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5 Ethical Procedures and Community Engagement
Pages 121-130

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From page 121...
... . The authors of these documents have laid out plans for addressing numerous issues, such as informed consent, minimal risk, identifying risks, returning information to participants, community engagement, protection of privacy, and sharing of data.
From page 122...
... On a purely mechanical level, the plan needs to clarify whether assays will be conducted pursuant to the requirements of the Clinical Laboratories Improvements Amendments of 2007, since conveying noncompliant laboratory results that may influence participants' health care behavior may actually be illegal. With regard to assessments of participants' health and development, the plan is to provide to participants with findings that are "clinically relevant and actionable," with the caveat that results of genetic tests will be offered to participants and not automatically conveyed (NCS Research Plan, Vol.
From page 123...
... One substantive criterion that may be particularly desirable is requiring that internal or external validation studies be available before individual research results are disclosed to children and their families. Another issue that has not been addressed is that of "look-back liability," a term used to indicate that people who collect clinical data may be liable for damages if they fail to recontact the patient or subject if the data are later found to be clinically relevant (Hirschorn et al., 1999; Sharpe, 1999)
From page 124...
... . The steps currently planned by the coordinating center to protect data during the data collection phase appear to conform to current best practices, but these steps need to be reviewed periodically as best practices evolve.
From page 125...
... While recognizing the enormous value of the data collection efforts of NCS investigators, the panel views the compensation argument as flawed. Because data collection sites were selected with probability sampling methods by the NCS to maximize diversity and generalizability (NCS Research   Examples include the National Longitudinal Survey of Adolescent Health, the Health and Retirement Survey, the Fragile Families and Child Wellbeing study, and the Panel Study of Income Dynamics.
From page 126...
... Census Bureau, which enable qualified researchers to analyze highly sensitive data compiled by the Census Bureau, the Internal Revenue Service, and the Social Security Administration. All of these considerations argue for releasing data to all analysts, both inside and outside the study centers, but with appropriate privacy safeguards, as soon as they are cleaned and documented.
From page 127...
... The proposal to do a trial of a video-assisted consent process in which study personnel are present is sound. However, the way the process is described of allowing respondents to continue after they give an incorrect answer in the video consent process raises questions (IRB draft, Section 12.2)
From page 128...
... These include but are not limited to the promotion of trust between study centers and communities through shared knowledge; more effective and efficient implementation of research, including better recruitment of participants, as noted by the NCS; enhancement of both the quantity and quality of data collected; a sharing of control in the interpretation and presentation of research findings, which may benefit communities as they use the data to address some of their own pressing needs; development of culturally appropriate measurement instruments, which may be useful for those measures that still require validation for diverse populations; and, ultimately, a more accurate understanding of a community's circumstances in comparison to other communities. Moreover, for some of the ethical concerns raised thus far in this chapter, such as the kinds of information that should be provided to participants about their own health or about potential services that may be beneficial to them, community input and perspectives should be sought and represented in decision-making bodies.
From page 129...
... A successful study will require ongoing and, at times, difficult conversations and collaborations with research participants and with the communities in which they live. The NCS should pay particular attention to defining processes for deciding which research results should be returned to participants, to revising the plans for investigators' access to research data, and to developing more robust plans for engaging communities involved in the study.


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