Informed Consent PDF

INFORMED CONSENT Eden Shiz A.Parpa, RN,MAN Faculty of CSAB-CHAP INFORMED CONSENT Let us consider three significant elements in understanding Informed Consent Procedure Ethical Requirement Process Teaching Tool INFORMED CONSENT Ethical requirement “For all research involving h...

INFORMED CONSENT Eden Shiz A.Parpa, RN,MAN Faculty of CSAB-CHAP INFORMED CONSENT Let us consider three significant elements in understanding Informed Consent Procedure Ethical Requirement Process Teaching Tool INFORMED CONSENT Ethical requirement “For all research involving humans, the investigator must obtain the voluntary informed consent of the prospective research participant. In the case of an individual who is incapable of giving or who has diminished capacity to give informed consent, the permission of a legally authorized representative in accordance with applicable laws must be obtained.” NEGHHR INFORMED CONSENT Process A process by which a subject voluntarily confirms his or her willingness to participate in a particular trial, after having been informed of all aspects of the trial that are relevant to the subject’s decision to participate. It is documented by means of a written signed and dated informed consent form. INFORMED CONSENT Process Ongoing interaction between the subject and research personnel. Begins with the first contact and exchange of informationContinues beyond study termination Each contact is an opportunity to reiterate information and ensure that participation continues to be fully informed and voluntary INFORMED CONSENT Teaching Tool Describes: requirements of the protocol responsibilities of the subject risks/benefits of participation Documentation of consent is only the first step; voluntary and informed consent, prior to any study procedures INFORMED CONSENT DISCLOSURE COMPETENCE ELEMENTS COMPREHENSION VOLUNTARINESS INFORMED CONSENT When is the process conducted? Before Screening Prior to any Trial or Study related Activity During Amendment INFORMED CONSENT Who signs the ICF? What Happens during the Signing? Investigator Participant LAR Impartial Witness INFORMED CONSENT NEGHHR 2017: ICF Guidelines for Specific Methods  Clinical Research  Health-related Social  Herbal Research Research  Complementary/  Mental Health Research Alternative Medicine  Emerging Technologies  Assisted Reproductive  Genetic & Genomic Health Research  Research on Cosmetics  Stem Cell Research  Environmental Health  Research Using Human Research Samples and Data from  Epidemiologic Research Biobanks, Registries and  Research Using Online & Databases Digital Tools INFORMED CONSENT What are included in the CONSENT? Project details Research information Terms of participation Risks & Benefits Privacy, Confidentiality, Future Use Financial Issues Researcher Information and COI Informed Consent for Clinical Trials (ICH-GCP E6 Section 4.8.10) Informed Consent (general) (CIOMS 2016, Annex 2) INFORMED CONSENT q Introduction q Purpose q Type of Research q Participant Selection q Voluntary Selection q Procedures q Duration q Risks q Benefit q Reimbursement q Confidentiality q Sharing of Results q Right to Refuse or Widraw q Who to Contact INFORMED CONSENT In withholding Information , let us remember the following: Essential to obtain vital information You should be aware that to complete this study, the No substantial risks investigator cannot inform you Participant informed of all its details. For this reason, deception is part of the certain details have been left approved design of study out of the description of the Participants consented study. However, the despite the deception investigator will be happy to Full disclosure will harm explain these details to you at the end of the study. You are participants free to choose not to participate There is provision for and your refusal will not be held debriefing against you.” (Wendler, 1996) INFORMED CONSENT In utilizing a WAIVER: TOTAL WAIVER WAIVER OF SIGNATURE If impracticable & low ONLY risk, waiver of consent for review of medical If the information is records can be obtained by means of a approved if anonymity questionnaire, and can be maintained and adequate information if information sought is has been given to the considered non- research participant sensitive INFORMED CONSENT ASSENT AND RE CONSENT As adolescents near the age of majority, their agreement to participate in research may be ethically (though not legally) equivalent to consent. In this situation, parental consent is ethically best considered as “co-consent” but legally, the adolescent’s agreement remains assent. If child or adolescent participants reach the legal age of majority according to applicable law and become capable of independent informed consent during the research, their written informed consent to continued participation must be sought and their decision respected CONSENT VS ASSENT Consent is a process by which a participant or legal guardian voluntarily confirms his or her willingness to participate in a particular research project, after having been informed of all aspects of the research that are relevant to the subject's decision to participate. Consent may be given only by someone who is legally able to provide consent. When the participant is a child under the age of 18, the parent or legal guardian provides parental permission, which is the consent for that participant. Assent is an agreement by an individual not competent to give legally- valid informed consent (e.g., a child aged 7-17 or cognitively-impaired person) to participate in research. INFORMED CONSENT WAIVER OF PARENTAL PERMISSION  RECs “may waive parental permission…but special protections must be devised to ensure…best interests  children or adolescents are being served or such as permission of a parent is not feasible or is undesirable…; studies…(on) investigation of adolescents’ beliefs a n d b e h a v i o r r e g a r d i n g s e x u a l i t y or u s e o f recreational drugs;... domestic violence, sexually transmitted diseases, pregnancy, abortion, or child abuse.”  