HEALTH INSURANCE SANITARY RECORDS AND PROCEDURES
ASSOCIATES
GUIDE FOR THE RESEARCH ETHICS COMMITTEES
Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 1 of 12
1. OBJECTIVE:
Provide the guidelines that the user must take into account for the conformation, procedures, monitoring,
surveillance and interaction of the Independent Ethics Committees with INVIMA.
2. REACH:
This informative document is addressed to ethics committees and actors involved in research with
human beings in the National territory (IPS, EPS, Universities, Sponsors, Territorial entities,
Researchers, research subjects or any entity that wants to carry out a research project with
medications in humans).
3. DEFINITIONS
Refer to the definitions established in Resolution 2378 of 2008 of June 27, 2008.
4. ETHICS COMMITTEE
The Ethics Committee is the organization responsible for guaranteeing the protection of rights, security
and well-being of the human beings involved in a clinical study through the review,
approval and constant monitoring of the research project, amendments, informed consent of the
Study participants, among other related documents.
This evaluation should always be focused on the integrity of the study participant, above the
feasibility that involves conducting a research study in a Center or IPS.
For this reason the Ethics Committee is the highest authority within the Research Center in what has to do with
maintaining the integrity of the research participant.
5. PROCEDURES OF THE ETHICS COMMITTEE
The Ethics Committee must have a document (guide, statute, etc.), which includes all procedures
what you should do in the investigation. These procedures must be in constant updating and socialization of
according to the advances in the field of Good Clinical Practices.
The minimum responsibilities to be met by an Ethics Committee must be defined, according to the
national regulations in force and supported by international regulations.
6. RESPONSIBILITIES
All research carried out in human beings must be evaluated and approved by the Ethics Committee. The Committee must
evaluate the research project, the researcher's competencies and the competencies of his team of
investigation; the informed consent form, the known information about the drug
(including reports of unexpected and expected adverse events) and all potential publicity
planned to obtain possible participants, in addition to any change in the protocol, however insignificant this
be.
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Research projects of institutions that do not have an Institutional Ethics Committee must be
approved by an Ethics Committee of another institution that has been evaluated and certified in the
compliance with Good Clinical Practices, document issued by the National Surveillance Institute of
Medications and Foods - INVIMA.
The national and international guidelines of Good Clinical Practices should be accepted and the ethical framework should
be based on the principles contemplated among others, in the Nuremberg Code of Ethics, the Declaration of Helsinki,
the Belmont Report and international ethical guidelines for biomedical research in humans
(CIOMS).
Every Ethics Committee must define its code of conduct, its conflict of interest management policy and its
operation must be consistent with them, in such a way that partiality or biases in the results are prevented
of the exercise of the Committee.
A. Safeguard the rights of research participants: The objective that the Ethics Committee should have
as a priority in the evaluation of research studies - above feasibility - is to ensure the
protection of the rights, security and welfare of the participants.
This has to be done whenever any document or change to the research project is received.
The responsibilities of this process fall primarily to the chairman of the Ethics Committee.
B. Evaluate and approve or disapprove, before its start, the proposed investigations: For evaluation and subsequent
approval or disapproval of the proposed investigations, the Ethics Committee must define the
methodology, tools and procedures previously agreed to comply with this
responsibility.
First: The Committee must establish the criteria that it will take into account for the evaluation of the different documents
Let them be analyzed.
Second: Define according to the competencies of the members, their functions with respect to the evaluation of
The aspects of the project.
Third: Standardize procedures for the socialization of the results of the evaluation, monitoring and
monitoring of recommendations to research projects, within the times established according to the
regulations and the characteristics of the research project.
Fourth: Define the measures that will be taken in case of non-compliance with their decisions. Fifth: The Committee must
specify criteria to express potential conflicts of interest of its members, define and record the measures
generated.
C. Obtain and maintain the required documentation of each study put to your consideration: The Committee of
Ethics must have a restricted access file with the appropriate security and confidentiality conditions.
Therefore, it is essential that there is an infrastructure that ensures compliance with this
responsibility, complying with the current document archiving standards.
The minimum custody time of the documentation must be established and defined in the contract signed with the
research Center.
Have a qualified staff for custody and file management, with these specific functions.
