INTRODUCTION
‘Measurement’ is of key importance in research. Every research study tries to achieve its objectives by making the relevant measurements. These measurements (also referred to as observations) help answer the research question. Consequently, the quality of research relies heavily on the appropriateness and adequacy of measurements made. Instruments and scales are the tools commonly employed to make such measurements in psychiatric research. It will not be erroneous to state that measurements in most research studies in psychiatry are centered around the use of instruments and scales. In fact, even the studies that make use of biological investigative tools also include at least one or more of these instruments and scales. This chapter addresses the ethical issues in use of instruments and scales in psychiatric research.
Ethical issues are integral to medical research. Ethical issues related to subject participation, study design, nature of evaluations, modifications to the ongoing treatment, and nature of controls have been well-debated and discussed in the literature. However, the issue of the ethical use of instruments and scales in research remains largely unaddressed. While the issues related to ethical use of instruments and scales in clinical care delivery have been documented, little has been written about the ethical use of instruments and scales in research.
There are multiple reasons that warrant due consideration to the ethical issues while using instruments and scales for research. Adherence to ethical standards in using instruments and scales is important to preserve the integrity of research. Also, it is important in order to protect the study subjects’ rights and to prevent harm to them. Additionally, it helps 76utilize the time, energy, effort and monetary investment of the study subjects, research staff, funding agency, readers and the general public judiciously while conducting research.
ETHICAL ISSUES IN USE OF INSTRUMENTS AND SCALES
Some of the important ethical issues in use of instruments and scales for psychiatric research are described below. Some of these ethical issues overlap with the issue of methodological appropriateness in research.
Validity and Reliability of Instruments and Scales
Quality of the observations made by instruments and scales depends to a large extent on their validity and reliability. Use of untested instruments and scales is likely to lead to invalid and unreliable observations. Researchers should use valid and reliable instruments only. However, it is likely that the instrument and scale that the researcher intends to use have not been tested for validity and reliability in the population being studied. In such situations, it is important to acknowledge the limitation of the instruments and scales being used. The researchers may also deviate from the standard way of administering the instruments and scales. For example, one may use only a specific section rather than the complete instrument or scale. This is also likely to impact the validity and reliability of the instruments and scales as these were not intended to be used piecemeal to begin with. Such use of only a specific section of the instruments and scales is not justified.
Use of Culturally Insensitive and Inappropriate Instruments and Scales
Certain mental health constructs vary across cultures. The conceptualization, experience, expression and even observation of the same construct in one culture could be explicitly or subtly different from another culture. Experience and expression of grief is one such example. Similarly, instruments aimed at assessment of intelligence may give spurious results 77if they are not culturally sensitive. Instruments and scales developed and validated in one culture might not be able to pick up these variations, especially the subtle ones. Similarly, it is not appropriate to use the instruments and scales that fail to factor in the relevant socioeconomic variables such as level of education and native language of the subjects, as they are likely to yield inaccurate observations. Translating the instruments and scales into the subjects’ native language may not be sufficient to achieve the cross-cultural construct equivalence. Researchers should not ignore this important aspect while selecting the instruments and scales.
Qualification and Training of the Research Staff Engaged in Administration of Instruments and Scales
The responses of the subjects on the instruments and scales are only as good as the questions asked by the interviewers. This is especially true of research based on semi-structured questionnaire and interviews. Required qualification of the administrators varies across instruments and scales. It is ethically inappropriate for an unqualified person to administer the instrument and scale. Similarly, use of instruments and scales warrants prior training. The intensity of training varies across the instruments and scales. Even if the research staff responsible for the administration of the instruments and scales is adequately qualified, it is important to ensure that they receive the required training.
Supervision of the Research Staff Engaged in Administration of Instruments and Scales
Ensuring the fidelity of the research is of utmost importance. Subjects who agree to respond to the study instruments and scales should be protected against any incorrect administration. Hence, it is important to ensure periodic supervision of the research staff engaged in administration of instruments and scales. This is especially true if the research staff has only limited prior experience with the instruments and scales. The frequency of supervision should be adapted according to the needs of the individual administrator.78
Use of Instruments and Scales that Make Proxy Observations
Choice of appropriate instruments and scales is important not only to ensure that the study is methodologically correct, but also to make it ethically sound. At times, researchers tend to use proxy observations for psychiatric constructs. For example, at times, stress or distress is assessed to reflect depression and vice versa. Use of such proxy observations is likely to lead to less than accurate observations. Presenting the findings from such proxy observations as a substitute to the original construct is methodologically inaccurate and not a sound ethical practice.
