Protection of Research Participants

Purpose

Harvard Business School researchers have traditionally enjoyed access to a wide variety of data sources, enabling research that is rich, of high quality, and often unique. We have enjoyed this access largely because the people and companies from whom we collect data trust us. HBS has always maintained strict norms concerning the protection of confidential company and individual data. This policy reaffirms those norms and sets forth explicit guidelines for the protection of individual research participants. The purpose of the policy is to protect not only our research participants but also ourselves as researchers, the School, and our future access to the research participants we will need to continue our work.

This policy supplements the University-wide Statement of Policies and Procedures Governing the Use of Human Subjects, which was adopted by the Harvard Corporation in September 2003, and the policies and procedures of the Committee on the Use of Human Subjects, which is the institutional review board that governs HBS human subjects research. These policies comply with the U.S. Department of Health and Human Services Code of Federal Regulations Title 45 Part 46 (the "Common Rule").

Coverage

This policy applies to all Harvard Business School faculty members, research associates, doctoral students, research fellows, and staff members. It includes all research that involves interaction with people or identifiable information that is not publicly available, with the exception of cases as noted below. All researchers should take steps to ensure that they and anyone who will interact with participants or identifiable data (including students, research, or administrative staff working under their supervision) understand and abide by the rules governing the use of human research subjects.

Principles for Protection of Research Participants

  1. Informed Consent. Individuals who participate in research should do so voluntarily, receiving an explanation of the nature of the research, the procedures in which they will be asked to participate, any possible benefits or risks of their participation, the steps that will be taken to ensure the confidentiality of their data, and how their data will be used and stored. More information is available in the guidelines for specific types of research.

  2. Minimal Risk. The focus on minimal risk for most HBS research should be that participation in research should not reasonably place participants at risk of criminal or civil liability or be damaging to the participants' financial standing, employability, reputation, or physical or psychological well-being. Moreover, participants should not be subjected to unusual stress.

  3. Protection of Data. Private data should be stored in such a way that they are protected from unauthorized access. Harvard University provides guidelines for protecting electronic private data at https://www.harvard.edu/privacy-statement. Data that are no longer needed should be destroyed. Researchers are encouraged to store data without identifiers whenever possible. Researchers must explain to participants how their data will be used and stored.

  4. Information Requests. Upon request from research participants, researchers should provide a summary of the research in a reasonable time period after the completion of the research.

  5. Procedures for Reporting Problems. Should there be reason to think that a participant is suffering or has suffered any harm, anticipated or not, as a result of participation, or if new, unanticipated risks become evident, the researchers must suspend the research and contact Alain Bonacossa, Senior Director, Research Administration (abonacossa@hbs.edu, 6-6348). The researcher may not resume until approval is given to proceed.

Human Subjects Approval

Researchers must demonstrate, prior to beginning data collection, that appropriate protections are in place for all research projects which involve interaction with people or identifiable information that is not publicly available, unless the data will be used exclusively for the development of a teaching case. A research protocol and supporting documents (including consent forms, recruitment materials, study materials, scripts, etc.) must be submitted for review through the Electronic Submission, Tracking & Reporting (ESTR) system at http://irb.harvard.edu. In most cases, HBS researchers will submit the CUHS protocol template. This template, a template guide, and sample materials are available on the CUHS website at http://cuhs.harvard.edu. The ESTR system is accessed with a Harvard University ID (HUID); HUIDs can be obtained for non-Harvard collaborators.

Protocols will be reviewed by Alain Bonacossa, Senior Director, Research Administration, and Alicia McGovern, Manager, Research Administration, who will work with researchers to ensure protection of research participants. Protocols should be submitted four weeks prior to the start of data collection, although two weeks may be sufficient for projects in which there is minimal risk.

Data collection may not begin until confirmation has been received, and until the Principal Investigator and all researchers who will interact with participants or identifiable data have completed human subjects training.

Guidelines for Specific Types of Research

Research that involves interaction with people or their identifiable data, with the exception of cases, must be reviewed. If you are not sure whether your study qualifies, you can use the HRP-215 Not Human Subjects Research Determination Request as a guide. This form can be submitted through ESTR if you need an official determination; otherwise, please email humansubjects@hbs.edu to receive confirmation via email that your projects does not require review.

  1. Field-based Research

    1. A protocol must be submitted through ESTR if you plan to collect field data for research purposes, unless the data will be used exclusively for a teaching case. If the data are not about individuals or their opinions, a protocol does not need to be submitted as the research does not qualify as human subjects research.

    2. Additional information about field research is available on the Case Services web site.

  2. Surveys, Experiments, and Other Participant-Testing Research

    1. HBS has a subject pool that is available for experimental and survey research conducted on or off campus or over the web. Contact Behavioral Research Services (behavioral_research@hbs.edu, or John Galvin at 6-3167) for more information.

    2. Studies conducted online must be reviewed if data collection is for research purposes and if the data are about individuals or their opinions. Online surveys will often qualify for an exemption determination if the information collected is not identifiable in any way and is not sensitive. A consent template for exempt online research is available on the CUHS website.

    3. For surveys with no more than minimal risk, it is not necessary for participants to sign a consent form. An informed consent statement should be included as a statement at the beginning of the survey

    4. Special permission is needed for survey research using HBS alumni. Contact Alain Bonacossa, Senior Director, Research Administration (abonacossa@hbs.edu, 6-6348), for more information.

    5. Use of students' as participants in research. Faculty are discouraged from collecting personal data from students in their own courses because of the potential for coercion and problems inherent in students revelation of private information. When students will be participants, the faculty should receive data without identifiers, if possible. When faculty would like to use data from an otherwise required class exercise for research purposes, students must have the option not to include their data for research purposes, without the possibility of coercion. The research protocol should include an explanation of steps that will be taken to minimize the possibility of coercion.

  3. Archival Research

    1. Archival research includes both data obtained through public sources (such as commercially available databases) and private sources (such as company archives). When the data are obtained from public sources or do not contain information that might be used to identify individuals.

    2. Research using health or medical-related data must also conform to the Health Insurance Portability and Accountability Act of 1996 (HIPAA) guidelines.