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 Type	Vulnerability	Indicator	# Matches
Political	vulnerable	vulnerable	1
Health	Drug Usage	drug	4
Health	Drug Usage	influence	1
Health	Motherhood/Family	family	3
Social	Access to Social Goods	access	2
Social	Access to information	access to information	1
Social	Age	age	2
Social	Incarcerated	restricted	1
Social	Property Ownership	property	1
Social	Religion	religious	1
Social	gender	gender	2
General/Other	Relationship to Authority	authority	6
General/Other	belmont	belmont	1
General/Other	cioms guidelines	cioms	1
General/Other	declaration of helsinki	helsinki	1

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.
...

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.
...

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:
...

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
...

Searching for indicator restricted:

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
...

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
...

Searching for indicator gender:

General/Other / Relationship to Authority

Searching for indicator authority:

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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:

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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:

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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:

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

Indicator	Vulnerability
access	Access to Social Goods
access to information	Access to information
age	Age
authority	Relationship to Authority
belmont	belmont
cioms	cioms guidelines
drug	Drug Usage
family	Motherhood/Family
gender	gender
helsinki	declaration of helsinki
influence	Drug Usage
property	Property Ownership
religious	Religion
restricted	Incarcerated
vulnerable	vulnerable

Indicator Peers (Indicators in Same Vulnerability)

Indicator	Peers
drug	['influence']
influence	['drug']

Trigger Words

capacity

consent

developing

ethics

protection

risk

welfare

Applicable Type / Vulnerability / Indicator Overlay for this Input

Vulnerability Type	Vulnerability	Indicator	# Matches
Political	vulnerable	vulnerable	1
Health	Drug Usage	drug	4
Health	Drug Usage	influence	1
Health	Motherhood/Family	family	3
Social	Access to Social Goods	access	2
Social	Access to information	access to information	1
Social	Age	age	2
Social	Incarcerated	restricted	1
Social	Property Ownership	property	1
Social	Religion	religious	1
Social	gender	gender	2
General/Other	Relationship to Authority	authority	6
General/Other	belmont	belmont	1
General/Other	cioms guidelines	cioms	1
General/Other	declaration of helsinki	helsinki	1

Guide for Ethics Committees

Applicable Type / Vulnerability / Indicator Overlay for this Input

Political / vulnerable

Health / Drug Usage

Health / Motherhood/Family

Social / Access to Social Goods

Social / Access to information

Social / Age

Social / Incarcerated

Social / Property Ownership

Social / Religion

Social / gender

General/Other / Relationship to Authority

General/Other / belmont

General/Other / cioms guidelines

General/Other / declaration of helsinki

Orphaned Trigger Words

Appendix

Indicator List

Indicator Peers (Indicators in Same Vulnerability)

Trigger Words

Applicable Type / Vulnerability / Indicator Overlay for this Input