EntranceResearch Ethics Committees. Ethics and Standards Commission Decision Making Procedure
Good afternoon doctor. Have a seat. You have been temporarily relieved of other tasks. Do not attempt to leave this room until you are told that the conversation is over. The door is already locked, but it is imperative that you listen carefully.
You have now been accepted into the Ethics Committee of the SCP Organization. This is not a demotion.
Sit down.
Yes, you are scared. You think you are being punished for some misstep, some misjudgment, some disaster in which you were involved. You feel like your career in the Organization is over. Perhaps you even thought that "transfer to the Ethics Committee" was a euphemism for the word "kill". This is not true.
Note that I said "kill", not "eliminate". That's exactly what I wanted to say. The ethics committee does not use euphemisms.
The activities of the SCP Organization are such that many employees consider the very idea of an Ethics Committee a stupid joke. They know that such a committee exists, but it seems to them that good-for-nothing clowns work on it. A handful of pants wipers in offices that have an "APPROVED" stamp and they just have the guts to put it on everything.
Yes, I see these stories were told to you. Here, for example: "How many members of the Ethics Committee does it take to change a burned-out light bulb? Not at all, Ethics Committee nothing doesn't change!"
Everything is fine. You have to laugh at this.
We breed rumors and opinions about our worthlessness because we are a secret power within the SCP Organization.
Sit down same.
Yes, there is O5. They judge that safely and what is not, and this is a very important and necessary work. But it is we who tell O-fifths that admissible and what is not.
You have done many terrible things in the service of the Foundation - don't try to deny it, Doctor. We all did a lot of creepy and terrible things while working for the Organization. This is an inevitable consequence of working with SCP, one of many. Have you ever wondered - what if we are, so to speak, the bad guys? Well... it's not. Precisely because there is an Ethics Committee. This is your first lesson. Do you understand?
Remember: Organization - not villains. We don't torture people "for no reason". We do not like excessive cruelty. Therefore, someone needs to decide in what cases cruelty is not redundant. And that "someone" is us.
Stop shaking.
It is very important that you remember this. This is the second lesson. Organization does not rule the world. Organization serves the world. Do you understand what this means? Whatever thought ordinary people about us and our goals, the affairs of the Organization - our affairs - are done in the interests of ordinary people. I think you already they realized this ... but they hardly thought about what follows from this. They comforted themselves with the thought that torture and murder were for the highest good. It follows that there is the highest good ... and there is not the highest. It follows that benefits can be different, they can be weighed, evaluated and compared. Exactly this and handled by the Ethics Committee.
It is we who evaluate all the affairs of the Organization from a moral point of view. And in order to evaluate these cases, it is necessary know them a price. Do you understand, doctor? It means that we know everything the Organization has done in the past, is doing now and will ever do. All the deleted data, all the blacked out words. We know them all, to the last detail.
Yes, even what happens after SCP-447-2 hits corpses. And we also know all the details of Procedure 110-Montauk. Obliged to know. After all, we developed it.
No, no, it's all right, the reaction is completely natural. I don't think you should schedule these conversations right after your lunch break. Here, take it, wipe your mouth.
You will no longer participate in scientific activities. You can still consider yourself a researcher, fly from project to project, from zone to zone, as you please. You don't have to keep secrets - you can tell your friends that you have been transferred to the Ethics Committee ... if you have the strength to endure their ridicule and condescending pity. You will observe what is being done and ask the participants - and yourself - the question, why it is being done. If you find something superfluous or unnecessary or wrong, report to us. We will call all the participants and ask them questions in that timid and goofy style that your colleagues laugh at.
And then the signal will go from the O5 through all the layers of our bureaucratic system. A reprimand will be declared unethical and recorded in a personal file. Either they will have their pay cut, or they will be demoted, or they will be transferred to another project.
Or they will be shot for crimes against humanity.
This is your third lesson. Remember it.
The letter "C" stands for "Save". The Organization keeps humanity from SCPs, and we keep the Organization from ourselves. We judge what the Organization can do and what is unacceptable. We choose evil so that in general, in the end achieve the lesser evil.
No, you cannot refuse to participate in the Committee.
……I see you appreciated all the humor in this situation.
