Manual for Research and Publication Ethics in Science and Engineering

Cho Eun Hee, Kim Young-Mog, Park Kibeom, Son Wha-Chul, Yoon Tae-Woong, Lim Jeong Mook, Hwang Eun Seong
ISBN-13: 978-89-5938-345-0-93190
Korean Federation of Science and Technology Societies
This is an open-access publication distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Bioethics

Bioethics

I. Principles and Scope of Bioethics

Research that tests the safety and efficacy of diverse technology and substances applied to humans can be divided into clinical research, which uses human subjects, and preclinical research, which uses animals instead of people.

Scientific research is a tool to fulfill the freedom of thought and right to know of the individual and has, at the same time, a social responsibility. The foundation of bioethical thinking with respect to research using humans and animals as subjects is maintaining dignity for life.

All research activities must comply with bioethical standards. To ensure compliance with ethical standards for research, independent organizations have been established to oversee this aspect of institutional research activities. Two of these organizations are: institutional review boards (IRBs), which deliberate on research on human subject research; and, institutional animal care and use committees (IACUCs), which monitor animal research.

Before research begins, researchers involved in human and animal testing must obtain approval from the appropriate committee by preparing protocols as prescribed by each committee (ex-post facto approval is strictly forbidden). All academic journals have considered IRB/IACUC approval of human and animal testing as a final prerequisite for publication.

1. Scope of human subject research

Human subject research is conducted not just in biomedical science, but in a variety of academic disciplines including: agricultural science; veterinary science; engineering; the humanities and social sciences; sports physiology; cosmetology; and in food science.

2. Principles of human subject research

In human subject experiments, the protection of the ‘subjects’ participating in the experiment is prioritized above the researcher or the ordinary people who benefit from the results of such clinical trials. Particularly, when the research subject is a human, the experiment is to be conducted only when necessary, and the subject's safety must be guaranteed in all situations. Additionally, the subject must be protected from risk and harm concomitant with the research by protecting the subject's personal information.1

All research involving human subjects must comply with a variety of regulations set out in the Declaration of Helsinki, the fundamental ethics policy on human research. In South Korea, depending on the type of research and its characteristics, research must comply with regulations prescribed by the Bioethics and Safety Act, the Pharmaceutical Affairs Act, the Medical Device Act, and the Personal Information Protection Act.

The credibility of the data must be ensured through the whole research process. To increase credibility, the experimental techniques of the research must be standardized and a sample selection ought to be generalized by random selection. The adoption of standard operating protocols (SOP) and good laboratory practices (GLP) greatly help to generate credible research results.

Fig. 1

Scope of experimentation involving human subjects (Korean Council of Science Editors Symposium Presentation Materials, 2013)

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3. Types of human subject research

1. Observational studies

Observational studies include: research that directly or indirectly uses identifiable personal information on research subjects; research that collects information through human relationship; and research that uses human biological materials.

In observational studies, the protection of personal information and management of human biological materials is critically important. In addition, the study's objective and plans, any benefits or compensation, the process and method of participation, as well as the risks involved in participating in the experiment must be clearly explained to the candidates expecting to participate in the experiment. Based on this, the study candidates must make their own decisions on whether or not to participate in the study. Referred to as ‘informed consent,’ this is the most fundamental element of such research.

Criteria for the waiver of informed consent in observational studies prescribed by the Bioethics and Safety Act (determined by the IRB)

  • When it is not possible to collect consent forms from all subjects providing data due to the use of big data or a large volume of data as research material

  • When the subjects' consent was not obtained but there are no risk factors that arise from carrying out the research

  • When there seems to be no reason for the subject to refuse consent (Even with a waiver of informed consent, measures such as: identification coding; isolation of data collected on subjects; and, separation of the observer-researcher must be implemented in order to minimize risk factors.)

2. Experimental studies

Experimental studies can be defined as a type of research in which some variables of a standardized experimental process are intentionally changed or altered, and their effects are observed. These alterations increase the level of risk in these studies compared to simple observational studies.

Check list for determining the validity of an experimental study

  • Did the subject provide voluntary consent to participate in the experiment based on a sufficient explanation by the researcher?