Use of Pilot Study
A lot of efforts go into the planning of a research work. Despite the best of efforts and intentions, there are certain issues that crop up only when the data collection begins. These issues include, among others, difficulty with the administration of the instruments and scales. This is especially true when the researcher is using the instruments and scales for the first time. Also, it becomes even more important in case the instruments and scales are designed for self-completion and there will be nobody around to clear the doubts. These factors necessitate modifications to the study protocol. Since research involves a significant investment of resources on the part of the research team and the study subjects, missing out on the benefits of a pilot study is unjustified.
(Non-)disclosure of Limitations of Instruments and Scales
No research is perfect. The very nature of the concept of research leaves a scope for improvement. The audience of the research has a right to know the limitation of the work being carried out. This includes the limitation of the instruments and scale used. Ignoring such limitations while making interpretations is unjustified.
Informed Consent
Informed consent is a key prerequisite to the inclusion of a subject in research. Before obtaining consent from the study 79subjects, detailed explanation of the study procedure is provided to them using Patient Information Sheet (PIS). While the study procedure and the possible risks and benefits of participation in the study are usually well explained to the subjects, details of the instruments and scales tend to get overlooked. This is of particular relevance in the context of studies that explore issues of great sensitivity. For example, studies that explore sexuality may include instruments and scales that include questions enquiring private issues which the subjects might find difficult to respond to. Consequently, many of these questions might go unanswered or inaccurately answered. This shall be especially true for scales and instruments which are administered by the interviewer, in comparison to those which are self-administered.
RECOMMENDATIONS ON ETHICAL USE OF INSTRUMENTS AND SCALES FOR RESEARCH
Based on the issues presented in the previous section, the following recommendations can be drawn regarding the ethical use of instruments and scales. Researchers are advised to be well-versed with and adhere to these recommendations.
The research staff entrusted with the responsibility of administration of instruments and scales should be adequately qualified. They should receive the required training before the administration as specified in the manual of the respective instrument and scale. Also, the investigators should ensure adequate and periodic supervision of such research staff during the administration of the instrument and scale. The sale of certain instruments and scales is restricted to professionals with specific qualification, and the same should be considered while making such purchases for research. In case the research staff is not fully competent to administer and interpret the instruments and scales, researchers with appropriate training and experience should ensure direct supervision of such research staff.
Ideally, the instruments and scales should be piloted on a small number of subjects who meet the selection criteria before starting the main study. The number of subjects included for the pilot phase shall depend on the sample size and ease of subject recruitment and can vary between 5 and 50.80
Researchers should be aware of the cultural bias of instruments and scales being used. Instruments and scales that rely heavily on formal education based on a different system and include culturally alien concepts should be avoided. The researcher must try to use the instruments and scales that have normative data available for the population being researched. If the researchers fail to find instruments or scales that are completely apt for the cultural setting being researched, the selected instruments and scales should be supplemented with additional avenues of data collection. Use of only quantitate instruments and scales in such scenarios may fail to explore important dimensions of the construct being researched. Use of a qualitative technique in addition to the use of instruments and scales is one option to consider.
Researchers should be cautious with the use proxy observations for various constructs. Use of such proxy observations is likely to lead to less than accurate observations. However, when it is unavoidable due to some reason, the researcher must mention it upfront as well as explain the rationale for the same.
The Patient Information Sheet used to appraise the potential study subjects about the study procedures and details should also include information on the instruments and scales to be used. Information like the purpose of scale, how it will benefit or risk the patient, the nature of questions included, and the nature of administration (interviewer or self-rated) must be communicated to the subjects before seeking informed consent.
The researchers should familiarize themselves with the strengths and limitations of the instruments and scales before using them. Not only should they be aware of the appropriate administration, but they should also make appropriate adjustments for the shortcomings due to factors such as lack of normative data and use of only a section rather than the complete instrument. These must be acknowledged, and the audience of the research must be made aware of the same. In case the researchers deviate from the standard administration of an instrument or a scale, the same must be acknowledged. The potential impact of the same must be noted and 81allowance made in the interpretation. The researchers should mention the limitations of their work in the research report and publications based on the research work, and this should include the limitation of the instruments and scale used. Also, the limitations should be presented in a form that is understandable to the intended readers. This helps the readers to make informed inferences from the findings. Also, it would offer valuable inputs for the future work on related themes.
Adherence to these recommendations shall help researchers with the ethical use of instruments and scales in research. It is advisable to make use of the checklist provided in Table 1 before finalization of the research protocol.
82This shall ensure that the relevant issues are not overlooked. In case there are any ethical dilemmas, the same should be discussed in research team meetings. The opinion of experts and peers is also valuable when faced with such questions. The researchers must strive to ensure the ethical use of instruments and scales. This, in turn, shall not only add to the scientific rigor but also safeguard the interests of all involved in research work.