The Ethics Committee may have a magnetic file, as long as it meets the safety criteria and
confidentiality of the information, which cannot be modified later and that
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GUIDE FOR THE RESEARCH ETHICS COMMITTEES
Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 3 of 12
they are also aligned with the quality management system of the Institution to which the Committee
belong.
D. Consider the competence of researchers: Establish the minimum criteria that the team must meet
researcher who will develop the research project.
These evaluation criteria must take into account the following:
The evaluation of the resumes and the corresponding supports of the entire research team (researcher
principal (IP), co-investigator or secondary researcher (IS), study coordinator, technical staff - (yes
there will be) -, bacteriologist and pharmaceutical chemist).
Professional degrees (diploma with their respective degree certificate) and a document certifying that the IPS has
verified the professional degree with the respective university, postgraduate approvals made in
abroad by the competent national entity, national professional card and the secretary
sectional according to the profession, certifications in good clinical practices for two years,
type of employment contract with the research center and labor contract that includes the functions with
Regarding the study, photocopy of the updated or foreign citizenship card.
In the letter of submission of the Principal or Secondary Investigator to the Ethics Committee, the time must be specified
of dedication to which the researcher undertakes to carry out the research in the study and the
number of protocols in which it conducts research, so that the Ethics Committee determines whether the time
Dedicated by the researcher is suitable for conducting the study. Attaching the respective supports of
The resume. The responsibility for the approval of each researcher (IP or IS) is the Committee of
ethics, so only the Principal Investigator will be submitted to INVIMA.
Evaluation researchers: The competencies of the Researcher must be in accordance with the specialty
Research project clinic. If the IP has the research experience but does not comply with the
clinical experience related to the specialty, this can be complemented by the
IS.
That the professional clinical care experience be a minimum of 3 years.
That the IP Research experience be of a minimum of 2 years.
It is accepted by INVIMA that a Principal Investigator be a professional in the area of ​​health specialized in
a postgraduate in research (epidemiology, clinical essayist, public health) and minimal experience in
same, as long as it is supported by an SI with the clinical specialty of the project subject of
research and that within the functions of this is the clinical assessment, application of the criteria of
inclusion, exclusion, medical decisions and clinical follow-up to research subjects.
Research Team:
Coordinator of studies: You must be a professional in the area of ​​health, with experience in
research, supported in training, certification in Good Clinical Practices, updated and valid for
two years.
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Code: ASS-RSA-GU040 Version: 00 Issue Date: 04/01/2015 Page 4 of 12
Bacteriologist: Must be a professional in bacteriology with IATA certification (International Air Transport
Association) in force, certification in good clinical practices with a validity of two years and with a professional card
valid.
Pharmaceutical Chemist: You must be a professional in pharmaceutical chemistry, with a professional card from the college of
Pharmaceutical and sectional secretary chemists, certified in good clinical practice with
validity of two years.
E. Periodically evaluate the progress of approved and developing studies: Within
procedures to be established are the periodic monitoring and evaluation that the Committee must have
Ethics defined before the initial approval of the research project.
7. COMPOSITION
It must be a multidisciplinary group, which is in the capacity to carry out an in-depth analysis of
research projects and raise an approval criteria based on competencies, professionalism and
Experience of its members.
All committee members should have a critical sense of the aspects of the project of
research, which should be reflected in the conclusions you make in each of the documents
analyzed.
All members must be trained and certified in Good Clinical Practice, certification that has
Valid for two years.
A. Number of Members that an Ethics Committee must have: The minimum number described in the regulations is five
members, but it is necessary to contemplate the following aspects before defining it.
You must guarantee all the minimum competencies necessary to evaluate a project of
Investigation.
It must agree to the number of studies that the Committee has in follow-up, always ensuring that
there is no alteration of its analysis due to work overload.
There may be evaluation subcommittees that assume some roles in the evaluation of research projects without
decision power
The members of the Committee must have adequate and sufficient time for the analysis and evaluation of the
set tasks
B. Balance by gender and age: The balance of age and gender must exist among the members of the Ethics Committee.
C. Multidisciplinary nature: The Committee must have a multidisciplinary nature, due to the characteristics
they will evaluate in a research project, because the different points of view make the analysis
an invaluable tool to be the most accurate in the final approval decision.
