Discussion Board on Code of Ethics in research

timer Asked: Oct 5th, 2017
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Question description

Based upon this week's reading and your own understanding please answer the following questions. Is it ethical to randomize clinical treatment trials? Meaning is it ok to hold treatment from one group and give it to another? Why is randomization important in research of a quantitative nature?

ANSWER: It removes researcher bias and improves reliability. But what ethical questions are raised? The question as stated above is whether we are withholding treatment from one group while giving it to another, whether it be a clinical drug trial or a new training tool. Is this ethical? Why or Why not?

What are some of the ethical or human subjects issues that may exist in your own research direction? What do you need to be careful about regarding your design?

Please see the attachment and links I provide to answer these questions above


Please read the following information on IRB which includes info on Background and history, Human Subject Definitions, Responsibilities, and Informed Consent. BACK GROUND AND HISTORY Human subjects protection began with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. In the United States, regulations protecting human subjects first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status Nil-I’s Policies for the Protection of Human Subjects, which were first issued in 1966. The regulations established the IRB as one mechanism through which human subjects would be protected. In July of 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission met from 1974 to 1978. In keeping with its charge, the Commission issued reports and recommendations identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and recommending guidelines to ensure that research is conducted in accordance with those principles. The Commission also recommended DHEW administrative action to require that the guidelines apply to research conducted or supported by DHEW. References for the Commission’s reports are listed in Appendix 1 (General Bibliography). The Commission’s report setting forth the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects is titled The Belmont Report, and is discussed in depth below. In 1981, in response to the Commission’s reports and recommendations, both the Department of Health and Human Services (DHHS, formerly DHEW) and the FDA promulgated significant revisions of their human subject regulations. As Levine (1986) points out, these revisions “do not alter the general principles of IRB review as they had evolved over the preceding three decades. Rather, they are concerned with some of the details of what the RB is expected to accomplish and some of the procedures it must follow” [p. 324]. The DHHS regulations are codified at Title 45 Part 46 of the Code of Federal Regulations. Those “basic” regulations became final on January 16, 1981, and were revised effective March 4, 1983, and June 18, 1991. The June 18, 1991, revision involved the adoption of the Federal Policy for the Protection of Human Subjects. The Federal Policy (or “Common Rule,” as it is sometimes called) was promulgated by the sixteen federal agencies that conduct, support, or otherwise regulate human subjects research; the FDA also adopted certain of its provisions. As is implied by its title, the Federal Policy is designed to make uniform the human subjects protection system in all relevant federal agencies and departments. Additional protections for various vulnerable populations have been adopted by DHHS, as follows: Subpart B, “Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women and Human in Vitro Fertilization” became final on August 8, 1975, and was revised effective January 11, 1978, and November 3, 1978. Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects” became final on November 16, 1978. Subpart D, “Additional Protections for Children Involved as Subjects in Research” became final on March 8, 1983, and was revised for a technical amendment on June 18, 1991. FDA regulations on the protection of human subjects are codified at Title 21 Parts 50 and 56 of the Code of Federal Regulations. Part 50, which sets forth the requirements for informed consent, became final on May 30, 1980, and was revised effective January 27, 1981, March 3, 1989, and June 18, 1991. Subpart C, which provides special protections for prisoners, was adopted on July 7, 1981; the effective date of Subpart C has been stayed until further notice. Part 56, which sets forth the provisions for institutional review boards, was adopted on January 27, 1981, with revisions to some sections effective February 27, 1981, March 3,1989, and June 18, 1991. Additional FDA regulations that are relevant to IRB review of research are Parts 312 (Investigational New Drug Application), 812 (Investigational Device Exemptions), and 860 (Medical Device Classification Procedures). The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which met from 1980 to 1983, produced numerous reports on various aspects of medical ethics and biomedical and behavioral research. Its mandate with respect to the protection of human subjects was, first, to review the federal rules and policies governing human subjects research, and second, to determine how well those rules were being implemented or enforced. References for the President’s Commission’s reports are listed in Appendix 1 (General Bibliography). Several excellent sources trace the history of human subject research and the development of the IRB system as a mechanism for the protection of human subjects. An account of the history of human subjects research and the human subjects protection system in the United States can be found in David J. Rothman’s Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (Chapters 1-5 and Epilogue) and in Dennis Maloney’s Protection of Human Research Subjects. Rothman details the abuses to which human subjects were exposed, culminating in Henry Beecher’s 1966 article, “Ethics and Clinical Research,” published in the New England Journal of Medicine, and ultimately contributing to the impetus for the first NIH and FDA regulations. Other equally useful sources include Robert J. Levine’s Ethics and Regulation of Clinical Research (Chapter 14), Joan E. Sieber’s Planning Ethically Responsible Research, Robert M. Veatch’s “Human Experimentation Committees: Professional or Representative?,” and William J. Curran’s “Government Regulation of the Use of Human Subjects in Medical Research: The Approaches of Two Federal Agencies.” A Brief History: Here are some significant dates in the development and history of informed consent. 