two discussion board questions about research ethics

timer Asked: Oct 5th, 2017
account_balance_wallet $15

Question description

1- Based upon the articles I attached and your own understanding please answer the following questions. Is it ethical to randomize clinical treatment trials? Meaning is it ok to hold treatment from one group and give it to another? Why is randomization important in research of a quantitative nature?

ANSWER: It removes researcher bias and improves reliability. But what ethical questions are raised? The question as stated above is whether we are withholding treatment from one group while giving it to another, whether it be a clinical drug trial or a new training tool. Is this ethical? Why or Why not?

2- What are some of the ethical or human subjects issues that may exist in your own research direction? What do you need to be careful about regarding your design? (to answer this question, my research will be conducted on the floods that occurred in Saudi Arabia, it will be just collecting data from scientific resources, so do you think that might face some ethical issues?) I also attached a simple article about the floods in Saudi Arabia to help you understand what is happening.

The articles:


2- Take a look at this course in this link

3- And the articles I attached below

Important notes:

1- Use APA format for citation.

Please read the following information on IRB which includes info on Background and history, Human Subject Definitions, Responsibilities, and Informed Consent. BACK GROUND AND HISTORY Human subjects protection began with the Nuremberg Code, developed for the Nuremberg Military Tribunal as standards by which to judge the human experimentation conducted by the Nazis. In the United States, regulations protecting human subjects first became effective on May 30, 1974. Promulgated by the Department of Health, Education and Welfare (DHEW), those regulations raised to regulatory status Nil-I’s Policies for the Protection of Human Subjects, which were first issued in 1966. The regulations established the IRB as one mechanism through which human subjects would be protected. In July of 1974, the passage of the National Research Act established the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The Commission met from 1974 to 1978. In keeping with its charge, the Commission issued reports and recommendations identifying the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects and recommending guidelines to ensure that research is conducted in accordance with those principles. The Commission also recommended DHEW administrative action to require that the guidelines apply to research conducted or supported by DHEW. References for the Commission’s reports are listed in Appendix 1 (General Bibliography). The Commission’s report setting forth the basic ethical principles that should underlie the conduct of biomedical and behavioral research involving human subjects is titled The Belmont Report, and is discussed in depth below. In 1981, in response to the Commission’s reports and recommendations, both the Department of Health and Human Services (DHHS, formerly DHEW) and the FDA promulgated significant revisions of their human subject regulations. As Levine (1986) points out, these revisions “do not alter the general principles of IRB review as they had evolved over the preceding three decades. Rather, they are concerned with some of the details of what the RB is expected to accomplish and some of the procedures it must follow” [p. 324]. The DHHS regulations are codified at Title 45 Part 46 of the Code of Federal Regulations. Those “basic” regulations became final on January 16, 1981, and were revised effective March 4, 1983, and June 18, 1991. The June 18, 1991, revision involved the adoption of the Federal Policy for the Protection of Human Subjects. The Federal Policy (or “Common Rule,” as it is sometimes called) was promulgated by the sixteen federal agencies that conduct, support, or otherwise regulate human subjects research; the FDA also adopted certain of its provisions. As is implied by its title, the Federal Policy is designed to make uniform the human subjects protection system in all relevant federal agencies and departments. Additional protections for various vulnerable populations have been adopted by DHHS, as follows: Subpart B, “Additional Protections Pertaining to Research, Development, and Related Activities Involving Fetuses, Pregnant Women and Human in Vitro Fertilization” became final on August 8, 1975, and was revised effective January 11, 1978, and November 3, 1978. Subpart C, “Additional Protections Pertaining to Biomedical and Behavioral Research Involving Prisoners as Subjects” became final on November 16, 1978. Subpart D, “Additional Protections for Children Involved as Subjects in Research” became final on March 8, 1983, and was revised for a technical amendment on June 18, 1991. FDA regulations on the protection of human subjects are codified at Title 21 Parts 50 and 56 of the Code of Federal Regulations. Part 50, which sets forth the requirements for informed consent, became final on May 30, 1980, and was revised effective January 27, 1981, March 3, 1989, and June 18, 1991. Subpart C, which provides special protections for prisoners, was adopted on July 7, 1981; the effective date of Subpart C has been stayed until further notice. Part 56, which sets forth the provisions for institutional review boards, was adopted on January 27, 1981, with revisions to some sections effective February 27, 1981, March 3,1989, and June 18, 1991. Additional FDA regulations that are relevant to IRB review of research are Parts 312 (Investigational New Drug Application), 812 (Investigational Device Exemptions), and 860 (Medical Device Classification Procedures). The President’s Commission for the Study of Ethical Problems in Medicine and Biomedical and Behavioral Research, which met from 