It is necessary that there is at least one member whose primary area of ​​interest is a non-scientific area. This is one
competence necessary to have a different point of view from the doctor or in general from the area staff
Of the health.
There must be at least one doctor. This professional must be a person with competence and
research experience, for the evaluation of the clinical aspects of the Research Project. The evaluation
Clinic should be based on experience and evidence-based medicine.
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The rule specifies that “there must be at least one member that is independent of the
institution / site where the study will be carried out ”. Therefore, it should be taken into account that
This statement must maintain the independence of the committee, avoiding any labor subordination.
In addition to the characteristics described in the multidisciplinarity of the Committee, it is clear that the
following competences for the evaluation and monitoring of a Research Project.
A member who has training in bioethics, to have a more precise criterion in the evaluation of a
Research Project in this aspect.
A member who has training in research methodology, to have a more precise criterion in the
evaluation of the protocol in terms of its technical characteristics.
A member who has training in epidemiology or some other specialty focused on research, with
experience in clinical research, topic review and database analysis; tools that are
Very useful in the evaluation of a research project.
A member of the branch of law, to advise the Ethics Committee in all aspects
legal that may arise in the evaluation of a research project.
A member who is a pharmaceutical chemist, to advise on the evaluation of the part
pharmacological research project and evaluation of adverse events in what has to do with the
drug interactions
With respect to community representatives, it must be ensured that these personnel also have a criterion
analytical but always focused on the point of view of the research participant and the research project.
It would be appropriate if you have previously been a participant in any research study.
All the members described above, with the exception of the community representative, may be
convened under the figure of external advisors or consultants and it will depend on each committee if these external advisors
They have voice or vote.
Within the members of the Ethics Committee there may be researchers from the projects of
Research being evaluated or other members of the research team. However, a researcher has the
restriction to be a member of the committee when:
He is the Chairman of the Committee
You have conflicts of interest because you participate in the development of studies evaluated by the Committee, or because your
affiliations or relationships imply bias for the development of the evaluation by the Committee. I know
you should keep in mind that if it is the only IP or IS of the majority of studies that the Committee is following,
it would not be appropriate to lose a member of the committee due to permanent impediments.
Have any interest from the labor, personal, family, economic, social, religious and / or academic point of view with
the sponsor of the study that is carrying out the protocol.
It does not timely inform if there is a conflict of interest in the exercise as a member of the Committee.
D. On the participation of consultants (when applicable): The participation of external consultants is given by the
specific training of these in subjects where there is no profile within the members of the
Committee to perform the analysis of a research proposal that requires a specialized concept in
any area
The independence of external consultants should be ensured in relation to sponsors or any other
entity that generates conflicts of interest.
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E. Requirements and processes for the selection of members in terms of the following aspects: The person (s)
in charge of selecting the members of the Committee must be absolutely independent of the persons
responsible for reviewing the convenience and feasibility of the research project within the center of
investigation.
In general, it is better that this appointment be proper to the Ethics Committee and that there is a consensus
General for the evaluation of the new member. It is essential that there are several candidates.
It is necessary to define what are the conflicts of interest and disabilities that will be in
account to define the candidate. Some of them are listed below:
Be part of an entity or be a direct actor in the research project (Sponsor, Researcher or
research center) or any other entity that has an economic interest in the research project.
That there is a labor, contractual, family or advisory relationship with entities that have economic interests in
the research projects to evaluate.
F. Conditions for the appointment of committee members:
Agree to make some personal information public for legal purposes.
Have established for each member, the general functions and those that must be fulfilled during the evaluation of each
study and support of acceptance thereof.
Agree to register and have available information regarding payments and refunds
received for their work as members of the Committee (if any).
Sign a confidentiality agreement by each of the members of the Committee on all the topics discussed
in each session and in the general information of the Committee.
Register knowledge of conflict of interest policy and code of conduct of the Committee.
G. Membership terms: A period of appointment must be contemplated within the statutes, which may be of
two (2) years extendable according to the policies defined within each Ethics Committee.
Within the Committee's procedures, policies on the
disqualification, replacement of Committee members and resignation, which must include among other factors:
conflicts of interest, the inability to violate them, as well as events that may affect the participation of
a member within the Committee (disabilities, workload, training, etc.).
