed consent freely given of each subject, prior to their participation in the study, which
p.(None): find in clear, readable letter, suitable for the sociocultural level where it will be applied, with a volume
p.(None): adequate, complete, that does not have ambiguities, that the coverage of the attention of events is explained
p.(None): adverse, information relevant to research, considerations regarding vulnerable populations,
p.(None): budgeted time for informed consent, people who should be witnesses and everything
p.(None): contemplated in Resolution 8430 of 1993.
p.(None): It is important to keep in mind that the participation of minors must follow the guidelines established in the
p.(None): Resolution 8430 of 1993.
...

Social / Access to information

Searching for indicator access to information:

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p.(None): There are situations that may generate a potential conflict of interest by the members of the Committee and by
p.(None): both skew the ideal development of its functions. These situations must be declared and
p.(None): communicate in a timely manner in order to generate relevant actions, such as abstention
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 8 of 12
p.(None): of evaluation and monitoring of specific studies. In turn, the Committee must establish and document how to handle the
p.(None): situation.
p.(None): Some circumstances that generate conflict of interest for the members of the Committee are mentioned below:
p.(None): Labor links with the sponsor such as consulting or advisory agreements, simultaneous participation as
p.(None): evaluation member of the Committee and as a researcher of research studies, owned by securities of
p.(None): signatures involved in studies submitted to the Committee's evaluation, familiar family relationship with
p.(None): participants and responsible for the study under evaluation, business relationship with participants and managers of the
p.(None): study under evaluation, past or present relationship with participants and responsible for the study under evaluation,
p.(None): relationships such as friendship, personal, close or enmity that could affect the judgment of the evaluator, among others.
p.(None): Membership in the Committee allows access to information with publication restrictions, which should be considered as a
p.(None): confidentiality policy that prevents the use of reserved information.
p.(None): 8. PROCEDURE
p.(None): A. Institutional authority under which the Committee is established
p.(None): It must be defined under what authority within the Research Center (Institution) you are
p.(None): constituted the Research Ethics Committee.
p.(None): To define the subordination it is necessary to clarify that the Ethics Committee is the highest authority in the center of
p.(None): research in what has to do with maintaining the safety of the research participant.
p.(None): Therefore, the Committee must always be on the process map of those in charge of
p.(None): approve, review and define the financial feasibility within the institution, such as: the researcher, office
p.(None): financial, clinical or scientific management (if these two offices have this function).
p.(None): He must be as an advisory body to the legal representative but never subordinate him.
p.(None): B. If you are free from direct subordination of that authority to deliberate and decide.
p.(None): It is necessary that the independence of the Ethics Committee be absolute not only from the legal point of view,
p.(None): but also in their concepts and decisions, which must be followed by all the actors within the
p.(None): organization to which they belong
p.(None): C. The methodology followed by the Committee to evaluate the proposals must be established in writing and
p.(None): specify at least:
...

Social / Age

Searching for indicator age:

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p.(None): procedures to be established are the periodic monitoring and evaluation that the Committee must have
p.(None): Ethics defined before the initial approval of the research project.
p.(None): 7. COMPOSITION
p.(None): It must be a multidisciplinary group, which is in the capacity to carry out an in-depth analysis of
p.(None): research projects and raise an approval criteria based on competencies, professionalism and
p.(None): Experience of its members.
p.(None): All committee members should have a critical sense of the aspects of the project of
p.(None): research, which should be reflected in the conclusions you make in each of the documents
p.(None): analyzed.
p.(None): All members must be trained and certified in Good Clinical Practice, certification that has
p.(None): Valid for two years.
p.(None): A. Number of Members that an Ethics Committee must have: The minimum number described in the regulations is five
p.(None): members, but it is necessary to contemplate the following aspects before defining it.
p.(None): You must guarantee all the minimum competencies necessary to evaluate a project of
p.(None): Investigation.
p.(None): It must agree to the number of studies that the Committee has in follow-up, always ensuring that
p.(None): there is no alteration of its analysis due to work overload.
p.(None): There may be evaluation subcommittees that assume some roles in the evaluation of research projects without
p.(None): decision power
p.(None): The members of the Committee must have adequate and sufficient time for the analysis and evaluation of the
p.(None): set tasks
p.(None): B. Balance by gender and age: The balance of age and gender must exist among the members of the Ethics Committee.
p.(None): C. Multidisciplinary nature: The Committee must have a multidisciplinary nature, due to the characteristics
p.(None): they will evaluate in a research project, because the different points of view make the analysis
p.(None): an invaluable tool to be the most accurate in the final approval decision.
p.(None): It is necessary that there is at least one member whose primary area of ​​interest is a non-scientific area. This is one
p.(None): competence necessary to have a different point of view from the doctor or in general from the area staff
p.(None): Of the health.
p.(None): There must be at least one doctor. This professional must be a person with competence and
p.(None): research experience, for the evaluation of the clinical aspects of the Research Project. The evaluation
p.(None): Clinic should be based on experience and evidence-based medicine.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 5 of 12
p.(None): The rule specifies that “there must be at least one member that is independent of the
p.(None): institution / site where the study will be carried out ”. Therefore, it should be taken into account that
p.(None): This statement must maintain the independence of the committee, avoiding any labor subordination.
p.(None): In addition to the characteristics described in the multidisciplinarity of the Committee, it is clear that the
...