1980 to 1983, produced numerous reports on various aspects of medical ethics and biomedical and behavioral research. Its mandate with respect to the protection of human subjects was, first, to review the federal rules and policies governing human subjects research, and second, to determine how well those rules were being implemented or enforced. References for the President’s Commission’s reports are listed in Appendix 1 (General Bibliography). Several excellent sources trace the history of human subject research and the development of the IRB system as a mechanism for the protection of human subjects. An account of the history of human subjects research and the human subjects protection system in the United States can be found in David J. Rothman’s Strangers at the Bedside: A History of How Law and Bioethics Transformed Medical Decision Making (Chapters 1-5 and Epilogue) and in Dennis Maloney’s Protection of Human Research Subjects. Rothman details the abuses to which human subjects were exposed, culminating in Henry Beecher’s 1966 article, “Ethics and Clinical Research,” published in the New England Journal of Medicine, and ultimately contributing to the impetus for the first NIH and FDA regulations. Other equally useful sources include Robert J. Levine’s Ethics and Regulation of Clinical Research (Chapter 14), Joan E. Sieber’s Planning Ethically Responsible Research, Robert M. Veatch’s “Human Experimentation Committees: Professional or Representative?,” and William J. Curran’s “Government Regulation of the Use of Human Subjects in Medical Research: The Approaches of Two Federal Agencies.” A Brief History: Here are some significant dates in the development and history of informed consent. 1947: Twenty-six Nazi physicians are tried at Nuremberg, Germany, for research atrocities performed on prisoners of war. This results in the Nuremberg Code, the first internationally recognized code of research ethics, issued by the Nazi War Crimes Tribunal (a prototype for later codes of ethics). 1940s: A series of research abuses starts in Tuskegee, Alabama. In one study on the natural history of untreated syphilis, poor, black males are uninformed of their disease and denied treatment even after a treatment is found in 1947. The abuses are revealed in 1972. 1962: The Kefauver-Harris Bill is passed to ensure greater drug safety in the United States after thalidomide (a new sleeping pill) is found to have caused birth defects in thousands of babies born in Western Europe. 1964: The 18th World Medical Assembly meets in Helsinki, Finland, and issues recommendations to guide physicians in biomedical research involving human subjects. 1974: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research is established, and the National Research Act is passed by Congress. This Act prompted the establishment of IRBs at the local level and required RB review and approval of all federally funded research involving human participants. 1979: The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research publishes The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research a guide for U.S. research with human subjects. -- 1993: The Albuquerque Tribune publicizes 1940s experiments involving plutonium injection of human research subjects and secret radiation experiments. Indigent patients and mentally retarded children were deceived about the nature of their treatment. 1994: President Clinton creates the National Bioethics Advisory Commission (NBAC). 1995: The President’s Advisory Committee on Human Radiation Experiments concludes that some of the radiation experiments from the 1940s were unethical. 1997: President Clinton issues a formal apology to the subjects of the Tuskegee syphilis experiments. NBAC continues investigation into genetics, consent, privacy. These events and others have prompted federal action to protect human subjects involved in all types of research. In December 1971, the U.S. Department of Health, Education, and Welfare began to require the creation of Institutional Review Boards (IRBs). The proposed research design of a University faculty, staff, or student must be reviewed by the IRB. The IRBs at The Pennsylvania State University are charged with reviewing plans that protect your participants. The IRBs ensure that human subjects do not bear any inappropriate risk and have properly consented to their involvement. Human Subject Definitions as defined by the Code of Federal Regulation 45 CFR 46.102 Department or Agency head means the head of any Federal Department or Agency and any other officer or employee of any Department or Agency to whom authority has been delegated. Institution means any public or private entity or Agency (including Federal, State, and other agencies). Legally authorized representative means an individual or judicial or other body authorized under applicable law to consent on behalf of a prospective subject to the subject’s participation in the procedure(s) involved in the research. Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities. Research subject to regulation, and similar terms, are intended to encompass those research activities for which a Federal Department or Agency has specific responsibility for regulating as a research activity (for example, Investigational New Drug requirements administered by the Food and Drug Administration). It does not include research activities which are incidentally regulated by a Federal Department or Agency solely as part of the Department’s or Agency’s broader responsibility to regulate certain types of activities whether research or non-research in nature (for example, Wage and Hour requirements administered by the Department of Labor). Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains • • (1) data through intervention or interaction with the individual, or (2) identifiable private information. Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects. IRB means an Institutional Review Board established in accord with and for the purposes expressed in this policy. IRB approval means the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB and by other institutional and Federal requirements. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Certification means the official notification by the institution to the supporting Department or Agency, in accordance with the requirements of this policy, that a research project or activity involving human subjects has been reviewed and approved by an IRB in accordance with an approved assurance. For further information, please see the Code of Federal Regulation 45 CFR 46. 102. Responsibilities The Institution is responsible for: • • • • • • protecting the rights and welfare of human participants of research; ensuring that affiliates cooperating in the conduct of federally sponsored research do so without an appropriate assurance of compliance and satisfaction of the Institutional Review Board (IRB) certification requirements; establishing and maintaining the IRBs; acquiring appropriate Assurances or Amendments; requiring additional safeguards in research that involves: (1) fetuses, pregnant women, or human ova in vitro fertilization, (2) prisoners, (3) children, (4) the cognitively impaired, or (5) other potentially vulnerable groups; overseeing the performance of all research involving human participants, including complying with Federal, state, or local laws as they may relate to such research. The Institutional Review Board (IRB) is responsible for: • • reviewing, and having the authority to approve, require modification in, or disapprove all research activities, including proposed changes in previously approved human participant research; reporting decisions and requirements for modifications to the investigators • • • • • • promptly; observing the quorum requirements; ensuring that legally effective informed consent will be obtained and documented in a manner that meets federal requirements; preparing and maintaining adequate documentation of its activities; suspending or terminating previously approved research that is not being conducted in accordance with the IRBs requirements or that has been associated with unexpected serious harm to subjects; ensuring effective input for all initial and continuing reviews conducted on behalf of performance sites where there will be human research participants; providing continuing review of each research activity at least every 12 months and may be more frequent on the basis of the degree of risk to participants. The Investigator is responsible for: • • • • • • • • • • • protecting the rights and welfare of the human research participants; complying with all federal, state, or local regulations established to protect human research participants; providing a copy of the IRB-approved and signed informed consent form to each participant at the time of consent; promptly reporting proposed changes in previously approved research activities to the IRB prior to their implementation; promptly reporting any injuries or other unanticipated problems involving risks to participants and others to the IRB; reporting progress of approved research at least every 12 months; complying with all IRB decisions, conditions, and requirements that are established within the guidelines of the 45CFR46; ensuring that legally effective informed consent will be obtained from each participant; ensuring that informed consent is documented; reporting any serious or continuing noncompliance with the federal or RB requirements; noting the Food and Drug Administration whenever it is anticipated that an experimental new drug or device exemption will be required Informed Consent The process of informed consent is a mandatory and integral component of research involving human subjects. An investigator may not involve a human subject in research prior to providing and obtaining informed consent from each participant. This document is to be presented in a format that is easy to follow and easily understood. Therefore, NIH has recommended that the consent document be written at an eighth grade, or lower, reading level for all subject populations. The consent document must contain the basic elements of consent, and if necessary, additional elements of consent may be required. Basic Elements of Consent • • • • • • • • • Provide name, address, and telephone number of investigator (and coinvestigators) in case participants have questions at a later date. A description of the purpose of the study (why you are doing the study) and a clear explanation of what they will be required to do. An explanation of any risks or discomforts the subject may experience. A statement describing any benefits to the subjects or potential benefits to society. If applicable, a statement informing participants of alternate means for obtaining treatment that may be helpful for the participant. Clearly describe how confidentiality will be maintained. A statement informing participants their participation is “voluntary” and they may decline to answer specific questions AND withdraw their participation at anytime without penalty. Participants are to be given a copy of the consent document for their record keeping. A statement informing subjects the amount of time that will be required for their participation. Additional Elements of Consent • • • • • • • • • • • • • A statement identifying researcher’s affiliation Measures (surveys, questionnaires, etc.) must not be attached to the consent form. The consent form is a “separate” document. Connecting page numbers (e.g., Page 1 of 2 and Page 2 of 2) are to be noted on the consent document to prove closure to the document. Consent documents that are double-sided must contain the connecting page number in case the consent document is reproduced as a single-sided document. A statement informing subjects they may contact the Office for Regulatory Compliance, 212 Kern Graduate Building, University Park, PA 16802, (814) 8651775 for additional information concerning their rights as research subjects. Signature and date lines for the participant to complete. An explanation of the amount of compensation a subject is to receive for participating in the research project. If necessary, explain how payment will be prorated if subjects withdraw before the research project is complete.