Lacking “identifiers or codes that can link a particular sample to an identified specimen or a particular human being.”
Source: 2000. Research Involving Human Biological Materials: Ethical Issues and Policy Guidance, Executive Summary. Rockville, MD: National Bioethics Advisory Committee, p. 2. (http://bioethics.georgetown.edu/nbac/hbm_exec.pdf)
“...affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.”
Source: 45 CFR 46.402(b)
“An individual capable of deliberation about personal goals and of acting under the direction of such deliberation.”
Source: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report — Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Department of Health and Human Services: Part B, section 1, “Respect for Persons” (http://ohsr.od.nih.gov/guidelines/belmont.html)
“Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”
Source: 45 CFR 46.402(a)
“...a prospective biomedical or behavioral research study of human subjects that is designed to answer specific questions about biomedical or behavioral interventions (drugs, treatments, devices, or new ways of using known drugs, treatments, or devices).”
Source: US Department of Health and Human Services Grant Application (PHS 398) Part II: Supplemental Instructions for Preparing the Human Subjects Section of the Research Plan (http://grants.nih.gov/grants/funding/phs398/phs398.pdf#page=109)
Identifiers are removed from the data in exchange for codes that correspond to the identifiers, and the identifiers are maintained separately from the rest of the dataset.
Influencing an individualís decision about whether or not to do something by using explicit or implied threats (loss of good standing in a job, poor grades, etc.).
Source: Faden, RR, and Beauchamp, TL. 1986. A History and Theory of Informed Consent. New York: Oxford University Press, p. 339.
May include money, other material compensation, such as a coupon or gift certificate, or other non-monetary rewards.
Misleading research participants about the research purpose or procedures.
“Complete separation of the fetus from the woman.”
Source: 45 CFR 46.202(b)
An individual with restricted capability of deliberation about personal goals and of limited ability to act under the direction of their deliberations.
Developed in contrast to the concept of the “autonomous person” in The Belmont Report. Source: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report — Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, D.C.: U.S. Department of Health and Human Services: Part B, section 1, “Respect for Persons.” (http://ohsr.od.nih.gov/guidelines/belmont.html)
Substantial scientific uncertainty about which treatments will benefit subjects most, or a lack of consensus in the field that one intervention is superior to another.
“The product of conception from implantation until delivery.”
Source: 45 CFR 46.202(c)
Withholding some information in order to conduct an unbiased study, with the understanding that the information could be material to a decision by prospective participants about whether or not to participate in the study.
A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.
“OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research. Examples of such additional activities include, but are not limited to: (1) the study, interpretation, or analysis of the data resulting from the coded information or specimens; and (2) authorship of presentations or manuscripts related to the research.”
Source: OHRP, HHS. 2004. Guidance on Research Involving Coded Private Information or Biological Specimens. (http://www.hhs.gov/ohrp/policy/cdebiol.html)
“An individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subjectís participation in the procedure(s) involved in the research.”
Source: 45 CFR 46.102(c)
“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.”
Source: 45 CFR 46.102(i)
Source: 45 CFR 46.202(d)
“The agreement of parent(s) or guardian to the participation of their child or ward in research.”
Source: 45 CFR 46.402(c)
An inactive intervention designed to resemble, as much as possible, its active counterpart in clinical research.
“Encompasses the period from the implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.”
Source: 45 CFR 46.202(f)
“Any individual involuntarily confined or detained in a penal institution. The term is intended to encompass individuals sentenced to such an institution under a criminal or civil statute, individuals detained in other facilities by virtue of statutes or commitment procedures which provide alternatives to criminal prosecution or incarceration in a penal institution, and individuals detained pending arraignment, trial, or sentencing.”
Source: 45 CFR 46.303
The tendency for research participants to: “downplay or ignore the risks posed to their own well-being by participation ... [due to] the participantsí deeply held and nearly unshakeable conviction that every aspect of their participation in research has been designed for their own individual benefit.”
Source: Emanuel, EJ et al., eds. 2003. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore, MD: The Johns Hopkins University Press, p.194.
Research populations must not be subject to undue burden, wherein they are “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.”
Source: National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. 1979. The Belmont Report — Ethical Principles and Guidelines for the Protection of Human Subjects of Research. Washington, DC: U.S. Department of Health and Human Services: Part B, section 3, “Justice” (http://ohsr.od.nih.gov/guidelines/belmont.html)
“An offer of an excessive, unwarranted, inappropriate, or improper reward or other overture in order to obtain compliance.”
Source: Emanuel, EJ et al., eds. 2003. Ethical and Regulatory Aspects of Clinical Research: Readings and Commentary. Baltimore, MD: The Johns Hopkins University Press, p.37.