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- Policy Topics
Definition of Human Subjects Research
According to 45 CFR 46 , a human subject is “a living individual about whom an investigator (whether professional or student) conducting research:
- Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or
- Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.”
Are you planning on conducting human subjects research? Learn more about research that meets the definition human subjects research, Federal regulation requirements, and whether your project may be considered exempt. Also, learn about NIH specific considerations and become more familiar with NIH policies, and other regulations as it relates to human subjects research protections.
The questionnaire is a tool to assist you with determining whether your project involves non-exempt human subjects research, meets the criteria for exempt human subjects research, or does not involve human subjects research.
This resource summarizes the definition of human subjects research and provides examples of human subjects research projects. It also describes what you will need when you are preparing your NIH application and what is required if you are funded.
This resource is a guide to simplify the understanding of the exemptions from the federal regulations for the protection of human subjects research. It summarizes Exemptions 1, 2, 3, 4, 5, 6, 7 and 8, providing basic definitions, examples of studies that meet and do not meet the criteria of the exemption, and aspects one must consider when engaged in exempt or non-exempt human subjects research.
Studies involving the use of human specimens or data may or may not be considered to be research involving human subjects, depending on the details of the materials to be used. Use this flowchart to help determine if studies involving private information or biospecimens may meet the definition of human subjects research.
Learn about research activities which may qualify for a public health surveillance exclusion. Find useful information, key resources, and instructions for NIH applicants and offerors.
- Clinical Trials
- Basic Experimental Studies with Humans and Special Awards
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- NIH Application Guide
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Studies That Are Human Subjects Research
- Studies that utilize test subjects or their specimens for new devices, products, drugs, or materials.
- Studies that collect data through intervention or interaction with individuals. Examples of this type of research include drug trials, internet surveys about alcohol consumption, studies that involve deception, research involving risky behaviors or attitudes, and open-ended interviews with minors that contribute to generalizable knowledge.
- Studies using private information that can be readily identified with individuals, even if the information was not collected specifically for the study in question.
- Studies that use bodily materials such as cells, blood, urine, tissues, organs, hair, or nail clippings, even if one did not collect these materials for the study. However, such research may be considered exempt or not human subjects research if the materials/data are coded and the investigator does not have access to the coding systems. Guidance on research involving coded private information or biological specimens is available on the web at:(http://www.hhs.gov/ohrp/humansubjects/policy/engage08.pdf.)
- Studies that produce generalizable knowledge about categories or classes of subjects from individually identifiable information.
- Studies that use human beings to evaluate environmental alterations, for example, weatherization options or habitat modifications to their living or working space or test chamber.
- Department of Defense Guide for Researchers at the University of Iowa
- 1. Introduction
- Chapter 1 — Introduction to the IRB & Human Subjects Office
- i. VA Research & Development (VA R&D)
- Chapter 2 — Foundation of Human Subjects Protection
- ii. VA Privacy Officer (VA PO)
- 2. What Is Department of Defense Research?
- Human Subjects Research
- iii. VA Information Security Officer (VA ISO)
- Chapter 4 — Scope and Purpose of Institutional Review Boards
- Defining Research
- iv. VA Research Compliance Officer (VA RCO)
- 3. Planning a Project with the DoD
- Chapter 5 — Categories of Review
- Defining Human Subjects
- Chapter 6 — The Informed Consent Process
- Identifying Human Research Studies
- 4. Required Review by the Applicable DoD Human Research Protection
- Chapter 7 — New Project Applications and IRB Review and Approval
- Studies That Are Not Human Subjects Research
- 5. International Research
- Chapter 8 — After Initial IRB Approval
- Studies That Are Human Subjects Research
- 6. Collaboration
- Chapter 9– Vulnerable Populations
- 7. Force Health Protection
- Chapter 10– Special Topics
- 8. Prohibited Research
- Chapter 11 — Allegations of Noncompliance
- 9. Unique Limitations on Waivers of Informed Consent
- Chapter 12– Investigator Questions, Concerns, and Suggestions
- 10. Vulnerable Populations
- 11. Enrolling Adult Subjects Who Cannot Provide Consent
- 12. Inclusion of Subject Populations
- 13. Minimal Risk
- 14. Research Monitor
- i. Principles Governing Restricted Access Research
- 15. Protections from Medical Expenses
- 16. Military Participants
- 17. DoD Civilian Personnel
- iv. Investigator reports 21 CFR 812.150
- v. Inspection of investigator’s records and reports 21 CFR 812.145
- 18. Limits on Compensation
- 19. Reporting
- 20. Recordkeeping
- Institutional Signatures
- Contact Us
- UI Investigator’s Guide\IRB Standard Operating Procedures
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Human Subjects in Research
Advances in human health and welfare ultimately depend on research with human subjects. Properly controlled studies with human subjects are essential to verify any conclusions about normal physiology, mechanisms of disease, effectiveness of treatment, learning, or behavior. Unfortunately, not all human studies have been justifiable and useful. Human cruelty can be perpetrated in the name of research. Some of the best known examples occurred in Nazi Germany. Investigations following the war uncovered many atrocities, such as studies in which subjects were immersed in very cold water to gauge how long it would take to die of hypothermia. The discoveries of these abuses were the basis for the Nuremberg trials and development of the Nuremberg Code (1949), the first international codification of minimal expectations for the conduct of research involving human subjects. Some of the most important provisions of the Code were that experiments with human subjects should occur only in the context of a clear scientific rationale and only with subjects who have freely chosen to participate.
Harm to unwilling subjects under the guise of research has not been unique to the Nazis. During World War II, the U.S. conducted medical experiments on people not competent to consent and on subjects without their knowledge (Vanderpool, 1996). In 1932, prior to the start of World War II, 400 African American males with syphilis had been entered into a study at Tuskegee, Alabama with the intended purpose of documenting the natural course of their disease (Rivers et al., 1953; Jones, 1993). Although treatments of some presumed efficacy were available, these were withheld while the study participants were led to believe that experimental procedures (such as spinal taps to examine cerebrospinal fluid) were for the purpose of therapy. By the 1950’s, penicillin was available and known to be highly effective against syphilis, but it also was withheld. The surviving participants were only given treatment in 1972, after the nature of the study became publicly known, 23 years after publication of the Nuremberg Code. Recognition of problematic studies published in the medical and social science literature resulted in the appointment of a federal commission to identify fundamental principles that should govern human subjects studies. The final product of this commission was the Belmont Report (1979). It defined the three ethical principles that now guide studies with human subjects in the U.S.
Rules and Regulations
Seventeen federal agencies have regulations governing the conduct of research involving human subjects. Examples of agencies with human subject requirements include the Department of Health and Human Services (DHHS), the Food and Drug Administration (FDA), the National Science Foundation, and the Departments of Defense, Education, Justice, and Veterans Affairs.
Recent concerns about protection of human subjects have resulted in new federal requirements for researchers to receive instruction in the responsible conduct of research (RCR). In June of 2000, the Department of Health and Human Services announced a requirement calling for education of all key personnel working on PHS-funded studies with human subjects (NIH, 2000). In December of 2000, the Office of Research Integrity (ORI) announced a new PHS policy extending the requirement for instruction in RCR to all staff with substantive involvement in PHS-funded research or training (PHS, 2000). Although now suspended (ORI, 2001), this requirement is likely to be re-introduced.
Different agencies define ‘human subject’ in different ways, but it includes (at minimum) any living person who is involved in research either as an experimental subject or as a control. The scope of activities included under the definition of ‘research’ is quite broad. One federal regulation defines research as any ‘systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.’ (Code of Federal Regulations for Department of Health and Human Services 45CFR46.102(d)).
Human subject protections are a shared responsibility of principal investigators, other personnel involved in studies with human subjects, and the Institutional Review Board (IRB). Although most institutions are concerned primarily with regulations of DHHS and FDA, investigators are obligated to identify any special regulations or guidelines implicated by the project funding source or by the institution in which the study is performed.
The IRB is a primary mechanism for institutional protection of human subjects. An IRB is designed to be an advocate for potential and actual research subjects. Under both DHHS and FDA regulations, the IRB has responsibility to approve or disapprove all covered research activity, requiring for instance that subjects are given enough information to be able to provide informed consent. The IRB must conduct periodic reviews of research to ensure continued protection of the welfare of human subjects and compliance with relevant regulations.
The membership of an IRB is defined to include at least five members. The membership must include at least one person whose concerns are primarily scientific, one with nonscientific concerns, and one person who is both unaffiliated with the institution and unrelated to anyone from the institution. As appropriate, the IRB should also seek out special expertise for the review of projects presenting unusual ethical, legal, social, or scientific considerations. The IRB membership cannot consist of members from only one profession or gender. Additionally, any member with conflicting interest should be excluded from the review process. The diverse membership of the IRB is designed to protect the interests and welfare of human research subjects.
The three principles listed below are from the Belmont report (1979). At least three important premises underlie these principles. The first is that studies with human subjects are necessary for improvements in health and welfare. Second, to conduct such research is a privilege, not a right, extended to researchers by society, institutions, and the research subjects themselves. Finally, neither the risks nor the costs of any research study should outweigh the likely benefits.
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.’
‘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.’
‘An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly… 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.’
Research that involves humans is subject to regulation. No procedure or study should be performed that is not explicitly exempted or a part of an approved protocol. Applicable regulations include requirements for adherence to IRB-approved research protocols, maintenance of documentation and records, obtaining approval prior to initiation of changes, and reporting of adverse events. Investigators are responsible for identifying all applicable regulations and complying with them.
Think about issues of responsible conduct
Responsible conduct of research involving human subjects requires much more than complying with regulations. The spirit of the regulations and of good science both require that researchers critically review what is known and give thoughtful consideration to what defines an acceptable study. This consideration is necessarily an ongoing process. Factors to be considered include changes in our best understanding of the science, of the risks and potential benefits, of alternative methods for study, and so on. The decision to conduct a study with human subjects carries both ethical and regulatory responsibilities to protect the welfare and interests of those subjects, to design the study so as to minimize risks to subjects, and to obtain adequate training for protecting the interests and welfare of the research subjects.
Make sure the use of human subjects is both justifiable and necessary
A prerequisite for the responsible research involving humans is a realistic examination of the probability and magnitude of both the risks and the benefits of the research. Investigators must assess whether the risks are reasonable in relationship to the benefits to the individual subjects and the knowledge to be gained.
It is not enough that a proposed line of work is found to be justifiable; it is also necessary to consider whether alternative methods would be preferable. Any study involving human subjects is likely to involve at least minimal inconvenience and risks; other studies may carry more or less significant physical, social, psychological, or financial risks. Can the same information be obtained with less cost or risk by a less invasive study, by the use of fewer subjects, or by studies of other species?
Investigators conducting a research study with human subjects have an absolute responsibility to ensure that consent to participate has been given freely and is based on an understanding of the risks and benefits. The Belmont principle of respect for persons requires that researchers avoid invading privacy, maintain confidentiality of data, and obtain informed consent. Federal regulations outline numerous requirements for informed consent, including general requirements, basic and additional elements, criteria for waiving informed consent, and documentation for informed consent. The basic assumption underlying the regulations is that subjects need certain information so they can exercise self determination. Informed consent is often needed even for studies in the social sciences that impose little or no inconvenience, but still present the risk of a loss of privacy or confidentiality. Although some costs or risks may be more injurious than others, it must be up to the potential research subject, not the research investigator, to decide whether such costs or risks are outweighed by the benefits of participation.
