Philosophy and Ethics of Research:

General and Specific Considerations for Medical Research

dr. Santoso Cornain D.Sc. Laboratory of Immunopathology, Department of Anatomic Pathology Faculty of Medicine, University of Indonesia

Research philosophy:

1. Objective / function 2. Principle 3. Methodology and materials 4. Scientific (biomedical) communication

ad 1. Objective / Function of Research:

To understand the phenomenon of nature (-general-); To increase the knowledge about diseases (-specicifc-); To increase the knowledge about health (-specific-); Prediction and control; Evaluation and the use of information.

Ad 2. The Principle of Research

The benefit for collection of knowledge; The benefit for humanity; The benefit for the patients / population: i.e. recovery of disease - improvement of health - prevention of disease

ad 3. Methodology and materials of research:

1. Methodology: * Observation * Experimentation: * Experimental Design; * Laboratory, Clinic, Population; 2. Materials: * Experimental system / model: on animals; * Human system: on patients;

ad 4. Scientific (biomedical) communication:

Scientific (biomedical) report, based on permanent records (through continuous and permanent recording) of the results of research; Integral component of the observation / experimentation; Ethical considerations: 1). Unethical if not publishing / communicating the research results; 2). Ethical rules in reporting.

Research Ethics

1. Ethics = a branch of philosophy with moral poblematic as the element; * depends on the culture; * dynamic / changes by time like other social behaviour; * the principle remains the same: # honesty, integrity, humanity, consideration of good deed / kind heartedness; # characteristic: more moral rather than legal.

Research ethics

2. Research Ethics General; Medical Ethics Specific; Medical Research Ethics Specific; Research ethics in animal system: Manual of laboratory animals; Research ethics in human system / patients: Medical ethics: * physician duty and medico-legal problems; Medical research ethics: * Experimentation on human / patients; * Started with experiments in animals; * Use of volunteers * Special procedures: children, certain diseases;

Conditions for creating research ethics:

Good planning and concept; Consideration of objections i.e. risk and danger (children, mother, patients with certain disorders: psychiatric / consciousness); Materials for reevaluation, retrospective study, against the influencing variables / factors; against therapeutical modality etc.: i..e - data registry; - medical records;

ad Good planning and concept:

Started with Experimental Design; Controlled Investigation: * performed with adequate capability and clear concept; * study characteristics: comparative and communicative; * control(s) reproducible; * every individuals recruited in the experiments should be explained about the experimental details and the possibility of error or artifact;

Research ethics are required in:

Organ transplantation: recipient and donor; Abortion; Family planning: contraception etc.; Sterilisation: - medical reason; - for contraception; Infertility: -therapeutical purpose; -artificial insemination; -in vitro fertilisation (test tube baby) Etc. Iatrogenic diseases.

Ethics in Scientific (biomedical) Communication

Contents of scientific report: * originality new concept; * or additional information / reevaluation for the previous concept; * or more effective presentation relative to the earlier information; Scientific integrity: -- not egoistic -- avoid data manipulation Ethics for presenting patients; Ethics for author, editor, reviewer, acknowledgement, science writer; Ethics for printing / publication, copywright and avoid scientific advertisement

ad Ethics for Authors

The draft of scientific paper was written based on strong thesis; The data were obtained ethically; The scientific data were adequate in validity; Writing the paper: * The author must be active to write the paper by her-/him-self ( as literary work); * Appropriate documentation; * Accurately written; * Made in clarity / understandable ( readable); Avoid redundant publication (that overlaps substantially with one already published); state to the editor all submissions and prior reports that might be regarded as redundent; The manuscript presented in a conference made available through a document reproduction service such as ERIC is permissible to submit; Perform literature search and cite the original publications influential or closely related to the work; Omitted citation can be interpreted as plagiarism.

Authorship Ethics (1)

Idividuals as authors should have significant contributions: 1. to the conception and design, or analysis and interpretation of data, or both; 2. to drafting of the manuscript or revising it critically for intelectual content; 3. to final approval of the versions of the manuscript to be published. Participation solely in acquisition of funding or collection of data does not merit authorship status;

Authorship Ethics (2)

Multiple authorship: The order of authorship should be a joint decision of the co-authors; Different ways: e.g. 1). Descending order of contribution, who leads writing or research first and most experience last; 2). Alphabetical order; 3). Random order. The co-authors share responsibility and accountability for the results;

Authorship Ethics (3)

The submission should be accompanied by a form stating that the manuscript has been read and approved by each of the co-authors; Acknowledgement section should mention the person with significant function and contribution to the work but did not justify authorship, specifying the intelectual or technical help, and the agency or institution providing the financial support or grants.

ad Ethics for Editor & Reviewer

Reading & studying the manuscripts: * the necessary scientific information; * based on appropriate reasoning; * experimentation complied ethical rules; * accurate documentation; * accurate presentation; * confidentiality; Responsibility: * allows publication as early as possible; * avoid drastic revision / changing revision; * provide documentation of critics and comments to the author for the paper being rejected

Ad Ethic for science writer

To make link between: - science and people; - science and government; Information should be obtained ethically; Consultation with the resource persons: avoid prematurity; avoid mistake / inappropriateness; avoid sensation.

Research / Ethical Misconduct (1)

The biggest misconducts include: 1. Fabrication = behavior that makes up data or results and recording or reporting them; 2. Falsification = behavior that manipulates research materials, equipment, or processes, or changing or omitting data or results such that he research is not accurately represented in the research record; 3. Plagiarism = behavior that appropriates another persons ideas. Processes, results, or words without giving appropriate credit; Research misconduct does not include honest error or honest differences of opinion;

Research / Ethical Misconduct (2)

Improprieties of Authorship = Improper assignment of credit, such as excluding other authors, inclusion of individuals as authors who have not made a definite contribution to the work published, or submission of multi-authored publication without the knowledge of all authors; Violation of Generally Accepted Research Practices: Deceptive practices in proposing, conducting or reporting research;

Research / Ethical Misconduct (3)

Material Failure to Comply with Governmental Requirements or Contractual Agreements Affecting Research: Including, but not limited to, serious, substanstial or repeated, willful violation involving the use of funds, care of animals, human subjects, investigational drugs, recombinant products, new devices, radiation or radioactive, biologic or chemical materials.

Plagiarism

Oxford dictionary: plagiarism = to take and use as ones own, the thoughts, the writings, of another; Most university definition elements: * a deliberate intention to cheat; * copying or paraphrasing a text without acknowledgement; * adopting someone elses ideas without acknowledgement; Three types: * intra-corpal: copying from other on the same course; * extra-corpal: copying from external source: books or website; * auto-plagiarism: citing ones own work without acknowledgement;

Special references:

The Nuremberg Code (Trials of War Criminal 1949); World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects (18th World Medical Assembly, Helsinki, Finland,1964, revised on the 29th World Medical Assembly, Tokyo, Japan, 1975); Code of Ethics in Animal Experimentation: * Council of the American Physiological Society
Kirsten L S & Lawrence M R. Authorship Ethics. Practical Assessment Research and Evaluation. (Summurized from Uniform Requirements for Manuscripts Submitted to Biomedical Journals).

The Mission of Medical Doctor

Declaration of Geneva of the World Medical Association: The health of my patient will be my first consideration; The International Code of Medical Ethics: Any act or advice which could weaken physical or mental resistance of a human being may be used only in his interest