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Presented at the Auditorium of the Sulaiman Rajhi College Auditorium Bukayriyah Qasim on April 19, 2018 by Omar Hasan Kasule MB ChB (MUK), MPH (Harvard), DrPH (Harvard) Chairman of the Institutional Review Board / Research Ethics Committee at King Fahad Medical City, Riyadh.
1.0 SCIENTIFIC RESEARCH AS IJTIHAD
• Ijtihad is applying intellectual effort to solve a practical and not a hypothetical problem. Intellectual speculation (كثرة السؤال).
• Research is reading, understanding, and applying Allah’s signs (آيات الله) in either or both books: book of revelation (كتاب الوحي) and the book of empirical knowledge (كتاب الكون).
• The book of revelation provides the principles and ethical values that protect empirical research from bias to human whims (hiwa al nafs) and ensure that research has objectivity (الاستقامة) and purposefulness (الغائية)
• The book of revelation teaches us that the cosmos is built on fixed physical laws (سنن الله في الكون). These laws are stable(لن تجد لسنة الله تبديلأ) and change when Allah wishes so. They explain the causal relations among phenomena. The purpose of scientific research is to discover and use the laws of causality to change the human and the environment for the better or for the worse.
• The scientific method arises from Quranic call for empirical observation (النظر) in ourselves (الانفس) and in the cosmos (الافاق).
• Scientific ijtihad, therefore, involves reading the two books (الجمع بين القراءتين), one to provide the ethical context and the other to provide empirical evidence.
2.0 SCIENTIFIC RESEARCH AS SEARCH FOR KNOWLEDGE (TALAB AL ‘ILM)
• The prophet told us to look for knowledge as far as China (اطلبوا العلم ولو بالصين) this must have referred to empirical knowledge (علم الكون) because knowledge of the revelation (علم الوحي) was near with the Prophet
• We have made a lot of progress. Starting with 1 university in 1957 we now have 27 public universities, 11 private universities, and 39 private colleges.
• Research productivity from our universities and hospitals is increasing in an encouraging upward trend (figure #1 and Figure #2) but we still have a long way to go and we have to face challenges.
• The first challenge is to move from consuming knowledge (تقليد) to creating knowledge(اجتهاد).
• The second challenge is to move from ‘publish or perish’ to ‘purposive research that increases knowledge and solves local problems’
• Purposiveness: Research is ijtihad to reach useful knowledge (ilm nafi) that fulfills the 5 purposes of the law (مقاصد الشريعة): diin, nafs, nasl, aql, maal). Research is an ethical obligation to improve health care (either better drugs and procedures or a better physician mind that solves problems systematically).
• The third challenge is to be ethical, truthful, and accurate. Hadith literature is a great guide to us in checking facts and documentation. Validity of the text (متن). Accuracy of transmission (سند). A special science not known in other civilizations (علم الرجال).
3.0 RESEARCH MALPRACTICE
• Research malpractices: common1 and leads to retractions retractions2
• No care attitude to research malpractice no whistle blowing4,5. Poor attitude to plagiarism in Iran6
• Motivation of research malpractice: Research grants7, career and reputation8 Funding expectations9 knowledge gaps in ethics and the pressure to publish10
• Common research malpractices: research without ethics approval, research without informed, publication malpractices, plagiarism, conflict of interest, publication malpractices
4.0 RESEARCH WITHOUT IRB/ETHICS COMMITTEE APPROVAL (case scenario)
• A very experienced professor of surgery wanted to undertake research comparing two surgical approaches that he has been using alternately over the past 15 years.
• He reviewed the Nuremberg and Helsinki declarations as well as the ICH-GCP guidelines and the Saudi regulations on research.
• He made sure he fulfilled all stipulations of these documents in his research
• He saw no reason to seek the approval of the local IRB that in his view consisted of young inexperienced members most of whom had been his students. (SCHS)
5.0 RESEARCH WITHOUT INFORMED CONSENT - 1
• Valid research requires voluntary consent after full disclosure. Consent can be oral or written depending on the type of research (exempt, expedited, full review).