* Subjects are to be informed that they may ask questions at any time. If extra credit is used as a means of compensation, an alternate comparable means of earning the extra credit needs to be identified.* An explanation of treatments or procedures that may cause unforeseen risks to the subject.* A statement explaining conditions that may require the researcher to terminate a subject’s participation.* Any additional costs the subject may incur as a result of their participation.* The procedure the subject is to follow for withdrawing their participation and consequences that may occur from this decision. * A statement regarding tape recording (audio/video) that will occur, who will have access to the tapes, where the tapes will be stored, and when the tapes will be • destroyed. * For surveys that are conducted electronically, subjects must be informed of the limited confidentiality levels that are available for electronic media. *
The Nuremberg Code From “Trials of War Criminals Before the Nuremberg Military Tribunals Under Control Council Law No. 10”, Vol. 2, Nuremberg, October 1946 April 1949. (Washington, DC: - US Government Printing Office, 1949). pp 181-182. The great weight of the evidence before us is to the effect that certain types of medical experiments on human beings, when kept within reasonably well-defined bounds, conform to the ethics of the medical profession generally. The protagonists of the practice of human experimentation justify their views on the basis that such experiments yield results for the good of society that are unprocurable by other methods or means of study. All agree, however, that certain basic principles must be observed in order to satisfy moral, ethical and legal concepts. 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 situated as to be able to exercise free power of choice, without the intervention of any element of force, fraud, deceit, duress, overreaching, or other ulterior form of constraint or coercion; and should have sufficient knowledge and comprehension of the elements of the subject matter involved as to enable him to make an understanding and enlightened decision. This latter element requires that before the acceptance of an affirmative decision by the experimental subject there should be made known to him the nature, duration, and purpose of the experiment; the method and means by which it is to be conducted; all inconveniences and hazards reasonably to be expected; and the effects upon his health or person which may possibly come from his participation in the experiment. The duty and responsibility for ascertaining the quality of the consent rests upon each individual who initiates, directs or engages in the experiment. It is a personal duty and responsibility which may not be delegated to another with impunity. 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 problems 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. 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.
Commentary Commentaire Occasional essay Humanitarian aid and medical research: an illusion of dichotomy in international health Daniel E. Roth ß This article is the winner in the student/resident category for the 2000 CMAJ Essay Prize. See page 1860 for the winner in the general category and The Left Atrium (page 1872) for 2 of the runners-up. The contest is described on page 1859. I f you’re a physician and you say that you’re heading to the tropics for a few weeks to offer your medical expertise to the members of a remote tribe, people are likely to smile and wish you the best in your altruistic pursuit. If, instead, you say that those same tribespeople are going to be participants in medical research you’re conducting, the reaction may not be one of smiles but of raised eyebrows. International work in health care is generally looked upon favourably, but fitting biomedical research into the picture is another matter. Let’s say a group of Canadian family physicians takes several box-loads of donated antibiotics and anti-inflammatory drugs to an isolated community in a developing country. Over the 3 weeks they are there, they go home to home, carrying out medical check-ups and handing out drugs when indicated. Access to treatment is normally limited in this community by the cost of medications and the distances that people have to travel to obtain care. The doctors leave with their boxes successfully emptied. There are few opportunities for follow-up exams, and no means of assuring compliance with medication. However, pill bottles in hand, the villagers express their gratitude for the foreign doctors’ visit and cling to the hope (conveyed by a local health promoter who understands some English) that the doctors will perhaps return the same time next year. Let’s also imagine that some Canadian researchers conduct an epidemiologic study that undertakes passive and active surveillance of malaria in a lowland region of a tropical country. Diagnosis and treatment are free in this particular country, but many people in remote areas use these services infrequently because of barriers such as distance and a lack of awareness of the national malaria program. The treatment that the investigators provide is already available, although the study doctors (local physicians hired by the foreign researchers) provide, in addition, regular physical exams. Their effort to detect every case of Plasmodium vivax or P. falciparum infection using regular home-to-home visits over the course of a year results in access to a diagnostic service that many people would not seek out on their own. Foreign medical students or residents paired with lo1862 CMAJ • JUNE 26, 2001; 164 (13) © 2001 Canadian Medical Association or its licensors cal health care workers act as the study’s fieldworkers; they facilitate treatment access for participants in need and monitor treatment compliance. The only extra risk or discomfort associated with participation pertains to the extra sample of blood that the fieldworkers request periodically. Also, the villagers are sometimes frustrated when the doctors inform them of possible health problems, only to indicate that they cannot give them medications apart from the malaria drugs or other medicines provided free by the government. Still, they know that they are being cared for better than usual (often, the doctors or fieldworkers ultimately do find a way to provide free medications or hospital access). As well, many people feel some satisfaction that their participation will help doctors learn about malaria so that the disease can be better prevented in the future. Both projects provide some benefit to the participants and their communities, but health care workers involved in either type of project need to be honest about their motives and their capacity to bring about change. In the absence of peace, shelter, clean water, food, effective waste disposal and, perhaps, immunizations and basic maternity care, medical doctors can’t make an ounce of impact on the actual health of a population. The fact is that no more than a barely sustainable improvement is likely to be achieved by either of the 2 efforts. Both may, however, be beneficial in increasing contact with health care professionals and raising awareness of certain health issues in the community. The research study would have had to pass through at least 2 institutional review boards (IRBs), one at the North American university to which the investigators are affiliated, the other in the local nongovernmental organization sponsoring the research. Did the charitable project require the same type of approval? Did it also require formal expressions of informed consent, as was sought from the particpants in the research study? Probably not. It was charity, to be sure. But the assumption that such work is inherently more ethical than a research study is questionable. Doing a research study and handing out free drugs are far more alike in a developing country than they might be in an affluent one. Both put people in contact with interventions Commentaire and their associated risks that they would not normally encounter. Ethical principles may be universal, but standards of medical care certainly are not.1 Sustainability and equality in health care access are generally not high on the list of research ethics problems in countries like Canada, where most clinical studies offer treatments or procedures for which there is a universally accessible alternative. In developing countries, alternatives may be nonexistent, and the experimental intervention may not be sustainable. But it is also true that when the charity doctors leave their adopted community, or when their drugs have run out, the community’s access to medications drops to the preintervention level. In the short time they were there, the doctors will have made only superficial contact with local health care providers, leaving many villagers with the impression that good Western medicine equals the dispensing of drugs. On the other hand, after the researchers in our example have completed their study, community members may no longer have the advantage of physician home visits, yet actual access to malaria diagnosis and treatment remains relatively unchanged. Perhaps the study will also have raised awareness of the free malaria care that is available. Local health care workers may have benefitted from their interactions with doctors and medical students from other countries. And, not least, the researchers may have gained valuable information about incidence and transmission patterns that may aid in the development of more effective control measures. Of course, not all research studies have such clearly definable benefits to participants or are as easily compared to charitable missions. Some studies have spurred furious debate, as in the case of recent placebo-controlled antiretroviral studies for perinatal HIV transmission in Africa.2 Studies in developing countries commonly raise questions about the motives for conducting such research outside the West3 or the justification for using an experimental method that might not be acceptable at home.4 Many humanitarian medical aid efforts are, likewise, not represented by our first example and provide much more comprehensive and sustainable health care than the group of well-intentioned family physicians in our example. Nevertheless, we might question the assumption of an ethical dichotomy between research studies and charitable medical interventions in developing countries. It is wrong to assume that research studies in developing regions are ethically precarious simply because they involve data collection. It is easy to accuse medical missions of not always being beneficial. It should also be understood that medical research is not necessarily exploitative. Not all research projects in the developing world are like the controversial studies that give placebos to HIV-infected pregnant women when effective means of reducing viral transmission to newborns have already been established. Most original research projects involving human subjects in developing countries are surveys, observational studies, epidemiologic explorations or community-based longitudinal analyses of baseline health parameters. Such research projects are aimed primarily at acquiring a clearer understanding of population health in developing regions. These types of