The most visible indication of ‘informed consent’ is a document to be signed by the research subject. This document is important because it provides a consistent body of information that the investigator and the IRB have agreed is necessary for individuals to provide their informed consent. Unfortunately, subjects may sign such forms without understanding them. Differences in language, levels of comprehension, or retention of what has been read can make subjects fail to appreciate what they have agreed to. Also, the risks of participating in a research project may be overlooked because of the perception that physician scientists, and other health professionals, are clinical caregivers and not researchers. For these reasons, informed consent typically requires a dialogue with the potential subject to ensure that the content of the document is understood. Similarly, circumstances may change during the course of an ongoing study. If those circumstances might have an impact on subjects’ willingness to continue with participation, then the investigator has an obligation to provide that new information. Informed consent is not a single event, but an ongoing process.
Not all subjects are able to give true informed consent. In some cases, it is difficult to ensure that consent is given freely, such as in prison populations. In other cases, it may be difficult to convey the necessary information or to verify an understanding in people with reduced decisionmaking capacity– such as subjects with some developmental disabilities, some psychiatric disorders, or advanced dementia. For all subject populations in which autonomy is diminished, research investigators are responsible for meeting ethical and regulatory obligations to protect the right for self-determination of any prospective or current research subject.
Children also require special consideration. Parents can give permission for their child’s participation in research; depending on age and maturity level of the child, however, it may also be appropriate to obtain ‘assent’ from the child.
Elements of an informed consent document
Eight basic elements:
- a statement that the study involves research
- a description of risks or discomforts
- a description of benefits to the subject or others
- a disclosure of alternatives
- a statement concerning confidentiality of records
- description of compensation, if any, and availability of medical treatment in the case of injury
- contacts for questions concerning the research, research related injury, or research subjects’ rights
- a statement that participation is voluntary
Six additional elements when appropriate:
- presence of unforeseeable risks
- circumstances under which a subject’s participation may be terminated
- possible additional costs to the subject
- consequences of decision to withdraw
- assurance that new findings that might affect the subjects decision to participate will be communicated to the subject
- approximate number of subjects involved in the study
UAF Specific Information
All UAF researchers must be familiar with the following UAF Policy governing human subjects research: Protection of Human Research Participants (PDF).
All research involving human subjects must be approved by the IRB. The key here is – Is it research? If it is not research, it is not in the purvue of the IRB. Questions about whether or not an activity is human subjects research are most common in projects that involve program assessment. The IRB has a guidance document (WORD) to help you make this determination. Research in some disciplines (i.e. oral history or linguistics) may or may not fit the definition of human subjects research even though it involves working with living people. If you have questions regarding whether or not your project requires IRB review contact the ORI for a determination BEFORE completing the IRB Protocol application.
When reviewing a protoccol the IRB applies three basic ethical principles: respect for persons, beneficence and justice. One of the most important parts of any human subjects protocol is the informed consent process. In most cases, consent forms should read at no more than an 8th grade reading level. A great litmus test for the informed consent process is to ask someone unfamilar with your research to read the consent documents; if they don’t easily understand what you are doing and what their options are then it isn’t ready to submit to the IRB!
- Belmont Report (1979)
- DHHS (2000): Protection of Human Subjects, Title 45 Part 46
- Jones JH (1993): Bad Blood: The Tuskegee Syphilis Experiment. Free Press, New York.
- NIH (2000): Required education in the protection of human research participants. Notice OD-00-039, June 5, 2000
- Nuremberg code (1949)
- ORI (2001): Notice of suspension of PHS Policy on Instruction in the Responsible Conduct of Research. Federal Register: February 21, 2001 66(35):11032-11033
- PHS (2000): PHS policy on instruction in the responsible conduct of research. December 1, 2000
- Rivers E, Schumann SH, Simpson L, Olansky S (1953): Twenty years of followup experience in a long-range medical study. Public Health Reports 68(4): 391-395.
- Vanderpool HY (1996): The Ethics of Research Involving Human Subjects: Facing the 21st Century. University Publishing Group, Frederick, Maryland, 531 pp.
Guidelines for Research with Human Subjects
- Helsinki declaration (1964-2002) The World Medical Association’s statement of ethical principles to provide guidance to physicians and other participants in medical research involving human subjects. Revised October 2000
- Shuster E (1997): Fifty years later: The significance of the Nuremberg Code. New Engl J Med 20(337): 1436-1440.
Human Subjects Research Regulations and Oversight
- FDA (2000): Institutional Review Boards, Title 21 Part 56
- FDA (2000): Protection of Human Subjects, Title 21 Part 50
- Office for Human Research Protections (OHRP)
- Office for Protection from Research Risks (OPRR) (1993): Protecting Human Research Subjects: Institutional Review Board Guidebook. US Government Printing Office, Washington, DC.
Ethics and Human Research
- Beecher HK (1966): Ethics and clinical research. New Engl J Med 274: 1354-1360.
- Brieger GH (1978): Human Experimentation: History. In: Encyclopedia of Bioethics, Macmillan, New York, pp. 684-692.
- Emanuel EJ, Wendler D, Grady C (2000): What Makes Clinical Research Ethical? Journal of the American Medical Association 283(20): 2701-2711.
- Levine RJ (1988): Ethics and Regulation of Clinical Research. 2nd Edition, Yale University Press, New Haven, CT.
- Milgram S (1983): Obedience to Authority. Harper Collins, New York.
- Rothman DJ (1995): Research, Human: Historical Aspects. In: Encyclopedia of Bioethics, Simon & Schuster Macmillan, New York, revised edition, pp. 2248-2258.
- Sieber JE (1993): Ethical considerations in planning and conducting research on human subjects. Academic Medicine 68(9)(suppl.): S9-S1.
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Human Subjects Research Overview
The Health and Human Services Policy for Protection of Human Research Subjects in 45 CFR Part 46 defines a human subject as a living person about whom an investigator obtains either 1) data through intervening or interacting with the person or 2) identifiable private information. Federal requirements to protect human subjects may apply to research on human specimens (such as cells, blood, and urine), residual diagnostic specimens, and medical information. Research involving existing data, documents, records, pathological specimens, diagnostic specimens, or tissues that are individually identifiable is considered “research involving human subjects.”
- Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject.
- Individually identifiable: The identity of the subject is or may readily be ascertained by the investigator or associated with the information. Private information must be individually identifiable in order for obtaining the information to constitute research involving human subjects.
- Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record).
Your research may fall under the umbrella of human subjects research even if you aren’t working on humans directly. For example, some basic research on biological samples would be considered human subjects research, even if they were collected for a different study. The NIH offers a decision tree (see example) to make the determination of whether the NIH will consider proposed research to be human subjects research. If you have questions about whether your application involves human subjects, consult your NIH Program Official or ask your institutional review board (IRB) or independent ethics committee (IEC) before writing your application.
If you’re using coded private information, data, or specimens, NIH will consider your research to involve human subjects unless it meets both of the following conditions:
- You are not collecting samples by interacting or intervening with living people.
- None of the investigators or collaborators/co-authors can identify the subjects through coded private information or specimens (e.g., an investigator’s access to identity is prohibited by a written agreement).
If any investigator involved in the research can determine a subject’s identity or has access to identifiers, the research is considered to involve human subjects and human subjects requirements apply.
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Homem como cobaia em uma pesquisa de 1946 sobre os efeitos do vento em humanos.
Experimentação humana é uma investigação sistemática e científica que pode ser intervencionista (um “julgamento”) ou observacional (não “artigo de teste”) e envolve seres humanos como sujeitos de pesquisa. Experiências deste tipo podem ser pesquisas médicas (clínicas) ou pesquisas não médicas (por exemplo, ciências sociais). A investigação sistemática incorpora tanto a coleta como a análise de dados para responder a uma pergunta específica. A pesquisa médica do ser humano geralmente envolve a análise de espécimes biológicos, estudos epidemiológicos e comportamentais e estudos de revisão de gráficos médicos.
A pesquisa de humanos é utilizada em vários campos, incluindo pesquisas sobre biologia básica, medicina clínica, enfermagem, psicologia, sociologia, ciência política e antropologia. À medida que a pesquisa se formalizou, a comunidade científica desenvolveu definições formais de “pesquisa em humanos”, em grande parte em resposta a abusos de seres humanos, como cometidos durante o Holocausto e na Unidade 731, durante a Segunda Guerra Mundial.
- ↑ «Definition of Human Subject Research». Research Administration, University of California, Irvine. Consultado em 4 de janeiro de 2012
|Controle de autoridade||: Q1331083GND: 4038649-1JSTOR: human-experimentationLCCN: sh85062870NDL: 01207132|
|Este artigo sobre medicina é um esboço relacionado ao Projeto Saúde. Você pode ajudar a Wikipédia expandindo-o.|
Human subject research
From Wikipedia, the free encyclopedia
1946 military human subject research on the effects of wind on humans
Human subject research is systematic, scientific investigation that can be either interventional (a “trial”) or observational (no “test article”) and involves human beings as research subjects, commonly known as test subjects. Human subject research can be either medical (clinical) research or non-medical (e.g., social science) research. Systematic investigation incorporates both the collection and analysis of data in order to answer a specific question. Medical human subject research often involves analysis of biological specimens, epidemiological and behavioral studies and medical chart review studies. (A specific, and especially heavily regulated, type of medical human subject research is the “clinical trial“, in which drugs, vaccines and medical devices are evaluated.) On the other hand, human subject research in the social sciences often involves surveys which consist of questions to a particular group of people. Survey methodology includes questionnaires, interviews, and focus groups.
Human subject research is used in various fields, including research into advanced biology, clinical medicine, nursing, psychology, sociology, political science, and anthropology. As research has become formalized, the academic community has developed formal definitions of “human subject research”, largely in response to abuses of human subjects.
- 1Human subjects
- 2Ethical guidelines
- 3Ethical concerns
- 4Clinical trials
- 5Human subjects in psychology and sociology
- 6Unethical human experimentation
- 7See also
- 9Further reading
- 10External links
The United States Department of Health and Human Services (HHS) defines a human research subject as a living individual about whom a research investigator (whether a professional or a student) obtains data through 1) intervention or interaction with the individual, or 2) identifiable private information (32 CFR 219.102). (Lim, 1990)
- Intervention – physical procedures by which data is gathered and the manipulation of the subject and/or their environment for research purposes.
- Interaction – communication or interpersonal contact between investigator and subject.
- Private Information – information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public.
- Identifiable information – specific information that can be used to identify an individual.
Human subject rights
In 2010, the National Institute of Justice in the United States published recommended rights of human subjects:
- Voluntary, informed consent
- Respect for persons: treated as autonomous agents
- The right to end participation in research at any time
- Right to safeguard integrity
- Protection from physical, mental and emotional harm
- Access to information regarding research
- Protection of privacy and well-being
Main article: Guidelines for human subject research
In general, it can be said that experimental infections in humans are tightly linked to a history of scandals in medical research, with scandals being followed by stricter regulatory rules. Ethical guidelines that govern the use of human subjects in research are a fairly new construct. In 1906 some regulations were put in place in the United States to protect subjects from abuses. After the passage of the Pure Food and Drug Act in 1906, regulatory bodies such as the Food and Drug Administration (FDA) and institutional review boards (IRBs) were gradually introduced. The policies that these institutions implemented served to minimize harm to the participant’s mental and/or physical well being.
The Common Rule
The Common Rule, first published in 1991, also known as the Federal Policy for the Protection of Human Subjects, is dictated by the Office of Human Research Protections under the United States Department of Health and Human Services and serves as a set of guidelines for institutional review boards (IRBs), obtaining informed consent, and Assurances of Compliance for human subject participants in research studies. On January 19, 2017, a final rule was added to the Federal Register with an official effective date of July 19, 2018.
