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Theory of knowledge (first assessment 2022) - DP resources - Home - IB programme resources

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Object- Ethics of Stem Cells-HEla Cells,Henrietta Lacks, the Tuskegee Experiment, and Ethical Data Collection: Crash Course Statistics 

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Object- Ethics of Stem Cells-HEla Cells,Henrietta Lacks, the Tuskegee Experiment, and Ethical Data Collection: Crash Course Statistics 

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Henrietta Lacks, the Tuskegee Experiment, and Ethical Data Collection: Crash Course Statistics #12

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Sample Object related to Ethics on Stem Cell research

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Sample Object related to Ethics on Stem Cell research

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Belmont Report
Regulations and Ethical Guidelines The Belmont Report
Ethical Principles and Guidelines for the protection of human subjects of research (PDF Version)
The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979
SUMMARY: On July 12, 1974, the National Research Act (Pub. L. 93-348) was signed into law, there-by creating the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. One of the charges to the Commission was to identify the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and to develop guidelines which should be followed to assure that such research is conducted in accordance with those principles. In carrying out the above, the Commission was directed to consider: (i) the boundaries between biomedical and behavioral research and the accepted and routine practice of medicine, (ii) the role of assessment of risk-benefit criteria in the determination of the appropriateness of research involving human subjects, (iii) appropriate guidelines for the selection of human subjects for participation in such research and (iv) the nature and definition of informed consent in various research settings.

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is the outgrowth of an intensive four-day period of discussions that were held in February 1976 at the Smithsonian Institution's Belmont Conference Center supplemented by the monthly deliberations of the Commission that were held over a period of nearly four years. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects. By publishing the Report in the Federal Register, and providing reprints upon request, the Secretary intends that it may be made readily available to scientists, members of Institutional Review Boards, and Federal employees. The two-volume Appendix, containing the lengthy reports of experts and specialists who assisted the Commission in fulfillingthis part of its charge, is available as DHEW Publication No. (OS) 78-0013 and No. (OS) 78-0014, for sale by the Superintendent of Documents, U.S. Government Printing Office, Washington, D.C. 20402.

Unlike most other reports of the Commission, the Belmont Report does not make specific recommendations for administrative action by the Secretary of Health, Education, and Welfare. Rather, the Commission recommended that the Belmont Report be adopted in its entirety, as a statement of the Department's policy. The Department requests public comment on this recommendation.
National Commission for the Protection of Human Subjects
of Biomedical and Behavioral Research Members of the Commission
Kenneth John Ryan, M.D., Chairman, Chief of Staff, Boston Hospital for Women.
Joseph V. Brady, Ph.D., Professor of Behavioral Biology, Johns Hopkins University.
Robert E. Cooke, M.D., President, Medical College of Pennsylvania.
Dorothy I. Height, President, National Council of Negro Women, Inc.
Albert R. Jonsen, Ph.D., Associate Professor of Bioethics, University of California at San Francisco.
Patricia King, J.D., Associate Professor of Law, Georgetown University Law Center.
Karen Lebacqz, Ph.D., Associate Professor of Christian Ethics, Pacific School of Religion.
David W. Louisell, J.D., Professor of Law, University of California at Berkeley.(Deceased.)

Donald W. Seldin, M.D., Professor and Chairman, Department of Internal Medicine, University of Texas at Dallas.
Eliot Stellar, Ph.D., Provost of the University and Professor of Physiological Psychology, University of Pennsylvania.
Robert H. Turtle, LL.B., Attorney, VomBaur, Coburn, Simmons & Turtle, Washington, D.C. (Deceased.)
Table of Contents

1. Ethical Principles and Guidelines for Research Involving Human Subjects

2. Boundaries Between Practice and Research

3. Basic Ethical Principles

1. Respect for Persons

2. Beneficence

3. Justice

4. Applications

1. Informed Consent

2. Assessment of Risk and Benefits

3. Selection of Subjects

Ethical Principles & Guidelines for Research Involving Human Subjects
Scientific research has produced substantial social benefits. It has also posed some troubling ethical questions. Public attention was drawn to these questions by reported abuses of human subjects in biomedical experiments, especially during the Second World War. During the Nuremberg War Crime Trials, the Nuremberg code was drafted as a set of standards for judging physicians and scientists who had conducted biomedical experiments on concentration camp prisoners. This code became the prototype of many later codes(1) intended to assure that research involving human subjects would be carried out in an ethical manner.

The codes consist of rules, some general, others specific, that guide the investigators or the reviewers of research in their work. Such rules often are inadequate to cover complex situations; at times they come into conflict, and they are frequently difficult to interpret or apply. Broader ethical principles will provide a basis on which specific rules may be formulated, criticized and interpreted.

Three principles, or general prescriptive judgments, that are relevant to research involving human subjects are identified in this statement. Other principles may also be relevant. These three are comprehensive, however, and are stated at a level of generalization that should assist scientists, subjects, reviewers and interested citizens to understand the ethical issues inherent in research involving human subjects. These principles cannot always be applied so as to resolve beyond dispute particular ethical problems. The objective is to provide an analytical framework that will guide the resolution of ethical problems arising from research involving human subjects.