studies are never free of ethical complexity. However, they can benefit participants in ways that are well-defined, clearly explained and even sustainable, without raising false hopes of greatly improved medical care in the immediate future. The examples we have considered also point to the powerful role of IRBs in the conduct of collaborative projects overseas. Increasingly stringent requirements for research protocol development and informed consent, not to mention steep fines for transgressions, are being established.5 A protocol review process replete with overwhelming administration obstacles (or at least the perception of such barriers) creates a risk that investigators will disproportionately abandon their research in disadvantaged regions, where logistics and feasibility issues are already at a maximum. We should not be fooled into believing that bureaucratic zealousness implies a system that more vigilantly protects human rights. The complexities of the process might even distract us from the real reasons why we concern ourselves with research ethics in the first place. IRBs should focus on developing specialized review processes for international collaborative projects to address the specific implications of their stipulations on health research in developing countries. They should train selected personnel to look at the issues that matter most in international health and to work as consultants to support investigators who study non-Western health problems. Although such a suggestion may invoke the fear of double standards in international bioethics,6 these changes would actually strengthen the crosscultural application of universal ethical standards. For example, written informed consent forms required by IRBs increasingly involve sophisticated and legalistic phrasing that is likely to be a barrier to the informed decision-making of technically inexperienced or illiterate participants. Greater emphasis could be placed on exploring alternatives to standard informed consent procedures for studies in developing countries. Of course, any such modifications need to coincide with a move toward greater collaboration with local ethics committees of the countries in which the studies are carried out.7 A priority in international health should be to encourage investigators from affluent countries to continue biomedical research into the problems that afflict developing countries. Just as free medications are not always equivalent to good health care, Western investigators in developing countries are not necessarily cultural imperialists. Rejecting such assumptions will permit us to demonstrate that both charitable interventions and clinical research have their place in international development strategies. We are capable of conducting both in a manner that will aid our neighbours and, ultimately, help to reduce global inequities. Mr. Roth is a third-year medical student at the University of British Columbia, Faculty of Medicine, Vancouver, BC. CMAJ • JUNE 26, 2001; 164 (13) 1863 Commentary Competing interests: None declared. 3. Acknowledgement: My thanks to everyone involved in the malaria surveillance study in Loreto, Peru, a product of collaboration between the Johns Hopkins School of Hygiene and Public Health and Asociación Benéfica PRISMA (Peru), for providing the inspiration for the “hypothetical” research study example. 4. 5. 6. References 1. 2. 7. Halsey NA, Sommer A, Henderson DA, Black RE. Ethics and international research: research standards are the same throughout the world; medical care is not. BMJ 1997;315:965-6. Clark PA. The ethics of placebo-controlled trials for perinatal transmission of HIV in developing countries. J Clin Ethics 1998;9:156-66. Determining Medical Fitness to Drive S I X T H Correspondence to: Mr. Daniel Roth, 4274 11th Ave. W, Vancouver BC V6R 2L7; A Guide for Physicians to On CM e f A m ree c em opy be rs E D I T I O N For a limited time, CMA members can obtain a complimentary first copy as a benefit of CMA membership. To order contact the CMA Member Service Centre at 1 888 855-2555 (Canada and US) or 613 731-8610 x2307 1864 Ijsselmuiden CB, Faden RR. Reseach and informed consent in Africa — another look. N Engl J Med 1992; 326:830-4. Angell M. The ethics of clinical research in the Third World. N Engl J Med 1997;337:847-9. Shalala D. Protecting research subjects. HHS Fact Sheet. Washington: US Department of Health and Human Services; 2000. Angell M. Ethical imperialism? Ethics in international collaborative clinical research. N Engl J Med 1988; 319:1081-3. Gambia Government-Medical Research Council Joint Ethical Committee. Ethical issues facing medical research in developing countries. Lancet 1998;351:286-7. This CMA publication is a tool to help physicians assess their patient's ability to drive safely. CMAJ • JUNE 26, 2001; 164 (13)
Rains and floods in KSA ... Alamri Rains and floods in Saudi Arabia. Crying of the sky or of the people? Yassar A. Alamri, MBChB/PhD. T he Kingdom of Saudi Arabia (KSA) has recently hit world news and has become well known for man-made disasters, such as terrorist attacks, and the high rate of motor vehicle accidents. However, natural disasters, such as floods have had much less attention, even though it leads to much more damage than the rest of other disasters or accidents combined. This article will present the 2 cases of Jeddah 2009 floods and Riyadh 2010 floods as the most recent disasters in the region. These 2 events were chosen since they are very recent, and have awakened policy makers to shift their emergency preparedness efforts to a more active approach. This article will also review the main lessons learnt and recommendations for future disaster preparedness strategies. There is a scarcity of literature published on natural disasters in KSA, and perhaps the best record on international disasters comes from the International Disaster Database (IDD). The