The records of the declaration of conflicts of interest of the members of the Committee, as well as the
generated actions.
In addition, responsibilities and functions must be defined according to the position held within the Committee:
President.
Preside over the meetings and will be the spokesperson for the socialization committee.
Sign the minutes, correspondence, informed consent form and the format established by INVIMA to
the submission of institutions, new protocols and other related documents.
To be the spokesperson before INVIMA of the decisions, concerns, measures and questions that are had within a project of
investigation.
Assign the functions to the members of the Committee.
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Secretary.
Coordinate the timely delivery and according to the competencies of all correspondence and documents
which will be submitted for evaluation to each of the members of the Committee.
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
the Administrative Secretary with a technical profile for file and correspondence management, who
It has no voice or vote, functions that must be defined for each case.
Active member.
It must fulfill the functions assigned to it by the Chairman of the Ethics Committee within the Committee, such as
the functions within the evaluation of the study.
H. Quorum requirements for session and deliberation: The number of required members must be established
to meet and the minimum number, disciplines and qualifications for quorum compliance. These guidelines
They must be defined by the Chairman of the Committee.
The minimum quorum could be established as follows: It must be half plus one (1)
Be a minimum of five members.
The President must be
There must be at least one medical member There must be at least one non-scientific member The Representative must be
of the community.
Considerations:
It is not recommended to session a new research project with the minimum quorum or any other
submission where the evaluation suspects damage to the research participant.
In the absence of the Chairman of the Committee, there must be a chairman in charge who assumes the functions of
charge for that session.
I. Description of the training or training that the members of the Committee must have.
There should be a continuous training program in research topics such as: Research methodology
Research bioethics Database analysis Informed Consent
Update on Good Clinical Practices Normative in Research
Drug Interactions
Adverse events in research projects.
II. Code of Conduct, Conflict of Interest Policy and Confidentiality Policy
There are situations that may generate a potential conflict of interest by the members of the Committee and by
both skew the ideal development of its functions. These situations must be declared and
communicate in a timely manner in order to generate relevant actions, such as abstention
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of evaluation and monitoring of specific studies. In turn, the Committee must establish and document how to handle the
situation.
Some circumstances that generate conflict of interest for the members of the Committee are mentioned below:
Labor links with the sponsor such as consulting or advisory agreements, simultaneous participation as
evaluation member of the Committee and as a researcher of research studies, owned by securities of
signatures involved in studies submitted to the Committee's evaluation, familiar family relationship with
participants and responsible for the study under evaluation, business relationship with participants and managers of the
study under evaluation, past or present relationship with participants and responsible for the study under evaluation,
relationships such as friendship, personal, close or enmity that could affect the judgment of the evaluator, among others.
Membership in the Committee allows access to information with publication restrictions, which should be considered as a
confidentiality policy that prevents the use of reserved information.
8. PROCEDURE
A. Institutional authority under which the Committee is established
It must be defined under what authority within the Research Center (Institution) you are
constituted the Research Ethics Committee.
To define the subordination it is necessary to clarify that the Ethics Committee is the highest authority in the center of
research in what has to do with maintaining the safety of the research participant.
Therefore, the Committee must always be on the process map of those in charge of
approve, review and define the financial feasibility within the institution, such as: the researcher, office
financial, clinical or scientific management (if these two offices have this function).
He must be as an advisory body to the legal representative but never subordinate him.
B. If you are free from direct subordination of that authority to deliberate and decide.
It is necessary that the independence of the Ethics Committee be absolute not only from the legal point of view,
but also in their concepts and decisions, which must be followed by all the actors within the
organization to which they belong
C. The methodology followed by the Committee to evaluate the proposals must be established in writing and
specify at least:
The Procedure must be in the Operational Guides of the Committee according to the Quality Management System.
You must include a list of the minimum documents to be submitted.
You must have a tool (checklist, logbook, etc.) that allows you to evaluate all the documents of the
investigation project. This tool should have a checklist that meets the evaluation criteria
of the documents and have a space that is mandatory filling in where the evaluating member exposes their
points of view. It is recommended to have one of these separate tools for each of the documents.