This statement consists of a distinction between research and practice, a discussion of the three basic ethical principles, and remarks about the application of these principles.
Part A: Boundaries Between Practice & Research
It is important to distinguish between biomedical and behavioral research, on the one hand, and the practice of accepted therapy on the other, in order to know what activities ought to undergoreview for the protection of human subjects of research. The distinction between research and practice is blurred partly because both often occur together (as in research designed to evaluate a therapy) and partly because notable departures from standard practice are often called "experimental" when the terms "experimental" and "research" are not carefully defined.

For the most part, the term "practice" refers to interventions that are designed solely to enhance the well-being of an individual patient or client and that have a reasonable expectation of success. The purpose of medical or behavioral practice is to provide diagnosis, preventive treatment or therapy to particular individuals. (2) By contrast, the term "research' designates an activity designed to test an hypothesis, permit conclusions to be drawn, and thereby to develop or contribute to generalizable knowledge (expressed, for example, in theories, principles, and statements of relationships). Research is usually described in a formal protocol that sets forth an objective and a set of procedures designed to reach that objective.

When a clinician departs in a significant way from standard or accepted practice, the innovation does not, in and of itself, constitute research. The fact that a procedure is "experimental," in the sense of new, untested or different, does not automatically place it in the category of research. Radically new procedures of this description should, however, be made the object of formal research at an early stage in order to determine whether they are safe and effective. Thus, it is the responsibility of medical practice committees, for example, to insist that a major innovation be incorporated into a formal research project. (3)

Research and practice may be carried on together when research is designed to evaluate the safety and efficacy of a therapy. This need not cause any confusion regarding whether or not the activity requires review; the general rule is that if there is any element of research in an activity, that activity should undergo review for the protection of human subjects.
Part B: Basic Ethical Principles
The expression "basic ethical principles" refers to those general judgments that serve as a basic justification for the many particular ethical prescriptions and evaluations of human actions. Three basic principles, among those generally accepted in our cultural tradition, are particularly relevant to the ethics of research involving human subjects: the principles of respect of persons, beneficence and justice.

1. Respect for Persons. -- Respect for persons incorporates at least two ethical convictions: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

An autonomous person is an individual capable of deliberation about personal goals and of acting under the direction of such deliberation. To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. To show lack of respect for an autonomous agent is to repudiate that person's considered judgments, to deny an individual the freedom to act on those considered judgments, or to withhold information necessary to make a considered judgment, when there are no compelling reasons to do so.

However, not every human being is capable of self-determination. The capacity for self-determination matures during an individual's life, and some individuals lose this capacity wholly or in part because of illness, mental disability, or circumstances that severely restrict liberty. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

Some persons are in need of extensive protection, even to the point of excluding them from activities which may harm them; other persons require little protection beyond making sure they undertake activities freely and with awareness of possible adverse consequence. The extent of protection afforded should depend upon the risk of harm and the likelihood of benefit. The judgment that any individual lacks autonomy should be periodically reevaluated and will vary in different situations.

In most cases of research involving human subjects, respect for persons demands that subjects enter into the research voluntarily and with adequate information. In some situations, however, application of the principle is not obvious. The involvement of prisoners as subjects of research provides an instructive example. On the one hand, it would seem that the principle of respect for persons requires that prisoners not be deprived of the opportunity to volunteer for research. On the other hand, under prison conditions they may be subtly coerced or unduly influenced to engage in research activities for which they would not otherwise volunteer. Respect for persons would then dictate that prisoners be protected. Whether to allow prisoners to "volunteer" or to "protect" them presents a dilemma. Respecting persons, in most hard cases, is often a matter of balancing competing claims urged by the principle of respect itself.

2. Beneficence. -- Persons are treated in an ethical manner not only by respecting their decisions and protecting them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. The term "beneficence" is often understood to cover acts of kindness or charity that go beyond strict obligation. In this document, beneficence is understood in a stronger sense, as an obligation. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: (1) do not harm and (2) maximize possible benefits and minimize possible harms.

The Hippocratic maxim "do no harm" has long been a fundamental principle of medical ethics. Claude Bernard extended it to the realm of research, saying that one should not injure one person regardless of the benefits that might come to others. However, even avoiding harm requires learning what is harmful; and, in the process of obtaining this information, persons may be exposed to risk of harm. Further, the Hippocratic Oath requires physicians to benefit their patients "according to their best judgment." Learning what will in fact benefit may require exposing persons to risk. The problem posed by these imperatives is to decide when it is justifiable to seek certain benefits despite the risks involved, and when the benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risk that might occur from the research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

The principle of beneficence often occupies a well-defined justifying role in many areas of research involving human subjects. An example is found in research involving children. Effective ways of treating childhood diseases and fostering healthy development are benefits that serve to justify research involving children -- even when individual research subjects are not direct beneficiaries. Research also makes it possible to avoid the harm that may result from the application of previously accepted routine practices that on closer investigation turn out to be dangerous. But the role of the principle of beneficence is not always so unambiguous. A difficult ethical problem remains, for example, about research that presents more than minimal risk without immediate prospect of direct benefit to the children involved. Some have argued that such research is inadmissible, while others have pointed out that this limit would rule out much research promising great benefit to children in the future. Here again, as with all hard cases, the different claims covered by the principle of beneficence may come into conflict and force difficult choices.

