Health research protocols: a template for empirical bioethics and other investigations

Abstract

We have formalized a protocol template suitable for all types of humanities and social sciences investigations in the domain of health, including empirical bioethics in particular. To achieve this, we revisited the protocol template proposed by O’Brien et al. in Academic Medicine in 2014, better known as the “Standards for Reporting Qualitative Research (SRQR)”. We reorganized, fused and/or renamed several of the sections, and partly or entirely rewrote several of the corresponding instructions. This made it possible to overcome the limitation of the initial protocol to qualitative approaches, and to render the resulting template equally suitable for quantitative and mixed approaches, and/or other approaches. This new protocol template should be seen as a highly adaptable base.

Background

Recently, we published the results of a preliminary empirical bioethics study on early-phase clinical trials in oncology [1]. We used some parts of a protocol template we have designed for this type of health research. Here, we present the whole template, and its genesis.

Main text

Research studies on human subjects, known in France as recherches impliquant la personne humaine (RIPH), are routinely performed at the hospital where we work as bioethicists. They are mostly clinical studies requiring the active participation of human subjects in interventional research (i.e. clinical trials) or non-interventional research (i.e. observational studies) [2]. Studies not involving human subjects, known in France as recherches n’impliquant pas la personne humaine (RNIPH), are also performed. The active participation of human subjects is generally not required for these studies because they are mostly based on the reuse, for research purposes, of data and/or samples generated in the framework of patient care, and on the results of studies not generating biological and/or medical knowledge [2]. Before RIPH studies are performed, their protocols must be evaluated by structures known in France as comités de protection des personnes (CPP). These structures are external ethics committees (EC) independent of healthcare establishments and specific to France, but they are also registered as institutional review boards (IRB) with the Office for Human Research Protection (OHRP) of the United States Ministry of Health [3], as required for publication in many international journals. By contrast, the protocols of RNIPH studies can be evaluated by the EC of a French hospital, which could be also registered as an IRB with the OHRP, but has more limited functions than a CPP within France.

This is the case in our hospital. The EC is an IRB, and is part of the ethics department. Its principal role is evaluating the protocols of RNIPH studies sponsored by our hospital. As a means of improving protocolization by investigators and the evaluation of protocols by our EC/IRB, the clinical research department of the hospital has progressively implemented two protocol templates: one for single-centre studies and the other for multicentre studies. Nevertheless, a practical problem has emerged over time, due to these two templates being primarily suitable for research studies in health and life sciences. Indeed, our EC/IRB is sometimes also asked to evaluate protocols for humanities and social sciences studies in the domain of health. These studies are different from health and life sciences studies in terms of both epistemology and methodology, but are also considered to be RNIPH studies according to the regulations in force. And they must also obtain the approval of an EC/IRB for publication in many international scientific journals [4]. The studies of this type performed at our hospital are essentially studies in empirical bioethics.

For greater convenience, we have formalized a protocol template suitable for all types of humanities and social sciences studies in the domain of health likely to be sponsored by our hospital, including empirical bioethics in particular. We do not consider the protocolization of studies of this type to imply a strict copying of the protocols of interventional or non-interventional research studies in medicine or biology. Again, the epistemological and methodological frameworks of studies in life and health sciences and those in humanities and social sciences in the domain of health, including empirical bioethics, differ significantly [5]. To achieve this, we revisited the protocol template proposed by O’Brien et al. in Academic Medicine in 2014 [6], better known as the “Standards for Reporting Qualitative Research (SRQR)”. O’Brien et al.’s protocol template was initially designed for qualitative studies in the domain of health, for use during the article-writing or planning phases of the study, and it is recommended by the international Enhancing the QUAlity and Transparency Of health Research (EQUATOR) network [7], and by various scientific journals. We did not draw comparisons with other existing templates. It is mostly based on our own work and experience, and that of our hospital colleagues. We decided to submit this new template to peer review through publication in a scientific journal to avoid being judge and jury in its design within our own EC/IRB, and to take into account the criticisms of other colleagues. This could help us to pursue its practical improvement.

