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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.

Professional Interviewers

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. No release of a sample unique for which only one record in the Restricted Data provides a certain combination of values from key variables.
  2. No release of a sample rare for which only a small number of records (e.g., 3, 5, or 10 depending on sample characteristics) in the Restricted Data provide a certain combination of values from key variables. For example, in no instance should the cell frequency of a cross-tabulation, a total for a row or column of a cross-tabulation, or a quantity figure be fewer than the appropriate threshold as determined from the sample characteristics. In general, assess empty cells and full cells for disclosure risk stemming from sampled records of a defined group reporting the same characteristics.
  3. No release of the statistic if the total, mean, or average is based on fewer cases than the appropriate threshold as determined from the sample characteristics.
  4. No release of the statistic if the contribution of a few observations dominates the estimate of a particular cell. For example, in no instance should the quantity figures be released if one case contributes more than 60 percent of the quantity amount.
  5. No release of data that permits disclosure when used in combination with other known data. For example, unique values or counts below the appropriate threshold for key variables in the Restricted Data that are continuous and link to other data from ICPSR or elsewhere.
  6. No release of minimum and maximum values of identifiable characteristics (e.g., income, age, household size, etc.) or reporting of values in the “tails,” e.g., the 5th or 95th percentile, from a variable(s) representing highly skewed populations.
  7. No release of ANOVAs and regression equations when the analytic model that includes categorical covariates is saturated or nearly saturated. In general, variables in analytic models should conform to disclosure rules for descriptive statistics (e.g., see #6 above).
  8. In no instance should data on an identifiable case, or any of the kinds of data listed in preceding items 1-7, be derivable through subtraction or other calculation from the combination of tables released.
  9. No release of sample population information or characteristics in greater detail than released or published by the researchers who collected the Restricted Data. This includes but is not limited to publication of maps.
  10. No release of anecdotal information about a specific Private Person(s) or case study without prior written approval.
  11. The above guidelines also apply to charts as they are graphical representations of cross- tabulations. In addition, graphical outputs (e.g., scatterplots, box plots, plots of residuals) should adhere to the above guidelines.

1 For more information, see the U.S. Bureau of the Census checklist. Supporting Document Checklist on Disclosure Potential of Data, at; NCHS Disclosure Potential Checklist at; and FCSM Statistical Policy Working Paper 22 (Second Version, 2005) at 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.