3. Justice. -- Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. Another way of conceiving the principle of justice is that equals ought to be treated equally. However, this statement requires explication. Who is equal and who is unequal? What considerations justify departure from equal distribution? Almost all commentators allow that distinctions based on experience, age, deprivation, competence, merit and position do sometimes constitute criteria justifying differential treatment for certain purposes. It is necessary, then, to explain in what respects people should be treated equally. There are several widely accepted formulations of just ways to distribute burdens and benefits. Each formulation mentions some relevant property on the basis of which burdens and benefits should be distributed. These formulations are (1) to each person an equal share, (2) to each person according to individual need, (3) to each person according to individual effort, (4) to each person according to societal contribution, and (5) to each person according to merit.

Questions of justice have long been associated with social practices such as punishment, taxation and political representation. Until recently these questions have not generally been associated with scientific research. However, they are foreshadowed even in the earliest reflections on the ethics of research involving human subjects. For example, during the 19th and early 20th centuries the burdens of serving as research subjects fell largely upon poor ward patients, while the benefits of improved medical care flowed primarily to private patients. Subsequently, the exploitation of unwilling prisoners as research subjects in Nazi concentration camps was condemned as a particularly flagrant injustice. In this country, in the 1940's, the Tuskegee syphilis study used disadvantaged, rural black men to study the untreated course of a disease that is by no means confined to that population. These subjects were deprived of demonstrably effective treatment in order not to interrupt the project, long after such treatment became generally available.

Against this historical background, it can be seen how conceptions of justice are relevant to research involving human subjects. For example, the selection of research subjects needs to be scrutinized in order to determine whether some classes (e.g., welfare patients, particular racial and ethnic minorities, or persons confined to institutions) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Finally, whenever research supported by public funds leads to the development of therapeutic devices and procedures, justice demands both that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research.
Part C: Applications
Applications of the general principles to the conduct of research leads to consideration of the following requirements: informed consent, risk/benefit assessment, and the selection of subjects of research.

1. Informed Consent. -- Respect for persons requires that subjects, to the degree that they are capable, be given the opportunity to choose what shall or shall not happen to them. This opportunity is provided when adequate standards for informed consent are satisfied.

While the importance of informed consent is unquestioned, controversy prevails over the nature and possibility of an informed consent. Nonetheless, there is widespread agreement that the consent process can be analyzed as containing three elements: information, comprehension and voluntariness.

Information. Most codes of research establish specific items for disclosure intended to assure that subjects are given sufficient information. These items generally include: the research procedure, their purposes, risks and anticipated benefits, alternative procedures (where therapy is involved), and a statement offering the subject the opportunity to ask questions and to withdraw at any time from the research. Additional items have been proposed, including how subjects are selected, the person responsible for the research, etc.

However, a simple listing of items does not answer the question of what the standard should be for judging how much and what sort of information should be provided. One standard frequently invoked in medical practice, namely the information commonly provided by practitioners in the field or in the locale, is inadequate since research takes place precisely when a common understanding does not exist. Another standard, currently popular in malpractice law, requires the practitioner to reveal the information that reasonable persons would wish to know in order to make a decision regarding their care. This, too, seems insufficient since the research subject, being in essence a volunteer, may wish to know considerably more about risks gratuitously undertaken than do patients who deliver themselves into the hand of a clinician for needed care. It may be that a standard of "the reasonable volunteer" should be proposed: the extent and nature of information should be such that persons, knowing that the procedure is neither necessary for their care nor perhaps fully understood, can decide whether they wish to participate in the furthering of knowledge. Even when some direct benefit to them is anticipated, the subjects should understand clearly the range of risk and the voluntary nature of participation.

A special problem of consent arises where informing subjects of some pertinent aspect of the research is likely to impair the validity of the research. In many cases, it is sufficient to indicate to subjects that they are being invited to participate in research of which some features will not be revealed until the research is concluded. In all cases of research involving incomplete disclosure, such research is justified only if it is clear that (1) incomplete disclosure is truly necessary to accomplish the goals of the research, (2) there are no undisclosed risks to subjects that are more than minimal, and (3) there is an adequate plan for debriefing subjects, when appropriate, and for dissemination of research results to them. Information about risks should never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research. Care should be taken to distinguish cases in which disclosure would destroy or invalidate the research from cases in which disclosure would simply inconvenience the investigator.

Comprehension. The manner and context in which information is conveyed is as important as the information itself. For example, presenting information in a disorganized and rapid fashion, allowing too little time for consideration or curtailing opportunities for questioning, all may adversely affect a subject's ability to make an informed choice.

Because the subject's ability to understand is a function of intelligence, rationality, maturity and language, it is necessary to adapt the presentation of the information to the subject's capacities. Investigators are responsible for ascertaining that the subject has comprehended the information. While there is always an obligation to ascertain that the information about risk to subjects is complete and adequately comprehended, when the risks are more serious, that obligation increases. On occasion, it may be suitable to give some oral or written tests of comprehension.

