Ethics In Research

2nd

DEFINITION OF TERMS Research – a systematic investigation of a phenomenon or activity Human research – any investigation or study involving humans as participants • • • • •

DEVELOPMENT OF RESEARCH ETHICS Nazi war crimes – Nuremberg Code Tuskegee Syphilis Study – Belmont Report (1989) Common Rule (1999) Helsinki Report Council for International Organization of Medical Sciences (CIOMS) Good Clinical Practice Guidelines ETHICAL PRINCIPLES INVOLVED IN HUMAN RESEARCH • Autonomy • Beneficence • Non-maleficence • Justice

NINE NORMS FOR ETHICAL RESEARCH Norm 1. The knowledge sought through research must be important and obtainable by no other means and the research is carried out by qualified people. Norm 2. Appropriate experimentation on animals and cadavers must precede human experimentation. Norm 3. The risk of suffering or injury must be proportionate to the good to be gained. Norm 4. Subjects should be selected so that risks and benefits will not fall unequally on one group in society. Norm 5. To protect personal integrity, free and informed consent must be obtained. Norm 6. At any time during the course of research, the subject (or the guardian who has given proxy consent) must be free to terminate the subject’s participation in the experiment. Norm 7. In psychological experimentations, which shade imperceptibly into social research, the researcher should work with rather than on the human subject. Norm 8. The researcher must avoid breaking down human trust by lying or manipulation, although subjects can give free and informed consent to experiments in which they must learn to interpret

ambiguous situations.

Medical Ethics III Ethics in Research Dra. Maria Ana Mariano shar, maqui,viki Shifting/August 22, 2008

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Norm 9. Researchers must not take serious risks of reducing the subjects’ ability to perceive reality as it is or to make free choices except as a temporary experience through which the subjects can learn to cope with distortions of truth and attacks on their freedom. FEATURES OF AN ETHICALLY SOUND STUDY Potential participants will be able to: • Give a valid and informed consent • Suffer minimal risks INFORMED CONSENT Definition

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A process by which a participant voluntarily confirms his willingness to participate in a particular study after having been informed of all aspects of the study that are relevant to the participant’s decision to participate.

Purpose • To protect research participants • To protect the researcher, institution or sponsor • To protect the quality of research Process 1. Initial contact with a prospective participant to inform him of the following: a. Why he is being recruited b. What the study is all about c. How the study will proceed o (when it will end or start) d. Who is recruiting him 2. During the study when: a. Changes are made in test procedures, dosages b. Investigators are replaced, changed or added c. Duration of the study is extended d. Study site is changed e. Unexpected adverse effects are noted f. A sub-study ensues from the approved study Elements 1. Full disclosure 2. Adequate comprehension 3. Voluntary choice • •

FULL DISCLOSURE Minimum information to disclose about the study May be written separately but it is a part of the Informed Consent (IC) document 1. Identity of principal investigator/s (Name, Position, Institutional affiliation) 2. Complete title of the study

MARY YVETTE ALLAIN TINA RALPH SHERYL BART HEINRICH PIPOY KC JAM CECILLE DENESSE VINCE HOOPS CES XTIAN LAINEY RIZ KIX EZRA GOLDIE BUFF MONA AM MAAN ADI KC PENG KARLA ALPHE AARON KYTH ANNE EISA KRING CANDY ISAY MARCO JOSHUA FARS RAIN JASSIE MIKA SHAR ERIKA MACKY VIKI JOAN PREI KATE BAM AMS HANNAH MEMAY PAU RACHE ESTHER JOEL GLENN TONI

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Objectives of the study Site of the study Start and duration of the study Targeted number of participants Study design (random or not) Inclusion/exclusion criteria Medicines and procedures to be used including their purpose, frequency, nature and duration. 10. Placebo if it will be used must include an explanation about it

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11. Alternative treatments/procedures available 12. Physical risks, adverse events, discomforts due to the procedures/drugs 13. Expected benefits, if any 14. Circumstances for discontinuation of the study Should be part of the Informed Consent document itself 1. That this is a research study 2. That the procedure/drug being tested is not yet used as a standard of care (if applicable) 3. That the participation is voluntary 4. That there will be confidentiality of data/records 5. That compensation for joining the study will be (or will not be) available 6. That injuries related to or sustained during the study will be treated without expense to the participants (and shouldered by PI/sponsor) 7. That participant can withdraw from study anytime without prejudice to receiving further treatment 8. That the participants’ responsibility includes disclosure of past medical history, follow-up visits, disclosure of non-compliance, etc.; injuries sustained while under the study OPTIONAL DISCLOSURE Statements to be included only when applicable and/or relevant 1. The participant will be provided with information regarding further (other) use of data or specimen gathered from him 2. The participant can access his data/records anytime during the study or provided with information on who else could access them 3. That the results of the study will be made known to the participant before publication 4. That the participant’s consent will be secured in case of a subsequent study using his data and records 5. That the participant will declare any conflict of interest 6. That the institution/investigator will receive incentives or reimbursements for conducting this study DESIGN OF DISCLOSURE Oral and written disclosure should contain the same essential information. At the very least, the 2 should not be contradictory Modifications in procedures should be documented after discussing them with the patient/participant and before signing the IC

ADEQUATE COMPREHENSION Elements: • Sound mind • Adequate education • Old enough to understand • Commonly used language • Enough time • Encouraged to ask questions (which should be answered promptly, honestly, completely) • Graphics, visual aids, etc. • With reliable companion/house member who can review disclosed information • Copy of the Informed Consent where all disclosed information is written and where necessary corrections agreed to, have been made

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VOLUNTARY CHOICE Disclosure and comprehension have been addressed Participant is able to exercise free power of choice without the intervention of any element of force, fraud, deceit or other ulterior form of constraint Any offer one cannot refuse is essentially coercive or “undue” Cultural and gender factors Vulnerability of person is not exploited o “Utang na loob” o Wives subservient to husband’s wish o Children cannot say “no” to parents Manipulation o Incentives ie free treatment, medicines o Privileges ie free consultations Coercion o Force o Intimidation o Fear WHAT SHOULD NOT BE IN THE INFORMED CONSENT? Irrelevant information Information overload Exculpatory language o Subjects may not be asked to waive (or appear to waive) any of their legal rights, nor may they be asked to release the investigator, sponsor or institution (or its agents) from liability for negligence. ASSENT FORM In research involving children, the consent of parents or immediate guardian/legally responsible person will have to be obtained The child who has reached the age of reason (7 yrs old) must also be explained to and asked to sign the consent The child’s negative attitude or expression of distress to any procedure must be respected as a sign of dissent INFORMED CONSENT WAIVER

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Participants in a life-threatening situation and the available treatments are unproven or unsatisfactory, thus a controlled investigation is necessary The research offers the possibility of direct therapeutic benefit (it is not a trial drug) to the subjects and is given the course of managing the patient. Obtaining consent is not feasible (studies on mentally ill patients) Non-exempt human subjects research in which it is not possible to get participants’ written informed consent (ex. Research on emergency medicine) The investigation could not be practically carried out without the waiver In phone surveys and questionnaires, the survey does not pose more than minimal risk Studies involving the dead or quality assurance tests Human subjects that may be exempted based on existing laws (surveys, observational studies) However, to the extent possible and for the integrity of research, a similar document must be accomplished for these “exceptions” o The underlying principle which must not be sacrificed at any time: RESPECT FOR PERSONS

DECEPTION IN INFORMED CONSENT Studies in the behavioral and social sciences, subjects may need to be intentionally misled Intentionally misleading the subject must not be mistaken for withholding essential information (general vs. specific purposes; ex. double blind studies) Deception must not be used where: o Other methodology will achieve the same purpose o There is a reasonably anticipated risk to the subjects o It would interfere with the subject’s understanding of facts which might influence a decision to give consent If ever used, the need for deception should be included in the research protocol application. Participants, however, should never be deceived about the identities, qualifications, affiliations of the researcher/s Alternatives o Use of “consent to research procedures” to enroll subjects o Debriefing that divulges the true nature of the study and offers subjects the opportunity to decline/continue participation o Use of “consent to the use of research data” after participation INFORMED CONSENT FOR THE REVIEW OF CHARTS/RECORDS IC is not needed when: o Records of dead persons (unless for genetics studies) are used o Sensitive information is not in these records

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Study could not be practically carried out if consent were required is not needed when: Notification of incoming patients that their records may be reviewed for research purposes Provision for an opportunity to consent or refuse to consent to such use is given Confidentiality of information from the records must still be observed

INFORMED CONSENT FORM Signed form is only a symbol of consent Worthless sheet of paper if there are no elements of an informed consent Purpose of the document o To document that the process took place o To protect the researchers from any liability o To educate prospective participants about a medical intervention or research protocol Who obtains the consent? o Investigator o Team coordinators/members o Persons qualified, sufficiently trained, knowledgeable about the study o Persons w/out existing relationship with the potential participant Use a specific IC form for: o Genetic research o Biodiversity studies o Studies involving vulnerable subjects o Community based research o Studies using children as participants At the end of the IC form present the ff: o Name and contact nos. of persons to contact in case of:  Doubt, Need for clarification, Additional questions, Complaints regarding the conduct of the study o Name and signature of at least 2 witnesses o Name and signature (fingerprint) of the participant o Name and signature of the person taking the IC o Date and place when signed by the above must be the same date and place STORAGE AND RETENTION o Observe confidentiality o Protect subject’s privacy o Retain a copy to help participants retain the information disclosed to them or o Help them formulate further questions   

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RESPONSIBILITIES OF ETHICS REVIEW COMMITTEES Review the submitted protocol for: o Minimal risks to participants o Risk/benefit assessment o Equitable selection of participants o Safeguards to protect vulnerable populations o Provisions to protect privacy and confidentiality

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Provisions for monitoring the data collected to ensure safety of participants o Completeness of informed consent o Adequate information in the IC form Examine the qualifications of the investigators Examine the study sites to include facilities and infrastructure Review any conflicts of interest between the PI, sponsors or institution Review study participants Examine the community involvement and impact Makes a decision based on a consensus whether to: o Approve as presented o Approve with modifications to consent o Require modifications to items noted o Review modifications to items and full committee review of materials o Request for further information regarding the item and full committee re-review o Disapprove o

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Classmates…yung mga susunod, kasama sa powerpoint ni dra pero di ko alam kung kailangan natin o hindi. But just in case...nilagay ko na…^_^ --shar

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CASE STUDY 1 In a community of indigenous populations a company wishes to study the effects of a new drug X, as a form of treatment to condition C. It is not a standard treatment so that there are difficulties in getting the approval from the IRB. Questions: o List down possible reasons for the delay in the approval of the research o What measures should be added to improve the research protocol? o What rights do these group possess which is peculiar from an ordinary urban community? CASE STUDY 2 Among breast cancer patients there are those who experience nausea and vomiting and headache after taking drug X. The research protocol did not pass the IRB’s approval because its sponsors are local politicians who have invested interests in the pharmaceutical company. After a month, there were more adverse events experienced among the study participants that reports have reached the DOH about this anomalous process. Questions: o What are violations of research ethics? o Discuss each violation and corresponding measures that could have been made at the start of the research study. o Should the DOH be the agency to address this problem? Why or why not? CASE STUDY 3 The informed consent form is read as follows: See attached document. Questions:

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What are the provisions lacking in the IC form? Who is responsible for making sure this IC form is prepared adequately? How can these provisions be improved? Does the subject participant have a choice not to join in this study after reading this protocol? Why or why not?

Eto end na talaga…^_^

Funniest Simpson Quotes 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12. 13. 14. 15. 16. 17. 18. 19.

Operator! Give me the number for 911! Oh, so they have internet on computers now! Bart, with $10,000, we'd be millionaires! We could buy all kinds of useful things like...love! Just because I don't care doesn't mean I don't understand. I'm normally not a praying man, but if you're up there, please save me, Superman. Son, if you really want something in this life, you have to work for it. Now quiet! They're about to announce the lottery numbers Well, it's 1 a.m. Better go home and spend some quality time with the kids. Maybe, just once, someone will call me 'Sir' without adding, 'You're making a scene.' Marge, don't discourage the boy! Weaseling out of things is important to learn. It's what separates us from the animals! Except the weasel. Doughnuts. Is there anything they can't do? You know, boys, a nuclear reactor is a lot like a woman. You just have to read the manual and press the right buttons. Lisa, if you don't like your job you don't strike. You just go in every day and do it really half-assed. That's the American way. When will I learn? The answer to life's problems aren't at the bottom of a bottle, they're on TV! Son, when you participate in sporting events, it's not whether you win or lose: it's how drunk you get. I'm going to the back seat of my car, with the woman I love, and I won't be back for ten minutes! [Meeting Aliens] Please don't eat me! I have a wife and kids. Eat them! What do we need a psychiatrist for? We know our kid is nuts. Marge, you're as beautiful as Princess Leia and as smart as Yoda. Kids, you tried your best and you failed miserably. The lesson is, never try.

20. The only monster here is the gambling monster that has enslaved your mother! I call him Gamblor, and it's time to snatch your mother from his neon claws! 21. When I look at the smiles on all the children's faces, I just know they're about to jab me with something. 22. I'm having the best day of my life, and I owe it all to not going to Church! 23. Lisa, if the Bible has taught us nothing else, and it hasn't, it's that girls should stick to girls sports, such as hot oil wrestling and foxy boxing and such and such. 24. I'm not a bad guy! I work hard, and I love my kids. So why should I spend half my Sunday hearing about how I'm going to Hell? 25. Getting out of jury duty is easy. The trick is to say you're prejudiced against all races. 26. It's not easy to juggle a pregnant wife and a troubled child, but somehow I managed to fit in eight hours of TV a day.

Medical Ethics III Ethics in Research Page 5 of 5 27. Lisa, Vampires are make-believe, like elves, gremlins, and eskimos. 28. I want to share something with you: The three little sentences that will get you through life. Number 1: Cover for me. Number 2: Oh, good idea, Boss! Number 3: It was like that when I got here. 29. Oh, people can come up with statistics to prove anything, Kent. 14% of people know that. 30. Remember that postcard Grandpa sent us from Florida of that Alligator biting that woman's bottom? That's right, we all thought it was hilarious. But, it turns out we were wrong. That alligator was sexually harrassing that woman. 31. Old people don't need companionship. They need to be isolated and studied so it can be determined what nutrients they have that might be extracted for our personal use. 32. How is education supposed to make me feel smarter? Besides, every time I learn something new, it pushes some old stuff out of my brain. Remember when I took that home winemaking course, and I forgot how to drive? 33. Television! Teacher, mother, secret lover. 34. Homer no function beer well without. 35. I've always wondered if there was a god. And now I know there is -- and it's me. 36. Kill my boss? Do I dare live out the American dream? 37. If something goes wrong at the plant, blame the guy who can't speak English. 38. I'm never going to be disabled. I'm sick of being so healthy. 39. I like my beer cold, my TV loud and my homosexuals flaming. 40. [Looking at a globe map...country being Uruguay] Hee hee! Look at this country! 'You-are-gay. ' 41. All my life I've had one dream, to achieve my many goals. 42. Dad, you've done a lot of great things, but you're a very old man, and old people are useless. 43. But Marge, what if we chose the wrong religion? Each week we just make God madder and madder. 44. I think Smithers picked me because of my motivational skills. Everyone says they have to work a lot harder when I'm around. 45. Dear Lord.. The gods have been good to me. For the first time in my life, everything is absolutely perfect just the way it is. So here's the deal: You freeze everything the way it is, and I won't ask for anything more. If that is OK, please give me absolutely no sign. OK, deal. 46. That's it! You people have stood in my way long enough. I'm going to clown college! 47. Beer: The cause of, and solution to, all of life's problems. 48. If something's hard to do, then it's not worth doing 49. I'm in no condition to drive...wait! I shouldn't listen to myself, I'm drunk 50. 'To Start Press Any Key'. Where's the ANY key?