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Belmont Report -ME

Terms in this set (115)

1. The World Medical Association (WMA) Declaration of Helsinki a statement of ethical principles for medical research involving human subjects, including research on identifiable human material and data.

2. Although the Declaration is addressed primarily to physicians, the WMA encourages other participants in medical research involving human subjects to adopt these principles.

3. It is the duty of the physician to promote and safeguard the health of patients, including those who are involved in medical research. The physician's knowledge and conscience are dedicated to the fulfilment of this duty.

4. The Declaration of Geneva of the WMA binds the physician with the words, "The health of my patient will be my first consideration," and the International Code of Medical Ethics declares that, "A physician shall act in the patient's best interest when providing medical care."

5. Medical progress is based on research that ultimately must include studies involving human subjects. Populations that are underrepresented in medical research should be provided appropriate access to participation in research.

6. In medical research involving human subjects, the well-being of the individual research subject must take precedence over all other interests.

7. The primary purpose of medical research involving human subjects is to understand the causes, development and effects of diseases and improve preventive, diagnostic and therapeutic interventions (methods, procedures and treatments). Even the best current interventions must be evaluated continually through research for their safety, effectiveness, efficiency, accessibility and quality.

8. In medical practice and in medical research, most interventions involve risks and burdens.

9. Medical research is subject to ethical standards that promote respect for all human subjects and protect their health and rights. Some research populations are particularly vulnerable and need special protection. These include those who cannot give or refuse consent for themselves and those who may be vulnerable to coercion or undue influence.

10. Physicians should consider the ethical, legal and regulatory norms and standards for research involving human subjects in their own countries as well as applicable international norms and standards. No national or international ethical, legal or regulatory requirement should reduce or eliminate any of the protections for research subjects set forth in this Declaration.
Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (a) research on regular and special education instructional strategies or (b) research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: a. information obtained is recorded in such a manner that subjects can be identified, directly or
through identifiers linked to the subjects and b. any disclosure of the human subjects' responses outside the research could reasonably place the
subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior that is not exempt under paragraph # 2 (above) if: a. the human subjects are elected or appointed public officials or candidates for public office, or
b. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens or diagnostic specimens, if these sources are publicly available or the information is recorded by the investigator in such a manner that the subjects cannot be identified directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of (federal) department or agency heads and which are designed to study, evaluate or otherwise examine: (a) public benefit or service programs, (b) procedures for obtaining benefits or services under those programs, (c) possible changes in or alternatives to those programs or procedures or (d) possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, if: a. wholesome foods without additives are consumed or b. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the FDA or approved by the EPA or the Food Safety and Inspection Service of the U. S. D. A.
An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in Expedited Research Categories
Research categories that may be reviewed using expedited review procedures by the University of Tennessee at Martin Institutional Review Board (IRB) match federal guidelines and include:


Category G: Clinical studies of drugs and medical devices only when condition
Category H: Collection of blood samples by finger stick, heel stick, ear stick, or venipucture as follows:
Category I: Prospective collection of biological specimens for research purposes by noninvasive means.
Category J: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwave. ● Category K: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis).
Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45CFR 46.101 (b)(4). This listing refers only to research that is not exempt.
● Category L: Collection of data from voice, video, digital, or image recordings made for research purposes.
● Category M: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identify, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
● Category N: Continuing review of research previously approved by the convened IRB
● Category O: Continuing review of research, not conducted under an investigational new drug application or investigational device exemption
Unless otherwise authorized by an IRB, research investigators must provide the following information to each subject in writing:

Strongly urged to use a format in the body of the consent form that presents information in sections, introduced by headings, and that clearly and simply identifies and describes each of the elements to be discussed, even if the sections repeat information that appears on the printed form.
A statement that the study involves research;*
An explanation of the purpose of the research and the expected duration of the subject's participation;
A description of the procedures to be followed and identification of any procedures that are experimental;
A description of any foreseeable risks or discomforts to the subject, an estimate of their likelihood, and a description of what steps will be taken to prevent or minimize them;
A description of any benefits to the subject or to others that may reasonably be expected from the research. Monetary compensation is not a benefit. If compensation is to be provided to research subjects or healthy volunteers, the amount should be stated in the consent document;
A disclosure of any appropriate alternative procedures or courses of treatment that might be advantageous to the subject;
A statement describing to what extent records will be kept confidential, including a description of who may have access to research records;*
For research involving more than minimal risk, an explanation and description of any compensation and any medical treatments that are available if research subjects are injured; where further information may be obtained, and whom to contact in the event of a research-related injury;*
An explanation of whom to contact for answers to pertinent questions about the research and the research subject's rights (include the Clinical Center's Patient Representative and telephone number);* and
A statement that participation is voluntary and that refusal to participate or discontinuing participation at any time will involve no penalty or loss of benefits to which the subject is otherwise entitled.*
Basic elements of informed consent. In seeking informed consent, the following information shall be provided to each subject:
(1) A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
(2) A description of any reasonably foreseeable risks or discomforts to the subject.
(3) A description of any benefits to the subject or to others which may reasonably be expected from the research.
(4) A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
(5) A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained and that notes the possibility that the Food and Drug Administration may inspect the records.
(6) For research involving more than minimal risk, an explanation as to whether any compensation and an explanation as to whether any medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained.
(7) An explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject.
(8) A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.
(b)Additional elements of informed consent. When appropriate, one or more of the following elements of information shall also be provided to each subject:
(1) A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable.
(2) Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent.