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and ramadan mubarak it's a great.pleasure to welcome you all.to our research training course which is.organized by.king head specialist hospital in the mam.and the e1 cluster.in collaboration with event true my name.is dr.iman nasim and i am the iirb chair of.king fad specialist hospital de man.today we will start with our first.module.research ethics which will be composed.of three lectures.history of research ethics.second one will be about research ethics.during covet 19 pandemic.and the third one will be informed.consent.process our first speaker for tonight is.dr selwa cher.she is graduate of georgetown university.washington dc.with american board certification in.anatomic.clinical and hematopathology she is an.advocate for research and development.and has special interest in medical.ethics she has established the.institutional review board at john.hopkins.aramco healthcare center laharan.she continues to chair it as well as she.is a member of our.she is to be appointed.assistant professor of pathology at john.hopkins school of.medicine baltimore and has become the.first saudi woman team leader.representing college of american.pathology uh for.accreditation she has more than 80.publication including chapters in.textbooks.she's a reviewer in several medical.journals.and she conducts professional.educational sessions.conferences related to pathology medical.ethics.and institutional review board thank you.so much dr.salwa for being here with us and i leave.it.for you.thank you very much dr amen for the kind.introduction.and i would like to begin and today by.expressing my sincere gratitude.first of all for the audience for their.time and interest to join us.in this webinar and also for the.organizers.to make this great event happen since.this is a series of lectures.i actually would like to and i am the.person who's starting the first lecture.my talk will be mainly focused on real.basic concepts.or fundamentals of research ethics and.regulatory requirements.i will actually start uh my talk by.star uh talking about the historical.background of medical research.and then we'll move on to ethical.conduct and regulatory requirements.with very few words about institutional.or ethical review board for research.now um if.different there are different types of.research we have clinical research which.involves patients.we have basic research which involves.work in cellular molecular and.physiological mechanisms.involving patients and this is really a.rapidly evolving field.and then we have the translational.research that.actually uses application of basic.research into clinical practice.and this is what we refer to as bench to.bedside research.and really if we want to see the true.value of research.it lies in its ability to gather.information and make it useful.and applicable for patients in their.diagnosis and treatment.now evolution of research traverses.through a very long and fascinating.journey.these are random examples we can see the.work.of william harvey on circulatory system.in 1628.development of dna insulin.work on anesthesia lewis postures.germ theory and the famous discovery of.penicillin by alexander fleming in 1928.we also must not forget our own.arab and muslim scientists for example.muhammad ibn zakaria radhi he was the.first physician to detail the symptoms.and signs.of smallpox and measles and he was a.pioneer.in experimental medicine.abulkasim was referred to as the father.of modern surgery.he actually created a dissolvable.sutures made of cat guts.ibn cena or avicina is one of my.favorite scientists.he was the first one to recognize the.contagious nature of tuberculosis.and also that diseases can be.disseminated through water and soil.ibn cena has more than a thousand.publications including many books.and one of his very famous textbook.which is the canon of medicine.or el canon has been used and is still.used in several areas it was one of the.common textbooks that was used in.european universities and the list.continues.and more and more scientists came after.that.if you go back even further the first.study i could find.was actually in year 562 before common.era.by king nebuchadnezzar ii who was a king.of babylon.and he did a clinical trial where he was.comparing two different groups of.individuals.where one group was fed meat and wine.and the other.bread and pulses.so when we talk about research the most.important thing is to have research.integrity for research to do.and perform the research activities and.it is a very delicate.balance between two major goals you want.to have advancement of science and.research by doing research.while maintaining protection of human.subject welfare.ethically really it is a very difficult.task.to maintain this balance by researchers.since i mentioned ethics i would like to.talk.a little bit about the definition of.ethics.although we can find it in any.dictionary if we see.what is ethics it is defined as correct.rules of conduct.but it's always mind-boggling to me what.is really correct rule of conduct.is it the morals is it the principles.is it common sense is it rise versus.wrong.what we as children are being taught by.our parents and society.to um uh follow the right thing and.avoid the wrong.but who actually defines right from.wrong.you know history of medicine if you go.back to it medical research shows that.it