IDD is an established World Health Organization (WHO) project that originates from the Center for Research on the Epidemiology of Disasters, School of Public Health of the Université Catholique de Louvain in Belgium. It compiles and standardizes the data collection of all international natural and man-made disasters. Table 1 summarizes the main 10 natural disasters that occurred in KSA in the last century.1 It is obvious that floods have been the most frequently encountered natural disaster in the country. The exceptions to floods, being a main natural disaster, were only 3 incidents of bacterial/viral meningitis occurring during Hajj time (that is, annual pilgrimage to Makkah). Of all natural disasters enlisted, the 2009 Jeddah floods have topped the list in terms of severity, fatality, and cost. Some disasters have been omitted from Table 1 due to the strict inclusion criteria and definitions used for IDD (refer to Table 2).1 At approximately 6:30 in the morning of Wednesday (25th November 2009), rain started falling heavily in Jeddah, and continued for almost 12 hours. The amount of water in this relatively brief downpour (approximately 90 mm3) doubled the average annual rain fall in Jeddah.2 With sound infrastructure and proper drainage system lacking, this rain turned into a worst disaster that Jeddah has experienced in 27 years or so.3 The downpour resulted in the formation of water tides coming from the hills on the east of the city, heading west towards the Red Sea, and cutting their way through the city. Jeddah only rarely has rainfall, and hence preparedness to any risk arising from such a natural phenomenon is, at best, minimal. The passage of the floods through a city with an almost non-existent drainage system was devastating. Several residential houses collapsed, forcing many inhabitants to the upper floors and roofs. Laboratories and databases at the King Abdulaziz University and King Abdulaziz Hospital were destroyed, wasting valuable resources, specimen, and medical records.2,3 Major roads of the city were blocked by meters-high water waves, or by cars that have been washed out. As a result, thousands of pilgrims were rendered waiting in buses for hours before arriving in Makkah for the first day of Hajj. Furthermore, the King Abdullah Bridge on the South of Jeddah has partially collapsed, adding to the chaos and fright to the situation.2,3 Power and telecommunication services were not spared either. As early as 11 A.M, floods have already resulted in a temporary power outage on the whole Western region of Saudi Arabia (such as, Makkah, Madinah, and Jeddah). Many people were not even able to call for help as communication with emergency services (for example, Civil Defense Forces, police, Table 1 - Top 10 natural disasters in Saudi Arabia from 1900-2010 sorted by the number of people killed.1 Disaster Date Number of fatalities Flood 24 November 2009 163 Epidemic 11 September 2000 76 Epidemic March 2000 57 Epidemic 9 February 2001 35 Flood 28 April 2005 34 Flood 24 December 1985 32 Flood 22 January 2005 29 Flood 4 April 1964 20 Flood 8 April 2002 19 Flood 11 November 2003 12 Table 2 - Criteria and definitions. For a disaster to be entered into the database, at least one of the following criteria must be fulfilled: • Ten (10) or more people reported killed. • A hundred (100) or more people reported affected. • Declaration of a state of emergency. • Call for international assistance. killed - persons confirmed as dead and persons missing and presumed dead (official figures when available), affected - people requiring immediate assistance during a period of emergency; it can also include displaced or evacuated people Saudi Med J 2011; Vol. 32 (3) 311 Rains and floods in KSA ... Alamri and ambulance) has failed due to the overwhelmed network and power outage.2,3 Overall, 161 people lost their lives as a result of these floods, either drowning, or from car crashes. This disaster had an estimated cost of approximately US$900 million to reconstruct Jeddah and help its victims.2 On 3rd May 2010, Riyadh experienced a brief 45-minute water shower, accompanied by light hail and winds gusting up to 24 km/hour.4 As brief as the downpour was, however, it resulted in floods and car crashes across the city. Local newspapers reported that at least 2 people were killed, and that the floods caused almost 275 car crashes. Even though King Khalid International Airport was not affected, many people missed their scheduled flights due to poor road conditions.4 A survey committee appointed by the Prince of Riyadh has started assessing the extent of, and the reasons behind the damages that have been the result of this rain.5 Floods can be a notorious disaster since they have the potential of occurring suddenly (for example, breakdown of a dam, or quick melting of snowfall). However, taking proper precautionary actions well in advance can substantially reduce adversities from such disasters. Such measures can include establishing functional drainage systems, and proper use of dams and levees. Natural disasters do not respect geographical boundaries, and international emergency planning may be therefore required. The lessons from Jeddah and Riyadh floods are broad, and can be summarized into the following points: Lesson one. It is often said ‘history repeats itself: first as tragedy, second as farce’. Unfortunately, this has been true for the history of disasters in KSA. Floods have hit the county many times in 2000, 2001, 2002, 2003, 2005, 2009, and finally in 2010. However, lessons from these events pass by unnoticed. Preparations to such disasters are still lacking, and people return to their normal lives as if nothing happened. This might be because of the widely accepted attitude that “what Allah decrees to happen, will happen, and we cannot do anything about it.” Recommendation one. Disaster history has to be taken seriously, and lessons