Federal Laws, Guidelines, & Policies

A uniform policy was created for protecting the rights and welfare of human research subjects, providing for shared responsibilities between the federal Government and institutions. Those regulations were based upon the ethical principles set forth in the Belmont Report.

All VT research that includes the use of human subjects and/or private information about humans must comply with all of the regulations in the US Code of Federal Regulations (CFR) at 45 CFR 46. The basic components of the federal regulations at 45CFR46 are provided below:

Subpart A (Basic DHHS Policy)

Full text copy of Subpart A

This section deals with:

• Who is affected by this policy;
• Who assures compliance with this policy;
• What makes up IRB membership;
• Details IRB functions and operations;
• How IRB reviews research;
• Spells out the expedited review procedures for certain kinds of research involving no more than minimal risk;
• States the procedure for suspension or termination of IRB approved of research;
• What constitutes protocol records; and
• Provides for the general requirements for informed consent and the documentation of informed consent.

Subpart B (Pregnant Women, Fetuses, & Human In Vitro Fertilization)

Full text copy of Subpart B

This section provides information about:

• Additional duties of the Institutional Review Boards in connection with activities involving fetuses, pregnant women, or human in vitro fertilization;
• Activities directed toward pregnant women as subjects;
• Activities directed toward fetuses in utero as subjects;
• Activities directed toward fetuses ex utero, including nonviable fetuses, as subjects; and
• Activities involving the dead fetus, fetal material, or the placenta.

Visit the Research Involving Pregnant Women, Fetuses, & Human In Vitro Fertilization page within the Virginia Tech IRB website.

Subpart C (Prisoners)

Full text copy of Subpart C

This section provides information about:

• Composition of Institutional Review Boards where prisoners are involved;
• Additional duties of the Institutional Review Boards where prisoners are involved; and
• Permitted research involving prisoners.

Visit the Research Involving Prisoners page within the Virginia Tech IRB website.

Subpart D (Children)

Full text copy of Subpart D

This section provides information about:

• IRB duties regarding children used in research;
• Research not involving greater than minimal risk;
• Research involving greater than minimal risk but presenting the prospect of direct benefit to the individual subjects; and
• Requirements for permission by parents or guardians and for assent by children.

Visit the Research Involving Children page within the Virginia Tech IRB website.

Several federal agencies that conduct, support, and regulate human research simultaneously published a regulation or "Common Rule" on June 18, 1991 to regulate the conduct or support of research involving human subjects. They uniformally agreed to follow the requirements set forth in Title 45 Part 46 Subpart A - Code of Federal Regulations. This unanimity ensures that procedures and practices for human subject protection are standardized across federal agencies.

Federal Agencies that Have Adopted the Common Rule

The below cooperating federal agencies/departments have taken the Common Rule (45CFR46) and codified it under their own regulations, which are described within the Code of Federal Regulations in specific volumes relating to each agency, as listed below:

Under the Common Rule regulations, all institutions receiving funds from any of these departments/agencies are required to establish institutional review boards to review and monitor all funded research involving humans.

Infractions of the regulations could have very serious consequences: not only could grant or contract support be withdrawn from a single offending project, but the host institution could lose all federal funding. Consequently, Virginia Tech takes the protection of human subjects very seriously, not only for ethical reasons, but also for fiscal reasons as well.

Full text copy of the Belmont Report

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

The Belmont Report attempts to summarize the basic ethical principles identified by the Commission in the course of its deliberations. It is a statement of basic ethical principles and guidelines that should assist in resolving the ethical problems that surround the conduct of research with human subjects."

The federal Office of Human Research Protection (OHRP), through its process of approving and granting Federalwide Assurance for institutions which conduct human subject research, requires that an institution?s human subject activities, and all human subject activities of its Institutional Review Board (IRB) designated under the Assurance, regardless of funding source, will be guided by the ethical principles in "The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research" as established/written by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research.

The principles in the Belmont Report became the basis for the regulations in Title 45 Code of Federal Regulations Part 46 (45 CFR 46). All research that includes the use of human subjects and/or private information about humans must comply with all of the regulations in 45 CFR 46.

As an institution with an approved Assurance, Virginia Tech must ensure that research review and performance is in accordance with the Belmont Report. By extension, all researchers, staff, students, administrators, and IRB members who are involved in human subjects research or oversight must be familiar with (i.e., have read) the Belmont Report. Basic human subjects protection training provided by the Research Compliance Office at Virginia Tech is based upon the ethical principles set forth in the Belmont Report.

The Belmont Report establishes three main ethical principles underlying research including human subjects:

• Respect for Persons - Researchers must acknowledge the dignity and freedom of every person. Informed consent must be obtained from all potential research subjects or from their legally authorized representatives.
• Beneficence - Researchers should maximize benefits and minimize harms associated with research. Research-related risks must be reasonable in light of expected benefits.
• Justice - There should be equitable selection and recruitment and fair treatment of research subjects.