has.succeeded in improving the well-being of.patients.in much of the world however these.successes.are not without a cost if you go back to.major innovations.in uh studies many of them have.tragedies behind them and.in some studies these participants or.human subjects who the studies were.performed on.costed their health and sometimes even.their lives.i'm not expecting anyone to read this.this slide.but these are just a few examples of the.studies.thousands and thousands of studies have.been performed but there are some.studies who actually changed.the medical um knowledge changing the.diagnosis and treatment of patients.really great innovations and these are.the same studies.as examples where major violations have.been made.for patients human rights and dignity.and i would like to talk about some of.these examples.for example in 1920 henry cotton who was.a psychiatrist.he believed that insanity was actually a.toxic disorder.he thought that the patients have mental.illness because they had.infected teeth and so he started.removing the teeth of these patients.subsequently some of these patients were.not really improving.so he believed that the infection has.actually spread.so he pursued to remove organs.and body parts from these mentally ill.patients.cotton dr cotton performs.surgeries on more than 650 patients.and the mortality rate was 30 in his.patients.in 1939 a study was performed in iowa.later on.it was named the monster study.this was done by an assistant professor.johnson.who himself used to stutter and he.believed that he was.normal when he was up to the age of five.or six.and he was given negative feedback by.his teachers.subsequent to which he started.stuttering.so he recruited one of his graduate.students and they decided to do a study.on children normal healthy children.where they will.give positive feedback to half of them.and negative feedback to the other half.and see the impact whether normals will.stutter.and stuttering kids will stop and.improve in their.speeches so they recruited 22.orphans and did this study and the.results were actually quite disturbing.because many of the individuals are the.children who are giving negative.feedback.developed psychosocial and mental.illnesses which some.in some cases lasted for a lifetime.later on an apology was released and.more than a million dollar compensation.was given to some of the affected.individuals.another study in new york in willowbrook.school which is a school for children.and adolescent.adolescents who had mental disabilities.and many outbreaks were reported from.the school of hepatitis.later on it was discovered that the.scientists there they were feeding live.virus.to these children and adolescents and.the purpose of this study.was just to actually see the progression.and progression of the disease.and see how they can prevent it.in 1950 a very young enthusiastic.urologist dr kerry hudson in manhattan.decided to study more extensively about.the.prostate cancer who really at that time.was an.incurable disease so he recruited 1200.alcoholic men.who were homeless and they were offered.four to five days of hospital admission.shelter.and good meals three three meals a day.for.an open prostate biopsy at the time of.the biopsy.they will do frozen section and if the.patient has.um cancer they will proceed to develop.to.open radical prostatectomy archaectomy.and give them diazinostibural.the mortality rate for his patients.those who did not have cancer was 20.and for those who had cancer was 30.percent.in 1951 henrietta lack which many of you.probably.would have heard about her she was.admitted to hospital.a mother of five with cervical cancer.and died there.in baltimore part of her tumor was taken.for development of immortal.cell line which is one of the oldest.cell lines.used in scientific research the hela.cell line.great discovery noble were but the.patient was never informed and she never.consented.for this piece of tissue to be removed.from her.and used as a cell line.this is one of the very famous studies.the tuskegee study of untreated.syphilis in african american population.it was a study on males in alabama the.study started in 1932.and these participants were told that.they would be receiving free health care.from the government.midway in 1947 penicillin was discovered.as the treatment curative treatment for.syphilis.however these scientists withheld this.information.and this treatment was never given to.the um.study participants the scientists.continued to follow them.up and watch the progression of disease.and some people even die with the.disease.the last study i want to talk about is.the medical experiments that were.performed in concentration camps in.world war ii.there were extensive studies that were.done and they used medical torture.in many cases leading to disfigurement.permanent disabilities and death of the.participants.they used transplant experiences.experiments.without using any anesthesia a lot of.experiments were done on these prisoners.using poison high altitude to see the.impact of these.agents on pupil people drowning.experiences.drugs infectious agents sterilization.and horrific experiences on twins.there was vast amount of knowledge that.was added to science and medicine.by these by these experiments especially.the last one.a lot of information was gained which.had a lot of positive.impact on medical uh on.medicine treatment