Role of the RESEARCH ETHICS COMMITTEE Flashcards
- Experimental or not
- Study-related treatments and probability for random assignment; treatment arms
- Approximate number of participants in the study
. Sample size computation Sampling design
Research Design
- Qualification to address the clinical risks in implementing the trial
- Qualifications
⚫ Education
Clinical training if applicable
GCP training - Requirements extend to the study
team
Qualifications of Researchers
Role of investigator being at the same time participant’s healthcare provider
· Financial declarations of PI and study team
Patent interests
Conflict of Interest
Administrative vulnerability
* Deferential vulnerability
* Age-related/competence
vulnerability
Medical vulnerability
⚫ Economic vulnerability
Social vulnerability
Vulnerability
Study specific risks
Risks from allowable use of placebo (as applicable)
For vaccine trials add information that burden of risk is carried by the participant with benefits accruing mainly to the
community
* Foreseeable risks to participant/embryo/ fetus/nursing infant
Financial risks
Inconvenience
Risks
- Reasonably expected (or absence) benefits
- Expected benefits to the community or to society
- Contributions to scientific knowledge * Development of commercial products from biological specimens and whether the participant will receive monetary or other benefit from such development Access (or lack of) of participants to the results of the study (as applicable)
. Post-trial access (PTA): Patients entered into the study are entitled to be informed about the outcome of the study and to share any benefits that result from it, e.g., access to interventions identified as beneficial in the study or to other appropriate care or benefits (DoH 2013)
Benefits (1)
Confidentiality plan: Records identifying the participant will be kept confidential and will not be made publicly available, to the extent permitted by law; and that the identity of the participant will remain confidential in the event the study results are published; including limitations to the investigator’s ability to guarantee confidentiality
Privacy & Confidentiality (1)
Participation is voluntary, and that participant may withdraw anytime without penalty or loss of benefit to which the participant is entitled
* Look for possible undue inducement
* Look for possibly coercive
statements
Voluntariness
- Anticipated payment, if any, to the participant in the course of the study; whether money or other forms of material goods, and if so, the kind and amount
Compensation for the participant or the participant’s family or dependents in case of disability or death resulting from study-related injuries
Compensation
· Alternative procedures or treatment available to participant
* Treatment entitlements of the participant in case of study-related injury
* Foreseeable circumstances and reasons under which participation in the study may be terminated
Care or treatment
“Informed consent is a process. The start of this process requires providing relevant information to a potential participant, ensuring that the person has adequately understood the material facts and has decided or refused to participate without having been subjected to coercion, undue influence, or deception”
CIOMS 2016
Consent & assent form (1)
. ICF: 18 and above
* Assent for adults
Assent for children or minors
00-under 7: no assent
07-under 12: verbal
o12-under 15: simplified assent
015-under 18: can co-sign
Consent & assent form (2)
- Post approval review responsibilities of EC implied by the approval TOR of investigators (amendments, progress, end of study, deviations, etc.) (page 35
communicating decisions)
ICH-GCP
The IRB/IEC should conduct continuing review of each ongoing trial at intervals appropriate to the degree of risk to human subjects, but at least once per year (3.1.4)
Post Approval Review
WHO
Thorough and
inclusive process of discussion and deliberation (Standard
8)
. Clear options for decisions, including approval, conditional approval, a request to revise and resubmit, or disapproval; (page 34, REC meeting)
ICH-GCP
Review a clinical trial within a reasonable time and document its views in writing, clearly identifying the trial, the documents & the dates * Decisions
✓approval/favorable opinion;
modifications; ✓disapproval/negative
opinion; ✓Termination/
suspension
Standard Decisions
WHO
Composition (Membership) Appointment
Independent Consultants Functions & Responsibilities Meetings Training
Review Fees
Accreditation
PHILIPPINE NATIONAL
HEALTH RESEARCH SYSTEM
PHILIPPINE HEALTH RESEARCH ETHICS BOARD
NATIONAL ETHICAL GUIDELINES
FOR HEALTH AND HEALTH-RELATED RESEARCH
2017
SOP to Ensure Quality
(Standard 9)
1. Written policies/ procedures based on regulations 2. Membership,
Independent consultants 3. Committee governance 4. Submissions, review, and decision-making 5. Communicating decisions
6. Follow-up reviews and monitoring
7. Documentation and
archiving
ICH-GCP (3.2.2)
The IRB/IEC should perform its functions according to written operating procedures, should maintain written records of its activities and minutes of its meetings, and should comply with GCP and with the applicable regulatory requirement(s)
Standard Operating Procedures
Research performed only by persons with scientific, clinical, or other relevant qualifications who are familiar with the ethical standards applicable to their research to ensure ethical conduct of research (Standard 10)
The IRB/IEC should
consider the
qualifications of the investigator for the proposed trial, as documented by a current CV and/or by any other relevant documentation (3.1.3)
Approval of Investigator/Researcher
WHO
ICH-GCP
is the
protection of human subjects in research
* Assessment by an REC is regulatory-
and guideline-based
REC primary function
are intended to support the operations of the REC, training activities, and continuing education of its members. Charging review fees for other purposes puts the REC in a COI situation, from which it may not be easy to extricate itself
DOH DO 2017-0265: correspond to the type of protocol
* Referral fees are not allowed per NEGHHR2017
Review fees
which currently conduct review for ethical soundness of research
proposals (or intend to review researches)
involving human
participants must
register and undergo accreditation by PHREB by December
PHREB ACCREDITATION
LEVELS
* Level 1
* Level 2
30, 2015. Updated last 7 Sep 2016
* Level 3
Ethics Committee Accreditation
RERCS
All of the REC’s documentation and communication is dated, filed, and archived according to the committee’s written procedures. Records may be kept either in hard copy or electronically (page 19, Standard 9)
ICH-GCP
The IRB/IEC should retain all relevant records (e.g., written procedures, membership lists, lists of occupations/affiliations of members, submitted documents, minutes of meetings, and
correspondence) for a period of at least 3-years after completion of the trial (3.4)
Documentation of Review
WHO
Act in the full interest of potential research participants and affected
communities…regard for the requirements of relevant regulatory agencies and applicable laws
Report to institution,
PHREB
* Maintain database
·
*
REVIEW SCOPE
Scientific merit & ethical acceptability Foreign research (even if these carry foreign approvals) Sensitivity to national health needs
COI resolution
Continuing review
Functions & Responsibilities
- Regular meeting (based on a cycle)
Quorum: 50%+1 with non-medical or
nonscientist and one non-affiliated member * COI management - Clear decision making process (consensus or voting
- Timelines
* - PNHRS Memo 2012-01: Action letter within 6 weeks from submission
· DOH DO2017-0265: 7-15 calendar days step (submission to reviewer, review, communication of results, resubmission) - Turnaround time: DOH 30-60 days
REC Meetings & Deliberations