The Research Ethics Committee (REC) evaluates the ethical acceptability of scientific research before its participants are involved in its conduct. In addition, the ethics committee scientific research studies certain related financial and scientific aspects.
Powers, role and tasks of research ethics committees
Structure, legal status and the functioning of research ethics committees may vary from country to country. Research ethics committees are usually set up by the government or government agency(for example, a hospital, research institute or university).
In some cases, research ethics committees are set up by private entities, but are held to some extent publicly accountable (eg through accreditation). However, there is no reason to believe that the quality of ethical review provided by private committees differs from the quality of ethical review provided by a public institution or organization.
The mission of ethics committees is to ensure the welfare, safety and security of individuals involved in scientific research. In this regard, before the start of the study, its evaluation is carried out and a positive opinion of the ethics committee is issued, and then the study is constantly monitored.
Independence of research ethics committees and their members
Research ethics committees should be independent of sponsors, investors, researchers and free from any kind of influence (eg political, institutional, professional or commercial). This fact ensures that the interests of the study participants are paramount.
Ensuring the independence of research ethics committees is not an easy task. It requires proper accountability (ie the right people are appointed to positions of responsibility) and balanced membership (ie the right people are involved). Research ethics committee members may not have conflicts of interest, or such conflicts of interest must be properly managed and declared. Ethics committee members with a conflict of interest may be excluded from participating in decisions related to a particular study protocol.
Structure and functioning of the committee
Typically, a research ethics committee is composed of members who are qualified and experienced to ensure that an appropriate peer review ethical, scientific, medical and financial aspects of scientific research. In many countries, the committee also includes individuals from outside the scientific community. Committee members are appointed authorized body in the prescribed manner for a specified period. The Committee may decide to invite external experts who are not members of the Committee to consult on a particular project.
Appropriate composition of research ethics committees and standard operating procedures (SOPs)
Research ethics committees should ensure that their written procedures comply with national or local and/or institutional requirements, as well as with their own standard operating procedures.
Guidelines and regulations in place in a number of countries stipulate that the procedures for the operation of research ethics committees should govern:
- the order of the meetings;
- procedure for filing applications for examination;
- the manner in which the research ethics committee makes decisions at regular meetings, including a minimum quorum (i.e. the minimum number of persons whose presence and participation in voting is necessary for a decision to be made);
- the procedure for conducting an ethical review;
- a rule that provides for the impossibility of attracting any person to participate in a scientific study until the ethics committee issues a written positive decision on this study;
- Investigators' obligation to promptly inform the ethics committee of any significant changes in protocol or safety issues, including major and unexpected adverse events (AARs).
Discussion of the ethical side of scientific research and decision making
Discussion of the ethical side of scientific research
Discussing the ethical side of scientific research involves a thorough review and analysis of scientific research, which takes into account the principles and values of research ethics, as set out in relevant national and international guidelines. All documents relevant to scientific research must be reviewed by the committee prior to discussion, during which each member of the committee comes up with his own opinion and expresses his vision of the situation.
Decision-making
The Research Ethics Committee, whenever possible, makes a decision that all its members find ethically satisfactory (consensus). This decision is valid provided that the discussion that took place was open, honest and based on available and complete factual information and in accordance with standard operating procedures.
Decision-making by voting - unlike consensus - is possible only in exceptional cases, since voting gives priority to the number of people expressing a particular opinion, but does not take into account the arguments that influenced the specified opinion.
Opinions "against" and "abstentions"
If a decision is made that is not supported by all members of the committee, it is necessary to indicate in the minutes the number of persons who “abstained” (did not take part in the voting) or spoke “against” (disagree with the opinion of the majority).
Decision procedure
The decision-making procedure implies that the committee takes impartial decisions at regular meetings and only if there is a quorum. Only those members of the committee who took part in the discussion participate in the decision-making; researchers and sponsor
A sponsor is a person, company, institution, or organization that takes responsibility for initiating and managing a clinical trial. Funding for a clinical trial may come from a sponsor, but may also come from a third party. The organization of a clinical trial is particularly difficult because important aspects of the trial are not under the direct control of the sponsor.
" target="_blank">sponsors must be able to express their opinion (but they are not allowed to participate in the discussion and in the decision-making process).
The decision (positive or negative opinion) is provided in writing to the applicant and to the relevant authorities. The Research Ethics Committee maintains and makes available appropriate records of its decisions and standard operating procedures when required.