and diagnosis.but really the big question is was it.the right thing to do.we are all health care workers we all.have a moral obligation to do the right.thing.as doctors we have even taken the oath.to do no harm.so how come this balance was tipped how.come we.only saw the positive side of the study.and we never saw that the people were.being tortured.and they were dying.so based on this concentration camp.experiences and the atrocities that were.committed.there was a major trial that was uh held.in nuremberg in 1947 and it was called.the.doctor's trial 23.people that were convicted out of them.15 were found guilty.seven were hanged and five were given.life sentences.and this was actually the first time.that they.released a set of formal guidelines for.clinical research.and the main purpose here was to have an.informed consent.no participant should be involved in any.research without.having informed consent in addition.there is always a need for a third party.or an.independent ethical review of research.before it is performed.subsequent to that in 1964 there was.declaration by.a world medical organization of the.ethical.conduct many many updates came.afterwards the main focus is the.informed consent.after the publicity of the tuskegee.trial the national research act was.passed in 1974.not only focusing on informed consent.but.voluntary informed consent the patient.had the.participant has the the right to.voluntarily decide whether he would like.to participate.in the study or not and also there has.to be an institutional review board or.an ethical review board for the.researchers.in 1971 79 the belmont report.came out which is the foundational.document.and it summarizes all the ethical.principles and guidelines for research.involving human subjects the core.principles.are three respect for person is number.one.beneficence and justice.after the publicity of the henrietta.lacks case.the common rule was passed in 1981 which.was subsequently.um recently updated and the list.continues and it.and these regulations will continue to.be updated.based on more and more information that.comes out.but the bottom line is the same in any.country.any code everything whatever you read.all the ethical calls advocate the same.principle number one.priority is the human well-being respect.for person.it's his or her autonomy they have to.voluntarily decide.whether they would like to be.participating in the research or not.and when we talk about human subject.it's not only direct interaction with.the person himself.it's any data relevant to the person and.any identifiable private information.that the research is done uh on.so in saudi arabia in 2001.a royal decree was passed by the.custodian of the two holy mosques.to develop actually and create a.national committee.for such activities it was named at that.time.national committee of bio and medical.ethics which was later renamed.as the national committee of buyer.ethics in 2010..the royal decree has.a certain committee membership which.involves many of the ministries.and major institutions and uh government.and non-government bodies.such as ministry of health ministry of.education national guard.human rights and saudi fda and so on and.so forth.and usually cast oversees and chairs the.national committee.this is actually the website of the.national committee of bioethics.and it has a lot of information for.example there are always.updates on the educational activities.and the symposia that are being.performed.and there is information for researchers.there is also a lot of information about.the ethics.and more and more information for the.local committees or the irbs.it also has a very extensively written.by-laws both in arabic and english which.talks about.all the regulation regulations and the.requirements.for the various types of studies.with the 2030 vision there are even.more enhancements and activities of.these regulatory requirements and more.activities by the ministry of health and.national committee of bioethics.i would like to say a couple of words.about the institutional review board.it is the administrative administrative.body that actually reports to the.highest authority.in any institution it reviews research.involving human subjects.and the main purpose is really not to.review the scientific component.and the type of study and the.statistical analysis that will be done.in the research that is to ensure that.the rights and welfare of these human.participants are adequately protected.it is mainly to maximize safety of human.participants.and they have to follow the guidelines.whether they are national.and or international guidelines and they.need to maintain they must maintain.all ethical codes pertinent to the human.subjects.the membership is very unique it's not.just any comedy.there should be mixed background minimum.of five regular members.the the committee should represent.different genders different ethnic group.different professions and the most.important member.in the in the irb uh committee is the.community member.because he is the person who represents.human subjects or the community.and without him the member the members.in the committee.actually cannot vote on any research uh.project.that is reviewed.so what is supposed to be reviewed by.irb.all new studies all new research.activities.are to come to irb for review.once approved if there is any amendment.or modification.needed