Social / Incarcerated

Searching for indicator restricted:

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p.(None): This has to be done whenever any document or change to the research project is received.
p.(None): The responsibilities of this process fall primarily to the chairman of the Ethics Committee.
p.(None): B. Evaluate and approve or disapprove, before its start, the proposed investigations: For evaluation and subsequent
p.(None): approval or disapproval of the proposed investigations, the Ethics Committee must define the
p.(None): methodology, tools and procedures previously agreed to comply with this
p.(None): responsibility.
p.(None): First: The Committee must establish the criteria that it will take into account for the evaluation of the different documents
p.(None): Let them be analyzed.
p.(None): Second: Define according to the competencies of the members, their functions with respect to the evaluation of
p.(None): The aspects of the project.
p.(None): Third: Standardize procedures for the socialization of the results of the evaluation, monitoring and
p.(None): monitoring of recommendations to research projects, within the times established according to the
p.(None): regulations and the characteristics of the research project.
p.(None): Fourth: Define the measures that will be taken in case of non-compliance with their decisions. Fifth: The Committee must
p.(None): specify criteria to express potential conflicts of interest of its members, define and record the measures
p.(None): generated.
p.(None): C. Obtain and maintain the required documentation of each study put to your consideration: The Committee of
p.(None): Ethics must have a restricted access file with the appropriate security and confidentiality conditions.
p.(None): Therefore, it is essential that there is an infrastructure that ensures compliance with this
p.(None): responsibility, complying with the current document archiving standards.
p.(None): The minimum custody time of the documentation must be established and defined in the contract signed with the
p.(None): research Center.
p.(None): Have a qualified staff for custody and file management, with these specific functions.
p.(None): The Ethics Committee may have a magnetic file, as long as it meets the safety criteria and
p.(None): confidentiality of the information, which cannot be modified later and that
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 3 of 12
p.(None): they are also aligned with the quality management system of the Institution to which the Committee
p.(None): belong.
p.(None): D. Consider the competence of researchers: Establish the minimum criteria that the team must meet
p.(None): researcher who will develop the research project.
p.(None): These evaluation criteria must take into account the following:
p.(None): The evaluation of the resumes and the corresponding supports of the entire research team (researcher
p.(None): principal (IP), co-investigator or secondary researcher (IS), study coordinator, technical staff - (yes
p.(None): there will be) -, bacteriologist and pharmaceutical chemist).
...

Social / Property Ownership

Searching for indicator property:

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p.(None): disqualification, replacement of Committee members and resignation, which must include among other factors:
p.(None): conflicts of interest, the inability to violate them, as well as events that may affect the participation of
p.(None): a member within the Committee (disabilities, workload, training, etc.).
p.(None): The records of the declaration of conflicts of interest of the members of the Committee, as well as the
p.(None): generated actions.
p.(None): In addition, responsibilities and functions must be defined according to the position held within the Committee:
p.(None): President.
p.(None): Preside over the meetings and will be the spokesperson for the socialization committee.
p.(None): Sign the minutes, correspondence, informed consent form and the format established by INVIMA to
p.(None): the submission of institutions, new protocols and other related documents.
p.(None): To be the spokesperson before INVIMA of the decisions, concerns, measures and questions that are had within a project of
p.(None): investigation.
p.(None): Assign the functions to the members of the Committee.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 7 of 12
p.(None): Secretary.
p.(None): Coordinate the timely delivery and according to the competencies of all correspondence and documents
p.(None): which will be submitted for evaluation to each of the members of the Committee.
p.(None): It must be clarified that there may be the secretary on the property of the Ethics Committee who can have a say and vote and
p.(None): the Administrative Secretary with a technical profile for file and correspondence management, who
p.(None): It has no voice or vote, functions that must be defined for each case.
p.(None): Active member.
p.(None): It must fulfill the functions assigned to it by the Chairman of the Ethics Committee within the Committee, such as
p.(None): the functions within the evaluation of the study.
p.(None): H. Quorum requirements for session and deliberation: The number of required members must be established
p.(None): to meet and the minimum number, disciplines and qualifications for quorum compliance. These guidelines
p.(None): They must be defined by the Chairman of the Committee.
p.(None): The minimum quorum could be established as follows: It must be half plus one (1)
p.(None): Be a minimum of five members.
p.(None): The President must be
p.(None): There must be at least one medical member There must be at least one non-scientific member The Representative must be
p.(None): of the community.
p.(None): Considerations:
p.(None): It is not recommended to session a new research project with the minimum quorum or any other
p.(None): submission where the evaluation suspects damage to the research participant.
p.(None): In the absence of the Chairman of the Committee, there must be a chairman in charge who assumes the functions of
p.(None): charge for that session.
p.(None): I. Description of the training or training that the members of the Committee must have.
p.(None): There should be a continuous training program in research topics such as: Research methodology
p.(None): Research bioethics Database analysis Informed Consent
p.(None): Update on Good Clinical Practices Normative in Research
...

