Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
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4 Enhancing Informed Consent
4 Enhancing Informed Consent
Pages 81-112
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From page 81... ...
are that informed consent will be sought and that it will be appropriately documented, usually by a participant's signing a written consent form in advance of participation. Other sections of the regulations specify elements of informed consent and special conditions when consent elements may be waived (see Boxes 4-1 and 4-21; and required documentation of informed consent, including when advance written consent may be waived (see Box 4-31.
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From page 82... ...
a statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained; (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)
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From page 83... ...
Documentation should be tailored to facilitate and not impede or confuse the actual process of obtaining informed consent, which may oftenbut not always include obtaining a signed written consent form. We urge OHRP to begin immediately to work with relevant professional associations, IRBs, investigators, and representatives of research participants to develop detailed guidance, with examples for types of research and populations studied, on informed consent processes and to add to and modify the guidance as needed in the future (see discussion in Chapter 71.
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From page 84... ...
(d) An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent provided the IRB finds and documents that: (1 )
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From page 85... ...
of this section, informed consent shall be documented by the use of a written consent form approved by the IRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
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From page 86... ...
Almost all such modifications involved the content of consent forms; less than 1 percent involved the consent process (e.g., timing or setting of consent, who obtained consent)
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From page 87... ...
However, this discrepancy does not invalidate a conclusion that IRBs were more likely in 1995 than in 1975 to require modifications to protocols. 3 The large percentage of protocols for which modifications were required to consent forms suggests that IRBs could provide clearer guidance to researchers on appropriate content and language (see Chapter 7)
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From page 88... ...
Sieber, Plattner, and Rubin (2002) cite the following examples provided to them by researchers of inappropriate IRB actions with respect to documentation of consent: · requiring participants who are members of a preliterate society to read and sign a consent form; · requiring written consent of members of cultural groups who consider it insulting to sign an agreement, as if their word were not to be trusted; requiring written consent in situations when oral consent or implicit consent is adequate (e.g., answering a survey question)
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From page 89... ...
There is no evidence on whether IRB attention to consent forms improves the level of protection for participants, but there is some evidence that requiring advance signed written consent inhibits participation for some people who would otherwise not hesitate to join a minimal-risk research study. Readability of Consent Fowns The 1975 Michigan survey devoted considerable attention to evaluating the consent forms that were used by the research projects included in the study.
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From page 90... ...
, there are still no agreed-upon procedures that are demonstrated to provide adequate, comprehensible information to prospective research participants. Furthermore, it is clear that, on average, IRB efforts to improve participant protection by focusing on consent forms have had relatively little effect and, as such, have diverted scarce time and resources of IRB members and investigators alike, particularly when empirical information is lacking about effective ways to improve consent forms and procedures.
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From page 91... ...
Such understanding is also helpful for determining when it may be appropriate and good practice to waive elements of informed consent. For research that is of more than minimal risk to participants, understanding the effects of different informed consent procedures is critical for developing the most effective means for clearly communicating the risks and benefits of participation.
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From page 92... ...
found that most people who failed to return a signed consent form in the mail did not intend to refuse participation (based on a subsequent telephone query)
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From page 93... ...
RESEARCH TO IMPROVE CONSENT PROCEDURES Recommendation 4.1: Social, behavioral, and economic science researchers should conduct research on procedures for obtaining and documenting informed consent that will facilitate comprehension of benefits, harms, and risks of harm, confidentiality protection, and other key features of research protocols for different types of SBES research and populations studied. There are many challenges to developing effective consent procedures that truly support a voluntary, informed decision to participate (or not)
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From page 94... ...
INFORMED CONSENT FOR SPECIAL POPULATIONS Recommendation 4.2: The Office for Human Research Protections should develop detailed guidance for IRBs and researchers on appropriate consent procedures for different types of populations including language minorities and such vulnerable groups as undocumented immigrantsstudied in social, behavioral, and economic sciences research. The process of informed consent emphasizes the elements of disclosure, competence, comprehension, and, finally, a voluntary decision to consent or refuse to participate.
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From page 95... ...
Because we considered informed consent and other ethical practices for research with human participants in the context of the Common Rule (subpart A of 45 CFR 46) , which applies to the general population, our report does not address special concerns for children (or other people with diminished capacity for informed consent, such as mentally retarded people)
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From page 96... ...
requirements for written documentation of informed consent in studies with immigrant populations or in international settings may be particularly problematic when study par~See discussion of financial incentives, which are ordinarily appropriate in SEES research, in "Survey Research" below.