it should come to irb for.approval before they are applied to the.research.also if if a research is.approved by the irb there is a.requirement by the investigator the.primary investigator.to have a continuous ongoing process of.review and reporting.to the irb there is a special focus on.a vulnerable population and these are.group of individuals.who whose voluntariness and.ability to make sound decisions.can be compromised either by undue.influence.or by coercion these include children.elderly mentally disabled unconscious.people.poor socioeconomic status who cannot.really who can be influenced by for.example food and shelter.and money uh people who have poor.education.and they have lack of awareness prisons.who are under the influence.and pregnant women with fetuses so there.are special regulatory requirements.when there is any research that involves.this vulnerable group.when the research researchers come to.the irb they are usually stratified.based on the risk.the level of risk and once they are.stratified the level of risk determines.the level of uh thoroughness of the.review.of course every single proposal is.thoroughly reviewed.but for example the researchers with.higher risk actually require full board.review.and voting process for the decisions.again not only the first time approval.but even the amendments when they.involve vulnerable group.there is a special regulatory.requirements to make sure that these.individuals.are safe and their welfare is maintained.once a proposal is approved it must be.done.as it is approved any deviation or.change cannot be applied before it is.submitted again to the irb.and is approved by irb.so everything was going fine in dandy we.have.very oriented knowledgeable healthcare.workers.we are all adults we know what is right.from wrong we're all ethical.and there is a third party review by the.irb so.things should be perfect until between.1999 and 2000.there were two major incidents there was.death of a research participant in a.gene therapy trial.in pennsylvania and then another death.of a normal volunteer in baltimore.this actually prompted a major.investigation.by the office of human subject research.protection and more than.10 centers they actually stopped.research activities from universities.based on misconduct that was discovered.and some of the examples are here.there was still information in treatment.being withheld.by researchers from the participants.there were obvious conflicts of interest.by researchers.as for irbs there were insufficient.reviews.and the main purpose i i strongly.believe that people they are not.having evil intentions or at least most.of them.and most of these mistakes were actually.made because there was lack of knowledge.of.about the regulatory requirements and so.after this investigation there were.certain modifications that were made.one of the main requirement now is all.researchers.and also the irb members they have to.have human subject research protection.certification.whether they attend an online class or.online module or a live class there has.to be certification before they start a.research activity a national committee.of bioethics has.its own module for researchers and irb.members and the other thing that was.modified was.the audits that are performed by a.national committee of bioethics and.governing bodies for the irbs and.institutions.now as for ncbe it usually audits the.institutions.at least once a year to ensure.compliance with the.relevant regulations at the time of the.audit.they require access to all the records.in documents.they have the authority to cancel.suspend and actually.even terminate any study any ongoing.study.they also review any complaints or.grievances against irb decisions.and if any violation is discovered by.the.local committee irb or a researcher.they the national committee can actually.take it to the violation committee.and if the violation is confirmed there.are a set of penalties.starting from warning suspension of.research.financial uh fine even imprisonment.and not only these penalties are.given to the researchers and the.institution but there is also.publication of these decisions.in three local journals.so there is a very strong link between.the primary investigator.the irb and the national committee of.bioethics or any governing body in any.country.the primary investigator to start with.is supposed to perform the study exactly.how he presented it and how it is.approved by the irb.periodically he is to submit reports.to the irb.the irb submits periodic reports to the.national committee of bioethics at least.annually about.all their research activities.the national committee of bioethics.performs audits.and actually may ask the irb if they.have.any other queries they also have the.right.if needed to contact directly the.investigator.and even the participants of any.research if needed.so since i am the chair of irb i would.like.to say just a couple of words about the.irb office.you know there is an era before the irb.before i establish the irb.and then there is an era which is after.irb 2013.after i established irb once you are.involved in irb office.you have to know you will never win any.popularity context.your friends turn strangers not really.enemies because.they think that you are an obstacle now.they're making life difficult for them.you are preventing them to achieve their.dreams of doing