Role of the RESEARCH ETHICS COMMITTEE

Question 1

• 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

Answer 1

Research Design

Question 2

• Qualification to address the clinical risks in implementing the trial
• Qualifications
  ⚫ Education
  Clinical training if applicable
  GCP training
• Requirements extend to the study
  team

Answer 2

Qualifications of Researchers

Question 3

Role of investigator being at the same time participant’s healthcare provider
· Financial declarations of PI and study team
Patent interests

Answer 3

Conflict of Interest

Question 4

Administrative vulnerability
* Deferential vulnerability
* Age-related/competence
vulnerability
Medical vulnerability
⚫ Economic vulnerability
Social vulnerability

Answer 4

Vulnerability

Question 5

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

Answer 5

Risks

Question 6

• 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)

Answer 6

Benefits (1)

Question 7

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

Answer 7

Privacy & Confidentiality (1)

Question 8

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

Answer 8

Voluntariness

Question 9

• 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

Answer 9

Compensation

Question 10

· 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

Answer 10

Care or treatment

Question 11

“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

Answer 11

Consent & assent form (1)

Question 12

. 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

Answer 12

Consent & assent form (2)

Question 13

• 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)

Answer 13

Post Approval Review
WHO

Question 14

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

Answer 14

Standard Decisions
WHO

Question 15

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

Answer 15

SOP to Ensure Quality

Question 16

(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)

Answer 16

Standard Operating Procedures

Question 17

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)

Answer 17

Approval of Investigator/Researcher
WHO
ICH-GCP

Question 18

is the
protection of human subjects in research
* Assessment by an REC is regulatory-
and guideline-based

Answer 18

REC primary function

Question 19

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

Answer 19

Review fees

Question 20

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

Answer 20

Ethics Committee Accreditation
RERCS

Question 21

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)

Answer 21

Documentation of Review
WHO

Question 22

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

Answer 22

Functions & Responsibilities

Question 23

• 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

Answer 23

REC Meetings & Deliberations