• 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, over-reaching, 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 reasonable 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.
• 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.
• 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 problem under study that the anticipated results will justify the performance of the experiment.
• The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
• 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.
• 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.
• Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
• 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.
• 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.
• 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.

[Reprinted from Trials of War Criminals before the Nuremberg Military Tribunals under Control Council Law No. 10, Vol. 2, pp. 181-182. Washington, D.C.: U.S. Government Printing Office, 1949.]

Full text copy of the Helsinki Declaration

Basic Principles

1. Biomedical research involving human subjects must conform to generally accepted scientific principles and should be based on adequately performed laboratory and animal experimentation and on a thorough knowledge of the scientific literature.
2. The design and performance of each experimental procedure involving human subjects should be clearly formulated in an experimental protocol which should be transmitted for consideration, comment and guidance to a specially appointed committee independent of the investigator and the sponsor provided that this independent committee is in conformity with the laws and regulations of the country in which the research experiment is performed.
3. Biomedical research involving human subjects should be conducted only by scientifically qualified persons and under the supervision of a clinically competent medical person. The responsibility for the human subject must always rest with a medically qualified person and never rest on the subject of the research, even though the subject has given his or her consent.
4. Biomedical research involving human subjects cannot legitimately be carried out unless the importance of the objective is in proportion to the inherent risk to the subject.
5. Every biomedical research project involving human subjects should be preceded by careful assessment of predictable risks in comparison with foreseeable benefits to the subject or to others. Concern for the interests of the subject must always prevail over the interests of science and society.
6. The right of the research subject to safeguard his or her integrity must always be respected. Every precaution should be taken to respect the privacy of the subject and to minimize the impact of the study on the subject's physical and mental integrity and on the personality of the subject.
7. Physicians should abstain from engaging in research projects involving human subjects unless they are satisfied that the hazards involved are believed to be predictable. Physicians should cease any investigation if the hazards are found to outweigh the potential benefits.
8. In publication of the results of his or her research, the physician is obliged to preserve the accuracy of the results. Reports of experimentation not in accordance with the principles laid down in this Declaration should not be accepted for publication.
9. In any research on human beings, each potential subject must be adequately informed of the aims, methods, anticipated benefits and potential hazards of the study and the discomfort it may entail. He or she should be informed that he or she is a liberty to abstain from participation in the study and that he or she is free to withdraw his or her consent to participation at any time. The physician should then obtain the subject's freely-given informed consent, preferably in writing.
10. When obtaining informed consent for the research project the physician should be particularly cautious if the subject is in a dependent relationship to him or her or may consent under duress. In that case the informed consent should be obtained by a physician who Is not engaged in the investigation and who is completely independent of this official relationship.
11. In case of legal incompetence, informed consent should be obtained from the legal guardian in accordance with national legislation. Where physical or mental incapacity makes it impossible to obtain informed consent, or when the subject is a minor, permission from the responsible relative replaces that of the subject in accordance with national legislation. Whenever the minor child is in fact able to give a consent, the minor's consent must be obtained in addition to the consent of the minor's legal guardian.
12. The research protocol should always contain a statement of the ethical considerations involved and should indicate that the principles enunciated in the present Declaration are complied with.

Medical Research Combined with Clinical Care (Clinical Research)

1. In the treatment of the sick person, the physician must be free to use a new diagnostic and therapeutic measure, if in his or her judgement it offers hope of saving life, reestablishing health or alleviating suffering.
2. The potential benefits, hazards and discomfort of a new method should be weighed against the advantages of the best current diagnostic and therapeutic methods.
3. In any medical study, every patient -- including those of a control group, if any -- should be assured of the best proven diagnostic and therapeutic method.
4. The refusal of the patient to participate in a study must never interfere with the physician-patient relationship.
5. If the physician considers it essential not to obtain informed consent, the specific reasons for this proposal should be stated in the experimental protocol for transmission to the independent committee (I, 2).
6. The physician can combine medical research with professional care, the objective being the acquisition of new medical knowledge, only to the extent that medical research is justified by its potential diagnostic or therapeutic value for the patient.

Non-therapeutic Biomedical Research Involving Human Subjects (Non-clinical Biomedical Research)

1. In the purely scientific application of medical research carried out on a human being, it is the duty of the physician to remain the protector of the life and health of that person on whom biomedical research is being carried out.
2. The subjects should be volunteers--either healthy persons or patients for whom the experimental designed is not related to the patient's illness.
3. The investigator or the investigating team should discontinue the research if in his/her or their judgement it may, if continued, be harmful to the individual.
4. In research on man, the interest of science and society should never take precedence over considerations related to the wellbeing of the subject.