| what's Research Ethics? | refers to a diverse set of values, norms and institutional regulations that help constitute and regulate scientific activity. |
| what are the National and Institutional Committee and Board? | National Committee of BioEthics (NCBE),Alfaisal Institutional Review Board (IRB) |
| what is bioethics and what are the types? | -medical ethics, which focuses on issues in health care;
-research ethics, which focuses issues in the conduct of research;
-environmental ethics, which focuses on issues pertaining to the relationship between human activities and the environment,
- public health ethics, which addresses ethical issues in public health. |
| Why do I need to worry about research ethics? | • It’s true that we can’t do much about the bad person who is determined to do evil things.
• However, research ethics isn’t just – or even mostly about bad people doing bad things. |
| why do imperfect people do imperfect things, what are the reasons? | – Socially acceptable practice we later deem wrong
– ‘Misdemeanor’-level wrongs that we try to justify (e.g., taking shortcuts)
– Missing something, especially with new methods or technology
– One can become involved in research ethics violations through the wrongs of others.
– Sometimes the right thing to do just isn’t clear
– Self-deception and other psychological tendencies |
| what are Professional Pressures? | •Publish or perish
• Tenure/retaining a job
• “Keeping up” with peers
• Securing grants
• Being first to a discovery
thy all encourage shortcuts. |
| What are the moral foundations of research? | Doing good for humans, animals, the planet, future generations, etc. via the pursuit of truth and knowledge
-Our duty to respect individuals
-Our possible duties to animals
-Our obligations to society |
| What is expected of a researcher? | -The truth:Be honest about your research.
-The whole truth: Omission of parts of research findings might constitute research misconduct or violate other moral norms.
-Nothing but the truth: It’s also dishonest to Puff up one’s results by adding irrelevant or misleading information, or overstating their significance. |
| To whom do we owe the truth, and why? | To all the stakeholders (those with direct and indirect involvement in a research study):
• The public, for its funding support
• Individual research participants, out of respect for their autonomy
• Colleagues and collaborators, whose research may be based on our research
• Funding institutions, for giving us resources
• Research institutions/universities (our employers), for employment, resources, and because their reputations can be affected by what we do |
| what are Some areas of research ethics?s | 1-Research misconduct (falsification, fabrication and plagiarism)
2-Collaboration issues (Publications, authorship, data ownership and management)
3-Intellectual Property
4-Conflicts of interest or obligation
5-Complicity
6-Animal subject research
7-Human subject research |
| what does Responsible ethical conduct include ? | -applying for funding,
-experimental design,
-generating and analysing data,
-using equipment and facilities,
-publishing results and acknowledging the direct and indirect contribution of colleagues, collaborators and others. |
| Research misconduct means fabrication, falsification, or plagiarism what does each of them mean? | 1- Fabrication : means making up data or results and recording or reporting them.
2-Falsification: means manipulating research materials, equipment, or processes, or changing or omitting data or results such that the research is not accurately represented in the research record.
3-Plagiarism :means the appropriation of another person’s ideas, processes, results or words without giving appropriate credit. Research misconduct does not include honest error or differences of opinion. |
| what are Examples of research misconduct? | • Image manipulation
• Data fabrication or falsification
• Data omission/suppression
• Plagiarism from the work of another - could also be ideas gleaned |
| what is Research Data Policy? | -Comply with the university’s policy on data management.
-Clear and accurate records of the research procedures and the results obtained including interim and final results.
-Rigor with which the experiment is conducted
-Research data remains the property of the University when a researcher leaves.
-Researcher must comply with any data protection and/or information security requirements. |
| what are some Collaboration issues ? | Publications, authorship, data ownership and management |
| what are some Ethical obligation on authors in publications? | authors to acknowledge external sources
(Citation clubs, self citations –strongly discouraged).
Authors-Only who made significant contributions.
Those contributed materially though conceiving, executing or interpreting at least part of the relevant research.Co-authoring is accepting a commitment to reputation of publication.with other acknowledged to (Funders, colleagues, or others who assisted) |
| what is necessary in collaborative research publications? | it is necessary to seek permission for publication from all parties in advance.It must be disclosed to the publisher if a substantially.Accuracy of the published research should be ensure,If errors are identified in the published data, reasonable steps should be taken to correct errors in a correction, re-traction, erratum, or other appropriate publication means. |
| what are Intellectual Property Rights? | Contractual agreement determines the rights of university, funder, collaborator and the researcher,Maintaining confidentiality regarding the results of the research pending legal protection.researcher must protect the confidentiality of information provided. |
| what's Conflict of interest? | Situations in which financial or other personal considerations may compromise, or potentially comprise a researcher's professional judgment in conducting or reporting research. this should be avoided, if not it shall be disclosed to the appropriate people to minimize conflict. |
| what are some direct and indirect examples of conflict of interest? | Most direct example: being paid to say something untrue.
Indirect example: Knowing that if you say something positive about a company that gave you a grant, you may be more likely to get a grant from them again in the future. |
| what's Moral Complicity? | Moral issues beyond scientific misconduct can arise depending on one’s field of research and funding source.EX:stem cell research, dual-use biological agents . |
| is Animal experimentation necessary and subject to research ? | it remains a necessary part of the scientific discovery process and development of new medicines for veterinary and human clinical use.