Monitoring the progress of scientific research
The Research Ethics Committee reviews approved research periodically, with the frequency of review determined by the committee itself and depending on the level of risk the project poses to participants. As part of ongoing monitoring, monitoring of the activities of the research ethics committee may be necessary in the following cases:
- when making any significant changes to the Protocol
A clinical trial protocol is a document that contains the following information:
- goals (tasks) of the study;
- study design, including information about:
- method of selecting participants;
- required quantity participants;
- indicators and endpoints to be used; and
- ways to minimize the risk of bias;
- ways to keep the people involved in the study safe and keep their information private;
- data analysis methods;
- ways to generate research reports.
The protocol is very important for conducting a clinical trial; it is often referred to during research and, in general, in the drug development process." target="_blank">protocol that are likely to have a significant impact on the safety or physical or mental condition of the participants or, where applicable, on the scientific value of the trial, accompanied by an updated risk-benefit assessment;
- Unforeseen adverse reactions and serious adverse reactions related to the conduct of the study or the products used in the study.
Purpose of current ethical review
Ongoing ethical review is necessary to ensure that a scientific study is conducted in accordance with an approved protocol. In the event that the risk ratio has changed, it is necessary to inform the participants about this and obtain their repeated consent to participate in the study. They have the right to refuse further participation in the study.
Decision-making by the ethics committee in the course of ongoing monitoring of activities
If unacceptable circumstances are discovered during the monitoring of a scientific study, a positive ethics opinion may be suspended or canceled until it is submitted and studied. additional information. Updated information may be shared with participants to enable them to make an informed decision about continuing to participate in the study. The Research Ethics Committee may require changes to the protocol or informed consent form, which implies the need for re-approval and subsequent re-consent or refusal of research participants.
Accountability
Research ethics committees report to researchers and the general public and directly to the designated body, whether it be a government, an institutional body or private organization. Research Ethics Committees ensure full transparency of their own activities and decisions, including the official announcement of meetings.
What types of scientific research are subject to ethical review?
Any scientific research involving humans must be reviewed by a research ethics committee before participants can be selected for that research. This also applies to research that uses personal data (such as medical records) or human tissue and genetic material. Research that uses human germ cells (i.e., sperm or eggs), embryos, and fetal tissues, in addition to meeting a number of other requirements, also requires prior ethical review (see section on concrete examples below).
Some types of research may not require ethical review, for example, where there is no clear risk of harm or discomfort, where the research is expected to cause no more than inconvenience to participants (minor risk is the likelihood of harm or injury resulting from treatment in a clinical setting). practice or in research Harm or injury may be physical, psychological, social, or economic Risks include developing side effects of treatment or taking a drug that is less effective than standard treatment (as part of a trial) When a new drug is being tested, there may be side effects or other risks not foreseen by investigators This situation is most common in the early stages of clinical trials.
Conducting any clinical trial involves risks. Participants should be informed about possible benefits and risks before deciding to participate (see definition of informed consent).
" target="_blank">risk) This also applies to scientific research that involves the use of existing databases or documents that contain unidentifiable data about people (for example, information from open sources, archives or publications).
Special cases
Clinical trials are those scientific studies that have additional requirements. For example, in Europe, sponsors of clinical drug trials must obtain approval from the national competent authority and a positive opinion from the ethics committee before trials begin.
Research using human reproductive materials (eg stem cells, gametes, embryos), in addition to the opinion of an ethics committee, requires the evaluation of a national oversight committee.
Ethical aspects
Research that is not scientifically sound is not ethically acceptable. Such research exposes participants to trials and potential harm without the possibility of providing benefit to the participants and/or society. Thus, it is the responsibility of the ethics committee to ensure proper scientific judgment. If the research does not pass scientific evaluation, it also cannot be considered ethically.
Assessment levels
Ethics committees may apply a proportional approach to ethical evaluation: the wider the scope of the scientific study, the more thorough the evaluation. The evaluation may be carried out by the ethics committee, either as a whole or as part of a subcommittee (accelerated evaluation). Expedited Evaluation is permitted by a number of ethics committees for research that poses minimal risk to participants (as long as the amount of harm expected to occur during the research is less than the harm that would normally be caused to an organism in Everyday life or during routine medical, dental, or physiological examinations).
