Although physical harm to participants in social research is highly unlikely people can be harmed personally (e.g., by being embarrassed or humiliated), psychologically (e.g., by losing their self- esteem or by being forced to reveal something about themselves that they would not ordinarily share with others), and socially (e.g., by losing trust in others or suffering a blow to their reputation
or status). Almost any type of research that might be done carries the risk of harming others in some way. Determining potential risks is not always apparent at the outset of a study and can surface at some later point after the study has begun. Some participants may be at higher risk for harm than others.
What measures can researchers take to minimize risks to participants of social research?
Researchers have the obligation to inform participants of foreseeable risks or possible discomforts prior to the startup of a study and to give participants ample time to think about the implications of their participation. Researchers can screen participants for psychological harm that could be exacerbated by participation in the research. If stress or potential discomfort is a possible or anticipated outcome, measures need to be taken to assess the degree of risk or discomfort anticipated from the study. A common way of neutralizing stressful effects from participation in research is by debriefing participants and the study and providing them with procedures for contacting the principal investigator should problems develop.
Federal regulations require that researchers give special consideration to protecting the welfare of what are classified as protected populations. These include: children and minors, prisoners, pregnant women and fetuses, the institutionalized mentally disabled, the elderly, and the economi- cally or educationally disadvantaged. For more detailed information about protected populations visit the following Web sites:
www.hhs.gov=ohrp=children
http:==grants1.nih.gov=grants=guide=notice-files=not98-024.html www.hhs.gov=ohrp=irb=irb_chapter6htm#g2
There are two underlying principles involved in informed consent. One is the belief that participants have the right to choose whether to participate in research without fear of coercion or pressure. This ensures that participation in the research is voluntary. The other principle is based on the belief that participants have the right to be given information that is relevant and necessary for deciding whether or not to participate in the research. Federal regulations require that participants sign a written consent form when more than ‘‘minimal risk’’ is anticipated. According to federal regulations,‘‘minimal risk’’refers to risk that is no greater than what can be expected in daily life.
According to Westin, privacy refers to ‘‘the claim of individuals, groups, or institutions to determine for themselves when, how, and to what extent information about them is communicated to others (1968, p. 7). Sieber expands this to include confidentiality and argues that confidentiality
‘‘refers to agreements between persons that limit others’access to private information’’(1982:146).
Thus privacy refers to persons and confidentiality refers to information.
Deception is perhaps the most controversial aspect of the treatment of human subjects because it is widely used and there is a lack of consensus about whether it is appropriate. The most common way that participants are deceived involves intentionally misleading them about the purpose of the research. The frequent use of deception in research was documented by Adair et al. (1985) who found that 58 percent of the empirical studies published in three leading social psychological journals used deception. Deception has been justified by professional associations like the American Psychological Association when alternative procedures are not available or when methodological requirements necessitate it (APA, 1990, pp. 394–395).
With the advent of computerized databases, the potential for invading an individual’s privacy has grown. Medical information is now governed by the Privacy Rule of the Health Insurance Portability and Accountability Act (HIPAA) and restricts the release of medical records. If the research involves the disclosure of sensitive topics (e.g., HIV status, drug use, or immigration status) and the information will not be anonymous, researchers should apply to the Department of Health and Human Services for a Certificate of Confidentiality, which will protect the data from subpoena. It should be noted that research data is not privileged and can be subject to subpoena.
Returned surveys and questionnaires, notes,field records, andfiles can be accessed by the federal government under certain administrative provisions, such as the Freedom of Information Act and the Federal Property and Administrative Services Act. Gelles reminds us that‘‘[R]esearchers who
engage in research that deals with illegal, sensitive or taboo topics run the risks of being forced to turn over material they pledged would be kept confidential, of engaging in legal battles, or of spending time in jail for contempt of court’’(1978, p. 422).
When conducting research in a foreign country, the researchers should keep in mind that foreign governments vary in the approaches to research ethics. The Council of Europe developed research guidelines in 1985 that were reinforced by the European Union in 1990. Collaborative efforts between the World Health Organization and the Council for International Organizations of Medical Sciences generated proposed international guidelines for human subjects research to be used throughout the world. These guidelines reflect the principles expressed in the Declaration of Helsinki and include the following:
. Prior approval by an independent review board
. Obtaining informed consent from prospective subjects
. Favorable risk to benefit ratio
. Equitable selection of subjects
. Protection of data confidentiality
. Privacy of subjects
Numerous world organizations have emphasized that special attention should be given to research conducted by researchers from First World countries on human subjects from Third World countries. Attention needs to be given to the particular culture in which the research is being conducted especially with respect to obtaining informed consent. When international research is funded by the federal government the same procedures and protection should be accorded to human subjects as is provided to human subjects of domestic research.