Social / Religion

Searching for indicator religious:

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p.(None): A member who is a pharmaceutical chemist, to advise on the evaluation of the part
p.(None): pharmacological research project and evaluation of adverse events in what has to do with the
p.(None): drug interactions
p.(None): With respect to community representatives, it must be ensured that these personnel also have a criterion
p.(None): analytical but always focused on the point of view of the research participant and the research project.
p.(None): It would be appropriate if you have previously been a participant in any research study.
p.(None): All the members described above, with the exception of the community representative, may be
p.(None): convened under the figure of external advisors or consultants and it will depend on each committee if these external advisors
p.(None): They have voice or vote.
p.(None): Within the members of the Ethics Committee there may be researchers from the projects of
p.(None): Research being evaluated or other members of the research team. However, a researcher has the
p.(None): restriction to be a member of the committee when:
p.(None): He is the Chairman of the Committee
p.(None): You have conflicts of interest because you participate in the development of studies evaluated by the Committee, or because your
p.(None): affiliations or relationships imply bias for the development of the evaluation by the Committee. I know
p.(None): you should keep in mind that if it is the only IP or IS of the majority of studies that the Committee is following,
p.(None): it would not be appropriate to lose a member of the committee due to permanent impediments.
p.(None): Have any interest from the labor, personal, family, economic, social, religious and / or academic point of view with
p.(None): the sponsor of the study that is carrying out the protocol.
p.(None): It does not timely inform if there is a conflict of interest in the exercise as a member of the Committee.
p.(None): D. On the participation of consultants (when applicable): The participation of external consultants is given by the
p.(None): specific training of these in subjects where there is no profile within the members of the
p.(None): Committee to perform the analysis of a research proposal that requires a specialized concept in
p.(None): any area
p.(None): The independence of external consultants should be ensured in relation to sponsors or any other
p.(None): entity that generates conflicts of interest.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 6 of 12
p.(None): E. Requirements and processes for the selection of members in terms of the following aspects: The person (s)
p.(None): in charge of selecting the members of the Committee must be absolutely independent of the persons
p.(None): responsible for reviewing the convenience and feasibility of the research project within the center of
p.(None): investigation.
p.(None): In general, it is better that this appointment be proper to the Ethics Committee and that there is a consensus
p.(None): General for the evaluation of the new member. It is essential that there are several candidates.
p.(None): It is necessary to define what are the conflicts of interest and disabilities that will be in
...

Social / gender

Searching for indicator gender:

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p.(None): procedures to be established are the periodic monitoring and evaluation that the Committee must have
p.(None): Ethics defined before the initial approval of the research project.
p.(None): 7. COMPOSITION
p.(None): It must be a multidisciplinary group, which is in the capacity to carry out an in-depth analysis of
p.(None): research projects and raise an approval criteria based on competencies, professionalism and
p.(None): Experience of its members.
p.(None): All committee members should have a critical sense of the aspects of the project of
p.(None): research, which should be reflected in the conclusions you make in each of the documents
p.(None): analyzed.
p.(None): All members must be trained and certified in Good Clinical Practice, certification that has
p.(None): Valid for two years.
p.(None): A. Number of Members that an Ethics Committee must have: The minimum number described in the regulations is five
p.(None): members, but it is necessary to contemplate the following aspects before defining it.
p.(None): You must guarantee all the minimum competencies necessary to evaluate a project of
p.(None): Investigation.
p.(None): It must agree to the number of studies that the Committee has in follow-up, always ensuring that
p.(None): there is no alteration of its analysis due to work overload.
p.(None): There may be evaluation subcommittees that assume some roles in the evaluation of research projects without
p.(None): decision power
p.(None): The members of the Committee must have adequate and sufficient time for the analysis and evaluation of the
p.(None): set tasks
p.(None): B. Balance by gender and age: The balance of age and gender must exist among the members of the Ethics Committee.
p.(None): C. Multidisciplinary nature: The Committee must have a multidisciplinary nature, due to the characteristics
p.(None): they will evaluate in a research project, because the different points of view make the analysis
p.(None): an invaluable tool to be the most accurate in the final approval decision.
p.(None): It is necessary that there is at least one member whose primary area of ​​interest is a non-scientific area. This is one
p.(None): competence necessary to have a different point of view from the doctor or in general from the area staff
p.(None): Of the health.
p.(None): There must be at least one doctor. This professional must be a person with competence and
p.(None): research experience, for the evaluation of the clinical aspects of the Research Project. The evaluation
p.(None): Clinic should be based on experience and evidence-based medicine.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 5 of 12
p.(None): The rule specifies that “there must be at least one member that is independent of the
p.(None): institution / site where the study will be carried out ”. Therefore, it should be taken into account that
p.(None): This statement must maintain the independence of the committee, avoiding any labor subordination.
p.(None): In addition to the characteristics described in the multidisciplinarity of the Committee, it is clear that the
p.(None): following competences for the evaluation and monitoring of a Research Project.
...

