Protecting Participants and Facilitating Social and Behavioral Sciences Research (2003) / Chapter Skim
Currently Skimming:
2 Basic Concepts
2 Basic Concepts
Pages 23-58
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 23... ...
human research participant protection system researchers, institutional review boards (IRBs) , research institutions, funding agencies, and the Office for Human Research Protections (OEIRP)
|
From page 24... ...
Resolving conflicts among principles, however, can prove challenging in practice and underscores the necessity of the ethical review processes that are in place for research with humans. In practice, the three principles translate into consideration of three requirements: informed consent, assessment and appropriate balancing of risks and benefits, and fair procedures for selection of research participants.
|
From page 25... ...
Under carefully considered circumstances, however, it can be appropriate to use less than fully informed consent for example, keeping information about a particular feature of a study from a prospective participant until the study is completed when such information would likely alter the participant's behavior, the knowledge to be gained is important, and the risk to the participant from omitting the particular information is minimal. Assessment of Harms, Risks, and Benefits—weighing and appropriately balancing the risks of harm and the potential for benefits from participation in the proposed study.
|
From page 26... ...
(2001:71-72) and adding examples from SBES research, below we discuss six types of harms that can occur to research
|
From page 27... ...
Examples in SBES research range from death or injury due to the failure of an alternative automated method of helping blind people cross at traffic signals to discomfort from being subjected to loud noises or bright lights during a stimulus-response study. Physical harm, including injury and death, can also result from a breach of confidentiality that discloses sensitive information (e.g., that one is participating in a study of gang violence, which could lead to retaliation by gang members)
|
From page 28... ...
Differences in methods used in SBES research relate to the appropriate focus of IRBs in determining the kinds of potential harm to human participants. For research involving interventions, such as a laboratory experiment in which the participant is subjected to a stimulus, a primary focus must be on the potential harm to the participant from the intervention itself.
|
From page 29... ...
: behav~oral/social research includes social science, behavioral science, educational research, and health services research; clinical/biomedical research includes clinical research, biomedical science, and epidemiology. SOURCE: 1995 survey of IRBs in Bell, Whiton, and Connelly (1998:Figure 1 la)
|
From page 30... ...
. Moreover, even if IRBs and researchers agree on the risks of a particular research study, it may still be a matter of judgment as to whether the study meets the Common Rule definition of posing no more than "minimal risk" to participants (see "Minimal Risk" below)
|
From page 31... ...
Yet a major issue for clinical trials of experimental drugs or devices is that participants may confuse research with medical care and expect an immediate benefit to themselves when such benefit may not be likely even if the participant receives the experimental treatment and not a placebo. For most, if not all, SBES research, there is usually little direct benefit to participants in the sense that the results of the research will be of immediate help to them, but SBES and biomedical research can provide two other kinds of benefits.
|
From page 32... ...
Having determined the type of review, the IRB then must conduct that review to evaluate the research practices and procedures of the protocol as they relate to the ethical treatment of human participants, including judgments about the key practices discussed earlier informed consent, balancing of risks and benefits, selection, and confidentiality considering both the vulnerability of the population of interest and who is being invited to participate in the study. IRBs must impose stringent requirements for informed consent when the IRB judges a protocol to be more than minimal risk.
|
From page 33... ...
Even if most or all respondents are annoyed, an innocuous survey is still minimal risk because the harm to any one respondent is minor and fleeting, and people experience similar transitory annoyances every day. In addition, the working group formulation suggests that projects posing serious harms to participants can be minimal risk if the probability of such harm occurring to any given participant is extremely low.
|
From page 34... ...
We argue in subsequent chapters that much more concrete guidance is needed for IRBs and researchers on the kinds of research protocols that qualify as minimal risk. We also acknowledge that there will always be a role for judgment on the part of IRB members to apply appropriately the Common Rule regulations and guidance regarding minimal risk to individual research populations and settings.
|
From page 35... ...
that IRBs are overloaded, underfunded, and, consequently, hard pressed to fully carry out their responsibilities for protecting human participants in more-than-minimal-risk research; and (2) that IRBs are spending too much time on scrutinizing minimal-risk research (perhaps as a reaction to heightened scrutiny of IRB operations by the federal government and the media in the light of highly publicized deaths to research participants; see Chapter 31.
|
From page 36... ...
It appears that at least half of IRBs at academic research institutions have heavy workloads, with the number of reviews per year (including initial reviews of new projects, continuing reviews, and reviews of proposed changes to previously approved projects) totaling more than the number of calendar days.
|
From page 37... ...
Workload volume deciles computed by Bell, Whiton, and Connelly on the basis of initial reviews only. SOURCE: Computed from Bell, Whiton, and Connelly (1998:7,9)
|
From page 38... ...
· Total time spent per review of all initial proposals averaged 7 hours for high-volume IRBs in 1995 and 15 hours for low-volume IRBs in 1995, compared with 38 hours for all IRBs in 1975 (Bell, Whiton, end Connelly, 1998:48,51; Gray, Cooke, end Tannenbaum, 1978:10951.6 Clearly, IRBs are stretched thin. Whether that situation adversely affects human participants is not an easy matter to assess.
|
From page 39... ...
fine found only one study of human research participant protection that included an independent assessment of risks. In that study, members and staff of the Advisory Committee on Human Radiation Experiments (1996:443)
|
From page 40... ...
and to allow IRBs to use an expedited procedure for review of many other projects that were deemed to be minimal risky Exemption A 1983 study found reluctance among IRBs to avail themselves of the new Common Rule exemption provisions: almost all IRBs at that time had decided not to exempt research projects from review that fell under one of the four eligible categories of educational, social, and be~The 1995 Bell survey reported that three-fourths of projects were judged by investigators to have less than 10 percent likelihood of a "low" degree of harm (Bell, Whiton, and Connelly, 1998:20)
|
From page 41... ...