The standard operating procedures for a fast track assessment should govern:
- the nature of the applications;
- amendments and other options;
- quorum requirements; besides,
- the need to confirm the conclusion at full strength committee.
Ethical review of joint international scientific research
For collaborative international research studies, as well as for any other multicenter trials, several ethical assessments in the respective countries may be required.
Regardless of where the scientific research is carried out, the EU requires that it be carried out in accordance with the principles of the Declaration of Helsinki 1 if the results of the scientific research are to be used to obtain a marketing authorization in the EU.
Documents subject to ethical review
Due to the variability between individual research projects and the evolution of ethical assessment methods over time, it has become difficult to determine the exact list of documents that an ethics committee requires for a full assessment. Therefore, the ethics committee may require any document that it considers important. 2
Disclosure to potential participants
Potential participants must be fully informed about all aspects of the study, including objectives and methods, funding sources, investigator and sponsor identification, expected benefits. Participants receive an official invitation to participate in the study, and they are informed that they have the right to refuse (refrain) from participating in it or withdraw their consent to participate at any time without any retaliatory measures. Need to be given Special attention all measures taken to maintain the confidentiality of members' personal information. Research participants must provide contact details of individuals who can be contacted at any time for information and guarantee their access to free treatment (as well as compensation for ill health, disability or disability) in case of damage as a result of procedures carried out during the study . Participants are also informed of the type of compensation they will receive for participating in the research study (where applicable).
An application for an opinion on a clinical trial of medical products for human use submitted to the ethics committee must contain detailed guidance on the format for applying for participation and related documentation.
Additional sources
- European Commission (2006). Detailed guidance on the application format and documentation to be submitted in an application for an Ethics Committee opinion on the clinical trial on medicinal products for human use. Brussels: European Commission. Source as of June 24, 2015:
http://ec.europa.eu/health/files/eudralex/vol-10/12_ec_guideline_20060216_en.pdf
Reference literature for the article
- World Medical Association (2013). Declaration of Helsinki - Ethical Principles for Medical Research Involving Human Subjects. Source as of June 24, 2015:
http://www.wma.net/en/30publications/10policies/b3/
- European Parliament and the Council (2009). DIRECTIVE 2001/20/EC on the approximation of the laws, regulations and administrative provisions of the Member States relating to the implementation of good clinical practice in the conduct of clinical trials on medicinal products for human use. Source as of June 24, 2015:
http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_20/dir_2001_20_en.pdf
At present, an ethics commission exists in every educational, departmental, and medical institution. The issues discussed at the meetings relate to the relationship between employees, patients, students, parents. Let's discuss the main issues that the ethics committee considers. Let's touch on the history of its appearance, as well as the main areas of activity.
History of creation
There is no exact information about the period when the commission on ethics and standards appeared. AT modern history allocate 1947. It was at this time that the Nuremberg Code was adopted, which was developed within the framework of the international Military Tribunal. It contains the basic ethical principles that the ethics commission still uses in its work today. Today they function in all military, medical and educational institutions.
Functions and structure of the ethics committee
The Ethics Commission is an independent body, which consists of persons with special education, which makes it possible to analyze violations of the rights and working conditions of employees. For example, in medical institution such a commission includes not only persons with medical education, but also representatives of other professions (lawyers, economists).
In the event of any conflict situation, a third party resolves all conflicts and contradictions.
Ethical committees are divided into two types: "European", "American". In the European version, consultative and advisory work is distinguished among the powers of the commissions.
In medical and educational institutions, the commission on professional ethics meets in cases where moral problems arise. The prerogative of such committees is to discuss difficult problems that arise in practice, as well as to formulate recommendations on how to solve them.
The essence of the functioning of such committees is that the conflict situation does not reach the court, it is possible to resolve the problem in a pre-trial order.
Such a commission is formed from independent people with certain competencies in matters of ethics, able to assess the situation, give recommendations to both sides of the conflict.
at school
Increasingly, parents of schoolchildren are turning to school principals with written statements in which they accuse teachers of violating professional ethics exceeding their powers. What are the actions of the leader educational institution in a similar situation? How can a teacher protect his reputation? Let's try to understand these complex and relevant issues for domestic education.