General/Other / Relationship to Authority

Searching for indicator authority:

(return to top)
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 1 of 12
p.(None): 1. OBJECTIVE:
p.(None): Provide the guidelines that the user must take into account for the conformation, procedures, monitoring,
p.(None): surveillance and interaction of the Independent Ethics Committees with INVIMA.
p.(None): 2. REACH:
p.(None): This informative document is addressed to ethics committees and actors involved in research with
p.(None): human beings in the National territory (IPS, EPS, Universities, Sponsors, Territorial entities,
p.(None): Researchers, research subjects or any entity that wants to carry out a research project with
p.(None): medications in humans).
p.(None): 3. DEFINITIONS
p.(None): Refer to the definitions established in Resolution 2378 of 2008 of June 27, 2008.
p.(None): 4. ETHICS COMMITTEE
p.(None): The Ethics Committee is the organization responsible for guaranteeing the protection of rights, security
p.(None): and well-being of the human beings involved in a clinical study through the review,
p.(None): approval and constant monitoring of the research project, amendments, informed consent of the
p.(None): Study participants, among other related documents.
p.(None): This evaluation should always be focused on the integrity of the study participant, above the
p.(None): feasibility that involves conducting a research study in a Center or IPS.
p.(None): For this reason the Ethics Committee is the highest authority within the Research Center in what has to do with
p.(None): maintaining the integrity of the research participant.
p.(None): 5. PROCEDURES OF THE ETHICS COMMITTEE
p.(None): The Ethics Committee must have a document (guide, statute, etc.), which includes all procedures
p.(None): what you should do in the investigation. These procedures must be in constant updating and socialization of
p.(None): according to the advances in the field of Good Clinical Practices.
p.(None): The minimum responsibilities to be met by an Ethics Committee must be defined, according to the
p.(None): national regulations in force and supported by international regulations.
p.(None): 6. RESPONSIBILITIES
p.(None): All research carried out in human beings must be evaluated and approved by the Ethics Committee. The Committee must
p.(None): evaluate the research project, the researcher's competencies and the competencies of his team of
p.(None): investigation; the informed consent form, the known information about the drug
p.(None): (including reports of unexpected and expected adverse events) and all potential publicity
p.(None): planned to obtain possible participants, in addition to any change in the protocol, however insignificant this
p.(None): be.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
...

p.(None): communicate in a timely manner in order to generate relevant actions, such as abstention
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 8 of 12
p.(None): of evaluation and monitoring of specific studies. In turn, the Committee must establish and document how to handle the
p.(None): situation.
p.(None): Some circumstances that generate conflict of interest for the members of the Committee are mentioned below:
p.(None): Labor links with the sponsor such as consulting or advisory agreements, simultaneous participation as
p.(None): evaluation member of the Committee and as a researcher of research studies, owned by securities of
p.(None): signatures involved in studies submitted to the Committee's evaluation, familiar family relationship with
p.(None): participants and responsible for the study under evaluation, business relationship with participants and managers of the
p.(None): study under evaluation, past or present relationship with participants and responsible for the study under evaluation,
p.(None): relationships such as friendship, personal, close or enmity that could affect the judgment of the evaluator, among others.
p.(None): Membership in the Committee allows access to information with publication restrictions, which should be considered as a
p.(None): confidentiality policy that prevents the use of reserved information.
p.(None): 8. PROCEDURE
p.(None): A. Institutional authority under which the Committee is established
p.(None): It must be defined under what authority within the Research Center (Institution) you are
p.(None): constituted the Research Ethics Committee.
p.(None): To define the subordination it is necessary to clarify that the Ethics Committee is the highest authority in the center of
p.(None): research in what has to do with maintaining the safety of the research participant.
p.(None): Therefore, the Committee must always be on the process map of those in charge of
p.(None): approve, review and define the financial feasibility within the institution, such as: the researcher, office
p.(None): financial, clinical or scientific management (if these two offices have this function).
p.(None): He must be as an advisory body to the legal representative but never subordinate him.
p.(None): B. If you are free from direct subordination of that authority to deliberate and decide.
p.(None): It is necessary that the independence of the Ethics Committee be absolute not only from the legal point of view,
p.(None): but also in their concepts and decisions, which must be followed by all the actors within the
p.(None): organization to which they belong
p.(None): C. The methodology followed by the Committee to evaluate the proposals must be established in writing and
p.(None): specify at least:
p.(None): The Procedure must be in the Operational Guides of the Committee according to the Quality Management System.
p.(None): You must include a list of the minimum documents to be submitted.
p.(None): You must have a tool (checklist, logbook, etc.) that allows you to evaluate all the documents of the
p.(None): investigation project. This tool should have a checklist that meets the evaluation criteria
p.(None): of the documents and have a space that is mandatory filling in where the evaluating member exposes their
p.(None): points of view. It is recommended to have one of these separate tools for each of the documents.
p.(None): D. Minimum documents to be evaluated for each research project
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 9 of 12
p.(None): Researcher's Manual: The general purpose of this document is to provide the researcher with a
p.(None): clear knowledge of possible risks and adverse reactions, as well as specific tests,
p.(None): observations and precautions that may be necessary in a clinical trial.
...