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From page 97... ...
depend on accurate and meaningful translations of informed consent documents. A process of back-translation is recommended when translation of consent forms is required: researchers translate the consent form from one language to another, then it is translated back to the original language by someone else, preferably by someone who is not associated with the study.
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From page 98... ...
THIRD-PARTY CONSENT Recommendation 4.3: The Office for Human Research Protections should develop detailed guidance for IRBs and researchers, including specific examples, on when it is and
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From page 99... ...
Recently, concerns about third-party consent for studies that ask respondents for information about others (third parties) have become more prominent in discussions of ethical research.
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From page 100... ...
Authorized Proxy Response When the desired respondent cannot participate because of disability or other incapacity and an authorized representative of the individual is present, then consent can be obtained from that representative as provided in the Common Rule (see Box 4-31. Household Proxy When surveys or participant observation research pertain to an entire family or household, the issue is whether consent must be obtained from every member for one member to respond for the family or household as a whole.
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From page 101... ...
WAIVING WRITTEN CONSENT Recommendation 4.4: The Office for Human Research Protections should develop detailed guidance for IRBs and researchers—with clear examples for a variety of social, behavioral, and economic sciences research methods and study environments—on when it is appropriate to waive signed written consent. The Common Rule requirement for obtaining a signed written consent form may be waived under one of two conditions: (1)
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From page 102... ...
To facilitate survey research, we conclude that signed written consent should be waived, as a matter of standard practice, for minimal
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From page 103... ...
Mail Generally, mail surveys of the general population should be treated as minimal risk and, hence, not require written consent, even if the subject matter appears to be sensitive. The reason is that there is no interaction between the investigator and the participant and therefore no danger that a participant will feel threatened the participant can simply toss the survey in the trash.~° It is possible to imagine scenarios it However, mail surveys of specific populations (e.g., cancer patients, people on .herapy for HIV or AIDS)
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From page 104... ...
Thus, as for mail surveys, signed consent is rarely, if ever, necessary for participants in telephone surveys of the general population and for the same reasons such documentation does not provide any added protection to the respondent, and it will likely reduce participation. The interviewer's script should provide information the respondent needs in order to decide whether to participate, such as provisions for protecting confidentiality and the right of the respondent to refuse to answer questions and to break off the interview at any time.
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From page 105... ...
In these situations, verbal consent is usually adequate. In studies involving more than minimal risk to the participants, written consent may be appropriate, but if research participants could come to harm because of potential stigmatization, emotional distress, or physical injury should there be a breach of confidentiality, it may be better to obtain consent verbally rather than create a paper record that could intentionally (e.g., by subpoena)
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From page 106... ...
It would be burdensome for both the researcher and the study participants to continually obtain consent under these conditions. Verbal or written consent for semistructured interviews conducted during focus groups, oral histories, or ethnographic research should clearly identify strategies in place to protect the confidentiality of individuals.
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From page 107... ...
When publicly available microdata sets are studied that were collected from research participants who gave consent for the original data collection for research purposes, no consent is required for secondary analysis. Indeed, IRBs should routinely
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From page 108... ...
OMITTING ELEMENTS OF INFORMED CONSENT Recommendation 4.5: The Office for Human Research Protections should develop detailed guidance for IRBs and researchers, including specific examples, on when it is acceptable to omit elements of informed consent in social, behavioral, and economic sciences research. The Common Rule acknowledges the appropriateness, under some circumstances, of omitting or modifying some of the required elements of the consent process.
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From page 109... ...
Including that element in the consent form for, say, a study using structured or semistructured interviews would just add length and confusion to the form. Some SEES research may purposefully manipulate a condition of the research environment by deceiving participants about aspects of the research- passively by withholding information about the true purpose of the research, or actively by presenting information that is not correct in order to observe reactions to the condition created by that information.
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From page 110... ...
The code (revised in 2002, see http://www.apa.org/ethics L4/10/031) essentially incorporates the Common Rule provisions: It explicitly and strictly limits the use of deception to research for which deception is necessary for valid results and the research is likely to have significant scientific, educational, or applied value; the research is not expected to cause physical pain or severe emotional distress; and participants are debriefed about the deception as soon as possible after data collection.
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From page 111... ...
CONCLUSION Informed, voluntary consent is a critically important principle of human research participant protection and one of the most difficult to implement in an effective manner. We hope that a combination of systematic research on consent procedures and development of detailed guidance for IRBs and researchers will raise the standard of practice for seeking and documenting consent to participate in research in ways that increase the protection and respect for human participants and are commensurate with the risks of the research.
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From page 112... ...
be treated as minimal risk and, hence, not require written consent, even if the subject matter appears to be sensitive. The reason is that there is no interaction between the investigator and the participant and therefore no danger that a participant will fee!
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