Definitions and Examples of Terms used in Human Subjects Research Applications
Refers to a guarantee of privacy by virtue of recording data collected so that there is no way for anyone (including the researcher) to be able to identify participants by the data collected. This is more common in research involving one-time data collection, such as that which occurs when using survey methods, taking only one set of physical or psychological measurements, or having subjects complete questionnaires without asking for their names.
It is important to inform subjects that when data are recorded anonymously, subjects will not have the right to withdraw from the study once the data have been collected, because there is no way to determine which data belong to which subject.
Be aware that surveys or questionnaires which require extensive demographic data may violate the principle of anonymity by providing enough information to allow the researcher to directly identify one subject from all others.
A person's affirmative agreement to participate in research. Individuals under age 18 may give assent, but not consent, to participate as subjects in a research study. Assent should be sought from adults for whom a legal guardian has been appointed. Failure to object must not be construed as assent. The minimum age for assent depends on the maturity and psychological state of the individual.
One of three ethical principles in the Belmont Report stating that there is an obligation to secure the well-being of participants in research by maximizing possible benefits and minimizing possible harms.
A person who has "not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of jurisdiction in which the research will be conducted" (FR 46.401 (a), p. 15). See Legal Age.
Coercion means to compel or force someone to participate in or perform an action that would not ordinarily be done of the individual's own free choice. In the Milgram experiments in the 1960s, subjects were coerced by an authority figure to continue to administer false (sham) electrical shocks of supposedly increasing intensity to actors who were pretending to be volunteer subjects even when the actors appeared to be in great pain and were begging not to be shocked. The researcher compelled subjects to continue administering shocks to the volunteers even when, ordinarily, the subject would not have continued the behavior.
Coercion may also occur unintentionally in the manner in which the investigators may encourage subjects to perform within the study. Encouraging subjects to perform to the best of their ability is not coercion, however, investigators must clearly explain the risks of physical/psychological exertion. It should be clear to the subject what are the expected sensations/discomforts/risks associated with exertion in the study and efforts should be made to minimize any discomforts/risks unless necessary to the study. It should also be clear to the subject that s/he can stop participation at any time based on discomfort/exertion.
Coercion may be present but less obvious when recruiting subjects for research. For example, telling parents or guardians of subjects or subjects themselves how much they will be helping the investigator by participating in a study can be interpreted as coercive. Participation should be free and voluntary, with no overriding statements.
Mentioning a relationship which exists between the researcher and the potential subjects may be coercive. Subjects may feel obligated to participate because they know or have seen the researcher at various times. In cases of infants and children, mentioning that the researcher cares for or has cared for the child puts parents in a very awkward and unfair position.
Face-to-face recruitment has the potential to be coercive. It is difficult for individuals to say no to someone who is directly in front of them and talking about his or her project. Inflection, tone of voice, and nonverbal cues can inadvertently slip into the recruitment process without the researcher's awareness. Coercion can be reduced if an impartial third party presents the request for participation.
Subjects should be protected from coercion. If subjects are not protected, the HSRRC application must include an explanation of why coercion is necessary as well as any possible repercussions of the coercion. The methods to be used for coercing subjects must be detailed in the Procedures section of the research proposal. A plan for informing subjects at the end of the study of how and why they were coerced must be fully explained (see Debriefing). Potential physical and/or psychological risks that may be incurred by subjects due to the coercion must be identified, and procedures for addressing the risks must be established as part of the debriefing procedures.
Confidentiality refers to protection of subjects' privacy so that information collected about them as part of the research process is not disclosed. Information may be revealed in group form, or as individual examples, but not in a way that an individual may be identified.
If the investigator collects information on subjects over a period of time, such as in test-retest reliability or in pretest-posttest study designs, there must be a mechanism to relate various data to the same subject. This may be done by using codes or identifiers (e.g., subject ID numbers) on both sets of data that only the researcher can trace to a master name-number list. Because names and numbers can be related, this list must be kept confidential by storing it in a private and secure location, such as a locked file cabinet.
If data are recorded anonymously in cases where the researcher personally knows subjects, it must be acknowledged that the researcher knows the subjects personally, and the data must be treated confidentially, because anonymity is not possible. It is important to acknowledge that subjects may waive the right of confidentiality. This may occur, for example, when a subject specifically requests to be quoted.
In the United States, all confidential data must be stored by the researcher for 3 years. In Canada, data must be stored for 6 years.
Willingness to participate as a subject in a research study by individuals 18 years of age or older. See Implied Consent and Informed Consent.
Debriefing is a process of telling subjects all the information related to the study that was initially withheld, and the reasons for withholding the information. Debriefing is used when subjects have been deceived or coerced, and as a means of briefly informing subjects about the study purpose(s) immediately after data have been collected (if possible without compromising the remaining data collection). In the first case, debriefing may take the form of dehoaxing or desensitizing subjects. Do not confuse debriefing with summary of the study results. See Summary of Results.