  • Does the study protect vulnerable subjects who may have difficulty protecting themselves (children, students, employees, senior citizens, etc.)?

  • Does the study's research design have appropriate social value?

  • Does the benefit given to the public through the study outweigh the risk related to the subject?

  • Does the study expose subjects to ethical injustice caused by the experimental treatment (deprivation of opportunity for treatment, etc.)?

  • Does the study guarantee the privacy of the subjects' personal information?

  • Does the study pass legitimate IRB review?

4. Principles in experimentation on animals

1. Research on animals

Laboratory animals essential for clinical study are defined as “animals that are developed, improved, and produced in order to be used in experiments, diagnosis, teaching, research, and the manufacturing of medical substances and devices.”

Quality assurance is needed in order to ensure the credibility of all clinical research, and all stages of the experimental procedure and animal management should be standardized. Quality control of laboratory animals includes disease management based on microbial control, breeding control to maintain genetic quality, the use of materials as regulated, and environmental control to maintain a uniform facility environment.

To obtain credible research results by complying with and maintaining quality control specifications in all clinical experiments, research institutions established the IACUC, which operates as an independent entity. Additionally, a non-governmental civil organization, the Association for Assessment and Accreditation of Laboratory Animal Care International (AAALAC International) evaluates the qualifications of the institution and the conditions of the animal research facilities with the goal of enhancing the credibility of research institutions.

2. Guidelines for animal research

Experimentation on animals must be conducted while taking into consideration both the dignity of the life of the animal and the advancement of human welfare. Experimentation must be carried out by a person possessing knowledge and experience with the ethical treatment and scientific use of animals.

All researchers must comply with the basic principles of animal testing, called the 3Rs (replacement, reduction, refinement).

  • Replacement: Where possible, methodologies that do not require animal testing should be implemented.

  • Reduction: The numbers of animals used in experiments should be minimized.

  • Refinement: To improve animal welfare, methods that eliminate or reduce unnecessary pain and distress should be used. To improve research credibility, research protocols should be simplified and refined.

In potential painful experiments, species of laboratory animals which have a lower sensitivity to pain should be used. Appropriate treatments, such as the use of analgesics, sedatives, or anesthetic agents, should be administered to mitigate the pain.

In cases where a post-trial exam reveals that an animal is not expected to recover or will live in pain, euthanasia must be carried out.

The Royal Society for the Prevention of Cruelty to Animals in England identifies five freedoms possessed by animals. The animals having these protected rights include farm animals, exhibition animals, household pets, and laboratory animals:

  • Freedom from hunger or thirst;

  • Freedom from fear and distress;

  • Freedom to express normal behavior;

  • Freedom from pain, injury, and disease; and,

  • Freedom from discomfort

While difficult to implement in their entirety, suggestions by environmental NGOs regarding laboratory animal research, do offer opportunities for researchers to adopt common sense practices which can improve the performance of rational animal research.

In the case of South Korea, besides the 3Rs, effort is being made to enhance the credibility, ethicalness, and proper management of experimentation on animals through the enactment of the Animal Protection Act (2007) and the Laboratory Animal Act (2010).

The implementation of the Bioethics and Safety Act contributes to the promotion of national health by creating a morally sound life sciences field respectful of the dignity of human and animal life.

3. Procedures for experimentation on animals

The procedures for animal experimentation involve: animal resource management; researcher education; IACUC review; and performance evaluations of the experiment. At each stage, professional standardized management is needed. Each process is systemically connected, and only research procedures that have obtained approval through IACUC can conduct animal experimentations.

As science develops and new academic activities, such as convergence research, gain momentum; the kinds of laboratory animals used in research have has diversified. Accordingly, the establishment of special rearing facilities and proper management of animals is becoming very important. Depending on the research institution, comprehensive management of animal resources is carried out through a dedicated laboratory animal resource center.

II. Institutional Review Boards (IRBs)

1. IRB mission

In accordance with Korea's Bioethics and Safety Act, IRBs conduct reviews, investigations, and supervision concerning: research involving humans; research using human biomaterial specimens; and research using people's personal information.