At the other extreme, 2 percent of IRBs in the 1995 survey conducted no full board reviewsthat is, all new protocols were reviewed by an expedited procedure or were exempted from review. Variability At present, there appears to be wide variability in the extent to which IRBs avail themselves of the option for either exemption or expedited review.
|
From page 42... ...
IRB meeting time averaged 2 minutes per expedited initial review, compared with 8 minutes per full board initial review. Expedited reviews are also completed in less elapsed time than are full board reviews: 18 percent of expedited reviews in the 1995 Bell survey were completed in 1 week or less, compared with only 5 percent of full board reviews; 84 percent of expedited reviews were completed in 1 month or less, compared with only 49 percent of full board reviews.
|
From page 43... ...
SBES research is extremely diverse, including classical laboratory experiments, ethnographic research, oral histories, large-scale field experiments, small-scale surveys, large-scale surveys, secondary analysis, other types of methods, and combinations of methods. This diversity can pose challenges for overworked IRBs, particularly in the absence of detailed guidance about how to handle particular situations.~2 Clearly, a "one size fits all" approach is not appropriate, whether the issue is protecting confidentiality, evaluating harms and risks, minimizing risk of harm, or ensuring informed consent.
|
From page 44... ...
lessee, for example, Intemationat Encyclopedia of the Social and Behavioral Sciences (Smeller and Baltes, 2001:Table 2) , which lists these fields as SBES research or as "related fields." Other related fields listed include archaeology, demography, geography, law, linguistics, and philosophy.
|
From page 45... ...
SBES Research Methods SBES research uses a wide variety of research methods. Traditionally, some methods have been more frequently used by some disciplines than others for example, laboratory experiments in psychology, and observations and unstructured interviews in anthropology.
|
From page 46... ...
Below we briefly describe and provide illustrative examples of some commonly used methods in SBES research laboratory experiments, field experiments, observations of natural behaviors, unstructured interviews with participants, structured interviews in sample surveys, and analyses of existing data on individuals. For each example, we
|
From page 47... ...
of human participants. Field experiments are more difficult to carry out than laboratory experiments for at least two reasons: the environment is more difficult to control in the field than in the laboratory, and field experiments are conducted on a larger scale.
|
From page 48... ...
at the outcome; identifying information is not retained and so the risk that participants' identities could be linked with their decisions is minimal. Such experiments could be exempted from IRB review or reviewed by an expedited procedure.
|
From page 49... ...
Fair selection of participants is also a concern that is, how the jurisdictions are chosen and whether any are included that offer neither job behavior coaching nor work skill training as standard practice. If the experiment is evaluating a federal benefits program for a federal program agency, then it is eligible for exemption under the Common Rule (see Box 1-1 in Chapter 1)
|
From page 50... ...
An investigator working in the area of [IIV prevention, for example, may use unstructured interviews with injection drug users to explore beliefs and practices associated with accessing treatment programs. While the general topic has been defined, there is no attempt to follow a predetermined line of inquiry using an interview guide of questions to be asked.
|
From page 51... ...
Semistructured interviews might be implemented in situations in which the researcher needs to be sure that the same data are collected from all participants. Semistructured interview guides also may be used in focus groups with small numbers of individuals selected on the basis of specific criteria to discuss a particular topic (e.g., a sample of women with known risk factors for breast cancer discussing genetic testing; family members caring for an elderly parent with Alzheimer's disease)
|
From page 52... ...
For example, a study of advance care planning in a hospice program might include a survey of a random sample of patients and their families and health providers, along with semistructured interviews with some study participants. See Box 2-4 for three examples of research using unstructured or semistructured interviews; two of the examples are minimal risk, one of which involves changes in the interview protocol as the study proceeds.
|
From page 53... ...
See Box 2-6 for two examples an analysis of public-use files from a large government survey and a study of school transcript records, both minimal risk. CONCLUSION We have discussed a broad array of issues related to the determination of harm, risk, benefit, and minimal risk in SBES research, along with evidence that many IRBs despite punishing workloads—do not appear to be using the flexibility in the Common Rule regulations to exempt eligible research or to use an expedited procedure to review minimal-risk SBES and biomedical research.
|
From page 54... ...
Case Study of Informed Consent Practices in International Genetic Research A semistructured interview is administered to 20 health professionals in a Nigerian town to explore challenges associated with obtaining informed consent in community-based genetic research being conducted in their area. The study participants are invited to participate in this case study because of their involvement in international scientific investigations.
|
From page 55... ...
Verbal consent is appropriate when semistructured interviews are conducted. The IRB should ask investigators to outline procedures for obtaining informed consent and strategies for protecting confidentiality, including the disposition of audiotapes if they are used for interviews.
|
From page 56... ...
Data are linked with administrative records, including social security earnings records and descriptions of employer pension and health benefit plans. Some of the data are provided for public use; access to the full microdata requires special arrangements.
|
From page 57... ...
Commentary This type of analysis is minimal risk given that the researcher has no way of linking student records to individual students. The principal concern is whether the students gave consent for their records to be used for research; another concern is whether students might be identifiable by inference.
|
From page 58... ...
at the outcome; identifying information is not retained and so the risk that participants' identities could be linked with their decisions is minimal. Such experiments could be exempted from IRB review or reviewed by an expedited procedure.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.