First, the director invites the teacher, takes from him written explanations about the situation described in the application.
By order, a commission is formed in the educational institution, which studies this conflict, tries to find a way to reconcile the parties. A teacher who is sure of his innocence has the right to file an application with the ethics commission.
The purpose of such an appeal will be to protect their pedagogical competence, encroachments on the "good name" on the part of parents. The completed protocol of the ethics commission can be submitted by the teacher to the court by filing a claim for compensation for moral damage.
Deputy ethics
What does the Parliamentary Ethics Committee do? What are the rules of its activity?
According to the legislation in force in the Russian Federation, even persons who have committed crimes can be deputies, if they have fully atoned for their guilt. If such a person is nominated for deputies, the issue moves from the realm of law to the realm of ethics. At present, not only talented and worthy people have rushed into politics, but also those who, first of all, think about realizing their own ambitions, material enrichment.
The most important requirement of deputy ethics is the overpowering of personal vanity, respect for voters, social movements and organizations. It is difficult to understand those who, after receiving a deputy mandate, refuse orders and their own election promises.
Important Aspects
The regulations of the commission on ethics and standards include consideration of the behavior of such unscrupulous people's deputies, consideration of the issue of depriving them of their powers.
Ethics presupposes the rejection of propaganda hype, creating the appearance of observing the interests of voters, collectives, and public organizations.
The Ethics Commission ensures that deputies respectfully treat representatives of other parties, officials who do not share their point of view, political views.
The deputy is obliged to keep his word, promises, periodically give voters a report on his own activities, respectfully treat Russian legislation.
First of all, it is necessary to mention correctness, decency, decency, delicacy. Ethical rules are formulated in the code, their implementation is monitored by the commission on etiquette.
Lawyer ethics
This term was introduced by Aristotle. He meant by ethics a practical philosophy that helps answer the question of what a person does.
The subject of lawyer ethics is the behavior of representatives of this profession in the circumstances where he represents his profession. This is a specific behavior of a member of the legal community, prescribed for cases that are not mentioned in the legislation.
Sources of ethics
The Commission on Ethics of Advocates is created to resolve disputes arising between representatives of this profession and their principals. The main sources of professional lawyer ethics are:
- code;
- precedents of the qualification commission;
- customs.
Principles of work of the commission
They will include the presumption of possession of ethical norms by lawyers, the prevention of conflict situations, and the image.
When working with a client, a lawyer must comply with certain ethical rules. Relationships are based on trust. The lawyer's task is to choose an algorithm of actions aimed at a complete justification (mitigation of the court sentence) for the client.
The lawyer informs the client of the probable outcome of the case, gives advice on resolving the essence of the conflict within the framework of the current Russian legislation.
In cases where the defendants admit their own guilt, but there is no evidence in the case, in agreement with the client, the lawyer analyzes the reasons for the behavior, tries to convince the client to change his testimony.
He should pay increased attention to the client in custody, because the arrested person is isolated from the usual social environment. Deprivation of liberty causes him not only physical, but also moral suffering.
If the client's requirements conflict with Russian law, the lawyer may refuse to represent his interests in court.
A lawyer should not enter into close relations with a client. All issues relating to the amount of the fee for the implementation of the protection are resolved by mutual agreement with the client. Its value is affected by the complexity of the case under consideration, time limits, financial situation of the client, legal reputation.
In the event of conflict situations, the Commission on Attorney Ethics pays special attention to the behavior of the lawyer during the court session.
As one of ethical rules advocates a conscientious attitude of the lawyer to the court. He cannot influence the decision taken by the judge, provide false evidence of the innocence of the client, bribe witnesses. In case of violation of the rules of the Lawyers' Code, the Ethics Commission decides on the exclusion from the Bar Association, decisions on the rights to exercise protection.
Conclusion
Currently, special attention is paid to ethical relations in various spheres of public and economic activity Key words: medicine, pedagogy, legal practice. In order to avoid serious conflict situations between the participants in relations, special commissions on ethics are created in each organization.
Their main duties include pre-trial settlement of various disputes between employees and other persons related to the company. The commission maintains documentation: minutes of meetings, decisions taken, statements of the injured party.
Depending on the specifics of a particular organization, the ethics committee may include not only employees of this company, but also independent experts who help resolve controversial issues.