Premise: Parental knowledge of the topic of the research may place the children or adolescents at risk of questioning, intimidation, or even physical harm by their parents. INFORMED CONSENT EXECUTION OF A LAR A parent or legally appointed guardian who gives permission for a child or adolescent to participate in research must generally be given the opportunity, to a reasonable extent and without violating the privacy of other study participants, to observe the child’s participation as the study proceeds INFORMED CONSENT -SPECIAL POPULATION PARTICIPATION OF THE ELDERLY  Young old (60-69), middle old (70-79), oldest old (80 & older)  Cognitive, psychiatric, and functional issues affecting consent  Multiple consent (LAR, caregiver, assent), in case significant information is required from 3rd parties  Do not dismiss attempts of the elderly to comply with IC  Can use thumb mark if there are motor skills issue NATIONAL ETHICAL GUIDELINES ON HEALTH & HEALTH RELATED RESEARCH 2017 INFORMED CONSENT -SPECIAL POPULATION ICU PATIENTS/ EMERGENCY ROOM PATIENTS  Critically ill patients are vulnerable  Informed consent still applies  Sometimes the patient is unable to personally give consent, thus, consent from legally authorized representative (LAR) may be required  Once patient improves, re-consent from the patient needs to be done NATIONAL ETHICAL GUIDELINES ON HEALTH & HEALTH RELATED RESEARCH 2017 INFORMED CONSENT -SPECIAL POPLATION EMERGENCY AND DISASTERS  General guidelines apply  Prior community permission  Prior determination of barriers needed  Research vis a vis community priorities  Collection of personal traumatic experiences needs justification  Caution against group data collection methods (e.g. FGD) INDIGENOUS PEOPLE  General guidelines for individual consent apply, additional considerations for community permission  Need for iterative process; requires preliminary community consultation to NATIONAL ETHICAL design IC process and ICF; NCIP GUIDELINES ON HEALTH &  IC includes information re protection of HEALTH RELATED RESEARCH 2017 biodiversity, ecology of IP land, transportation of indigenous materials/knowledge INFORMED CONSENT PARTICIPATION OF PEOPLE WITH DISABILITIES Respecting autonomy of PWDs who participate in a research to have the right to make their own decisions regarding participation in the research process Address impairment: Use of large print materials or audio tape for people with vision impairments; facilitation of interviews through lip- reading, written materials, or sign language interpretation for people who have hearing impairments; use of physically accessible venues during interviews or focus group discussions (FGDs The researcher shall consult with PWDs or their representative groups regarding the research topic, research questions, and research design Researchers and the research staff shall have disability awareness training (or equivalent qualifications) NATIONAL ETHICAL GUIDELINES ON HEALTH & HEALTH RELATED RESEARCH 2017 INFORMED CONSENT Research Involving Children and Adolescent Justification for involvement of children Order of involvement Assent and reConsent Managing deliberate objection of children LAR and waiver of parental consent Entitlements of the LAR INFORMED CONSENT DIGITAL CONSENTING  Use of tablets or computers as the medium for information and seeking consent  Same regulations apply to electronic consent forms & paper-based consent  Signature must be trustworthy, reliable, and equivalent to handwritten signature and capture the date  Can supplement or replace paper- based  REC is the ultimate approving body NATIONAL ETHICAL GUIDELINES ON HEALTH & HEALTH RELATED RESEARCH 2017 RISKS ASSESSMENT Risks/Benefit Ratio Assessment Risk to participants must be reasonable in relation to anticipated benefits, if any, and the importance of the knowledge that may reasonably be expected to result. The benefits of a study do not alter the risk classification. The risk/benefit assessment only refers to the acceptability of the risk, not the level of the risk. A study deemed greater than minimal risk cannot be classified as minimal risk just because the potential benefits are great, but the research could be approved for this reason. However, the same study may not be approvable if the risks are greater than minimal, but anticipated benefits are minimal or lacking. In evaluating risks and benefits, the IRB will consider only those risks and benefits that are directly related to participation in the research, as distinguished from risks and benefits of procedures/interventions individuals would receive even if not participating in the research. IRB reviewers identify any anticipated risks involved with the study and classify those risks as minimal or as greater than minimal risk. RISKS ASSESSMENT Types of Risk to Research Subjects Physical Harms: This would consist of pain, discomfort or injury from a procedure or side effect from a drug. The physical harm could be permanent but most are transient in nature, e.g. nausea, dizziness, headaches, muscle soreness, numbness, tingling. Psychological Harms: Research may result in undesired changes in thought processes and emotion (e.g. episodes of depression, confusion, feelings