research.but we have to know that we are in the.irb.office is a huge responsibility and you.must do.the right thing as it is following the.regulations and requirements.just looking at the applications is a.huge challenge.to start with you may get proposals that.are poorly written.incomplete information lack of.certification.irb review process of research is a very.thorough and meticulous job if you're.doing it the right way.the compliance you need to maintain.compliance.of all the regulatory requirements there.are many reports that are generated by.irb.office for the institution and for ncbe.there are still major challenges to.actually find.qualified knowledgeable irb.administrators and members.and not only knowledgeable but those.members.who are continuously updating their.knowledge about regulatory requirements.because it keeps changing.so in the last couple of slides i want.to highlight.a major controversy that is ongoing in.literature.since establishment of the belmont.report mainly the three core.ethical principles there has been.profound growth in medical.research and these continuing changes.a raising question as to the proper.application of these.core principles on up-to-date advanced.research activities that we have these.days.especially when it comes to clinical.trials because in these trials we're.comparing effectiveness of interventions.and the major argument by this group is.that not.all immoral or illegal acts must be.tolerated.but the research should have some leeway.to tolerate.some activities where they think and.they judge this to be necessary.to do their work.so basically not only this group is.questioning the legitimacy of these.established.regulations but also the capability of.irb.or ethical committee whether they are.able to.um to make sound judgment and review.these up-to-date proposals it is argued.by them that increased regulations will.not raise the ethical standards of.science.but will probably worsen the quality of.what the study produce.so the million dollar question is do we.need irb or ethical review.and if you forget everything that i have.said today.this is the one fact that you have to.remember the answer to this question.is what you need to keep in your mind.the answer is yes.you have and you must need an irb.ethical review.for all research activities and why it's.not because.the people's integrity is questioned no.it's because.no one can be objective about his or her.own work.people they underestimate the risks that.are involved in things that they are.very familiar.with and they overestimate the benefits.when they are.when the work is very special to them is.close to their heart.so you definitely need a third party um.an outsider to review the research.proposal before.it is conducted for the ethical.component.and the well-being of these participants.so to conclude i can only say that.science really does not have a moral.dimension.it is like a knife how you use it if you.give it to a surgeon.or a murderer each will use it.differently ethics is knowing the.difference between what you have the.right to do.and what is right to do having said that.there must.be an ethical national or international.framework.of all these regulatory requirements of.course in our part of the world.employing islamic.islamic sharia law to oversee these.research activities and maintain the.dignity.and rights of these human participants.and i guess with this i.came to the end of my talk i would be.happy to take any comments or questions.that you might have and thank you all.for your patience.thank you.thank you so much dr selwa i think that.you have really summarized.the history the fundamentals of.institution review board in.such an elegant way and in such a.concise time which is great.uh in the chat here i don't see.any questions i think that you have.really.done it so well that people really don't.have.i'm just saying i'm just saying praise.to your talk this is what i'm seeing in.the chat.thank you.i'm happy to take any comments also.positive or negative regarding the.controversy.ethical background anything that you.would like or the audience would like to.discuss.will i see none at this time and i think.uh in this case although we are ahead of.time but i think that we.are safe to say that we conclude for.tonight.and we hope to see the audience in.the next webinar which is going to be.held on monday.and it's going to be at the different.time it will be morning 11 30.p.m where we are going to talk about.covet 19 research ethics.thank you so much for joining us for.today and see you again.thank you.

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Make it fast. Ask them as few questions as possible (don't collect unnecessary information) and pre-populate as many fields as possible. Don't ask offputting questions where the respondent might have to enter sensitive personal information. If some users see you collecting sensitive information, they might not be ready to share that with you yet based on what you are offering, and they will think twice about completing the form.

Which one is correct, "fill in a form" or "fill out a form"?

In terms of outcome, they mean the same thing. Usage, at least in my Canadian neighbourhood, varies depending on how specific the circumstance is. [Clerk hands you a blank form.] Here, fill in this form. Here, fill this out.

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