Protection of Human Subjects
Since its launch in 1995, the Chitwan Valley Family Study (CVFS) has strictly followed U.S. federal regulations for the protection of human subjects in research and local codes for the conduct of ethical research. All CVFS research involving human subjects is reviewed and approved by an Institutional Review Board (IRB) prior to the start of the research. Currently, projects are subject to oversight by the University of Michigan’s Institutional Review Board (FWA 00004969). Research staff at Michigan and the Institute for Social and Environmental Research-Nepal (ISER-N), the collaborating institute responsible for most daily research operations, also acquire approval from the Nepal Health Research Council as needed to ensure all local requirements for the conduct of human subject research are met.
Interviews are conducted by ISER–N staff, trained to protect the privacy and confidentiality of respondents. ISER-N has been involved in the CVFS since its inception and follows the same standard guidelines for survey research as the professional interviewing staff at the Survey Research Center’s Survey Research Operations unit at the University of Michigan. Interviewers are trained to urge respondents to choose a location for interview that is private. Interviewers are also trained to suspend or postpone interviews if necessary to assure respondents have adequate privacy throughout the interview.
Informed Consent Process
Informed consent for the CVFS takes place at two levels: (1) appropriate government approval to work among the study population; and (2) individual consent to participate in each specific data collection activity. (1) Permission is obtained from appropriate local government officials to conduct all survey data collection activities. These permissions are renewed regularly. (2) Informed consent is obtained from each research participant for each data collection activity. All of the informed consent procedures are developed in consultation with IRB experts and in accordance with IRB guidelines. During the informed consent process, the interviewers clearly explain:
- purpose of the research
- participation is voluntary
- time it will take to participate
- exactly what will happen if the respondent agrees to take part in the research
- respondent has the option to refuse to answer any question or set of questions that they choose
- respondent may stop the interview at any time
- risks and benefits of participating
- steps the researchers are taking to protect the respondent against the risks
- respondent is free to leave the study at any time
- there is no penalty for leaving the study before it is finished
The informed consent process also includes a clear description of the operation of the survey data repository and the procedures in place for protecting the privacy of subjects and maintaining the confidentiality of the data. The process includes assurances that no individuals will be linked to specific answers or data records.
How to Reduce Disclosure Risk
The CVFS takes the risk of deductive disclosure seriously. Deductive disclosure is the indirect identification of respondents through the use of the CVFS data. As put forth in the Restricted Data Use Agreement for Restricted Data from the Inter-university Consortium for Political and Social Research (ICPSR), CVFS data users are required to (the following are exact words from the ICPSR) “avoid inadvertent disclosure of Private Persons by being knowledgeable about what factors constitute disclosure risk and by using disclosure risk guidelines, such as but not limited to, the following guidelines 1 in the release of statistics or other content derived from the Restricted Data.2
1 For more information, see the U.S. Bureau of the Census checklist. Supporting Document Checklist on Disclosure Potential of Data, at http://www.census.gov/srd/sdc/S14-1_v1.3_Checklist.doc; NCHS Disclosure Potential Checklist at https://www.census.gov/srd/sdc/drbchecklist51313.docx; and FCSM Statistical Policy Working Paper 22 (Second Version, 2005) at http:// http://www.hhs.gov/sites/default/files/spwp22.pdf 2 If disclosure review rules were established for a specific Restricted Dataset, they will be included in the dataset’s documentation and are covered by this Agreement.” More information about ICPSR’s approach to protecting participants’ identities can be found here.