ETHICAL GUIDELINES
The National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research (the Belmont Report) in 1979 identified three ethical principles for research on humans: beneficence—maximizing good outcomes for humanity and research subjects while minimizing or avoiding risk or harm; respect—protecting the autonomy of all persons and treating them with courtesy and respect, including those who are most vulnerable; and justice—ensuring reasonable, nonexploitative, and well-considered procedures are administered fairly (the fair distribution of costs and benefits). These principles have been fashioned into the following ethical guidelines for researchers and evaluators to follow.
Guideline 1: Research Participants Must Be Volunteers—All of those participating in a research or evaluation effort should freely decide to do so without coercion of any kind. They must also be competent to understand their choices. If eligible participants are under age 18 or not considered able to fully comprehend the consent process due to mental impairment, their legal caretaker must give permission, and the participant still must assent. Although very young children are generally asked to orally assent to research procedures in language they can understand, the older the minor, the more the informed consent should conform to a written document like adults would receive.
Study participants’ right to self-determination must be respected, and their freedom to withdraw from the study at any time carefully protected. In most instances, IRBs require that consent forms are in writing and signed permission be obtained, but exceptions can be made and verbal consent with an information sheet used instead. Studies with no more than minimal risk are most likely to obtain this approval. Examples of approved waivers of signed consent include studies where the identities of participants would be anonymous except for the signed consent form, where cultural standards are violated by obtaining signed consent, and where there are legal, social, or economic risks involved in signing, for example, an HIV-positive participant whose identity would be made known.
Consent forms and information sheets provide general but brief information on the nature of the project and indicate that the participant is free to withdraw consent and to discontinue participation in the project at any time without any penalty or loss of benefits. When evaluating a social service program, it is vitally important that recipients of services fully understand these assurances. Evaluators can use a checklist to ensure that all the necessary informational items are contained in the consent forms
(Royse 42-43)
Royse, David. Program Evaluation: An Introduction to an Evidence-Based Approach, 6th Edition. Cengage Learning, 20150105. VitalBook file.
The citation provided is a guideline. Please check each citation for accuracy before use.
Consent forms are not typically employed with mail, Internet, or telephone surveys unless the data being gathered are in some way sensitive (e.g., involve information about past or present drug use or illegal activities). In such cases, consent forms may need to be mailed in advance and consent obtained before the participant is contacted for data collection. When questionnaires or surveys are used with adults who are not part of a vulnerable population, the principle of implied consent may be used—that is, the act of participation is seen as giving informed consent.
A problem arises when potential participants feel that they cannot refuse consent. If they are on probation or parole, or receiving some form of public assistance, they may not feel free to refuse without putting themselves in some jeopardy. Clients in treatment for mental health problems, if approached by a clinician, may fear losing their therapist if they are critical of services. A homeless person could be considered “coerced” into participation by being offered a substantial financial incentive. This is when consultation with an IRB can come in handy—extra steps may be needed to allay suspicions and inform potential participants of their rights.
Human services professionals must be alert to the possibility that even good-naturedly encouraging clients to participate in research can be perceived as coercion. Because professionals are “gatekeepers” of services, clients can feel pressured into participating in order to gain access to or continue receiving services.
Guideline 2: Potential Participants Should Be Given Sufficient Information About the Study to Determine Any Possible Risks or Discomforts as Well as Benefits—Sufficient information includes an explanation of the purpose of the research, the expected duration of participation, the procedures to be followed, and the identification of any procedures that are experimental and/or can potentially cause harm. Participants should be given the opportunity to raise and have answered any questions about the study or any procedures that will be used. They must also be allowed to inquire at any time and have their questions answered. Consent forms should be written at a level of readability—a good rule of thumb is to try not to exceed a ninth- or tenth-grade reading level with adult populations. Further, the use of first person “I” seems to make the informed consent easier to understand than use of the second or third person.
Guideline 3: No Harm Shall Result as a Consequence of Participation in the Evaluation—Typically, there is much less possibility of harm resulting from research in the social or human services than from biomedical research. This does not mean, however, that harm cannot occur. This guideline would be violated, for instance, if an evaluator from a shelter contacted women some months after they had returned to an abusive partner and there was a risk that talking to researchers might trigger another episode of violence. Clients can also suffer emotional or psychological harm. Psychological risks could result from questions that upset participants or give them a sense that they are not as smart as some others. Without proper safeguards, asking questions about past traumatic or abusive episodes could make certain participants feel distressed or even re-traumatized.