D. Minimum documents to be evaluated for each research project
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Researcher's Manual: The general purpose of this document is to provide the researcher with a
clear knowledge of possible risks and adverse reactions, as well as specific tests,
observations and precautions that may be necessary in a clinical trial.
This document must contain all available information on safety data,
pharmacodynamics, pharmacokinetics, toxicity, teratogenicity, physical and chemical properties, etc. of the molecule in
research, in addition to reliable information from preclinical studies (pharmacological and not
pharmacological) and previous clinicians that justify the use of the molecule in humans. It must also capture the
information from phase I, II, III clinical studies (if any, as appropriate), drug interactions,
side effects, adverse reactions, all focused on the protection of the participant.
Resume of the research team.
Research protocol: The aspects that imply the technical quality of the research protocol should be evaluated.
research, as well as its subsequent development within the research site.
We must take into account aspects such as: the socialization of the study, access barriers, factors
economic factors that may affect the research participant, the randomization method,
blinding, confidentiality of information, statistical method and the feasibility of the project of the
research (possibility of reaching the expected conclusions, benefit / risk balance and
inconveniences for participants, financing and necessary resources) among other documents. Inside of the
protocol is also necessary to review the mechanisms (if any) with which it is intended to compensate or reward the
Participation of the subjects.
Informed Consent: This document should evaluate aspects such as materials and methods that will
be used to obtain the informed consent of the participants in the study. It must also be obtained
an informed consent freely given of each subject, prior to their participation in the study, which
find in clear, readable letter, suitable for the sociocultural level where it will be applied, with a volume
adequate, complete, that does not have ambiguities, that the coverage of the attention of events is explained
adverse, information relevant to research, considerations regarding vulnerable populations,
budgeted time for informed consent, people who should be witnesses and everything
contemplated in Resolution 8430 of 1993.
It is important to keep in mind that the participation of minors must follow the guidelines established in the
Resolution 8430 of 1993.
Likewise, informed consent must be evaluated for genetic samples, in which the sponsor
specify the use of these samples, the retention time and the handling of the confidentiality of this
information.
Recruitment announcements and materials delivered to participants: These documents and their equivalents are
They should always analyze thinking about the well-being and confidentiality of the research subject.
Study Budget: The Ethics Committee must verify in the budget that will be considered
for the realization of the protocol, that all the expenses that have to do with the project of
research are covered by the same budget of the study and that the own resources of the study will not be used
research participant, contemplating the budget for food and transportation for the participant
of the study, if applicable.
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Insurance policy for participants: The committee must verify that the policy is in force, which
cover adverse events of the study, compensation in case of death and also must verify the
accessibility of said policy.
Contract: There must be a contractual agreement between the sponsor and the institution / researcher, which must be
signed by the legal representative of each of the parties, document that must include aspects such as: term of
contract, budget and method of payment, responsibilities of the parties, confidentiality, insurance or compensation,
conflicts of interest, measures or penalties in case of non-compliance, file retention time, between
others.
Similarly, agreements made between other parties involved in the clinical trial must be in writing, between
the institution and contracted services such as the ethics committee, clinical laboratory or other services
hired
It must be defined according to the profile of the member of the Ethics Committee who must evaluate each of the documents of the
investigation project. This procedure will also depend on the evaluation time of each document and
the workload of each member. These functions must be defined by the Chairman of the Committee or
by whom he delegates, as well as the minimum documents that each member must evaluate.
There must be a documentary support of said evaluation, which must contain the considerations and
opinions of each of the evaluators. All committee members must participate actively within the
Evaluation of the research project.
A maximum evaluation time of each of the documents should be considered; this time must be
coordinated with the meeting schedule. The predefined method to reach a decision must be established (by
consensus, by vote) and decision mechanisms when consensus is not reached, which can be cited
to the researcher, sponsor or external consultant for further information. In case one or more
members declare conflicts of interest, a Restriction Policy must be defined to establish
mechanisms of how these people can participate in the evaluation of the proposals.
E. The committee must establish the requirements and mechanisms for approval
expedited / extraordinary, including:
Studies that can be evaluated through this type of approval.
Be clear that this procedure is acceptable only for those studies and / or
procedures that carry only a minimum risk for the subject of investigation.