Deception is defined as misrepresenting, tricking, or disguising. Deception is common in some research. An example is in drug testing, where some subjects receive a placebo, some receive experimental drug A, and others receive experimental drug B, but subjects do not know whether they are receiving the drug or the placebo. Another example of deception is testing the effects of a treatment with control and experimental groups, but not telling subjects what dependent variable the researcher is using to measure effectiveness. The subjects must, of course, be aware of which measurements will be taken so they can sign an informed consent to participate in the study, but the researcher may choose to not tell participants what is looked for in order to prevent the subjects from biasing the results.
Subjects should be protected from deception. If subjects are not protected, the researcher must explain in the HSRRC application why this is necessary, as well as any possible repercussions for the subjects. The methods to be used for deceiving subjects must be detailed in the Procedures section of the research proposal, and a plan for informing subjects at the end of the study as to how and why they were deceived must be fully explained (see Debriefing). Potential physical and/or psychological risks that may be incurred by subjects due to deception must be identified, and procedures for addressing the risks must be established.
Dehoaxing is the process of convincing subjects who have been deceived as part of a research study that they have in fact been deceived.
The purpose of dehoaxing is to prevent possible future harm to the subject. For example, subjects may be given false pretest scores in order to test the effect of these scores on subsequent tests of motivation levels. If subjects believe that the false scores represent their true abilities, their level of self-esteem may become jeopardized. In cases such as these, simply informing the subjects that they were deceived and that the pretest scores were false may not be sufficient. In addition to informing the subjects, some form of demonstration may be needed to convince subjects that they were deceived and thereby diminish the undesirable effects of the experiment.
Desensitization is the process of helping subjects deal with information they learn about themselves as a result of participating in research. Again, consider the outcome of the Milgram study in which some subjects thought they had administered lethal electrical shocks to another person because the experimenter told them to do so. This knowledge of their behavior, coupled with their previous self-perception, required counseling for some subjects who became depressed as a result of participating in the study.
One way to desensitize subjects is to reinforce the idea that their behavior resulted from the circumstances of the research, and that their behavior was not abnormal or unusual. Desensitization is used to help subjects accept behaviors that were performed which seemed inconsistent with their self-perceptions.
The extent to which a subject may be made physically or psychologically uncomfortable by the topic or activity that is the focus of the research.
Individual authorized under applicable state or local law to consent on behalf of a child to general medical care.
"A living individual about whom an investigator conducting research obtains: (a) data through intervention or interaction with the individual, or (b) identifiable private information" (FR 46.102 (f), p. 6).
Implied consent means that subjects give their consent to participate in the study by virtue of their participation. That is, the subjects' voluntary participation in the study is accepted as their consent to be a part of the study. Implied consent can be used only when the only record linking the subject and the research would be the informed consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Thus, implied consent is only possible with data that are recorded anonymously.
Implied consent is often used in mailed survey research where subjects are asked to return a completed questionnaire to the researcher without recording their names on the survey or questionnaire. The data must be anonymous so that there is no way for the researcher to link the data with the subject. As a result, subjects must be informed that they cannot withdraw their data once provided to the researcher, since there is no way to know which data are theirs.
Implied consent may be used when coding mechanisms, such as master name-number lists, are employed in the survey design such that the researcher knows which subject returned, which survey, ONLY when (a) subjects are informed that coding is being used, (b) the researcher destroys the coding mechanism at the completion of data collection (thus, at this point, the once-confidential data becomes anonymous), and (c) subjects are informed of the date on which the coding mechanism is to be destroyed.
Informed consent should be viewed as a process and not just a form. Full, accurate, and comprehensible information must be provided to individuals to enable them to voluntarily decide whether or not they want to participate in a research study. The explanation of procedures used to obtain informed consent should be presented to the individuals being asked to participate in the research in terms they can understand. Thus, the language of informed consent must be presented in lay language. It must be made clear to individuals that their signature on the form serves as documentation of their consent to willingly participate in the research.
Institutional Review Board.
Determination by an HSRRC that research "has been reviewed and may be conducted at an institution within the constraints set forth by the HSRRC and by other... requirements" (FR 46.102 (h) p. 6).
One of three basic ethical principles regarding the conduct of research described in the Belmont Report. This principle requires that there be fair procedures and outcomes in the selection of research subjects.
Legal age is defined as 18 years old or older.
Maintenance of Data
Confidential data must be securely maintained in a locked file cabinet, locked desk, or through some other secure method. Applicants must specify where the data will be maintained. Data must be stored for three (3) years in the United States and six (6) years in Canada.
"The probability and magnitude of harm or discomfort anticipated in the (proposed) 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" (FR 46.102 (i), p. 6).
