Tips in Human Subject Protection

1. Tips in Human Subject Protection ศ.พญ. พรรณแข มไหสวริยะ ผู้อำนวยการศูนย์ส่งเสริมจริยธรรมการวิจัยในคน มหาวิทยาลัยมหิดล Center of Ethical Reinforcement for Human Research MU CERif

2. ประเด็นที่ควรทราบ • Recruitment process • Informed consent process • Consent for screening • Observational Study • Incomplete disclosure of information • Waiver of informed consent

3. Recruitment process • One of the most important, difficult and time consuming process • As the beginning of the informed consent and subject selection process • The investigator should determine feasibility of recruiting subject before accepting a study • Unacceptable to use confidential/private data to which the investigator would not ordinarily accessto approach potential subjects

4. Variety of recruitment methods and material to be used • Formal referral or informal word-of-mouth • Community meeting places ( barber shop, recreation spots, etc.) • Direct advertising • Posters • Flyers, mass mailing • Newsletter, newspaper • Press release: TV, radio spots • Websites & electronics mailers • Health workshops, health fairs, screening

5. Advertising materials • No misleading text • No claims of safety, efficacy, equivalence or superiority • No overemphasis of payment • No overstatement of benefits Should generally limited to • Study title, name and address of the investigator and/ or research site • The purpose of study or condition under study • A brief description of eligibility requirements • Time commitment required of participation • Whom to contact for more information

6. Recruitment objectives • To enroll interested, eligible and informed subject in the manner that respects their privacy and autonomy • Free of advertising strategy or incentive arrangement that unduly influence subjects’ decision • Utilize several recruitment tactics concurrently • Prepare to measure success rate of each methods • Prepare to change the recruitment campaign mid-stream if some or all of the components are not successful

8. Consent ways • Imply consent by voluntary actions, • Express consent orally, investigators are responsible for providing documentation or proof of consent • Sign a consent form by subject, or, in the case of incompetence, a legal guardian or other duly authorized representative should do so CIOMS Guidelines 2002

9. waiver of the requirement of a signed consent form if the research carries • no more than minimal risk (risk that is no more likely and not greater than that attached to routine medical or psychological examination) • the procedures to be used are only those for which signed consent forms are not customarily required outside the research context. • a signed consent form would be an unjustified threat to the subject's confidentiality

10. waiver of the requirement of a signed consent form • when the information is complicated, it is advisable to give subjects information sheets • subjects information sheets may resemble consent forms in all respects except subjects' signature

11. Waiver of the consent requirement • Received explicit approval to do so from an ethical review committee • The research design involves no more than minimal risk • a requirement of individual informed consent would make the conduct of the research impracticable (for example, where the research involves only excerpting data from subjects' records)

12. Renewing consent • Changes in material or the procedures of a study • Periodically in long-term studies • New information, either from the study or from other sources, about the risks or benefits of products being tested or about alternatives to them

13. Cultural considerations • approach prospective subjects for their individual consent only after obtaining permission from a community leader, a council of elders, or another designated authority • the permission of a community leader or other authority may not substitute for individual informed consent

14. Cultural considerations • Sponsors and investigatorsshould develop culturally appropriate ways to communicate information that is necessary for adherence to the standard required in the informed consent process • For collaborative research, resources should be provided to ensure that informed consent can indeed be obtained legitimately within different linguistic and cultural settings

16. Use of medical records and biological specimens taken in clinical care • May be used for research without the consent of the patients/subjects only if an ethical review committee has determined that • the research poses minimal risk • the rights or interests of the patients will not be violated • theirprivacy and confidentiality or anonymity are assured • the research is designed to answer an important question andwould be impracticable if the requirement for informed consent were to be imposed

17. Use of medical records and biological specimens taken clinical care • Refusal or reluctance of individuals to agree to participate would not be evidence of impracticability sufficient to warrant waiving informed consent • Records and specimens of individuals who have specifically rejected such uses in the past may be used only in the case of public health emergencies.

18. Consent to use for research purposes biological materials (including geneticmaterial) from subjects in clinical trials • a separate section for clinical-trial subjects who are requested to provide the use of their biological specimens for research • Separate consent may be appropriate in some cases

19. Secondary use of research records or biological specimens • to use records or biological specimens that another investigator has used or collected, in another institution in the same or another country - secondary uses are generally constrained by the conditions specified in the original consent • should discuss withprospective subjects in the original informed consent process • i) whether there will or could be any secondary use and whether such secondary use will be limited to the type of study that may be performed on such materials

20. Secondary use of research records or biological specimens • ii) the conditions under which investigatorswill be required to contact the research subjects for additional authorization for secondary use • iii) the investigators'plans to destroy or to strip of personal identifiers the records or specimens • iv) the rights of subjects to request destruction or anonymization of biological specimens or of records or parts of records that they might consider particularly sensitive, such as photographs, videotapes or audiotapes.

22. Withholding information • Investigators may withhold certain information in the consent process to ensure the validity of research (since if they knew, they might modify their behaviour and hence invalidate results) • In biomedical research, this withholding information is typically about the tests performed to monitor their compliance with the protocol • Must receive the explicit approval of the ethical review committee

23. Withholding information • The prospective subjects are asked to consent to remain uninformed of the purpose of some procedures until the research is completed; after the conclusion of the study they are given the omitted information • In other cases, because a request for permission to withhold some information would jeopardize the validity of the research, subjects are nottold that some information has been withheld until the research has been completed

24. deception • Deception is not permissible if the deception itself would disguise the possibility of the subject being exposed to more than minimal risk • Social and behavioural scientists sometimes deliberately misinform subjects to study their attitudes and behaviour. For example, researchers have pretended to be patients to study the behaviour of health-care professionals and patients in their natural settings • Deceiving persons other than the subjects by either withholding or disguising elements of information, for example, studies of the abuse of spouses or children

25. deception • The investigators must demonstrate to an ethical review committee that • no other research method would suffice • significant advances could result from the research • nothing has been withheld that, if divulged, would cause a reasonable person to refuse to participate

26. deception • The ethical review committee should determine • the consequences for the subject of being deceived • whether and how deceived subjects should be informed of the deception (called "debriefing", ordinarily entails explaining the reasons for the deception) upon completion of the research • justification to deceive persons other than the subjects

27. deception • A subject who disapproves of having been deceived should be offered an opportunity to refuse to allow the investigator to use information thus obtained • Subjects may resent not having been informed when they learn that they have participated in a study under false pretences • Subjects are entitled to prompt and honest answers to their questions