and recommendations from each event should be analyzed in order to make better decisions, and take better preparatory actions for the next event. It is also important to realize that Islam has taught us to “trust in Allah, but tie your camel,” indicating that people have to take a proactive role. It is sad that such precious experiences are not documented nor shared, which is a considerable waste of knowledge that could save lives down the line. 312 Saudi Med J 2011; Vol. 32 (3) Lesson 2. Recent floods have revealed serious fragmentation in the coordination between different sectors in the management of such emergencies. Currently, emergency management in KSA is a reactive system, rather than an anticipatory system. This may sometimes not be sufficient to face such a widespread disaster as a flood, for example, during the Jeddah 2009 floods people were not aware whom they should contact for help. Emergency services in Jeddah were unavailable to public as early as 11 A.M on the day of the floods, due to panic and spontaneity in trying to save the victims. Added to this chaos was the power outage that occurred early in the day. Recommendation 2. An emergency requires a wellrehearsed strategy, planned well before any disaster hits. It is not feasible to expect different parties to work harmoniously under a crisis situation if they have no coordination beforehand. A local organizing body should be formed, and aimed at bringing together different local agencies, such as hospitals, local Civil Defense Forces, local police, local businessmen, and stake holders. Also, a unified ‘emergency number’ should be created and publicized for people to call, instead of occupying the lines of individual police and Civil Defense Force centers. Lesson 3. During Jeddah floods, King Abdulaziz Hospital was also affected by the water waves. The hospital’s underground was repeatedly reported to have been submerged with water. Basic understanding of the pattern of natural disasters was lacking. Recommendation 3. Better understanding of the local geography of the city will lead to better understanding of potential natural disasters. Thus, preparing robust infrastructures would enable to mitigate such hazards. For example, Jeddah is a costal city and ‘excess’ treated water can be safely let run into the Red Sea, provided there is proper drainage system. Lesson 4. The floods were a shock to the people of Jeddah and Riyadh, and this stimulated volunteer work. The attitude of helping others when able is an Arab characteristic, and an Islamic quality that drives people to volunteer. However, this has resulted in a sharp rise of the number of volunteer bodies, many of which were disorganized, duplicated work that had already been carried out, and sometimes hindered professional aid, such as first aid by professional paramedics. Recommendation 4. All volunteers should follow one big organized agency, so as to serve people in need efficiently and professionally. Thankfully, such organization called Jeddah Friends was recently organized, and approved by the Jeddah Governorate. Rains and floods in KSA ... Alamri Saudi Arabia has a history of frequent floods. Jeddah and Riyadh floods are the most recent ones, and they have awakened policy makers to take a more proactive action. Lessons from these events should be considered seriously to efficiently minimize the impact of future disasters. These policies, if implemented, will enhance the readiness and preparedness of the population in the country to respond effectively to such events. Active and holistic planning has to be a priority among agencies in the country. It is, perhaps, time to look back to history and learn some lessons in disaster preparedness. Received 24th October 2010. Accepted 20th December 2010. From the Department of Medicine, University of Otago, Van der Veer Institute for Parkinson’s and Brain Research, Christchurch, New Zealand. Address correspondence and reprints request to: Dr. Yassar A. Alamri, Department of Medicine, University of Otago, Van der Veer Institute for Parkinson’s and Brain Research, Christchurch, New Zealand. Tel. +64 (3) 3786348. Fax. +64 (3) 3786080. E-mail: References 1. International Disaster Database. Center for Research on the Epidemiology of Disasters. Country Profile: natural disasters (2010). [Updated 2010 Aug. Accessed 2010 March 23] Available from URL: 2. Al-Zahrani S. Damage may top SR1 billion. Saudi Gazette. [Updated 2009 November 27. Accessed 2010 May 24]. Available from URL: cfm?method=home.regcon&contentID=2009112755625 3. Anqawi A. Flooding kills 12 in Jeddah, Thousands of pilgrims stranded on highway. Saudi Gazette. [Updated 2009 November 26. Accessed 2010 May 24]. Available from URL: http://www. ID=2009112655554 4. Al Jazeerah. Heavy rains flood Riyadh streets. [Updated 2010 May 04. Accessed 2010 May 26]. Available from URL: http:// 731245.html 5. Al-Oraifij A. Riyadh Floods. Saudi Gazette. [Updated 2010 May 09. Accessed 2010 May 24]. Available from URL: regcon&contentID=2010050971778 References * References should be primary source and numbered in the order in which they appear in the text. At the end of the article the full list of references should follow the Vancouver style. * Unpublished data and personal communications should be cited only in the text, not as a formal reference. * The author is responsible for the accuracy and completeness of references and for their correct textual citation. * When a citation is referred to in the text by name, the accompanying reference must be from the original source. * Upon acceptance of a paper all authors must be able to provide the full paper for each reference cited upon request at any time up to publication. * Only 1-2 up to date references should be used for each particular point in the text. Sample references are available from: Saudi Med J 2011; Vol. 32 (3) 313

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