• Full disclosure is needed to enable the research subject make an informed decision about the research to protect his interests from harm (q’aidat al dharar)
• The information to be disclosed: why is the study done? what is involved in the study? What is expected of the research subject?, what are the benefits of the study?, what are the risks, costs/payments, privacy and confidentiality of the information etc
• Research without consent led to research ethics codes: Nuremburg 1947, Helsinki 1964, Belmont 1972
• In practice we fail to give full disclosure or the patients is not interested in the details
• We do not pay money to research subjects except for transport and food expenses
6.0 INDIVIDUAL CONSENT (case scenario)
• A physician was recruiting patients for a large multi-center study of myocardial infarction.
• The informed consent sheet was 10 pages long because there were many procedural details and adverse effects to disclose.
• Most of the subjects were bored reading through or listening to the details and were ready to sign because they trusted the physicians doing the study.
7.0 COMMUNITY CONSENT (case scenario)
• A community randomized study was needed to establish whether adding multivitamin tablets to food served in public restaurants would help reduce cardiovascular risk.
• Permission was obtained from the mayor of the city since it was not possible to get consent from each individual participant.
8.0 INDIVIDUAL vs PUBLIC INTEREST (case scenario)
• A new vaccine against flu was found effective overseas.
• The Ministry of Health wanted to test its efficacy by a randomized study.
• Because of a negative media campaign, there were no volunteers for the study.
• The Ministry decided to force all hospital employees above 50 years to enter the study in the next winter season.
9.0 PUBLICATION MALPRACTICES
• All names mentioned must have a substantial recorded contributions of an intellectual nature. Nonintellectual contributions must just be acknowledged
• All names mentioned must have agreed to be investigators or authors. Journals may ask for their signatures
• Author problems: ghost author, gift author (senior?, boss?, friend/colleague? -scratch my back and I scratch yours)
• Doubtful cases: students, research assistants, data monitors, laboratory technicians, faculty supervisor?
• Copyright breaches: unauthorized use of questionnaires
• Data or image manipulation/fabrication/falsification. Use someone else’s data without permission
• Impact factors: manipulation of IF by quoting one another unnecessarily.
• Multiple submissions: When a manuscript (or substantial sections from a manuscript) is submitted to a journal when it is already under consideration by another journal.
• Overlapping publications: 2 or more publications based on analysis of the same data set
• Paying someone to write part or all the proposal
• Undeclared conflicts of interest: financial or non-financial
10.0 PLAGIARISM
• Plagiarism (When somebody presents the work of others (data, words or theories) as if they were his/her own and without proper acknowledgment. Self-plagiarism exists.
• Create vs copy. Is it possible to create from nothing?11.
• Thorough literature review assures originality. Cite and acknowledge all information and opinions used in the proposal that are not your own.
• Why repeat research already done? Local experience / training/scientific validation.
• Plagiarism is a complex phenomenon that may be related to memory lapses and not always deliberate deception12,13,14. Un-intended plagiarism: ideas gained in discussions or from the class room? What if it is your original idea bit someone already thought of it? Self plagiarism15?
• Plagiarism detection: if in doubt check. Use google browser or use special plagiarism detection software16, 17, 18
• Protecting your ideas from plagiarists: document evidence of your ideas before sharing them with others
11.0 CONFLICT OF INTEREST (case scenario)
• The hospital received a big grant from a pharmaceutical company to do a post marketing survey on a new analgesic.
• After trial initiation it was discovered that the physicians in the hospital rarely prescribed the drug.
• The principal investigator called a meeting of all physicians in the outpatient clinic and asked them to start prescribing the drug so that the hospital would not lose the grant.
• He explained that the drug had already been found to be effective and was safe.
Source: (PEER Handbook SCHS 2014)
FIGURE 1: RESEARCH APPROVED BY THE INSTITUTIONAL REVIEW BOARD AT KING FAHAD MEDICAL CITY 2007-2017
FIGURE 2: RESEARCH PRODUCTIVITY OF RIYADH AREA HOSPITALS
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