Main article: Nuremberg Code
In 1947, German physicians who conducted deadly or debilitating experiments on concentration camp prisoners were prosecuted as war criminals in the Nuremberg Trials. A portion of the verdict handed down in the doctors’ trial became commonly known as the Nuremberg Code, the first international document to clearly articulate the concept that “the voluntary consent of the human subject is absolutely essential”. Individual consent was emphasized in the Nuremberg Code in order to prevent prisoners of war, patients, prisoners, and soldiers from being coerced into becoming human subjects. In addition, it was emphasized in order to inform participants of the risk-benefit outcomes of experiments.
Declaration of Helsinki
Main article: Declaration of Helsinki
The Declaration of Helsinki was established in 1964 to regulate international research involving human subjects. Established by the World Medical Association, the declaration recommended guidelines for medical doctors conducting biomedical research that involves human subjects. Some of these guidelines included the principles that “research protocols should be reviewed by an independent committee prior to initiation” and that “research with humans should be based on results from laboratory animals and experimentation”.
The Belmont Report
Main article: Belmont Report
The Belmont Report was created in 1978 by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research to describe the ethical behaviors that involve researching human subjects. It is most heavily used by the current United States system for protecting human subjects in research trials. By looking primarily at biomedical and behavioral research that involve human subjects, the report was generated to promise that ethical standards are followed during research of human subjects. There are three standards that serve as the baseline for the report and how human subjects are to be researched. The three guidelines are beneficence (ethics), justice and respect for persons. Beneficence (ethics) is described as protecting the well-being of the persons and respecting their decisions by being ethical and protecting the subjects from harm. The two rules of beneficence are maximizing the benefits of research and minimizing any possible risks. It is the job of the researcher to inform the persons of the benefits as well as the risks of human subject research. Justice is important because it causes the researchers to be fair in their research findings and share what they have found, whether the information is good or bad. The selection process of the subject is supposed to be fair and not separate due to race, sexual orientation or ethnic group. Lastly, respect for persons explains that at any point a person who is involved in a study can decide whether they want to participate, not to participate or withdraw themselves from the study altogether. Two rules of respect for persons involve the person being autonomous and persons with diminished autonomy and entitled to protection. The sole purpose of these guidelines is to ensure autonomy and to protect against those with a lesser chance to remain autonomous because of something out of their control.
As science and medicine evolve, the field of bioethics struggles to keep up with updating guidelines and rules to follow. There has been an interest in revisiting the ethics behind human subject trials. Members of the health field have commented that it may be useful to have ethics classes available to students studying to be health care professionals as well as have more discussions surrounding the issues and importance of informed consent. There have also been a bigger push to protect participants in clinical trials. Rules and regulations of clinical trials can vary by country. Suggestions to remedy this include installing a committee to keep better track of this information and ensure that everything is properly documented. Research coordinators and physicians involved in clinical studies have their own concerns, particularly that an implementation of ethics rules could potentially disrupt the logistics of preparing a research study, specifically when it comes to enrolling patients. Another concern that research teams may have is that even if the rules are ethically sound, they may not be logical or helpful for conducting their studies.
Of note currently in the research field is the manner in which researchers direct their conversations with potential human subjects for a research study.
Research in rural communities
Recently there has been a shift from conducting research studies at research institution facilities or academic centers to rural communities. There is concern surrounding the topics addressed during the discussions with this specific demographic of participants, particularly having to do with funding, overall efficacy of the treatment being studied, and if conducting such studies is done to the highest ethical standard.
Ann Cook and Freeman Hoas from the University of Montana’s Department of Psychology conducted a study to gain more understanding about what influences potential candidates to consent to participation in any given clinical trial. They published their findings in February 2015. Cook and Hoas asked for the perspectives of the researchers and whether they would consent to being a subject in a clinical trial. To assess the shift to rural communities, they surveyed 34 physicians or researchers and 46 research coordinators from states that have “large rural populations and have historically demonstrated limited participation in clinical research.” Proper consent forms were provided and signed at the start of the study. Of the physicians and research coordinators that participated in this study, 90% were from hospital centers or worked in a hospital-clinic setting. Of all the participants, only 66% of research coordinators and 53% of physicians received training in research methods, while 59% of the coordinators received any ethics training. Only 17% of the physicians had ethics research training prior to this study.
Hoas and Cook categorized their findings into the following main topics:
- source of funding
- morally nagging and challenging issues
- willingness to join a research study
The role of funding
Cook and Hoas found that funding played a significant role in participant selection. One of Hoas’s and Cook’s participants commented that “in his practice, the income from conducting pharmaceutical trials sometimes [is] used to offset the losses of conducting scientifically interesting but poorly funded federal studies,” and most other participants administered trials because “reimbursements generated from such trials made it possible to maintain a financially viable, as well as profitable, practice.” Cook and Hoas found that most of the physicians and coordinators could not explain directly if they actually told their patients or subjects about any financial compensation they received. Respondents worry that discussing funding or compensation would affect enrollment, effectively swaying participants from joining a research study. In most respondents’ experience, most patients do not even ask for that information, so they assume that they do not have to discuss it with them and not jeopardize enrollment. When asked if information about funding or compensation would be important to provide to patients, one physician replied “…certainly it may influence or bring up in their mind questions whether or not, you know, we want them to participate because we’re gonna get paid for this, you know, budget dollar amount. But, you know, when you talk about full disclosure, is that something that we should be doing? That’s an interesting question.”
Morally nagging or challenging issues
Respondents more often pointed out practical or logistical issues with the overall process rather than ethical issues. There was a general consensus that the whole practice of conducting research studies was more focused on the business aspects like funding and enrolling participants in the study in time. A physician commented that “[industry] relationships are very important because of cash flow.”