2. Background of IRB establishment

A fundamental idea guiding human subject research is Bernard's assertion (1865) that: “the moral principle of medical testing is to not conduct experiments which could cause harm to a human subject even if the test results would be highly beneficial to science and helpful to the health of others.”

Major reports and declarations forming the basis of IRB establishment.

  • The Nuremburg Code: After the Second World War, this document stipulated that voluntary consent of the subject of human experimentation is required.

  • The Declaration of Helsinki: This document presents the theoretical basis for the establishment of IRBs, emphasizing the protection of vulnerable test subjects and the responsibility (prudence, sense of responsibility, and qualifications) of the researcher.

  • The Belmont Report: This document defined “scientific activity as based on respect for people, beneficence, and justice.”

  • Afterwards, the International Conference on Harmonisation Good Clinical Practice (ICH-GCP) strongly advocated for the standardization of clinical trial processes and reporting. As well, the ethical guidelines of the Council for International Organizations of Medical Science (CIOMS), suggest conducting trials within a country's socio-economic landscape.

3. Role of IRBs

As prescribed in the Bioethics and Safety Act, researchers seeking to conduct human subject research must submit their research protocol to the IRB for a review of its ethical validity prior to commencing research (Article 15).

IRBs review the research protocol to ensure the subject's protection (guarantee the rights, ensure the safety, and maintain the welfare of the subject) by:

  • Determining the ethical and scientific validity of the proposed research protocol;

  • Inquiring into whether consent was obtained from the research subjects following valid procedures;

  • Complying with matters related to the safety of the research subjects;

  • Determining whether measures were established for the protection of the research subject's personal information; and,

  • When reviewing the research of an institution with (or without) an IRB, determining whether there was compliance with all bioethics regulations.

IRBs can perform the following activities independently: plan and conduct education initiatives for related staff and researchers at an institution; provide ethical guidelines for researchers; and conduct bioethics-related research and services deemed necessary by the board.

Human subject research may only begin after the review and approval by the IRB. Ex-post facto review is strictly prohibited.

4. IRB composition and main members

The number of IRB members varies depending on the research institution, and the member qualifications are as follows:

  • A member from within the life sciences or medical fields or someone with expertise in human subject research

  • A member from outside of the life sciences or medical fields, who is able to evaluate the ethical and scientific validity of human subject research as well as its social influence

  • An external member who represents the public good with respect to bioethics and safety (a member, who is not related to the corresponding institution that conducts the experiment such as a lawyer, religious leader, ethicist, etc., should be appointed)

The head of a research institution has full responsibility for every case decided independently by the IRB. Parts of these responsibilities include ensuring the effective operation and independence of the IRB.

5. IRB review

In medical and bioengineering research, obtaining IRB/IACUC approval is a prerequisite to publishing an academic paper. Recently, approval for research involving human or animal subjects has become required, not just for academic papers, but for graduate theses and dissertations.

Depending on the content, the IRB reviews the submitted research protocols in one of three ways: full board review; expedited review; and exempt review.

1. Expedited review categories of research

  • Research using a minimal quantity of biological specimens or materials and the data derived from medical devices

  • Research using biological specimens from subjects at another institution and with IRB approval from that institution

  • Research conducted using interviews or questionnaires

  • Research requiring a second review after the expiration of the original research project

  • A previously approved research proposal requiring an amendment

2. Exempt review categories of research

  • Research involving surveys or observation of simple behaviors without collecting private or sensitive information from research subjects

  • Research using human biological materials that has minimal risk to the donor and the public

  • Research that does not collect personal information and is carried out within the scope of normal educational practices

  • Research requested by federal or local government in emergency situations (i.e. public health matters)

  • Research conducted using materials from a human biological material bank

  • Research using human biological materials leftover from diagnosis and treatment

  • Research using donated samples whose genetic traits and personal information are unidentifiable

When a research protocol receives a review exemption, the researcher is notified immediately. In the case of an expedited review, the board members review the protocol and can approve it, approve it with corrections required but without further review, approve it with corrections and further review or return it to full board review.