At the end of the day, we reorganized, fused and/or renamed several of the sections, and partly or entirely rewrote several of the corresponding instructions (Table 1, sections 1 and 6–22). This made it possible to overcome the limitation of the initial protocol to qualitative approaches and to render the resulting protocol template equally suitable for quantitative and mixed approaches, and/or other approaches. We also added four new regulatory and administrative sections (Table 1, sections 2–5), perhaps more specific to French frameworks, and one epistemological section (Table 1, section 9). This last section has two advantages in practice: for investigators, it overcomes the need to restrict use of the protocol to research in empirical bioethics, and for the EC/IRB, it makes it possible to determine precisely which humanities and social sciences are concerned, facilitating the choice of the most appropriate evaluators. From our point of view, the result is a single protocol template that is more explicit, both for investigators and evaluators, particularly as concerns the application and mastery of theoretical and methodological frameworks and the identification and management of biases. These aspects are particularly important in empirical bioethics using normative rather than descriptive approaches, because the passage from empirical data to normative proposals depends on both the quality of the empirical data collected and the correct application of the chosen ethical theory (Table 1, section 10) [8].

Table 1.

Protocol template adapted from O’Brien et al. [6]

1	Title, short title and acronym	→	Describe the nature and subject of the study concisely, identify the approach used in the study (e.g. quantitative, qualitative, etc.), and/or indicate the methods of data collection (e.g. questionnaire, interviews, etc.)
2	Study sponsor(s)	→	Specify the organization(s) (e.g. university, institute, hospital, etc.) and/or their representative(s) (i.e. name, title, function, contact, etc.) legally responsible for organizing the study
3	Principal investigator(s)	→	Specify the researcher(s) (i.e. name, title, function, contact, etc.) scientifically responsible for performing the study
4	Other contact details	→	Specify particularly the legal department, and/or the ethics committee, and/or their representative(s) (i.e. name, title, function, contact, etc.) involved
5	Research team(s)	→	Specify the coordinating research team (e.g. department, laboratory, etc.) and/or their representative(s) (i.e. name, title, function, contact, etc.), and list any research teams associated with the study (N.B., for multicentre studies in particular). If appropriate, specify the co-investigator(s) (i.e. name, title, function, contact, etc.)
6	Summary	→	Summarize the key elements of the study, including, in particular, its context, primary objective and general method. Do not include bibliographic references
7	Problem studied	→	Explain the importance of the problem and/or phenomenon studied. Summarize the most significant theoretical or practical works, including, if appropriate, bibliographic references. State the problem studied
8	Objective(s) of the study	→	Present the objective(s) and/or question(s) specific to the study
9	Disciplinary field of the study	→	Present the principal disciplinary field(s) or subfield(s) of the humanities and/or social sciences (e.g. empirical bioethics, experimental philosophy, medical anthropology, etc.) corresponding to this study
10	Research paradigm of the study	→	Present and explain the research paradigm of the study, i.e. specify its methodological framework (e.g. qualitative, quantitative, mixed, descriptive, normative, etc.) and, if applicable, its theoretical framework (e.g. principlism, global bioethics, precautionary principle, etc.). If appropriate, include particularly significant bibliographic references
11	Site and duration of the study	→	Present and justify the study site, and its important contextual factors, together with the study duration. Specify the period of inclusion, data collection, data analysis and publication of the results
12	Characteristics of the investigator(s)	→	Specify the characteristics of the investigator(s) involved in the research, notably their qualifications, experience and possible relationships to the participants/populations and, potentially, the hypotheses and/or assumptions relating to the study that could potentially have a direct or indirect effect. Attention should be devoted to cultural biases. If appropriate, specify whether public members (e.g. patients, associations, etc.) would be included in the research team
13	Characteristics of the participants/populations	→	Specify the characteristics of the participants/populations included in the study. If appropriate, evaluate the number of participants/populations required in advance. Attention should be devoted to cultural biases too
14	Sampling of participants/populations	→	Explain how and why the participants/populations were sampled. If appropriate, specify the precise criteria used to determine when it is no longer necessary to continue sampling (e.g., large sample, data saturation, etc.). If necessary, include key bibliographic references
15	Consent and information of the participants/populations	→	Specify and justify the type of informed consent (e.g. explicit, implicit, oral, written, etc.) and information notice (e.g. collective, individual, oral, written, etc.) used for the participants/populations. If written, provide a copy in appendix. If necessary, include key bibliographic references or regulations
16	Data collection	→	Present and justify the type(s) of data collected, and, if possible, the dates on which data collection began and ended (for retrospective studies), the procedures, particularly the instruments (e.g. interview guides, questionnaires, etc.) and equipment/tools (e.g. tape recorder, computer programs, etc.) used. If appropriate, specify whether any changes in the instruments and other means or modes of use might occur during the study, and the participation of public members in the process. If necessary, include key bibliographic references
17	Data processing, storage, protection and confidentiality	→	Present and justify the methods of data processing for data transcription and/or input, and the means or mode of data storage protection and confidentiality, particularly for data anonymization or pseudonymization. If necessary, include key bibliographic references
18	Data analysis	→	Present and justify the process of data analysis, referring to a specific paradigm and/or approach (e.g. statistical analysis, comparative analysis, content analysis, thematic analysis, etc.). If possible, specify the means and mode of strengthening the reliability and credibility of the data analysis (e.g. statistical tests, verification by members, triangulation, etc.). If appropriate, specify the participation of public members in the process, and include key bibliographic references
19	Regulation	→	Detail the regulatory framework of the study as a function of the country or countries in which it is performed
20	Planned publication and communication	→	Specify the means of scientific valorization for the results of the study. If appropriate, specify the participation of public members in the process
21	References	→	List the most significant of the bibliographic references already mentioned
22	Appendices	→	For multicentre studies, list the participating centres, transmit a copy of the informed consent form and/ or the information notice (N.B. if written), indicate funding sources, specify any significant conflicts of interest for the study, etc.