Typical ethical issues that arise in this type of research trials include participant enrollment, the question of coercion if a physician refers their own patients, and any misunderstandings regarding treatment benefits. Patients are more likely to enroll in a trial if their primary care physician or a provider that they trust recommends the study. Most respondents seem to[weasel words] agree that patients consent to participate because they believe that through this study, they would be receiving “more attention than my regular patients” and that “there are an awful lot of additional opportunities for interaction.” One respondent commented “…the way that we’re required to actually recruit patients, which is to have their providers be the point of contact, some ways is–I mean, I don’t want to use the word ‘coercion’, but it’s kind of leaning in that direction because basically here’s this person that they entrust themselves to, who they’re very dependent on for, you know, getting their healthcare.”
There was a large amount of respondents who thought that research participants did not read or understand the documents provided for informed consent. However, those respondents did not believe that was an ethical or moral concern.
Willingness to join a research study
Most of the coordinators and researchers showed some hesitation when they were asked if they would enroll as a subject in a clinical trial, not necessarily their own, but any study. When asked to elaborate on their hesitation, many said that they would be “concerned about the motivations behind the study, its purpose, its funding, as well as expectations of what participation might entail.” Ultimately, only 24% of the respondents said they would be willing to participate with a majority of them stating they would need full transparency and an indication that there would be some personal benefit in order for them to even consider participating. Some had a list of criteria that had to be met. Eleven percent indicated that they would not at all be willing to enroll in a research study. One respondent commented “If it involved taking a medication, no. Never. I would be in a clinical trial if there was something, like…track [your] mammogram…[something] I am already subjecting myself to.” Cook and Hoas stated that these answers were “particularly puzzling” because “these respondents still reported that their patient/participants received ‘optimal care’ ” from clinical trials.
Main article: Clinical trial
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Clinical trials are experiments done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. Clinical trials generate data on safety and efficacy. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. These authorities are responsible for vetting the risk/benefit ratio of the trial – their approval does not mean that the therapy is ‘safe’ or effective, only that the trial may be conducted.
Depending on product type and development stage, investigators initially enroll volunteers and/or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. Clinical study design aims to ensure the scientific validity and reproducibility of the results.
Trials can be quite costly, depending on a number of factors. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. For example, a clinical drug trial case at the University of Minnesota that was under investigation in 2015 for the Death of Dan Markingson was funded by AstraZeneca, a pharmaceutical company headquartered in the United Kingdom.
Human subjects in psychology and sociology
Stanford prison experiment
Main article: Stanford prison experiment
A study conducted by Philip Zimbardo in 1971 examined the effect of social roles on college students at Stanford University. Twenty-four male students were assigned to a random role of a prisoner or guard to simulate a mock prison in one of Stanford’s basements. After only six days, the abusive behavior of the guards and the psychological suffering of prisoners proved significant enough to halt the two-week-long experiment. The goal of the experiment was to determine whether dispositional factors (the behavior of guards and prisoners) or positional factors (the social environment of prisons) are the major cause of conflict within such facilities. The results of this experiment showed that people will readily conform to the specific social roles they are supposed to play. The prison environment played a part in making the guards behavior more brutal, due to the fact that none of the participants showed this type of behavior beforehand. Most of the guards had a hard time believing they had been acting in such a way. The evidence concludes this to be positional behavior, meaning the behavior was due to the hostile environment of the prison.
Main article: Milgram Experiment
In 1961, Yale University psychologist Stanley Milgram led a series of experiments to determine to what extent an individual would obey instructions given by an experimenter. Placed in a room with the experimenter, subjects played the role of a “teacher” to a “learner” situated in a separate room. The subjects were instructed to administer an electric shock to the learner when the learner answered incorrectly to a set of questions. The intensity of this electric shock was to be increased for every incorrect answer. The learner was a confederate (i.e. actor), and the shocks were faked, but the subjects were led to believe otherwise. Both prerecorded sounds of electric shocks and the confederate’s pleas for the punishment to stop were audible to the “teacher” throughout the experiment. When the subject raised questions or paused, the experimenter insisted that the experiment should continue. Despite widespread speculation that most participants would not continue to “shock” the learner, 65 percent of participants in Milgram’s initial trial complied until the end of the experiment, continuing to administer shocks to the confederate with purported intensities of up to “450 volts”. Although many participants questioned the experimenter and displayed various signs of discomfort, when the experiment was repeated, 65 percent of subjects were willing to obey instructions to administer the shocks through the final one.
Asch conformity experiments
Main article: Asch conformity experiments
Psychologist Solomon Asch‘s classic conformity experiment in 1951 involved one subject participant and multiple confederates; they were asked to provide answers to a variety of different low-difficulty questions. In every scenario, the multiple confederates gave their answers in turn, and the subject participant subject was allowed to answer last. In a control group of participants, the percentage of error was less than one percent. However, when the confederates unanimously chose an incorrect answer, 75 percent of the subject participants agreed with the majority at least once. The study has been regarded as significant evidence for the power of social influence and conformity.
Robber’s Cave study
A classic advocate of Realistic conflict theory, Muzafer Sherif‘s Robber’s Cave experiment shed light on how group competition can foster hostility and prejudice. In the 1961 study, two groups of ten boys each who were not “naturally” hostile were grouped together without knowledge of one another in Robber’s Cave State Park, Oklahoma. The twelve-year-old boys bonded with their own groups for a week before the groups were set in competition with each other in games such as tug-of-war and football. When competing, the groups resorted to name-calling and other displays of resentment, such as burning the other group’s team flag. The hostility continued and worsened until the end of the three-week study, when the groups were forced to work together to solve problems.
Main article: Bystander effect
The bystander effect is demonstrated in a series of famous experiments by Bibb Latane and John Darley. In each of these experiments, participants were confronted with a type of emergency, such as the witnessing of a seizure or smoke entering through air vents. A common phenomenon was observed that as the number of witnesses or “bystanders” increases, so does the time it takes for individuals to respond to the emergency. This effect has been shown to promote the diffusion of responsibility by concluding that, when surrounded by others, the individual expects someone else to take action.