Special provision may need to be made when comprehension is severely limited -- for example, by conditions of immaturity or mental disability. Each class of subjects that one might consider as incompetent (e.g., infants and young children, mentally disable patients, the terminally ill and the comatose) should be considered on its own terms. Even for these persons, however, respect requires giving them the opportunity to choose to the extent they are able, whether or not to participate in research. The objections of these subjects to involvement should be honored, unless the research entails providing them a therapy unavailable elsewhere. Respect for persons also requires seeking the permission of other parties in order to protect the subjects from harm. Such persons are thus respected both by acknowledging their own wishes and by the use of third parties to protect them from harm.

The third parties chosen should be those who are most likely to understand the incompetent subject's situation and to act in that person's best interest. The person authorized to act on behalf of the subject should be given an opportunity to observe the research as it proceeds in order to be able to withdraw the subject from the research, if such action appears in the subject's best interest.

Voluntariness. An agreement to participate in research constitutes a valid consent only if voluntarily given. This element of informed consent requires conditions free of coercion and undue influence. Coercion occurs when an overt threat of harm is intentionally presented by one person to another in order to obtain compliance. Undue influence, by contrast, occurs through an offer of an excessive, unwarranted, inappropriate or improper reward or other overture in order to obtain compliance. Also, inducements that would ordinarily be acceptable may become undue influences if the subject is especially vulnerable.

Unjustifiable pressures usually occur when persons in positions of authority or commanding influence -- especially where possible sanctions are involved -- urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins. But undue influence would include actions such as manipulating a person's choice through the controlling influence of a close relative and threatening to withdraw health services to which an individual would otherwise be entitled.

2. Assessment of Risks and Benefits. -- The assessment of risks and benefits requires a careful arrayal of relevant data, including, in some cases, alternative ways of obtaining the benefits sought in the research. Thus, the assessment presents both an opportunity and a responsibility to gather systematic and comprehensive information about proposed research. For the investigator, it is a means to examine whether the proposed research is properly designed. For a review committee, it is a method for determining whether the risks that will be presented to subjects are justified. For prospective subjects, the assessment will assist the determination whether or not to participate.

The Nature and Scope of Risks and Benefits. The requirement that research be justified on the basis of a favorable risk/benefit assessment bears a close relation to the principle of beneficence, just as the moral requirement that informed consent be obtained is derived primarily from the principle of respect for persons. The term "risk" refers to a possibility that harm may occur. However, when expressions such as "small risk" or "high risk" are used, they usually refer (often ambiguously) both to the chance (probability) of experiencing a harm and the severity (magnitude) of the envisioned harm.

The term "benefit" is used in the research context to refer to something of positive value related to health or welfare. Unlike, "risk," "benefit" is not a term that expresses probabilities. Risk is properly contrasted to probability of benefits, and benefits are properly contrasted with harms rather than risks of harm. Accordingly, so-called risk/benefit assessments are concerned with the probabilities and magnitudes of possible harm and anticipated benefits. Many kinds of possible harms and benefits need to be taken into account. There are, for example, risks of psychological harm, physical harm, legal harm, social harm and economic harm and the corresponding benefits. While the most likely types of harms to research subjects are those of psychological or physical pain or injury, other possible kinds should not be overlooked.

Risks and benefits of research may affect the individual subjects, the families of the individual subjects, and society at large (or special groups of subjects in society). Previous codes and Federal regulations have required that risks to subjects be outweighed by the sum of both the anticipated benefit to the subject, if any, and the anticipated benefit to society in the form of knowledge to be gained from the research. In balancing these different elements, the risks and benefits affecting the immediate research subject will normally carry special weight. On the other hand, interests other than those of the subject may on some occasions be sufficient by themselves to justify the risks involved in the research, so long as the subjects' rights have been protected. Beneficence thus requires that we protect against risk of harm to subjects and also that we be concerned about the loss of the substantial benefits that might be gained from research.

The Systematic Assessment of Risks and Benefits. It is commonly said that benefits and risks must be "balanced" and shown to be "in a favorable ratio." The metaphorical character of these terms draws attention to the difficulty of making precise judgments. Only on rare occasions will quantitative techniques be available for the scrutiny of research protocols. However, the idea of systematic, nonarbitrary analysis of risks and benefits should be emulated insofar as possible. This ideal requires those making decisions about the justifiability of research to be thorough in the accumulation and assessment of information about all aspects of the research, and to consider alternatives systematically. This procedure renders the assessment of research more rigorous and precise, while making communication between review board members and investigators less subject to misinterpretation, misinformation and conflicting judgments. Thus, there should first be a determination of the validity of the presuppositions of the research; then the nature, probability and magnitude of risk should be distinguished with as much clarity as possible. The method of ascertaining risks should be explicit, especially where there is no alternative to the use of such vague categories as small or slight risk. It should also be determined whether an investigator's estimates of the probability of harm or benefits are reasonable, as judged by known facts or other available studies.

Finally, assessment of the justifiability of research should reflect at least the following considerations: (i) Brutal or inhumane treatment of human subjects is never morally justified. (ii) Risks should be reduced to those necessary to achieve the research objective. It should be determined whether it is in fact necessary to use human subjects at all. Risk can perhaps never be entirely eliminated, but it can often be reduced by careful attention to alternative procedures. (iii) When research involves significant risk of serious impairment, review committees should be extraordinarily insistent on the justification of the risk (looking usually to the likelihood of benefit to the subject -- or, in some rare cases, to the manifest voluntariness of the participation). (iv) When vulnerable populations are involved in research, the appropriateness of involving them should itself be demonstrated. A number of variables go into such judgments, including the nature and degree of risk, the condition of the particular population involved, and the nature and level of the anticipated benefits. (v) Relevant risks and benefits must be thoroughly arrayed in documents and procedures used in the informed consent process.