In full board reviews, protocols are either: approved, approved as modified by the IRB, deferred for expedited review, or rejected. The research protocol must include an informed consent form which is reviewed in an identical manner and determined to: be approved, require revisions, require additions, needing full board review, or exempt from review. Other materials reviewed as part of the protocol include the researcher's credentials, a case report form, as well as documents provided to research participants.

Should a protocol be rejected or require changes, the principal investigator must re-submit the protocol with the required changes; the protocol is reviewed a second time depending on its appropriate level of review. Generally, the principal investigator provides a written response but may also be invited by the board to answer questions in person.

Fig. 2

Institutional Review Board (IRB) review process and examples of research review results (Seoul National University IRB data; http://snuethics.snu.ac.kr)

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III. Institutional Animal Care and Use Committee (IACUC)

1. IACUC mission

In accordance with the Animal Protection Act (2007) the heads of institutions conducting animal testing must establish and operate an IACUC in order to ensure the ethical treatment and protection of laboratory animals.

The IACUC ensures the credibility, safety and ethics in experimentation on animals and promotes the ethical treatment and protection of laboratory animals. To this end, IACUC reviews all activities using animals, which includes research, investigation and educational training, within animal facilities.

Researchers conducting animal research must submit an application for approval to the IACUC, and may only begin research after obtaining the board's approval.

2. IACUC's review objectives and criteria

IACUC's animal testing research review includes:

  • Determining the ethical and scientific validity of the research protocol;

  • Determining the appropriateness of the production, introduction, management, testing, use, and disposal of the laboratory animals;

  • Evaluating and confirming the training and education of personnel involved in experimentation on animals; and,

  • Evaluating and confirming the operating conditions of the animal research facilities.

IACUC uses the following criteria to review animal research protocols:

  • Consideration of animal welfare;

  • Adequacy of alternatives to animal experimentation and methods to minimize or alleviate pain and anxiety in animals;

  • Appropriateness of the reasons for using animals / Justification for proceeding with the proposed experimentation on animals;

  • Justification for the number of animals and species;

  • Appropriateness of the proposed methods of euthanasia;

  • Whether research practices are unnecessary or may worsen the condition of the animal;

  • Application of appropriate veterinarian techniques for aseptic surgery and preoperative and postoperative care;

  • Establishment of testing facilities appropriate to the animal and to the safety of the researcher;

  • Appropriateness of using hazardous materials for experimentation on animals; and,

  • Other considerations of the ethical animal experimentation and scientific validity

3. IACUC review process

The IACUC review process consists of a preliminary review of protocols received online by an expert member, after which the proposal is designated for: an expedited review; a regular review; or a full board review.

1. Expedited review

Used to evaluate research protocols that involve the use of established research techniques and where review is relatively straightforward.

  • Simple experiments using rodent subjects and microorganisms monitoring

  • After committee review, the chair decides the acceptance or rejection of the protocol.

2. Regular review

Used to evaluate interdisciplinary research protocols.

  • Multiple reviewers from a number of relevant fields are selected, and after the review, the chair decides on the acceptance or rejection of the protocol.

3. Full board review

Full board review used in cases where the research protocol involves animal testing in which new testing methods are developed or where there is the possibility of serious ethical issues or physical harm to the researcher or animal.

  • After all IACUC members have participated in the review, the chair decides upon the acceptance or rejection of the protocol.

Based on the nature of the protocol, there may be research that requires initial approval multiple committee approval for example: approval by the IACUC, as well as an IRB from another field.

  • Protocols that require initial review from an IRB include:

    • Research using imported genetically modified organisms (GMO)

    • Animal experiments conducting genetically modified or pathogenic organisms

    • Manufacturing or causing genetically modified organisms to occur through the research and experiment

  • Protocols required to go before the IRB include: Research using animals and human subjects, or human biological materials

Fig. 3

Animal Experiment Procedures (Seoul National University Institutional Animal Care and Use Committee data; http://snuethics.snu.ac.kr)

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Reference

1 

CH HamOH KwonSY KimGood publication practice guidelines for medical journals2nd ed.SeoulKorean Association of Medical Journal Editors2013

Notes

[1] CH Ham OH Kwon SY Kim Good publication practice guidelines for medical journals 2nd ed. Seoul Korean Association of Medical Journal Editors 2013 2 3.

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