Human Subjects Review

The World Wide Web has had a substantial impact on research methodology in counseling psychology and in the social and behavioral sciences in general. Indeed, the Internet offers opportunities for research in content areas where traditional methodologies have struggled and special samples have previously been difficult to recruit. However, the Internet also presents many challenges for the ethical conduct of research involving human subjects.

There are two primary types of research utilizing the Internet: online survey research and observational research. Online surveys, created by either the researcher or outside agencies, allow researchers to collect self-report data via an Internet Web page as opposed to more conventional methods (e.g., in person, via mail). Observational research involving chat rooms and discussion boards on the Internet is the second type; here researchers monitor the social behavior of online groups by examining current or archived written communications (e.g., e-mails). Online data collection has several potential benefits to the researcher, including the possibility of collecting data from respondents across geographical and cultural boundaries, access to specialized or difficult-to-find populations, reduced time spent in collecting data, and decreased cost for discussion.

There is a third, emerging research use of the Internet that involves the delivery and evaluation of therapeutic interventions. Besides the ethical considerations shared with other types of online research, this type presents some additional challenges. (For a discussion of the ethical issues surrounding online therapeutic interventions, see Childress & Asamen, 1998).

This entry presents a general overview of guidelines for protection of human subjects in research as well as a description of the Institutional Review Board (IRB) criteria for work with human subjects that are most critical for evaluating online research. Then it outlines the criteria used by IRBs with respect to the main types of online research.

General Ethical Guidelines

The Belmont Report, by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, presents the basic principles to guide ethical scientific research. The principles put forth in the Belmont Report allow for the weighing of costs or risks to human subjects and the benefits of conducting the research. These principles of respect for persons, beneficence, and justice have been standardized into the federal policy for the Protection of Human Subjects, or the Common Rule. The Common Rule established the IRB system to assist those conducting research to comply with the regulation.

The IRB at each college, university, agency, or private research company has its own interpretation of particular policies and procedures regarding human subject protection, but there is a set of criteria common across each IRB. To be considered protective of human subjects, the proposed research should (1) minimize risk to participants, (2) present a favorable benefit/cost ratio, (3) ensure equitable selection of participants, (4) provide informed consent to all participants, and (5) document informed consent.

These goals reflect the principles of respect for persons or autonomy (i.e., providing and documenting informed consent), beneficence (i.e., minimizing risk to participants, presenting a favorable benefit/cost ratio) and justice (i.e., equitable selection of participants) put forth in the Belmont Report.

Ethical Issues Related to Autonomy for Online Research

Appropriate documentation of voluntary informed consent from research participants is a requirement of IRBs. However, ensuring understanding of research procedures and obtaining signatures through the Internet presents a challenge to researchers. IRBs have the option to waive this requirement if the research involves minimal risk to the participant or in cases where the documentation would be the only link between the participant and his or her data. Thus, some IRBs have indicated that simply completing the online survey signifies consent to participate.

Of course, the challenge of ensuring understanding is not unique to online research. One study by Varnhagen and colleagues compared the recall of online consent forms to regular paper format versions. Little difference in recall was found between participants who viewed the online version and those who received the paper version. However, on average, participants’ recall was quite low across conditions, with participants recalling less than 10% of presented material. This suggests that researchers need to make every effort to attract participants’ attention to the information about the study in the consent document.

Ethical Issues Related to Beneficence for Online Research

A primary aim of IRBs is to ensure that researchers minimize the risks to research participants. Two potential sources of risk exist: harm resulting from a breach of confidentiality and harm resulting from direct participation in research. Online research raises several concerns regarding privacy, anonymity, and confidentiality. Discussion of ethical issues on the Internet has focused on whether or not the Internet, and the information posted therein, lies in the public or the private domain. When online behavior is considered public, a research project examining this behavior is considered in the “exempt” category, though it still must receive review and approval from an IRB. However, chat rooms and bulletin boards may lead an individual to develop an expectation of privacy when, for example, an account and password are required to access the site. This expectation of privacy needs to be considered before conducting research utilizing such sites. Indeed, some have recommended that IRBs evaluate the public versus private nature of each project on a case-by-case basis.

A concern associated with direct participation in online research is data security. According to Im and Chee, online data collection raises the possibility that data may be viewed by others unbeknownst to the researcher. For example, employers may have access to their employees’ Internet history and e-mail account, and hackers may attempt to discover individuals’ personal information. Researchers should be able to articulate and demonstrate that the data are collected, stored, and transmitted in a way that maintains confidentiality. The more sensitive the data collected, the greater the precautions that should be taken to ensure the protection of this information.

Ethical Issues Related to Justice for Online Research

A touted benefit of online research is the potential for the recruitment of large, diverse samples. However, researchers need to be aware that samples may not represent an equitable selection of potential participants. In fact, researchers may be unintentionally excluding particular groups of people from the research. For example, individuals who cannot be identified via the Internet, who are illiterate, or who are not fluent in the language used in the online survey or on the Web page discussion board may be excluded. Further, researchers have noted the presence of educational, economic, racial, and gender disparities among those who have access to the Internet—the so-called digital divide. There is evidence, however, that these differences are diminishing. In any case, researchers need to provide evidence to IRBs that they are making their best effort to recruit samples that give the most individuals an opportunity for selection.

References:

  1. Childress, C. A., & Asamen, J. K. (1998). The emerging relationship of psychology and the Internet: Proposed guidelines for conducting Internet intervention research. Ethics & Behavior, 8(1), 19-35.
  2. Code of Federal Regulations, Title 45, Part 46: Protection of Human Subjects. Retrieved from http://www.hhs.gov/ohrp/regulations-and-policy/regulations/45-cfr-46/
  3. Eysenbach, G., & Till, J. E. (2001). Ethical issues in qualitative research on Internet communities. British Medical Journal, 323, 1103-1105.
  4. Im, E., & Chee, W. (2002). Issues in protection of human subjects in Internet research. Nursing Research, 51(4), 266-269.
  5. Kraut, R., Olson, J., Banaji, M., Bruckman, A., Cohen, J., & Couper, M. (2004). Psychological research online: Report of Board of Scientific Affairs’s advisory group on the conduct of research on the Internet. American Psychologist, 59, 105-117.
  6. National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. (1979, April). Belmont report: Ethical principles and guidelines for the protection of human subjects of research. Retrieved from http://www.hhs.gov/ohrp/regulations-and-policy/belmont-report/
  7. Rhodes, S. D., Bowie, D. A., & Hergenrather, K. C. (2003). Collecting behavioural data using the World Wide Web: Considerations for researchers. Journal of Epidemiology and Community Health, 57, 68-73.
  8. Sixsmith, J., & Murray, C. D. (2001). Ethical issues in the documentary data analysis of Internet posts and archives. Qualitative Health Research, 11, 423-i32.
  9. Varnhagen, C. K., Gushta, M., Daniels, J., Peters, T. C., Parmar, N., Law, D., et al. (2005). How informed is online informed consent? Ethics & Behavior, 15, 37-48.

See also:

  • Counseling Psychology
  • Personality Assessment
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