Dogs, cats and other animals suffer from cancers, heart diseases, diabetes, They can be used to study these conditions .Research involving these and other species enables the development . |
| how can we use animals in research? | 1-only when replacement alternatives are not available.
2-The work is fundamental to advances in understanding that will prevent suffering, protect and prolong human or animal life.
3-the animal use protocol has been approved by a relevant authority (IRB).
(Protocols includes background, research objectives, including details of the species or strain of animal used) |
| what's the 3Rs principal? | they are basic principles related to the humane experimental techniques :
Replacement: strategies to replace or avoid the use of animals in research and testing
Reduce: reducing the number of animals used if possible
Refine: refining experiments to cause less pain and distress |
| what are the ARRIVE (Animal Research: Reporting In Vivo Experiments) guidelines ? | The reproducibility of biomedical research is a formidable challenge,Transparent and accurate reporting is vital to this process
The minimum information necessary to report in publications describing in vivo experiments. |
| what are the ARRIVE Essential 10? | 1. Study design
2. Sample size
3. Inclusion and exclusion criteria
4. Randomisation
5. Blinding
6. Outcome measures
7. Statistical methods
8. Experimental animals
9. Experimental procedures
10. Results |
| what are some Unethical Examples of using humans for research ? | -Direct ophthalmic injection of toxic substances
(Nazi)
-Patients had been injected with live cancer cells (Jewish Chronic Disease Hospital, NY, 1963)
-400 men had been left to suffer with syphilis long after a cure ( penicillin) was available. (Tuskegee, Alabama, 1932-72) |
| what's the Nuremberg Code and what are its three main elements? | The first attempt to answer these questions with guidelines for the use of human subjects of research
1-voluntary and informed consent
2-a favorable risk-to-benefit analysis
3- the right to withdraw without repercussions |
| what are the points of the Nuremberg Code 1-5 ? | 1.The voluntary consent of the human subject is absolutely essential. This means that the person involved should have legal capacity to give consent; should be so with free power of choice, without force.
2. The experiment should be such as to yield fruitful results for the good of society, unprocurable by other methods or means of study, and not random and unnecessary in nature.
3. The experiment should be so designed and based on the results of animal experimentation and a knowledge of the natural history of the disease or other problem under study that the anticipated results will justify the performance of the experiment.
4. The experiment should be so conducted as to avoid all unnecessary physical and mental suffering and injury.
5. No experiment should be conducted where there is an a priori reason to believe that death or disabling injury will occur; except, perhaps, in those experiments where the experimental physicians also serve as subjects. |
| what are the points of the Nuremberg Code 6-10 ? | 6. The degree of risk to be taken should never exceed that determined by the humanitarian importance of the problem to be solved by the experiment.
7. Proper preparations should be made and adequate facilities provided to protect the experimental subject against even remote possibilities of injury, disability, or death.
8. The experiment should be conducted only by scientifically qualified persons. The highest degree of skill and care should be required through all stages of the experiment of those who conduct or engage in the experiment.
9. During the course of the experiment the human subject should be at liberty to bring the experiment to an end if he has reached the physical or mental state where continuation of the experiment seems to him to be impossible.
10. During the course of the experiment the scientist in charge must be prepared to terminate the experiment at any stage, if he has probable cause to believe, in the exercise of the good faith, superior skill and careful judgment required of him that a continuation of the experiment is likely to result in injury, disability, or death to the experimental subject. |
| what's The National Research Act and what are its main 3 principals? | it the Belmonte Report, the minimum requirements for ethical human subjects research:
-respect for persons
-beneficence
-justice. |
| what are the Basic ethical standards in research? | -Disclosure: Disclose whether it is research or clinical study, nature and purpose of research, Procedures used, expected benefit to the participant or society, foreseeable risks, research subjects’ rights in case of injury, contact person.
-Understanding: The participant must understand what has been explained and must be given the opportunity to ask questions and have them answered by someone fully conversant in the study particulars.
-Voluntariness: The participant's consent to participate in the research must be voluntary, free of any coercion or inflated promise of benefits from participation
-Competence: The participant must be competent to give consent.
-Consent: The potential human subject must authorize his/her participation in the research study, preferably in writing |
| what are the Components of ethically valid informed consent for research? | -Proper identification: Giving clear details of who you are and what you are doing
-Autonomy refers to the right of an individual to determine what activities they will or will not participate in.
-Informed consent for example, not putting pressure on or deceiving the respondents.
-The Privacy and confidentiality: the respondents' contributions should not be made available to other people.
-The right to anonymity. Meaning that respondents' contributions must remain anonymous.
-Safety of the research participant. Identify potential risks to the subject, to establish means of minimizing those risks, and to continually monitor the ongoing research for adverse events how will they be handled and who will provide care for a participant injured in a study and who will pay for that care.
-Beneficience: risks vs. potential benefits to the individual and/or society.
Justice. distribution of risk across society. |