3. Selection of Subjects. -- Just as the principle of respect for persons finds expression in the requirements for consent, and the principle of beneficence in risk/benefit assessment, the principle of justice gives rise to moral requirements that there be fair procedures and outcomes in the selection of research subjects.

Justice is relevant to the selection of subjects of research at two levels: the social and the individual. Individual justice in the selection of subjects would require that researchers exhibit fairness: thus, they should not offer potentially beneficial research only to some patients who are in their favor or select only "undesirable" persons for risky research. Social justice requires that distinction be drawn between classes of subjects that ought, and ought not, to participate in any particular kind of research, based on the ability of members of that class to bear burdens and on the appropriateness of placing further burdens on already burdened persons. Thus, it can be considered a matter of social justice that there is an order of preference in the selection of classes of subjects (e.g., adults before children) and that some classes of potential subjects (e.g., the institutionalized mentally infirm or prisoners) may be involved as research subjects, if at all, only on certain conditions.

Injustice may appear in the selection of subjects, even if individual subjects are selected fairly by investigators and treated fairly in the course of research. Thus injustice arises from social, racial, sexual and cultural biases institutionalized in society. Thus, even if individual researchers are treating their research subjects fairly, and even if IRBs are taking care to assure that subjects are selected fairly within a particular institution, unjust social patterns may nevertheless appear in the overall distribution of the burdens and benefits of research. Although individual institutions or investigators may not be able to resolve a problem that is pervasive in their social setting, they can consider distributive justice in selecting research subjects.

Some populations, especially institutionalized ones, are already burdened in many ways by their infirmities and environments. When research is proposed that involves risks and does not include a therapeutic component, other less burdened classes of persons should be called upon first to accept these risks of research, except where the research is directly related to the specific conditions of the class involved. Also, even though public funds for research may often flow in the same directions as public funds for health care, it seems unfair that populations dependent on public health care constitute a pool of preferred research subjects if more advantaged populations are likely to be the recipients of the benefits.

One special instance of injustice results from the involvement of vulnerable subjects. Certain groups, such as racial minorities, the economically disadvantaged, the very sick, and the institutionalized may continually be sought as research subjects, owing to their ready availability in settings where research is conducted. Given their dependent status and their frequently compromised capacity for free consent, they should be protected against the danger of being involved in research solely for administrative convenience, or because they are easy to manipulate as a result of their illness or socioeconomic condition.

(1) Since 1945, various codes for the proper and responsible conduct of human experimentation in medical research have been adopted by different organizations. The best known of these codes are the Nuremberg Code of 1947, the Helsinki Declaration of 1964 (revised in 1975), and the 1971 Guidelines (codified into Federal Regulations in 1974) issued by the U.S. Department of Health, Education, and Welfare Codes for the conduct of social and behavioral research have also been adopted, the best known being that of the American Psychological Association, published in 1973.

(2) Although practice usually involves interventions designed solely to enhance the well-being of a particular individual, interventions are sometimes applied to one individual for the enhancement of the well-being of another (e.g., blood donation, skin grafts, organ transplants) or an intervention may have the dual purpose of enhancing the well-being of a particular individual, and, at the same time, providing some benefit to others (e.g., vaccination, which protects both the person who is vaccinated and society generally). The fact that some forms of practice have elements other than immediate benefit to the individual receiving an intervention, however, should not confuse the general distinction between research and practice. Even when a procedure applied in practice may benefit some other person, it remains an intervention designed to enhance the well-being of a particular individual or groups of individuals; thus, it is practice and need not be reviewed as research.

(3) Because the problems related to social experimentation may differ substantially from those of biomedical and behavioral research, the Commission specifically declines to make any policy determination regarding such research at this time. Rather, the Commission believes that the problem ought to be addressed by one of its successor bodies.

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Regulations and Ethical Guidelines The Belmont Report Ethical Principles and Guidelines for the protection of human subjects of research (PDF Version) The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research April 18, 1979 SUMMARY: On July 12, 1974, the National Research Act (Pub. L.

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First Nations Greens senator refers to 'the colonising her majesty Queen Elizabeth the second' in her oath of allegiance before being interrupted by Senate president, Sue Lines, and made to restart. 'You're not a senator if you don't do it properly,' another senator says

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Lidia Thorpe refers to the Queen as a coloniser while making oath in Senate - video

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First Nations Greens senator refers to 'the colonising her majesty Queen Elizabeth the second' in her oath of allegiance before being interrupted by Senate president

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Texas woman arrested after racist rant, assault in restaurant lot

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Texas woman arrested for racist rant and attack against Indian-American women

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Texas police arrested a woman who was filmed hurling racist insults and attacking three Indian-American women near Dallas. NBC News' Maggie Vespa reports on how that nearly five-and-a-half-minute video has gone viral as police are now investigating the incident as a hate crime.