1947: Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics). 1940s: A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of untreated syphilis, poor, black males are uninformed of their disease and denied treatment even after a treatment is found in 1947. The abuses are revealed in 1972. 1962: The Kefauver-Harris Bill is passed to ensure greater drug safety in the United States after thalidomide (a new sleeping pill) is found to have caused birth defects in thousands of babies born in Western Europe. 1964: The 18th World Medical Assembly meets in Helsinki, Finland, and issues recommendations to guide physicians in biomedical research involving human subjects. 1974: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and the National Research Act is passed by Congress. This Act prompted the establishment of IRBs at the local level and required RB review and approval of all federally funded research involving human participants. 1979: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research publishes The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research a guide for U.S. research with human subjects. -- 1993: The Albuquerque Tribune publicizes 1940s experiments involving plutonium injection of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment. 1994: President Clinton creates the National Bioethics Advisory Commission (NBAC). 1995: The President’s Advisory Committee on Human Radiation Experiments concludes that some of the radiation experiments from the 1940s were unethical. 1997: President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. NBAC continues investigation into genetics, consent, privacy. These events and others have prompted federal action to protect human subjects involved in all types of research. In December 1971, the U.S. Department of Health, Education, and Welfare began to require the creation of Institutional Review Boards (IRBs). The proposed research design of a University faculty, staff, or student must be reviewed by the IRB. The IRBs at The Pennsylvania State University are charged with reviewing plans that protect your participants. The IRBs ensure that human subjects do not bear any inappropriate risk and have properly consented to their involvement. Human Subject Definitions as defined by the Code of Federal Regulation 45 CFR 46.102 Department or Agency head means the head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated. Institution means any public or private entity or Agency (including Federal, State, and other agencies). Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. Research means a 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. Research subject to regulation, and similar terms, are intended to encompass those research activities for which a Federal Department or Agency has specific responsibility for regulating as a research activity (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a Federal Department or Agency solely as part of the Department’s or Agency’s broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor). Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains • • (1) data through intervention or interaction with the individual, or (2) identifiable private information. 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. 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). Private information must be individually identifiable (i.e., identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. IRB means an Institutional Review Board established in accord with and for the purposes expressed in this policy. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Certification means the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. For further information, please see the Code of Federal Regulation 45 CFR 46. 102. Responsibilities The Institution is responsible for: • • • • • • protecting the rights and welfare of human participants of research; ensuring that affiliates cooperating in the conduct of federally sponsored research do so without an appropriate assurance of compliance and satisfaction of the Institutional Review Board (IRB) certification requirements; establishing and maintaining the IRBs; acquiring appropriate Assurances or Amendments; requiring additional safeguards in research that involves: (1) fetuses, pregnant women, or human ova in vitro fertilization, (2) prisoners, (3) children, (4) the cognitively impaired, or (5) other potentially vulnerable groups; overseeing the performance of all research involving human participants, including complying with Federal, state, or local laws as they may relate to such research. The Institutional Review Board (IRB) is responsible for: • • reviewing, and having the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human participant research; reporting decisions and requirements for modifications to the investigators • • • • • • promptly; observing the quorum requirements; ensuring that legally effective informed consent will be obtained and documented in a manner that meets federal requirements; preparing and maintaining adequate documentation of its activities; suspending or terminating previously approved research that is not being conducted in accordance with the IRBs requirements or that has been associated with unexpected serious harm to subjects; ensuring effective input for all initial and continuing reviews conducted on behalf of performance sites where there will be human research participants; providing continuing review of each research activity at least every 12 months and may be more frequent on the basis of the degree of risk to participants. The Investigator is responsible for: • • • • • • • • • • • protecting the rights and welfare of the human research participants; complying with all federal, state, or local regulations established to protect human research participants; providing a copy of the IRB-approved and signed informed consent form to each participant at the time of consent; promptly reporting proposed changes in