Other risks to consider are those associated with damage to reputations and one’s employment if information about illegal or unsavory behaviors—drug use, stealing, lying, and so on—became known. An employee’s job could be jeopardized in an evaluation that asked for an honest appraisal of management if someone else in the agency was able to read or overhear responses that were critical of a supervisor.
Strict assurances of confidentiality must be breached by professionals in certain circumstances when they discover incidents of child or elder abuse since they are legally required to report these. Such a possibility must be noted in the consent form signed by research participants. In general, the “rule” favoring confidentiality should be superseded only by legal requirements and the potential for inadvertent harm should concern every evaluator. Unlike attorneys and physicians, researchers are not given immunity from legal action if a local prosecutor decides to subpoena data on illegal activities (an extremely rare event). One way to address this is to obtain a Federal Certificate of Confidentiality, which protects the researcher from having to disclose such information to the authorities. This certificate is relatively easy to obtain (see http://grants.nih.gov/grants/policy/coc/).
Guideline 4: Protection of Sensitive Information—Privacy of research participants is protected by:
- Allowing them to respond anonymously, if at all possible. If the research design cannot accommodate anonymity, protection is provided by:
- Separating any personally identifying information from the research data through the use of numeric or other special codes. Where complete anonymity is not possible (a common occurrence in program evaluation), it is preferable to use code numbers to help guard against unauthorized persons accidentally recognizing or identifying program participants.
The privacy of research participants is further protected by not capturing or reporting personal information unless it is necessary to the study. Whether sensitive or not, all research data must be kept in locked cabinets or files until no longer needed, and then destroyed. (Material to be protected includes names of respondents, mailing lists, completed questionnaires, and transcripts of interviews.) Keep in mind that anonymity in research is very rare since the researchers almost always know who is participating (the exception being a survey without identifying information). What is universal in research is confidentiality, that is, guarding against any disclosure of participants’ identities and responses.
In health care, the federal government enacted legislation designed to protect the privacy of medical patients and their records. The Health Insurance Portability and Accountability Act (HIPAA) of 1996 introduced sweeping changes in researchers’ access to medical records. Although a patient’s experience of HIPAA typically involves reading and signing an information sheet about medical privacy rights, researchers in health care must meet the challenges of HIPAA-related restrictions and the additional permissions that are required. Because hospital and medical institutions tend to interpret HIPAA requirements with varying degrees of strictness, researchers should consult closely with the IRBs under whose jurisdiction the study is being conducted. On a more encouraging note, many health care institutions and IRBs have HIPAA waiver forms for researchers to adapt to their needs. (For more information on the HIPAA Privacy Rule and federal and state government online resources, see www.cdc.gov/mmwr/preview/mmwrhtml/m2e411a1.htm and http://www.hhs.gov/ocr/privacy/hipaa/faq/)
The choice of methodology can affect how vulnerable a research participant may feel. Compared to qualitative methods that depend on in-depth information and use of verbatim quotes, quantitative methods offer greater protection via research findings presented as statistical aggregates (Padgett, 2012). On the other hand, qualitative research depends on establishing trust and this can reduce feelings of vulnerability. For qualitative evaluations, the challenge is to never report anything that could be traced back to a specific individual. For instance, it would be a serious mistake to use the following quotation to show the depth of employees’ feelings about a new director in a study of job satisfaction at a county-run social service agency:
- I’ve been working abuse investigation longer than anyone else here—22 years—and I can say, without any doubt in my mind, that our new executive director doesn’t have a clue about how to do his job; I’m not sure he would even recognize an abused child if he saw one.
To protect privacy, many IRBs prefer that researchers recruit participants through flyers soliciting volunteers who contact them directly, but this mode of sampling may not conform to an evaluation’s design requirements. Other means of gaining access to eligible participants can take a number of forms. For example, an outside researcher may request that the agency contact clients through a letter informing them of the study and requesting their participation. If they give permission, client names, addresses, or phone numbers would be released to the researcher. If such contact conveys even a perception of coercion by the agency (and consequent fear of loss of services), the outside researcher may wish to reach out to clients directly by having study staff approach them in a waiting room or by letter and follow-up telephone call.
(Royse 43-47)
Royse, David. Program Evaluation: An Introduction to an Evidence-Based Approach, 6th Edition. Cengage Learning, 20150105. VitalBook file.
The citation provided is a guideline. Please check each citation for accuracy before use.