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Related KQs related to certainty:
Scope:
• Are the arts best seen as a system of knowledge, a type of knowledge or a means of expressing knowledge?
Perspectives-
• How does knowing more about the social, cultural or historical context of a work of art have an impact on our knowledge of the work itself? • Can art change the way we interpret the world? • What are the justifications for, and implications of, claiming that there are absolute standards for “good art”? • Who determines what art is valued, and on what criteria?
Methods
* To what extent are the methods of justification different in the arts compared to other areas of knowledge?
Ethics
In what ways are moral judgments similar to, or different from, aesthetic judgments? • Do the arts play a role in the development of our personal value systems?  Is the production and enjoyment of art subject to ethical constraints? • On what criteria could it be decided if the state has the right to censor art that is deemed immoral or blasphemous? • Do the arts have the power to challenge established moral values? • Are moral and aesthetic judgments more a matter of taste than a matter of truth? • Can we separate the moral character of the artist from the value of the artwork?

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'Satanic Verses' author Salman Rushdie on ventilator after attacked on stage

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A USA TODAY employee witnessed a man storm the stage in a "bizarre" attack on Salman Rushdie, who suffered an "apparent stab wound to the neck."

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Link for Knowledge Issues

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In TOK, there are eight different ways we can know something - eight different ways of knowing (WOKs).

Although many people think of emotion as an 'unreliable' way of knowing, which is somehow less useful than reason for instance, it's also often the case that we know things emotionally with more certainty than by any other way of knowing. For example, it's usually very hard to reason someone out of being in love, or being very sad.

Most of what we think we know, we remember. Memory is also vital to our sense of who we are. In other words, it's one of the most important ways of knowing. However, memory can be unreliable, or play tricks on us. Our memories of past experience can also influence how we gain new knowledge using the other ways of knowing.

Without the evidence of our senses we wouldn't even know that the outside world exists. So, sense perception is an absolutely vital way of knowing, covering what we can see, hear, touch, smell, and taste. Although it's vital, people disagree about whether our senses give an accurate picture of the outside world or not.

It's difficult to define what imagination is precisely, but it's still a very important way we know things. People whose imaginations work in unusual ways are often diagnosed with conditions such as autism or synaesthesia. Imagination is also the key to being creative and solving problems.

Working things out logically, using reason, lets us go beyond what we've discovered using sense perception. It's a very important way of knowing, but has lots of different meanings depending on who you ask. A mathematician, for example, might see the definition of reason in their subject very differently from a historian.

This is sometimes seen as the opposite to reason: the idea that we 'just know' something instinctively strikes some people as illogical or unreliable. However, intuition can be extremely useful to us if we need to make very quick judgments.

This is probably the most loudly argued over way of knowing. Religious people often believe that faith is the most certain, useful, and important way of knowing there is, while some non-religious people claim the exact opposite, that faith is completely useless. However, we all have faith (or trust) in things we can't know using other ways of knowing, for instance, that the chair you're sitting on won't collapse under you. How reliable is this knowledge?

Language, whether spoken or written, is a vitally important way of communicating knowledge. If it wasn't, then why would you be reading this? But some people would argue that language is more important than this: that the process of putting our thoughts into words actually shapes what we know - in other words, that what we know can be defined by our ability to put it into words.

When we say that we 'know something' in maths, that's often not the same as saying we 'know something' in history or in art. Why not? The answer is because these are different areas of knowledge. There are eight areas of knowledge in TOK.

Knowledge in mathematics strikes many people as unique: in none of the other areas of knowledge would many people claim that their knowledge is both absolutely certain and able to be shown using rigorous logical proof. Yet this is something mathematicians claim all the time. Are they right? And if they are, what does this tell us about mathematical knowledge, especially when we apply it to the real world?

Knowing the difference between right and wrong is something that all societies demand of their members - and people who disagree can often find themselves labelled as criminals. But is ethical knowledge ever absolutely certain? And if it isn't, then does this mean that our strongly-held ethical views should be up for debate? The debatable nature of much ethical knowledge is important to recognize, and vital to understanding human behaviour.

Is it possible to talk meaningfully about what really happened in the past? Can we know for certain what people were thinking centuries ago? These are some of the big questions that face any student of history, and further questions about the reliability of different types of historical evidence are also important in deciding how reliable and useful knowledge in this area really is.

Human science is not science done in laboratories -rather, it's the scientific study of human behaviour and social interaction. Many of the Group 3 Diploma Programme subjects, such as economics or psychology, count as human science: in them, knowledge can be used to draw general rules or principles, but these are often not as useful as knowledge in the natural sciences when it comes to making predictions for the future.

Religious Knowledge Systems

Knowledge in religious knowledge systems is usually about fundamental and important things: how the world was created, how we should live our lives, and so on. This knowledge is extremely important to very many people, so religious knowledge sometimes needs to be treated sensitively. Religious knowledge might also make claims about a god or gods; but some religious knowledge might not be concerned with gods at all.

Natural science makes claims about the natural world, and attempts to find laws by which the world works. These laws are defined, often, as the result of experiments or tests, and usually claim to be true at all times, under the same conditions. But how certain is knowledge gained by these methods? And how useful are scientific laws for predicting the future?