The procedure to follow for the review
The mechanism for ratification by the committee of the decision taken expeditiously. The
approval of studies with medications for the first time.
F. The Committee must notify the investigator in writing within two weeks after the meeting
the decisions taken regarding the project under evaluation. This notice must include, as
minimum:
Study ID Documents studied.
Evaluation date and minutes of the corresponding session. Decisions or opinions related to the study.
Reasons for decisions, especially in case of failure.
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Procedures that the researcher must follow to submit the project to reconsideration.
G. The Committee must have measures to ensure the success of its sessions. These include:
Schedule Committee sessions with due priority. Timely notify members.
Send to each member previously the necessary documents for the session. Record what was discussed in an act and
decided.
Keep the record of the minutes.
Maintain the correspondence files to the members of the Committee.
H. The procedures established by the Committee to follow the course of
studies from approval to completion.
The Committee must have a procedure to monitor each of the research projects
That are submitted for consideration.
When the Committee approves the research project for the first time, it must define in that approval and taking into account
account of the characteristics of the study, how often the researcher must report the progress. This report
it must be done at least once a year according to national regulation, but the Committee is free to establish
a shorter time according to the case.
For the Periodic Report, the following must be considered at least: number of subjects
recruited, latest version of the project, summary of adverse events, summary of unanticipated problems,
Summary of new information available and copy of current consent.
The committee must have established an evaluation audit mechanism to the centers of
research where the studies submitted are carried out. The periodicity is freely established
by the Committee but must be predefined according to the type of study. For these audits a format must be designed
of audit that includes all the aspects that are in the norm adding the own criteria of the committee.
In these audits, the following must be reviewed, among others: the progress of the studies submitted, the evaluation of
serious adverse events, deviations and violations presented to the protocol, the recruitment rate and the
proposed recruitment goal.
I. The committee must establish procedures and measures in case of finding irregularities.
The measures to be taken should be defined in case of finding irregularities in the conduct of the Projects
research. The actions that can generate these measures, are among others:
Inclusion of participants in a study before the committee issues its written approval. Implement without prior
Notice of changes - amendments to the project.
Failure to submit reports for project monitoring.
The absence of notification by the investigator of deviations from the project and of the
adverse reactions or events.
That the investigator does not notify about new information that may affect the safety of
participants or the conduct of the study.
Investigators should be informed about the sanctions that cause non-compliance with this
numeral.
The Ethics Committee, due to its constitution, cannot take judicial measures of a sanitary nature against the Center for
Investigation, neither against the Investigator or the study sponsor, but it can impose
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sanctions when in defense of the protection of the welfare of research participants, what
consider necessary. These sanctions can be among others:
Warning call Warning
Suspension of the approval of the research project, a measure that immediately generates remission or
report to the regulatory entity (INVIMA) and the sponsor.
9. CONSIDERATIONS ABOUT THE ETHICS COMMITTEE
Among the considerations about the Ethics Committee, the following should be established:
The Ethics Committee is the highest authority in relation to the safety of the participant of
investigation; therefore, it will not be subject to any external influence and all actors (sponsor, center
of investigation, research group) must comply with the decisions and / or measures that are generated from it.
In case such decisions are not followed, the Committee will have the support and obligation to report said decisions.
irregularities to INVIMA. The Committee, by virtue of its composition and competence, can refute the analyzes, decisions
and changes in the research project, which according to its criteria affect the safety of the participant in the
center that is endorsing. According to the above, the Committee may define the qualification of an adverse event not
serious to a serious adverse event above the investigator's criteria, as long as this decision
Affect the participant.
In case of deviations or violations committed by the principal investigator, the Ethics Committee establishes
If this report is adequate, according to the provisions of the protocol and the security of the
competitor.
The Committee must have a budget with its own resources, either generated by the research center to which
find attached, or by resources derived from its services. This budget must be handled sovereignly by
the Committee, which can be made public and must have items intended for operation
routine, stationery, office maintenance, human resources, file management, training and,
if it is contemplated, the payment of fees of its members.
The ethics committee should not receive the sponsor's budget directly, it must be managed by the
certified institution whereby the contract between the Ethics Committee and the institution must be specified as
It is the payment of fees, when applicable.
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