p.(None): adverse reactions or events.
p.(None): That the investigator does not notify about new information that may affect the safety of
p.(None): participants or the conduct of the study.
p.(None): Investigators should be informed about the sanctions that cause non-compliance with this
p.(None): numeral.
p.(None): The Ethics Committee, due to its constitution, cannot take judicial measures of a sanitary nature against the Center for
p.(None): Investigation, neither against the Investigator or the study sponsor, but it can impose
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 12 of 12
p.(None): sanctions when in defense of the protection of the welfare of research participants, what
p.(None): consider necessary. These sanctions can be among others:
p.(None): Warning call Warning
p.(None): Suspension of the approval of the research project, a measure that immediately generates remission or
p.(None): report to the regulatory entity (INVIMA) and the sponsor.
p.(None): 9. CONSIDERATIONS ABOUT THE ETHICS COMMITTEE
p.(None): Among the considerations about the Ethics Committee, the following should be established:
p.(None): The Ethics Committee is the highest authority in relation to the safety of the participant of
p.(None): investigation; therefore, it will not be subject to any external influence and all actors (sponsor, center
p.(None): of investigation, research group) must comply with the decisions and / or measures that are generated from it.
p.(None): In case such decisions are not followed, the Committee will have the support and obligation to report said decisions.
p.(None): irregularities to INVIMA. The Committee, by virtue of its composition and competence, can refute the analyzes, decisions
p.(None): and changes in the research project, which according to its criteria affect the safety of the participant in the
p.(None): center that is endorsing. According to the above, the Committee may define the qualification of an adverse event not
p.(None): serious to a serious adverse event above the investigator's criteria, as long as this decision
p.(None): Affect the participant.
p.(None): In case of deviations or violations committed by the principal investigator, the Ethics Committee establishes
p.(None): If this report is adequate, according to the provisions of the protocol and the security of the
p.(None): competitor.
p.(None): The Committee must have a budget with its own resources, either generated by the research center to which
p.(None): find attached, or by resources derived from its services. This budget must be handled sovereignly by
p.(None): the Committee, which can be made public and must have items intended for operation
p.(None): routine, stationery, office maintenance, human resources, file management, training and,
p.(None): if it is contemplated, the payment of fees of its members.
p.(None): The ethics committee should not receive the sponsor's budget directly, it must be managed by the
...

General/Other / belmont

Searching for indicator belmont:

(return to top)
p.(None): evaluate the research project, the researcher's competencies and the competencies of his team of
p.(None): investigation; the informed consent form, the known information about the drug
p.(None): (including reports of unexpected and expected adverse events) and all potential publicity
p.(None): planned to obtain possible participants, in addition to any change in the protocol, however insignificant this
p.(None): be.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 2 of 12
p.(None): Research projects of institutions that do not have an Institutional Ethics Committee must be
p.(None): approved by an Ethics Committee of another institution that has been evaluated and certified in the
p.(None): compliance with Good Clinical Practices, document issued by the National Surveillance Institute of
p.(None): Medications and Foods - INVIMA.
p.(None): The national and international guidelines of Good Clinical Practices should be accepted and the ethical framework should
p.(None): be based on the principles contemplated among others, in the Nuremberg Code of Ethics, the Declaration of Helsinki,
p.(None): the Belmont Report and international ethical guidelines for biomedical research in humans
p.(None): (CIOMS).
p.(None): Every Ethics Committee must define its code of conduct, its conflict of interest management policy and its
p.(None): operation must be consistent with them, in such a way that partiality or biases in the results are prevented
p.(None): of the exercise of the Committee.
p.(None): A. Safeguard the rights of research participants: The objective that the Ethics Committee should have
p.(None): as a priority in the evaluation of research studies - above feasibility - is to ensure the
p.(None): protection of the rights, security and welfare of the participants.
p.(None): This has to be done whenever any document or change to the research project is received.
p.(None): The responsibilities of this process fall primarily to the chairman of the Ethics Committee.
p.(None): B. Evaluate and approve or disapprove, before its start, the proposed investigations: For evaluation and subsequent
p.(None): approval or disapproval of the proposed investigations, the Ethics Committee must define the
p.(None): methodology, tools and procedures previously agreed to comply with this
p.(None): responsibility.
p.(None): First: The Committee must establish the criteria that it will take into account for the evaluation of the different documents
p.(None): Let them be analyzed.
p.(None): Second: Define according to the competencies of the members, their functions with respect to the evaluation of
p.(None): The aspects of the project.
...