Public concern with human subject experimentation was heightened with the revelation of the research practices employed in the federally funded Tuskegee experiment. The Tuskegee scandal led to congressional hearings, demands for greater research oversight, and eventually new legisla- tion and federal regulations. Congress passed the National Research Act in 1974. The Act required that institutions receiving Department of Health, Education, and Welfare research funds establish
‘‘Institutional Review Board[s] . . . in order to protect the rights of the human subjects. . . .’’Govern- ment estimates indicate that between 3000 and 5000 IRBs now operate across the country.
IRBs are mandated to review proposed research projects involving the use of human subjects.
This initial review generally consists of an examination of the proposed research design and protocol, informed consent documents, and any advertising or other recruitment devices. The IRB may vote to approve the project, to approve it with required modifications, or to reject it. To approve a project undergoing initial review, federal regulations require IRBs to determine that (1) risks to subjects are minimized through the use of a sound research design; (2) risks to subjects are reasonable in light of anticipated benefits to the subjects and the importance of the knowledge to be gained; (3) subjects are selected equitably; (4) informed consent will be obtained from subjects and documented; (5) when appropriate because of safety concerns, a plan is in place to monitor incoming data from subjects on the protocol; (6) there are adequate protections for protecting subjects’privacy and confidentiality; and (7) appropriate precautions are in place when particularly vulnerable subjects, such as children, prisoners, or the mentally disabled, will participate.
As indicated earlier, IRBs are to follow additional procedures, and consider other safeguards, when the research involves‘‘protected populations.’’Individual researchers are required to submit a written protocol to the IRB that describes the proposed research (including dissertation proposals) and outlines the measures that will be used to protect the rights of participants.
Funding agencies award research funds to institutions rather than individual researchers. This practice makes institutions accountable for the use of funds and for overseeing the conduct of research (Andersen, 1988). The presumption is that misconduct will be discovered at the institu- tional level through IRB oversight. In addition to IRB oversight, misconduct investigations can also
be undertaken by the ORI. In some cases, ethical violations may be turned over to local or federal prosecutors for criminal prosecution. We saw in Professor Hwang’s case that the Korean govern- ment initiated criminal sanctions against Professor Hwang.
Ethical violations may also lend themselves to prosecution under civil law. In the United States the relevant statute under civil law is the civil False Claims Act. The civil provisions of this act carry afine of $5,000–$10,000 per violation, plus treble damages (refers to the costs of the misconduct plus damages of three times that amount). Although civil cases are rarely used in cases of ethics violations, Friedman suggests that they may become more common simply because the stiff competition to receive government funding encourages researchers to ‘‘leapfrog’’ funds (1992).
This refers to doing the proposed research in advance to apply for funding and then using the money for the proposal to use on the next research project. This practice could constitute a false claim under the False Claims Act.
Increasingly, questions are being raised about the‘‘objectivity’’of the IRB process, particularly with respect to conflicts of interest among IRB members, their institutions, and industry. Conflicts of interest can occur when primary interests are eclipsed by secondary interests. The primary interest of IRBs is to ensure the rights, safety, and welfare of human subjects—all other interests, e.g.,financial gain, professional status, power, or recognition, are secondary. To maintain the commitment to protecting human subjects, federal regulations require that each IRB should have at least five members with varying backgrounds (to ensure the adequate review of research proposals). To provide a cross-section of expertise, members must include at least one nonscientist (such as a lawyer, an ethicist, or a member of the clergy), at least one member not affiliated with the research institution, and members who are competent to review specific research activities.
The concern over the potential conflict of interest between IRB members and the relationships with industry rests with the belief in the ‘‘integrity’’ of the researcher and scientific results. The potential to undermine this belief is present when there are no clear policies that define when an IRB member’sfinancial or other industry relationship is a conflict of interest. A recent study published in the New England Journal of Medicine found that 36 percent of all IRB members (a sample of 893 IRB members from 100 major research institutions) reported having at least one relationship with industry within the past year (Campbell, et al., 2006, p. 2321). Fifteen percent reported that at least one proposal came before their IRB within the prior year that was sponsored by a company with which they had a relationship or by a competitor of that company. Perhaps more troubling is the finding that more than half of the IRB members in this study reported that their IRBs did not have a formal procedure for disclosure of relationships with industry.