of stress, guilt, loss of self-esteem, embarrassment, distress). The possibility of psychological harm may be more prevalent when the research involves an element of deception. Invasion of Privacy: Participant’s perception/observation of behavior that is considered private. When developing your research, consider if the invasion of privacy involved is acceptable in light of the participants’ reasonable expectations of privacy in the situation and whether the research question is of sufficient importance to justify the intrusion. Invasion of privacy can be intrusion of one’s solitude or into one’s private affairs, public disclosure of embarrassing private information, publicity that puts the ndividual in a false light to the public, or appropriation of one’s name or picture for personal/commercial advantage. RISKS ASSESSMENT Types of Risk to Research Subjects Loss of Confidentiality: Unlike physical risks related to direct interaction and data collection from the participants, the risk of breach of confidentiality concerns safeguarding information given voluntarily by one person to another. Some research requires the use of medical, school or employment records. Access to such records for legitimate research purposes is generally acceptable, as long as the researcher protects the confidentiality of that information. It is important to recognize that a loss of confidentiality may result in psychological harm to individuals (in the form of embarrassment, guilt, stress, etc.) or in social harm. Social Harms: Some invasions of privacy and breaches of confidentiality may result in embarrassment within one’s business or social group, loss of employment, or criminal prosecution. Areas of particular sensitivity are information regarding alcohol and drug abuse, mental illness, illegal activities, and sexual behavior. Some social and behavioral research may yield information about individuals that could “label” or “stigmatize” the participants (e.g. as actual or potential delinquents or people with schizophrenia). Confidentiality safeguards must be strong in these instances. RISKS ASSESSMENT Types of Risk to Research Subjects Economic Harms: Participation in research may result in additional costs to individuals. Any anticipated costs to research participants should be described to prospective participants during the consent process. Legal Harms: Many researchers find themselves in ethical and legal quandaries when presented with a subpoena, which is a legal document requesting an appearance in court. While a subpoena is not likely for most research studies, if a study is examining things like sexual abuse, drug use or criminal activity, then it may cause the participants legal harm (consequences). Legal harm can be defined as causing an interaction between the participant and the court system. VULNERABLE GROUPS Vulnerable populations: Special considerations for risk assessment Pregnant Women, Fetuses, and Neonates: Prisoners: Minors Significantly Disadvantaged Person CONFIDENTIALITY PROCEDURE Researchers and RECs should consider the risk of stigmatization of practitioners or organizations due to the results of studies and should put in place adequate protection of data from multiple sources and on various entities. The protection of privacy and confidentiality in HPSR studies may be complicated using multiple data collection methods sourced from different levels. This is especially relevant in cases where HPSR studies may reveal poor performance or health outcomes. In all instances, researchers and RECs should consider the risk of stigmatization of practitioners or organizations due to the results of studies. CONFIDENTIALITY PROCEDURE Researchers must respect participants’ right to privacy. Unless required by law, the confidentiality of information shall always be observed. Records that link individuals to specific personal information shall not be released. This requirement shall be included in the informed consent form. Researchers shall refrain from identifying individuals or groups when the release of information about them can expose them to possible harm or social stigma. Release of information should be included among the items in the informed consent form; the participant must be specifically asked if he/she consents to release Information collected in the study and informed of the potential risks and consequences, if any, of such release. INSTITUTIONAL REVIEW BOARD An independent body (a review board or a committee, institutional, regional, national, or supranational), constituted of medical professionals and non-medical members, whose responsibility is to ensure the protection of the rights, safety and well-being of human subjects involved in a trial and to provide public assurance of that protection, by, among other things, reviewing and approving/providing favourable opinion on the trial protocol, the suitability of the investigator(s), facilities, and the methods and material to be used in obtaining and documenting informed consent of the trial subjects. INFORMED CONSENT YOU MAY ACCESS WHO TEMPLATES: http://www.who.int/rpc/research_ethics/informed_consent/en/ Sample 1: ICF clinical study, ICF non-clinical study Sample 2: ICF for parents (Clinical), ICF for parents (Non-Clinical) Sample 3: Assent for children Sample 4: ICF for Sample Storage INFORMED CONSENT REFERENCES Declaration of Helsinki (2013) ICH-GCP (1997, 2016) Council for International Organizations of Medical Sciences (CIOMS, 2016) National Ethical Guidelines for Health & Health- Related Research (2017) CLMMRH RERC FILES INFORMED CONSENT A HALLMARK in the Ethical Practice of Research