Indigenous Knowledge Systems

This area of knowledge explores the ever-changing knowledge of indigenous societies, which may have ancient roots, but are still influenced by recent global developments. Indigenous knowledge may often explain significant natural events, and they may do so using methods very different from other areas of knowledge. You could look at indigenous knowledge systems as a whole, or look at one particular system in depth.

The arts cover almost everything creative that people do, from dance to sculpture to painting to creative writing (and reading). What counts as knowledge in the arts is often hotly debated, and some would even claim that all knowledge in the arts is personal, rather than shared (and therefore, that artistic knowledge is very difficult or impossible to express). Yet some would also argue that the arts encompass some of humanity's most important thoughts.

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In TOK, there are eight different ways we can know something - eight different ways of knowing (WOKs). Although many people think of emotion as an 'unreliable' way of knowing, which is somehow less useful than reason for instance, it's also often the case that we know things emotionally with more certainty than by any other way of knowing.

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https://meet.google.com/vmi-iddj-agd

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Please join the Google Classroom using the link below

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Please join the Google Classroom using the link below

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https://classroom.google.com/c/MTE5Mjg1OTk5NzA1?cjc=vqq5cda

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What is TOK?
Krithi: It is understanding the why (KNOWLEDGE FRAMEWORK-Scope, Perspectives, Methods & tools, Ethics) of What (Areas of knowledge).

Question: How do the methods & tools of an AOK determine the scope of knowledge?

Olivia: Depends on the way the "knower" acquires knowledge, in this case the type of learner (verbal, visual, auditory or tactile).

Question when exploring the knowledge framework (Page 12 from syllabus guide)- What motivates pursuit of knowledge?

Chaitra: Primal Need to Know

Olivia: Feeling/State Dependent-Linked to Maslow Hierarchy of Needs

Krithi: Potent question on relationship of self esteem & actualization with pursuit of knowledge-Explored role of "perspectives" in pursuit of knowledge (Humanist versus Realist, Theorist, Idealist-Example Adam Zagajewski, Polish poet.

UPCOMING TASK:

Explore the Guide. We have a pop up group presentation next class. Group will be selected on that day.
Note: This is a marked assignment.

Things to focus on :
What is TOK?
What are the
elements/topics we cover in TOK?
How will you be assessed (exhibition rubric/essay rubric)
What is the knowledge framework
What are knowledge questions?
What are Areas of  knowledge?
What are the 12 concepts?

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https://meet.google.com/deq-ensh-gfu

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IA Prompt
Key Thinkers
https://tok2022.weebly.com/tok-exhibition.html

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Exhibition today at another school. We have permission to attend. Try to attend. Please be at your best since it's their assessement (IB). hold all questions. just observe. Join using your Candor accounts only please. We have been given an hour by Mr. Gourab 9:45-10:45 :)

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Exhibition today at another school. We have permission to attend. Try to attend. Please be at your best since it's their assessement (IB). hold all questions. just observe. Join using your Candor accounts only please. We have been given an hour by Mr. Gourab 9:45-10:45 :)

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https://meet.google.com/dme-vips-zzi

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What is TOK

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What is a TOK exhibition

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What is TOK?

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Meow talk app that aims to translate your cat’s miaow has been developed by a former Amazon Alexa engineer.

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Meow talk app that aims to translate your cat’s miaow has been developed by a former Amazon Alexa engineer.

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Google facial recognition fail, tags dark skinned people as gorillas

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Google facial recognition fail, tags dark skinned people as gorillas

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Seat belts designed only for men are killing and maiming women

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Seat belts designed only for men are killing and maiming women

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Scientist use Satellite image to  to study un contacted  Amazon tribe.

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Scientist use Satellite image to  to study un contacted  Amazon tribe.

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A Women’s History Textbook: “Through Women’s Eyes”

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A Women’s History Textbook: “Through Women’s Eyes”

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Edward Colston Statue pulled down during Black lives matter protest in Bristol

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Edward Colston Statue pulled down during Black lives matter protest in Bristol

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"The Future of Feeling: Building Empathy in a Tech-Obsessed World" by Kaitlin Ugolik Phillips

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"The Future of Feeling: Building Empathy in a Tech-Obsessed World" by Kaitlin Ugolik Phillips

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Is Illuminati Real?
Is the Kraken Real?
Are Vampires Real?

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The origin of countless conspiracy theories - PatrickJMT

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10 Times The Simpsons Predicted the Future

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Where do superstitions come from? - Stuart Vyse

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authority

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Serena William Right or Wrong

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Serena Williams calls umpire a 'liar' and 'thief' as Naomi Osaka wins US Open final - video

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The 23-times grand slam champion angrily responded to a code violation for coaching by telling the chair umpire that she'd "rather lose" than cheat, and the incident only escalated from there

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Popper

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Locke, Berkeley, & Empiricism: Crash Course Philosophy #6

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Karl Popper, Science, & Pseudoscience: Crash Course Philosophy #8

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Identity SHORT FILM (Award Winning Inspirational Short)

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Weird, or just different? | Derek Sivers

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Richard Dawkins Foundation for Reason & Science

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Is this Baloney?

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Trump Suggests Light And Disinfectant Treatments For Coronavirus | TODAY

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1. Life is temporary. Death is Eternal.