Main article: Cognitive dissonance
Human subjects have been commonly used in experiments testing the theory of cognitive dissonance after the landmark study by Leon Festinger and Merrill Carlsmith. In 1959, Festinger and Carlsmith devised a situation in which participants would undergo excessively tedious and monotonous tasks. After the completion of these tasks, the subjects were instructed to help the experiment continue in exchange for a variable amount of money. All the subjects had to do was simply inform the next “student” waiting outside the testing area (who was secretly a confederate) that the tasks involved in the experiment were interesting and enjoyable. It was expected that the participants wouldn’t fully agree with the information they were imparting to the student, and after complying, half of the participants were awarded $1, and the others were awarded $20. A subsequent survey showed that, by a large margin, those who received less money for essentially “lying” to the student came to believe that the tasks were far more enjoyable than their highly paid counterparts.
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In the automotive industry, research has shown that civilian volunteers decided to participate in vehicle safety research to help automobile designers improve upon safety restraints for vehicles. This research allows designers to gather more data on the tolerance of the human body in the event of an automobile accident, to better improve safety features in automobiles. Some of the tests conducted ranged from sled runs evaluating head–neck injuries, airbag tests, and tests involving military vehicles and their restraint systems. From thousands of tests involving human subjects, results indicate no serious injuries were persistent. This is largely due to the preparation efforts of researchers to ensure all ethical guidelines are followed and to ensure the safety and well-being of their subjects. Although this research provides positive contributions, there are some drawbacks and resistance to human subject research for crash testing due to the liability of injury and the lack of facilities that have appropriate machinery to perform such experiments. Research with live persons provides additional data which might be unobtainable when testing with cadavers or crash test dummies.
The increased use of social media as a data source for researchers has led to new uncertainties regarding the definition of human subject research. Privacy, confidentiality, and informed consent are key concerns, yet it is unclear when social media users qualify as human subjects. Moreno et al. conclude that if access to the social media content is public, information is identifiable but not private, and information gathering requires no interaction with the person who posted it online, then the research is unlikely to qualify as human subjects research. Defining features of human subject research, according to federal regulations, are that the researchers interact directly with the subject or obtain identifiable private information about the subject. Social media research may or may not meet this definition. A research institution’s institutional review board (IRB) is often responsible for reviewing potential research on human subjects, but IRB protocols regarding social media research may be vague or outdated.
Concerns regarding privacy and informed consent have surfaced regarding multiple social media studies. A research project by Harvard sociologists, known as “Tastes, Ties, and Time,” utilized data from Facebook profiles of students at an “anonymous, northeastern American university” that was quickly identified as Harvard, potentially placing the privacy of the human subjects at risk. The data set was removed from public access shortly after the issue was identified. The issue was complicated by the fact that the research project was partially funded by the National Science Foundation, which mandates the projects it funds to engage in data sharing.
A study by Facebook and researchers at Cornell University, published in the Proceedings of the National Academy of Sciences in 2014, collected data from hundreds of thousands of Facebook users after temporarily removing certain types of emotional content from their News Feed. Many considered this a violation of the requirement for informed consent in human subjects research. Because the data was collected by Facebook, a private company, in a manner that was consistent with its Data Use Policy and user terms and agreements, the Cornell IRB board determined that the study did not fall under its jurisdiction. It has been argued that this study broke the law nonetheless by violating state laws regarding informed consent. Others have noted that speaking out against these research methods may be counterproductive, as private companies will likely continue to experiment on users, but will be dis-incentivized from sharing their methods or findings with scientists or the public. In an “Editorial Expression of Concern” that was added to the online version of the research paper, PNAS states that while they “deemed it appropriate to publish the paper… It is nevertheless a matter of concern that the collection of the data by Facebook may have involved practices that were not fully consistent with the principles of obtaining informed consent and allowing participants to opt out.”
Moreno et al.’s recommended considerations for social media research are: 1) determine if the study qualifies as human subject research, 2) consider the risk level of the content, 3) present research and motives accurately when engaging on social media, 4) provide contact information throughout the consent process, 5) make sure data is not identifiable or searchable (avoid direct quotes that may be identifiable with an online search), 6) consider developing project privacy policies in advance, and 7) be aware that each state has its own laws regarding informed consent. Social media sites offer great potential as a data source by providing access to hard-to-reach research subjects and groups, capturing the natural, “real-world” responses of subjects, and providing affordable and efficient data collection methods.
Unethical human experimentation
Main article: Unethical human experimentation
Unethical human experimentation violates the principles of medical ethics. It has been performed by countries including Nazi Germany, Imperial Japan, North Korea, the United States and the Soviet Union. Examples include Project MKUltra, Unit 731, Totskoye nuclear exercise, the experiments of Josef Mengele, and the human experimentation conducted by Chester M. Southam.
Nazi Germany performed human experimentation on large numbers of prisoners (including children), largely Jews from across Europe, but also Romani, Sinti, ethnic Poles, Soviet POWs and disabled Germans, by Nazi Germany in its concentration camps mainly in the early 1940s, during World War II and the Holocaust. Prisoners were forced into participating; they did not willingly volunteer and no consent was given for the procedures. Typically, the experiments resulted in death, trauma, disfigurement or permanent disability, and as such are considered as examples of medical torture. After the war, these crimes were tried at what became known as the Doctors’ Trial, and the abuses perpetrated led to the development of the Nuremberg Code. During the Nuremberg Trials, 23 Nazi doctors and scientists were prosecuted for the unethical treatment of concentration camp inmates, who were often used as research subjects with fatal consequences. Of those 23, 15 were convicted, 7 were condemned to death, 9 received prison sentences from 10 years to life, and 7 were acquitted.
Unit 731, a department of the Imperial Japanese Army located near Harbin (then in the puppet state of Manchukuo, in northeast China), experimented on prisoners by conducting vivisections, dismemberments, and bacterial inoculations. It induced epidemics on a very large scale from 1932 onward through the Second Sino-Japanese war. It also conducted biological and chemical weapons tests on prisoners and captured POWs. With the expansion of the empire during World War II, similar units were set up in conquered cities such as Nanking (Unit 1644), Beijing (Unit 1855), Guangzhou (Unit 8604) and Singapore (Unit 9420). After the war, Supreme Commander of the Occupation Douglas MacArthur gave immunity in the name of the United States to Shirō Ishii and all members of the units in exchange for all of the results of their experiments.