previously approved research activities to the IRB prior to their implementation; promptly reporting any injuries or other unanticipated problems involving risks to participants and others to the IRB; reporting progress of approved research at least every 12 months; complying with all IRB decisions, conditions, and requirements that are established within the guidelines of the 45CFR46; ensuring that legally effective informed consent will be obtained from each participant; ensuring that informed consent is documented; reporting any serious or continuing noncompliance with the federal or RB requirements; noting the Food and Drug Administration whenever it is anticipated that an experimental new drug or device exemption will be required Informed Consent The process of informed consent is a mandatory and integral component of research involving human subjects. An investigator may not involve a human subject in research prior to providing and obtaining informed consent from each participant. This document is to be presented in a format that is easy to follow and easily understood. Therefore, NIH has recommended that the consent document be written at an eighth grade, or lower, reading level for all subject populations. The consent document must contain the basic elements of consent, and if necessary, additional elements of consent may be required. Basic Elements of Consent • • • • • • • • • Provide name, address, and telephone number of investigator (and coinvestigators) in case participants have questions at a later date. A description of the purpose of the study (why you are doing the study) and a clear explanation of what they will be required to do. An explanation of any risks or discomforts the subject may experience. A statement describing any benefits to the subjects or potential benefits to society. If applicable, a statement informing participants of alternate means for obtaining treatment that may be helpful for the participant. Clearly describe how confidentiality will be maintained. A statement informing participants their participation is “voluntary” and they may decline to answer specific questions AND withdraw their participation at anytime without penalty. Participants are to be given a copy of the consent document for their record keeping. A statement informing subjects the amount of time that will be required for their participation. Additional Elements of Consent • • • • • • • • • • • • • A statement identifying researcher’s affiliation Measures (surveys, questionnaires, etc.) must not be attached to the consent form. The consent form is a “separate” document. Connecting page numbers (e.g., Page 1 of 2 and Page 2 of 2) are to be noted on the consent document to prove closure to the document. Consent documents that are double-sided must contain the connecting page number in case the consent document is reproduced as a single-sided document. A statement informing subjects they may contact the Office for Regulatory Compliance, 212 Kern Graduate Building, University Park, PA 16802, (814) 8651775 for additional information concerning their rights as research subjects. Signature and date lines for the participant to complete. An explanation of the amount of compensation a subject is to receive for participating in the research project. If necessary, explain how payment will be prorated if subjects withdraw before the research project is complete.* Subjects are to be informed that they may ask questions at any time. If extra credit is used as a means of compensation, an alternate comparable means of earning the extra credit needs to be identified.* An explanation of treatments or procedures that may cause unforeseen risks to the subject.* A statement explaining conditions that may require the researcher to terminate a subject’s participation.* Any additional costs the subject may incur as a result of their participation.* The procedure the subject is to follow for withdrawing their participation and consequences that may occur from this decision. * A statement regarding tape recording (audio/video) that will occur, who will have access to the tapes, where the tapes will be stored, and when the tapes will be • destroyed. * For surveys that are conducted electronically, subjects must be informed of the limited confidentiality levels that are available for electronic media. *
The Nuremberg Code From “Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10”, Vol. 2, Nuremberg, October 1946 April 1949. (Washington, DC: - US Government Printing Office, 1949). pp 181-182. The great weight of the evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts. 1. The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature. 3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problems under study that the anticipated results will justify the performance of the experiment. 4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury. 5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except perhaps, in those experiments where the experimental physicians also serve as subjects. 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment. 7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death. 8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment. 9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible. 10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject.

Tutor Answer

School: University of Virginia

See attached completed work. Do let me know if you need any clarification. Thank you.
Please find attached. Thank you.

Running head: ETHICS


Student’s name
Institutional affiliation



Randomization is the process of assigning patients different groups that receive different
treatments(Integrated Addendum). The groups are divided into investigative and control groups.
The assignment of groups is done randomly by a computer. The paper seeks to answer several
questions attached to human ethics.
Is it ethical to randomize clinical treatment trials?
Yes. Randomizing clinical treatment trials is ethical. Withholding treatment in one group
to administer to another is entirely ethical in the case of randomization and experimentation in
healthcare. Randomization is ethical in the case ...

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Wow this is really good.... didn't expect it. Sweet!!!!

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