2. Everything changes over time.
3. This padlet is in a website.
4. We cannot travel to other planets without assistance of technology.
5. Everyone in this class speaks english.
6. Everyone in this class has a gadget in their house.
7. Everybody in this world is either standing up, sitting down or sleeping
8. IB has TOK in their syllabus
9. Everybody has been born before.
10. Trees can’t talk.

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1. I need food and water to live
2. I was born in Bangalore.
3. I am 15 years old
4. I am a human being
5. I can hear things.
6. I am eating lunch right now.
7. We will all eventually die.
8. I am using a laptop to type this.
9. This lockdown is boring.
10. Pizza is tasty

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things i know for sure
1-i am real
2-Things happen for a reason
3-books are better than movies
4- pizza on pineapple is illegal
5-songs hit different at night
6-everyone's sleep schedule has changed due to lockdown
7-If you water water it grows
8- pizza is a cirle which comes inside a square box
9-if a homeless person makes something its not homemade
10- food is awesome

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1.Energy flows through everything (K)
2.1+1=2 (B)
3.Matter takes up space (K)
4.There is limited amount of resources (K)
5. Everything dies (K)
6.Nothing stops (K)
7.You can't escape death (K)
8.Data is never lost (K)
9.Everything is complex (B)
10. Nothing is faster than light (B)

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1. I am called Akshaya
2. I am female
3. I live in Bangalore
4. I'm taking a Tok introduction class right now
5. Ms Sakshi is taking the class
6. I just ate my lunch
7. I studied in Candor for 8 years
8. I'm leaving Candor after this year (yay)
9. I can't dance well (Belief?)
10. I have a dog :)

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1. i take up space
2. death is inevitable
3. i have a conscience
4. i live in Bangalore
5. my hair is black
6. the numbers
7. i can see the stars
8. time never stops
9. the alphabet
10. my shorts are gray

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1.that ib is going to be death
b
2.that i am a procrastinator
k
3.that i am in a tok sesh
k
4.that suits is the best 5.show
i would really like to say k but yes b
6.that i cant wait until lockdown is released
k
7. that i know what epistemology means now
k
9. that i am questioning whether i am real
k
10. that i wanna go to THE BAHAMAS
k

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1. I'm 16 years old
2. I was born in Haryana
3. I've lived in Bangalore all my life
4. I'm not adopted
5. I'm sitting at my desk right now
6. I live in an apartment
7. I'm taking IB
8. I'm drinking out of a glass bottle
9. I'm wearing clothes
10.The AC is on

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If tomatoes are fruits then ketchup is a smoothie.

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k1. How to play minecraft.
k2. I am eating something now.
k3. I am sitting down. now.
k4. I am in Bangalore.
k5. I am in India.
k6. I am a homo sapien.
k7. I am going to do ib.
b8. The earth is round(or is it?).
b9. I don't believe in God.
k10. I have watched Stranger Things.

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- I’m alive
- You are alive
- I have a brother
- My brother is annoying
- I’m not in any grade
- COVID 19 is a virus
- Oceans are salty
- Non- oceans are not salty other than salt
- Bangalore is a city
- I’m nearly unconscious

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my age

Matter takes up space

We live on earth

We need food n water to survive

Distance is a product of movement

Energy is produced by respiration

Mirrors reflect

Feelings

I’m lazy

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1. The earth is not flat: Real
2. Global warming is real: Real
3. People sometimes suck: Belief
4. Lamps give out light: Real
5. The moon is real : Real
6. My parents : Real
7. Objects: Belief
8. History: Real
9. People are pretty dumb: real
10. This is real :) : Belief

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Scotlands national animal is a unicorn.(k)
The moon is a sphere.(k)
The earth is a sphere.(b)
You can't smell anything when sleeping.(K)
Some fish can cough.(k)
Some people have a fear of ducks.(k)
The child of a donkey and a zebra is called a zonkey.(k)
The child of a tiger and a lion is a liger or  tigon.(k)
Covid-19 is a deadly disease.(b)
Your feet produce a pint of sweat everyday.(k)

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10 Statements I know are true:
1. If A is B and B is C, then A is C   K
2. If A is not B and B is not C, then A is also not C   K
3. 1 is diferrent from 2   K
4. Anything that takes up space is real   K
5. Matter is always conserved    K
6. Anything with 4 dimensions can't be projected onto 3 dimensions    K
7. Anything without any dimensions can not physically be expressed    K
8. Energy is conserved    K
9. 0 is an idea    K
10. Consciousness is different from awareness    K

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1. Consciousness is a state that nobody can prove (B)
2. our mind is very powerful (F)
3. My name is Kamalesh(F)
4. Global warming is real (F)
5. I don’t like dark chocolate (F)
6. Nobody really knows why we’re here (B)
7. Some people don’t have common sense (F)
8. The earth is round (F)
9. We could all be part of a larger force or we could all be part of a larger organism(B)

10. Our planet is very tiny compared to the literally everything yet complex and unique.(B)

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I have a nice personality, and let’s be real no one that’s not real can’t make this stuff up

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We live on earth
I have two eyes, a nose, mouth, ears etc
MY mother gave birth to me
my phone is black in color
I drank water today
I have mass
I am in Tok now
plants are green
I can hear,see,talk and smell
I excrete wastes everyday

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Reflection: Who decides what is knowledge?

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Reflection: Who decides what is knowledge?