General/Other / cioms guidelines

Searching for indicator cioms:

(return to top)
p.(None): investigation; the informed consent form, the known information about the drug
p.(None): (including reports of unexpected and expected adverse events) and all potential publicity
p.(None): planned to obtain possible participants, in addition to any change in the protocol, however insignificant this
p.(None): be.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 2 of 12
p.(None): Research projects of institutions that do not have an Institutional Ethics Committee must be
p.(None): approved by an Ethics Committee of another institution that has been evaluated and certified in the
p.(None): compliance with Good Clinical Practices, document issued by the National Surveillance Institute of
p.(None): Medications and Foods - INVIMA.
p.(None): The national and international guidelines of Good Clinical Practices should be accepted and the ethical framework should
p.(None): be based on the principles contemplated among others, in the Nuremberg Code of Ethics, the Declaration of Helsinki,
p.(None): the Belmont Report and international ethical guidelines for biomedical research in humans
p.(None): (CIOMS).
p.(None): Every Ethics Committee must define its code of conduct, its conflict of interest management policy and its
p.(None): operation must be consistent with them, in such a way that partiality or biases in the results are prevented
p.(None): of the exercise of the Committee.
p.(None): A. Safeguard the rights of research participants: The objective that the Ethics Committee should have
p.(None): as a priority in the evaluation of research studies - above feasibility - is to ensure the
p.(None): protection of the rights, security and welfare of the participants.
p.(None): This has to be done whenever any document or change to the research project is received.
p.(None): The responsibilities of this process fall primarily to the chairman of the Ethics Committee.
p.(None): B. Evaluate and approve or disapprove, before its start, the proposed investigations: For evaluation and subsequent
p.(None): approval or disapproval of the proposed investigations, the Ethics Committee must define the
p.(None): methodology, tools and procedures previously agreed to comply with this
p.(None): responsibility.
p.(None): First: The Committee must establish the criteria that it will take into account for the evaluation of the different documents
p.(None): Let them be analyzed.
p.(None): Second: Define according to the competencies of the members, their functions with respect to the evaluation of
p.(None): The aspects of the project.
p.(None): Third: Standardize procedures for the socialization of the results of the evaluation, monitoring and
...

General/Other / declaration of helsinki

Searching for indicator helsinki:

(return to top)
p.(None): evaluate the research project, the researcher's competencies and the competencies of his team of
p.(None): investigation; the informed consent form, the known information about the drug
p.(None): (including reports of unexpected and expected adverse events) and all potential publicity
p.(None): planned to obtain possible participants, in addition to any change in the protocol, however insignificant this
p.(None): be.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 2 of 12
p.(None): Research projects of institutions that do not have an Institutional Ethics Committee must be
p.(None): approved by an Ethics Committee of another institution that has been evaluated and certified in the
p.(None): compliance with Good Clinical Practices, document issued by the National Surveillance Institute of
p.(None): Medications and Foods - INVIMA.
p.(None): The national and international guidelines of Good Clinical Practices should be accepted and the ethical framework should
p.(None): be based on the principles contemplated among others, in the Nuremberg Code of Ethics, the Declaration of Helsinki,
p.(None): the Belmont Report and international ethical guidelines for biomedical research in humans
p.(None): (CIOMS).
p.(None): Every Ethics Committee must define its code of conduct, its conflict of interest management policy and its
p.(None): operation must be consistent with them, in such a way that partiality or biases in the results are prevented
p.(None): of the exercise of the Committee.
p.(None): A. Safeguard the rights of research participants: The objective that the Ethics Committee should have
p.(None): as a priority in the evaluation of research studies - above feasibility - is to ensure the
p.(None): protection of the rights, security and welfare of the participants.
p.(None): This has to be done whenever any document or change to the research project is received.
p.(None): The responsibilities of this process fall primarily to the chairman of the Ethics Committee.
p.(None): B. Evaluate and approve or disapprove, before its start, the proposed investigations: For evaluation and subsequent
p.(None): approval or disapproval of the proposed investigations, the Ethics Committee must define the
p.(None): methodology, tools and procedures previously agreed to comply with this
p.(None): responsibility.
p.(None): First: The Committee must establish the criteria that it will take into account for the evaluation of the different documents
p.(None): Let them be analyzed.
...


