Proposed Revisions to the Common Rule Perspectives of Social and Behavioral Scientists: Workshop Summary (2013) / Chapter Skim
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Session 3: The Consent Process and Special Populations
Session 3: The Consent Process and Special Populations
Pages 35-48
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From page 35... ...
Margaret Foster Riley, of the University of Virginia, noted in her introductory remarks that the proposed changes to the Common Rule bring up the possibility of a standardized informed consent form, but the variety of issues raised by these distinct populations makes it clear that it will be exceptionally difficult to develop a single form -- or a single informed consent process -- that can be applied uniformly to these disparate types of research participants. LONGITUDINAL RESEARCH WITH BEHAVIORAL AND BIOSPECIMEN DATA FROM FAMILIES Sally Powers, of the University of Massachusetts, Amherst, spoke about her 30 years of research on the effects of social stress on depression and the consent issues associated with such studies.
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From page 36... ...
She measures stress through observations of behavior, selfreports, and analysis of stress hormones in saliva samples taken before the conflict task, during the conflict task, and afterward. Rich Data Powers focused on consent issues involving rich data, which she defined as data that can be "recoded, reassayed, and retested to yield new information that was not proposed in the original study." She explained that she was not referring to the reanalysis of existing coded information from large survey datasets, which can produce new insights and interpretations but which usually does not produce new data.
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From page 37... ...
The proposed revision to the Common Rule would require getting prior consent whenever one obtains biospecimens and also asking for blanket consent for open-ended use, meaning that the research participants would agree to have their samples used for any type of future analysis. This consent would be requested whether or not the biospecimens were to be de-identified.
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From page 38... ...
Thus, she said, "I suggest that this [blanket, open-ended] standard is acceptable for video data, but not for biospecimen data." Because the proposed changes in the Common Rule seem to be focused mainly on biospecimen data, she said, it would be useful to think carefully about those changes as they would apply to behavioral research and, particularly, videotape data.
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From page 39... ...
"We ask them to give us contact information; we even ask them if they would give us names of friends who may know where they've moved." Consent for Interdependent Data Because her data involve multiple subjects who interact -- a videotape with a mother and daughter arguing, for example -- Powers must deal with consent issues involving interdependent data. She illustrated with an example of a woman who had taken part in an earlier wave of the study as an adolescent and is now a mother with her own teenager.
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From page 40... ...
The study was done in collaboration with Knowledge Networks, a research survey firm that retained the participants' identities to make longitudinal data collection possible while ensuring that all the data were de-identified. On behalf of Silver's collaborators, Knowledge Networks also went back to a random subsample of original participants and collected biospecimens -- saliva samples -- two years after the project ended, which were ultimately linked to the earlier data respondents had provided.
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From page 41... ...
She has also found it very valuable to have the IRB preapprove a generic proposal that can be activated immediately after a disaster. She has an approved generic disaster trauma protocol at her university that describes the background and rationale of the research, proposed methods, proposed risks and benefits, who the research team is, and sample questionnaires and interview questions.
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From page 42... ...
Both parents and children completed surveys before the intervention, and a subsample provided saliva samples for future cortisol and genetic analysis. The parents were randomly assigned, by school, to either a skills-based psychosocial intervention or a waiting list control group.
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From page 43... ...
Finally, eliminating the waiting period before exempt or excused data collection can commence would facilitate trauma or disaster research, whereas requiring even a brief waiting period -- as little as one week -- could impede the research. INFORMED CONSENT WITH CHILDREN AND VULNERABLE POPULATIONS Celia Fisher, of the Center for Ethics Education at Fordham University, spoke about a variety of issues that arise in studies involving children and other special populations (see also Fisher et al., 2013)
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From page 44... ...
Furthermore, written consent can jeopardize participant safety in war zones; in research in which partner violence is an issue; and in studies looking at stigmatized or illegal behavior, such as drug use, HIV status, or homosexual activity. Thus, Fisher said, it would be useful to have population-specific guidelines to help IRBs and investigators craft appropriate oral consent.
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From page 45... ...
However, Fisher said, most states do not include language specific to research participants in their emancipated and mature minor laws, and "this has been incredibly confusing to IRBs because they don't know whether or not they should require parental permission." As a result, she said, IRBs often needlessly require guardian permission for minors' involvement in research related to treatment and procedures for which they've already obtained a legal right to adult status. For example, an adolescent who can go to a clinic and get sexual health treatment or prescriptions independently under the mature minor rule may still be required by an IRB to get parental permission to participate in a survey that asks about his or her experiences.
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From page 46... ...
the original informed consent informed the guardians -- and minors old enough to understand -- that their consent represented a default permission for continuing to use the data after the child reached the age of maturity. Another important question, Fisher noted, is when it is acceptable to expand the original informed consent commitment to de-identified data for socially sensitive research.
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From page 47... ...
Whenever an original investigator or a new investigator wants to link archival identifiable data with collection of new data, she explained, it is necessary to get re-consent from the original participants, Fisher said. The original informed consent should indicate that any investigators interested in linking new data collection with the archival dataset will be given access to the participants' contact information in order to request additional permission for its use.
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