We stressed the relative freedom of choice for investigators concerning the exhaustiveness of the information notice to be delivered, the form of informed consent to be obtained (Table 1, section 15), and the mode of protection for the empirical data to be collected, stored and analyzed (Table 1, section 17). There were at least three reasons for this choice, which seems to be supported by other bioethicist colleagues [9]. With respect to the information notice, prior information that is too exhaustive or too oriented may, in this type of study, have a non-negligible influence on the behaviour to be observed and/or the responses to questions obtained. Thereby, it can increase bias in the study, and decrease the pertinence of the results obtained [9]. For consent, depending on the situation, it may be difficult, or even inappropriate with respect to the participant and/or the study, to obtain written consent systematically. This is particularly true when qualitative approaches are used, such as non-participant observations in the corridors of a hospital department or a research laboratory [9]. With respect to data protection, constraints imposing excessive modes of anonymization rather than responsible pseudonymization may considerably limit the researchers’ ability to deepen certain analyses that are nevertheless imperative for the study. This is particularly the case if the empirical data are collected in semi-directed interviews, or via open-ended questionnaires. In addition, it can also cause difficulty, or even impossibility, of reidentifying participants, therefore precluding the collection of additional better-targeted data [9]. It is thus important to add that the risks to the physical or mental health of the participants are generally small or nonexistent, at least in the domain of empirical bioethics [9]. Consequently, outweighing the importance of respecting the principle of participant autonomy, we think that it is essential for the ethical purposes and/or consequences of the study and its investigators to be considered by the EC/IRB and the evaluators for studies of this type. Evidently, such very specific and formalized contextualizations, only on a case-by-case basis, do not authorize the investigators, and/or the sponsors, to ignore fundamental research policies, standards and/or legislations, and the confidentiality of results in particular.

Conclusions

This new protocol template should be seen as a highly adaptable base. It could be used for EC/IRB evaluations, but also for study registries, reporting guidelines or other purposes. Obviously, it should be adapted according to the purpose for which it is used.

Availability of data and materials:

No datasets were generated or analyzed during the current study.

Abbreviations

CPP

Comité de protection des personnes (Committee for the protection of persons participating in research)

EC

Ethics committees

EQUATOR

Enhancing the QUAlity and Transparency Of health Research

IRB

Institutional review board

OHRP

Office for Human Research Protection

RIPH

Recherches impliquant la personne humaine (Research studies on human subjects)

RNIPH

Recherches n’impliquant pas la personne humaine (Studies not involving human subjects)

SRQR

Standards for reporting qualitative research

Author contributions

H.C.S. and C.H. contributed to the conception of the paper, drafting sections and discussing how different sections should be refined and integrated. All the authors have seen and approved the final manuscript.

Funding:

We thank Foch Hospital for funding.

Declarations

Ethics approval and consent to participate:

Not applicable.

Consent for publication:

All the authors have seen and approved the final manuscript.

Competing interests:

The authors declare no competing interests.