During World War II, Fort Detrick in Maryland was the headquarters of US biological warfare experiments. Operation Whitecoat involved the injection of infectious agents into military forces to observe their effects in human subjects. Subsequent human experiments in the United States have also been characterized as unethical. They were often performed illegally, without the knowledge, consent, or informed consent of the test subjects. Public outcry over the discovery of government experiments on human subjects led to numerous congressional investigations and hearings, including the Church Committee, Rockefeller Commission, and Advisory Committee on Human Radiation Experiments, amongst others. The Tuskegee syphilis experiment, widely regarded as the “most infamous biomedical research study in U.S. history,” was performed from 1932 to 1972 by the Tuskegee Institute contracted by the United States Public Health Service. The study followed more than 600 African-American men who were not told they had syphilis and were denied access to the known treatment of penicillin. This led to the 1974 National Research Act, to provide for protection of human subjects in experiments. The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research was established and was tasked with establishing the boundary between research and routine practice, the role of risk-benefit analysis, guidelines for participation, and the definition of informed consent. Its Belmont Report established three tenets of ethical research: respect for persons, beneficence, and justice.
From the 1950s-60s, Chester M. Southam, an important virologist and cancer researcher, injected HeLa cells into cancer patients, healthy individuals, and prison inmates from the Ohio Penitentiary. He wanted to observe if cancer could be transmitted as well as if people could become immune to cancer by developing an acquired immune response. Many believe that this experiment violated the bioethical principles of informed consent, non-maleficence, and beneficence.
- Genie (feral child)
- Human radiation experiments
- Doctors’ Trial (Part of the Nuremberg Trials)
- Duplessis Orphans
- Medical torture
- Unethical human experimentation in the United States
- Japanese human experimentations
- Nazi human experimentation
- Non-human primate experiments
- Statistical unit
- Institutional review board
- Military medical ethics
- Chester M. Southam‘s Cancer Injection Study
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About the National Human Genome Research Institute
At NHGRI, we are focused on advances in genomics research. Building on our leadership role in the initial sequencing of the human genome, we collaborate with the world’s scientific and medical communities to enhance genomic technologies that accelerate breakthroughs and improve lives. By empowering and expanding the field of genomics, we can benefit all of humankind.
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- One of the early goals of the Human Genome Project was to develop high-quality genetic maps of each human chromosome. Genetic maps are used by researchers to search for genes that, when mutated, can cause human disease. go.usa.gov/xuTK8
- The potential benefits of genomic research tend not to include underrepresented populations. On April 25, @genome_gov is hosting a #DNADay lecture with @The_Carter_Show to advance health equity. To watch the livestream, register below. genome.gov/dna-day/celebr…
- .@StarTrek Picard, we love you, but this statement is wrong: “To understand the true potential of the human genome is to envision a future free from disease.”
Genomics is about ensuring that this revolutionary science benefits everyone!
- One of the early goals of the Human Genome Project was to develop high-quality genetic maps of each human chromosome. Genetic maps are used by researchers to search for genes that, when mutated, can cause human disease. go.usa.gov/xuTK8
- The potential benefits of genomic research tend not to include underrepresented populations. On April 25, @genome_gov is hosting a #DNADay lecture with @The_Carter_Show to advance health equity. To watch the livestream, register below. genome.gov/dna-day/celebr…
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This resource organizes information on genomes including sequences, maps, chromosomes, assemblies, and annotations.
Genome Annotation and Analysis
National Library of Medicine
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The Human Genome Project
The Human Genome Project (HGP) was one of the great feats of exploration in history. Rather than an outward exploration of the planet or the cosmos, the HGP was an inward voyage of discovery led by an international team of researchers looking to sequence and map all of the genes — together known as the genome — of members of our species, Homo sapiens. Beginning on October 1, 1990 and completed in April 2003, the HGP gave us the ability, for the first time, to read nature’s complete genetic blueprint for building a human being.
The Human Genome Project was the international research effort to determine the DNA sequence of the entire human genome.
In 2003, an accurate and complete human genome sequence was finished two years ahead of schedule and at a cost less than the original estimated budget.
Key moments and press releases from the history of the Human Genome Project.
February 15, 2021 marks the 20-year anniversary of publications reporting the draft human genome sequence.
Video testimonials from prominent members of the genomics community commemorating and celebrating the 30th anniversary of the launch of the Human Genome Project.
Explore frequently asked questions and answers about the Human Genome Project and its impact on the field of genomics.
Last updated: December 22, 2020
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A genome is the complete set of genetic information in an organism. It provides all of the information the organism requires to function. In living organisms, the genome is stored in long molecules of DNA called chromosomes. Small sections of DNA, called genes, code for the RNA and protein molecules required by the organism. In eukaryotes, each cell’s genome is contained within a membrane-bound structure called the nucleus. Prokaryotes, which contain no inner membranes, store their genome in a region of the cytoplasm called the nucleoid. The full range of RNA molecules expressed by a genome is known as its transcriptome, and the full assortment of proteins produced by the genome is called its proteome.
There are 23 pairs of chromosomes in the human genome. Between 1990 and 2003, all twenty-three pairs were fully sequenced through an international research undertaking known as the Human Genome Project. The study and analysis of genomes is called genomics.
Concept Links for further exploration
DNA sequencing | genotype | plasmid | chromosome | chromatin | genomics | prokaryote | genomics | human genome project | mapping | RFLP | Southern blot | conjugation (prokaryotes) | transformation (prokaryotes) | transduction (prokaryotes) | bacteriophage | SNP | transcriptome | proteome | virus | eukaryote | polyploidy | single nucleotide polymorphism | DNA | transposable element
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