Protecting Data Privacy in Health Services Research (2000) / Chapter Skim
Currently Skimming:
5 Recommendations for Next Steps
5 Recommendations for Next Steps
Pages 78-92
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 78... ...
Throughout this report the committee has tried to refer inclusively to IRBs and/or other review boards (unless circumstances specified only IRBs)
|
From page 79... ...
The committee heard corroborating evidence that resources continue to be a problem for IRBs. A recent committee at the University of California at San Francisco, an institution conducting a great deal of research involving human subjects, recommended that high priority be given to adequate IRB staff support, increased use of computerized information systems, and increased funding for training investigators about IRB function (see also Appendix B)
|
From page 80... ...
, and others should continue or expand educational efforts regarding the protection of the confidentiality of personally identifiable health information in research. While these recommendations highlight DHHS as the sponsor of this study and a major sponsor of relevant research, the recommendations should be applied by other Common Rule signatory departments and agencies as well.
|
From page 81... ...
These stakeholders recognize that public confidence that personally identifiable health information will be used appropriately is crucial to the continued ability to carry out important HSR projects in a timely fashion. The committee found that these stakeholders were dedicated to resolving the tension between confidentiality and access to personally identifiable health information for HSR in an ethically acceptable manner.
|
From page 82... ...
Through its roles in funding HSR, supporting training programs in HSR, and overseeing human subjects protection, the DHHS can have great impact on strengthening IRB review of HSR while allowing valuable research to proceed. In the long run, greater public confidence that personally identifiable health information is adequately safeguarded will promote more support for HSR and perhaps avoid the restrictive legislation and regulation that some European nations have adopted (see for example Appendix D)
|
From page 83... ...
Organizations that furnish health services researchers with personally identifiable health information should ensure that the data are prepared in a manner that protects conf~dentiality adequately. The committee heard several instances reported at the workshop where HSR investigators requested de-identified data from federal agencies but received data that had not been de-identified because the agency in question lacked the resources to do so.
|
From page 84... ...
If an organization holding health data has made a dataset publicly available without restriction, as is done with the National Health Interview Survey (NHIS) , then projects using only such data can be considered minimal risk and eligible for exemption per 45 CFR 46.101 (b)
|
From page 85... ...
Health care organizations may have to identify episodes of illness in a patient, which may be found in records of emergency room visits, ambulance services, hospital stays, operative records, bills from independent medical providers, rehabilitation services, pharmacies and pharmacy benefit managers, and so forth. To recognize that the data drawn from these various sources refer to the same individual, it is important that researchers be able to identify the same patient in each set of records.
|
From page 86... ...
j - :~ ~-:t—-: :~:J~ :~:~-~-It~ .. t ~ ~ ~ t 1 .:.:.:.:.:.:LV:2-':': U ==':,:':'~:V':':':'=~:~:I'I:'I:~': :':"'I:':V U'~'O'.:':'-':':~:~:':':':~'l:':l':':':':=':':':'~'l:':l'~ ~ ~=':,:':'":I':I':'I:V'I:':I~':':':':~:U:~:I':'I:': :':~'=O'I:~:'I:':I':'-':'~I:':I':L=:I':'I:=':':':':':': -:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-~-:-:-:-:-:-:-:-:- 1 -:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:~-:-:-:-:-:-:-:-:-:-:-:-~:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-:-: - -- - - a-e-d on a ca et 11 defined set ot one atina r Ies sneCltic to the deslan lt ls ....................................................................................................
|
From page 87... ...
RECOMMENDATIONS FOR NEXT STEPS 87 Another type of linkage system would depend on trusted third parties to be responsible for linking the separate data files. These entities could hold the keys linking individuals to the data.
|
From page 88... ...
DHHS (AHRQ and/or NIH) and other federal departments or agencies should consider developing and supporting a research agenda concerning IRB protection of subjects from nonphysical harms such as risks to privacy and confidentiality in human subjects research (including cultural meanings of privacy and confidentiality)
|
From page 89... ...
Health services researchers, and institutions that participate in and benefit from HSR, should voluntarily adopt best practices for IRB review of HSR The committee found that some policies intended to strengthen confidentiality and privacy may have serious adverse consequences for HSR. The committee found that some nations have adopted laws or regulations that allow individuals to exclude their personally identifiable health information from databases, that require written consent from patients for use of health records for research, and that require the anonymization of data for any secondary data analysis.
|
From page 90... ...
Certain populations may be over-solicited as subjects of current HSR projects, because of availablity of suitable databases, federal requirements to have minorities adequately represented, or policy interest in certain topics, such as the impact of poor access to health care. Questions for consideration could include whether participation in many studies may increase the risk that confidentiality will be breached and harms or wrongs occur as a result, and, whether there may be a risk of stigma if a group is overrepresented in current research, even if individual subjects who are members of the groups are at minimal risk for having their individual confidentiality violated.
|
From page 91... ...
Resources are needed to support dedicated, trained IRB members and staff, to establish organizational confidentiality policies and electronic security practices, to educate researchers, and to provide statistical and computer expertise. The true test of our commitment to the twin values of advancing useful knowledge and protecting confidentiality is whether we are willing to make the needed investments to achieve both goals.
|
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.