Non-participation occurs when an individual who previously consented to participate in research fails to appear for scheduled sessions with the researcher, or who initially participates but then stops. Researchers may use all of the data that were collected on any individual who ceases participation in a study but has not withdrawn from the study. See Withdrawal.
"The agreement of parent(s) or guardian to the participation of their child or ward in research" (FR 46.402 (c), p. 15). See Assent, Guardian, and Informed Consent.
Physical Risk or Discomfort
Subjects should be protected from more than minimal physical risk/discomfort. If the planned research does not protect subjects, the researcher must indicate why this is necessary, the possible consequences for subjects, and what will be done to restore physical balance. Subjects must be informed ,of any potential for physical risk or discomfort. See Minimal Risk.
For example, in testing the concurrent validity of two tests of hand dexterity, subjects may be required to perform tests that could cause fatigue and or pain in the hand musculature. Subjects must be protected from this discomfort or informed of the possibility for this discomfort, and must have enough information to make an informed decision as to whether or not they want to participate in the study and endure the potential physical risk.
Psychological Risk or Discomfort
Subjects should be protected from more than minimal psychological risk or discomfort. If the proposed research does not protect subjects, the researcher must indicate why this is necessary, what are the possible consequences for subjects, and what will be done to restore psychological balance. Subjects must be informed of any potential for psychological risk or discomfort. See Minimal Risk.
For example, in a study of leadership style, subjects may be surveyed about their evaluation of superiors, which may lead to psychological discomfort for some individuals; either subjects who may feel they are passing judgment on their leaders, or for the leaders who are being evaluated (judged) by their subordinates. Subjects must have enough information to make an informed decision as to whether or not they want to participate in the study and endure the potential psychological risk.
"A systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge" (FR 46.102 (d), p. 6).
Respect for Persons
An ethical principle described in the Belmont Report which states that individuals should be treated as autonomous agents, and that individuals with diminished autonomy are entitled to protection.
The probability of harm or discomfort.
Summary of Results
Subjects often agree to participate in research without compensation. One way to thank them and to educate them about the research in which they were involved is to offer a summary of the study results. To do so, the researcher should include space on the consent form for subjects to write their address, should they wish to receive a copy of the summary of results.
The researcher must be careful to write a summary of the results especially for participants, and not simply give the participants a copy of the full results section of the study. Students engaged in master's thesis work should always seek the guidance of the thesis chair when preparing a summary of their results. In cases where research is performed at clinics or locations other than on the Daemen College campus, the researcher should prepare a draft of the summary of the results for review by the site supervisor or official assigned to the research project. No summary should be sent to participants without approval by the site official.
Also, the researcher must be sure to send a copy of the summary of results to all subjects who indicated a desire to receive this summary. In the rush to complete a study, the researcher must keep in mind that it was the subjects' agreement to participate in the study that made completion of the study possible, and that the subjects' request for results must be honored. The honoring of this agreement between subject and researcher encourages future participation in research efforts, while the failure to honor this agreement serves as a deterrent to all future research.
Withdrawal refers to how subjects in a research study may discontinue their involvement prior to the completion of the study. When a subject exercises this right, the informed consent to participate in the study becomes void. The data collected from a subject's participation cannot be used in any analyses, and the data must be destroyed immediately upon notification of withdrawal from the study.
For example, a subject may agree to participate in a 30-minute exercise session, twice per week, for 6 weeks. If, after the fourth exercise session, the subject no longer wishes to participate in the study, the subject may choose to discontinue participation in the study, and notify the researcher of withdrawal from the study.
The Procedures section of the research proposal, the script of introduction to recruit subjects, and the Informed Consent form must specify how and when subjects may exercise this right, and that there are no consequences for the subject if this right is exercised.
How a subject may withdraw refers to procedures established by the researcher for the subject to exercise this right. For example: "Subjects may withdraw from the study by informing __ (specify name of a person) either verbally or in writing, of their desire to withdraw. " Verbal notification implies that the subject may notify the contact person, either face-to-face, or over the telephone. Written notification may be in the form of a letter or handwritten note delivered to the contact person.
When a subject may withdraw refers to the maximum timeframe during which the subject may exercise the right of withdrawal. No minimum timeframe for participation can be established. That is, the researcher cannot require a subject to participate for any minimum time period; otherwise the subject would not truly have the right of withdrawal. The maximum timeframe refers to the longest period of time during which a subject may exercise the right of withdrawal. This timeframe is established to prevent subjects from withdrawing from the study after the study has been completed. For example: Subjects may withdraw from the study at any time up to 3 days after the subject's participation has been completed. In this example, subjects have only 3 days after their completed participation in the study to decide that the researcher may not use data from their participation.
It should be clearly explained to subjects that data collected anonymously limits their right to withdraw from the study only throughout the duration of their involvement because there is no way for the researcher to withdraw anonymous data once they have been collected. There can be no penalty or loss of benefits to subjects to which they are otherwise entitled, if they choose to withdraw from the study.
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