Orphaned Trigger Words



p.(None): confidentiality of the information, which cannot be modified later and that
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 3 of 12
p.(None): they are also aligned with the quality management system of the Institution to which the Committee
p.(None): belong.
p.(None): D. Consider the competence of researchers: Establish the minimum criteria that the team must meet
p.(None): researcher who will develop the research project.
p.(None): These evaluation criteria must take into account the following:
p.(None): The evaluation of the resumes and the corresponding supports of the entire research team (researcher
p.(None): principal (IP), co-investigator or secondary researcher (IS), study coordinator, technical staff - (yes
p.(None): there will be) -, bacteriologist and pharmaceutical chemist).
p.(None): Professional degrees (diploma with their respective degree certificate) and a document certifying that the IPS has
p.(None): verified the professional degree with the respective university, postgraduate approvals made in
p.(None): abroad by the competent national entity, national professional card and the secretary
p.(None): sectional according to the profession, certifications in good clinical practices for two years,
p.(None): type of employment contract with the research center and labor contract that includes the functions with
p.(None): Regarding the study, photocopy of the updated or foreign citizenship card.
p.(None): In the letter of submission of the Principal or Secondary Investigator to the Ethics Committee, the time must be specified
p.(None): of dedication to which the researcher undertakes to carry out the research in the study and the
p.(None): number of protocols in which it conducts research, so that the Ethics Committee determines whether the time
p.(None): Dedicated by the researcher is suitable for conducting the study. Attaching the respective supports of
p.(None): The resume. The responsibility for the approval of each researcher (IP or IS) is the Committee of
p.(None): ethics, so only the Principal Investigator will be submitted to INVIMA.
p.(None): Evaluation researchers: The competencies of the Researcher must be in accordance with the specialty
p.(None): Research project clinic. If the IP has the research experience but does not comply with the
p.(None): clinical experience related to the specialty, this can be complemented by the
p.(None): IS.
p.(None): That the professional clinical care experience be a minimum of 3 years.
p.(None): That the IP Research experience be of a minimum of 2 years.
p.(None): It is accepted by INVIMA that a Principal Investigator be a professional in the area of ​​health specialized in
p.(None): a postgraduate in research (epidemiology, clinical essayist, public health) and minimal experience in
p.(None): same, as long as it is supported by an SI with the clinical specialty of the project subject of
p.(None): research and that within the functions of this is the clinical assessment, application of the criteria of
p.(None): inclusion, exclusion, medical decisions and clinical follow-up to research subjects.
p.(None): Research Team:
p.(None): Coordinator of studies: You must be a professional in the area of ​​health, with experience in
p.(None): research, supported in training, certification in Good Clinical Practices, updated and valid for
p.(None): two years.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 4 of 12
p.(None): Bacteriologist: Must be a professional in bacteriology with IATA certification (International Air Transport
p.(None): Association) in force, certification in good clinical practices with a validity of two years and with a professional card
p.(None): valid.
p.(None): Pharmaceutical Chemist: You must be a professional in pharmaceutical chemistry, with a professional card from the college of
p.(None): Pharmaceutical and sectional secretary chemists, certified in good clinical practice with
p.(None): validity of two years.
p.(None): E. Periodically evaluate the progress of approved and developing studies: Within
p.(None): procedures to be established are the periodic monitoring and evaluation that the Committee must have
p.(None): Ethics defined before the initial approval of the research project.
p.(None): 7. COMPOSITION
p.(None): It must be a multidisciplinary group, which is in the capacity to carry out an in-depth analysis of
p.(None): research projects and raise an approval criteria based on competencies, professionalism and
p.(None): Experience of its members.
p.(None): All committee members should have a critical sense of the aspects of the project of
p.(None): research, which should be reflected in the conclusions you make in each of the documents
p.(None): analyzed.
p.(None): All members must be trained and certified in Good Clinical Practice, certification that has
p.(None): Valid for two years.
p.(None): A. Number of Members that an Ethics Committee must have: The minimum number described in the regulations is five ...

p.(None): Study Budget: The Ethics Committee must verify in the budget that will be considered
p.(None): for the realization of the protocol, that all the expenses that have to do with the project of
p.(None): research are covered by the same budget of the study and that the own resources of the study will not be used
p.(None): research participant, contemplating the budget for food and transportation for the participant
p.(None): of the study, if applicable.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 10 of 12
p.(None): Insurance policy for participants: The committee must verify that the policy is in force, which
p.(None): cover adverse events of the study, compensation in case of death and also must verify the
p.(None): accessibility of said policy.
p.(None): Contract: There must be a contractual agreement between the sponsor and the institution / researcher, which must be
p.(None): signed by the legal representative of each of the parties, document that must include aspects such as: term of
p.(None): contract, budget and method of payment, responsibilities of the parties, confidentiality, insurance or compensation,
p.(None): conflicts of interest, measures or penalties in case of non-compliance, file retention time, between
p.(None): others.
p.(None): Similarly, agreements made between other parties involved in the clinical trial must be in writing, between
p.(None): the institution and contracted services such as the ethics committee, clinical laboratory or other services
p.(None): hired
p.(None): It must be defined according to the profile of the member of the Ethics Committee who must evaluate each of the documents of the
p.(None): investigation project. This procedure will also depend on the evaluation time of each document and
p.(None): the workload of each member. These functions must be defined by the Chairman of the Committee or
p.(None): by whom he delegates, as well as the minimum documents that each member must evaluate.
p.(None): There must be a documentary support of said evaluation, which must contain the considerations and
p.(None): opinions of each of the evaluators. All committee members must participate actively within the
p.(None): Evaluation of the research project.
p.(None): A maximum evaluation time of each of the documents should be considered; this time must be
p.(None): coordinated with the meeting schedule. The predefined method to reach a decision must be established (by
p.(None): consensus, by vote) and decision mechanisms when consensus is not reached, which can be cited
p.(None): to the researcher, sponsor or external consultant for further information. In case one or more
p.(None): members declare conflicts of interest, a Restriction Policy must be defined to establish
p.(None): mechanisms of how these people can participate in the evaluation of the proposals.
p.(None): E. The committee must establish the requirements and mechanisms for approval
p.(None): expedited / extraordinary, including:
p.(None): Studies that can be evaluated through this type of approval.
p.(None): Be clear that this procedure is acceptable only for those studies and / or
p.(None): procedures that carry only a minimum risk for the subject of investigation.
p.(None): The procedure to follow for the review
p.(None): The mechanism for ratification by the committee of the decision taken expeditiously. The
p.(None): approval of studies with medications for the first time.
p.(None): F. The Committee must notify the investigator in writing within two weeks after the meeting
p.(None): the decisions taken regarding the project under evaluation. This notice must include, as
p.(None): minimum:
p.(None): Study ID Documents studied.
p.(None): Evaluation date and minutes of the corresponding session. Decisions or opinions related to the study.
p.(None): Reasons for decisions, especially in case of failure.
p.(None): THIS PRINTED DOCUMENT IS AN UNCONTROLLED COPY
p.(None): To view the controlled document go to www.invima.gov.co/procesos
p.(None): HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
p.(None): ASSOCIATES
p.(None): GUIDE FOR THE RESEARCH ETHICS COMMITTEES
p.(None): Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 11 of 12
p.(None): Procedures that the researcher must follow to submit the project to reconsideration.
p.(None): G. The Committee must have measures to ensure the success of its sessions. These include:
p.(None): Schedule Committee sessions with due priority. Timely notify members.
p.(None): Send to each member previously the necessary documents for the session. Record what was discussed in an act and
p.(None): decided.
p.(None): Keep the record of the minutes.
p.(None): Maintain the correspondence files to the members of the Committee.
p.(None): H. The procedures established by the Committee to follow the course of
p.(None): studies from approval to completion.
p.(None): The Committee must have a procedure to monitor each of the research projects
p.(None): That are submitted for consideration.
p.(None): When the Committee approves the research project for the first time, it must define in that approval and taking into account
p.(None): account of the characteristics of the study, how often the researcher must report the progress. This report
p.(None): it must be done at least once a year according to national regulation, but the Committee is free to establish
p.(None): a shorter time according to the case.
p.(None): For the Periodic Report, the following must be considered at least: number of subjects
p.(None): recruited, latest version of the project, summary of adverse events, summary of unanticipated problems,
p.(None): Summary of new information available and copy of current consent.
p.(None): The committee must have established an evaluation audit mechanism to the centers of
p.(None): research where the studies submitted are carried out. The periodicity is freely established
p.(None): by the Committee but must be predefined according to the type of study. For these audits a format must be designed
p.(None): of audit that includes all the aspects that are in the norm adding the own criteria of the committee.
p.(None): In these audits, the following must be reviewed, among others: the progress of the studies submitted, the evaluation of
p.(None): serious adverse events, deviations and violations presented to the protocol, the recruitment rate and the
p.(None): proposed recruitment goal.
p.(None): I. The committee must establish procedures and measures in case of finding irregularities.
p.(None): The measures to be taken should be defined in case of finding irregularities in the conduct of the Projects
p.(None): research. The actions that can generate these measures, are among others:
p.(None): Inclusion of participants in a study before the committee issues its written approval. Implement without prior
p.(None): Notice of changes - amendments to the project.
p.(None): Failure to submit reports for project monitoring.
p.(None): The absence of notification by the investigator of deviations from the project and of the
p.(None): adverse reactions or events.
p.(None): That the investigator does not notify about new information that may affect the safety of
p.(None): participants or the conduct of the study.
p.(None): Investigators should be informed about the sanctions that cause non-compliance with this
p.(None): numeral.
p.(None): The Ethics Committee, due to its constitution, cannot take judicial measures of a sanitary nature against the Center for ...

Appendix

Indicator List

IndicatorVulnerability
accessAccess to Social Goods
access to informationAccess to information
ageAge
authorityRelationship to Authority
belmontbelmont
ciomscioms guidelines
drugDrug Usage
familyMotherhood/Family
gendergender
helsinkideclaration of helsinki
influenceDrug Usage
propertyProperty Ownership
religiousReligion
restrictedIncarcerated
vulnerablevulnerable

Indicator Peers (Indicators in Same Vulnerability)

IndicatorPeers
drug['influence']
influence['drug']

Trigger Words

capacity

consent

developing

ethics

protection

risk

welfare


Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability TypeVulnerabilityIndicator# Matches
Politicalvulnerablevulnerable1
HealthDrug Usagedrug4
HealthDrug Usageinfluence1
HealthMotherhood/Familyfamily3
SocialAccess to Social Goodsaccess2
SocialAccess to informationaccess to information1
SocialAgeage2
SocialIncarceratedrestricted1
SocialProperty Ownershipproperty1
SocialReligionreligious1
Socialgendergender2
General/OtherRelationship to Authorityauthority6
General/Otherbelmontbelmont1
General/Othercioms guidelinescioms1
General/Otherdeclaration of helsinkihelsinki1