[06.21] UREO ICF and ICF Evaluation Process V2.pdf

UREO

What is the acronym for the University Research Ethics Office?

PHREB

What is the acronym for the Philippine Health Research Ethics Board?

Written document read and signed by a prospective participant

What is an Informed Consent Form (ICF)?

Aware of ALL the elements of a study

What does a prospective participant indicate by reading and signing the ICF?

Voluntarily participating in the study without any undue influence, pressure or coercion

What does signing the ICF signify?

Prepared by the investigator

Who prepares the Informed Consent Form?

Ensure that all the information surrounding the study is conveyed to the participant in an understandable manner

What is the primary goal of the investigator when preparing the ICF?

A simplified form of document that conveys all the message the researchers have in their protocol

How can the ICF be described in relation to the research protocol?

A disclaimer document that will rid the investigator of responsibility

What is the ICF explicitly NOT?

NOT proof that the investigator is not liable for anything that goes wrong in the study

What liability status is NOT granted by the ICF to the investigator?

Unique to every study

What characteristic must an ICF possess regarding its specific research?

SHOULD NOT be prepared from a generic ICF template

How should an ICF not be created?

An ICF guide that has all the essential elements

What should serve as a checklist when preparing an ICF?

Copying and pasting without thinking about the content of the ICF

What is noted as one common mistake in ICF preparation?

UREO (University Research Ethics Office) through the recommendation of the ASMPH dean

By whom are the members of the ASMPH-REC appointed?

PHREB (Philippine Health Research Ethics Board)

What body gives the UREO its mandate to implement ethical principles in research?

Ateneo-wide and not just ASMPH

What is the scope of the ASMPH-REC mandate?

Reviews protocols and ICFs

What does the ASMPH-REC review?

Ensure that human participation in the study is ethical and follows guidelines of proper research conduct

What is the purpose of the ASMPH-REC review?

Title

What is the first vital element of an ICF?

Describes or summarizes what the study is all about

What must a proper title do?

Descriptive, direct, accurate, appropriate, interesting, concise, precise, unique, and should not be misleading

What nine qualities should the title possess?

Explain technical terms that are in the title

What must be done if the title contains technical terms like "deep vein thrombosis" (DVT)?

Convey the information to prospective participants in a manner they will understand

What general principle applies to conveying title information to participants?

Purpose

What vital element of an ICF must be stated in layman's language?

Try to make prospective participants understand what you are trying to figure out

What should the statement of purpose aim to achieve?

Prevalence

What specific term might not be understandable to an average person in the example purpose statement, "The purpose of this study is to determine the prevalence of COVID-19 infections…"?

Spell out TMC and explain what prevalence is

What must be done for terms like TMC and prevalence in the purpose statement if the audience is the general public?

Procedures and Duration

What vital element details all actions involving the participant and the expected timeline?

ALL procedures involving the participant (e.g., doctor visits, watching videos, answering questionnaires, blood draws, etc.)

What must the procedures section include?

How many times the participants will need to do certain procedures

What specific frequency detail must be clear in the procedures section?

Expected duration of participant involvement (overall and in each step of participation)

What must be detailed regarding the timeline of participation?

No such thing as trying to hide things from the participants

What is the rule regarding concealing information, even in an RCT where bias is a concern?

Straightforward, upfront, and honest

What three qualities must the researcher maintain when describing the intervention (e.g., drug vs. placebo)?

Explain what placebo is and what the drug is, such as its mechanism

What must be explained to the participant if the study involves a placebo and a drug?

Deception

What practice is explicitly stated as not being part of any study?

Up to the participant whether they are okay and amenable to receive the placebo and sign up

What decision is left to the participant regarding receiving the placebo?

Appropriate and correct based on literature

What must be true about the information provided regarding the drug or procedure?

Lessen the participant interaction

What is generally better for a study involving participant visits?

Dropout rate

What is much less likely if a study requires 1 visit instead of 10 visits?

Specific as possible

How should the actions done at each visit be described?

Gauging if they can or cannot participate

What does clearly stating the time commitment allow participants to do?

Mention whatever they need to do

What must the ICF mention if preparation is needed (e.g., bring children, pen, or paper)?

Expectation you need from the prospective participants

What must be clarified regarding preparation?

Voluntary Participation

What vital element requires a statement confirming the participant's choice to join?

Right to decline to participate and to withdraw from the research after participation has begun

What two crucial rights must be stated regarding participation?

Withdrawal

What action is permitted at any time, even after a person has signed up for participation?

Give a statement or simply be quiet

What two ways can a participant use to communicate their withdrawal?

Cannot be removed and has to be found in the ICF

What is true about the statement of voluntary participation?

Potential Risks and Mitigation Plan

What vital element must detail foreseeable adverse effects and how to handle them?

Potential risks, discomforts, or adverse effects and other reasonably foreseeable factors

What must be listed under risks?

Mitigation plan

What must be included if any risks occur?

Wash it off immediately and apply an ice compress

What is the suggested mitigation plan if a participant develops an allergy to skin medication (example)?

Go immediately to the nearest emergency room for proper management

What is the instruction if breathing difficulty occurs (example)?

Inform the investigator at phone number 0917-xxxx at once

What specific action must be taken after seeking immediate emergency management for severe risks (example)?

An action

What does the mitigation plan provide, not merely a request to report to investigators?

Benefits

What vital element must detail both direct and indirect advantages?

Indirect benefit

What type of benefit is illustrated by the study results serving as the basis for developing educational programs for the community?

PHREB

What institution recently informed that studies should have a direct benefit to participants?

Anthropometrics (weight, height, BMI), or a blood test

What measurements, if given for free, are considered a direct benefit?

Education of what the study is all about, what a certain condition is

What type of information is often overlooked but recognized by the ethics review board as a direct benefit?

Compensation (presence or absence), amount, how it will be given, when will it be given

What four specific details must the compensation section include?

Appropriate

What quality must the compensation amount have so that it does not appear coercive?

The activity the participants are to do

What determines the amount of compensation given?

Correct, appropriate, and acceptable to be placed in the ICF

How is the statement "You will not be paid for answering the survey" described?

Offset the time that you will be participating in our study

What is the purpose of adding educational materials or other items when no monetary compensation is provided?

Be upfront about it to your participants

What must researchers do if they do not have any budget for the study?

Raffle

What compensation method requires the researcher to specify the prize, when it will be done, the chances of winning, and how the certificate will be given?

Above board

What must be ensured regarding the compensation process (e.g., when raffling a prize)?

False

According to PHREB, should studies only have an indirect benefit to participants?

Voluntary

What must participation be, according to the ICF statement?

False

Can one simply copy and paste the contents of a generic ICF template?

Purpose

What element of an ICF has to be stated in layman's terms?

Confidentiality protections and limits of confidentiality

What must be stated regarding confidentiality in the ICF?

Data Privacy Act of 2012

What is the usual reference for confidentiality?

"The study will be done in compliance with the Data Privacy act."

What statement is always included regarding confidentiality compliance?

You cannot share the participant’s information on their name, email, phone number, birthday, etc.

What four examples of participant information cannot be shared?

Only the information needed to be analyzed

What should be recorded in the data collection form?

Name and signature

What two pieces of identifying information must still be stated in the informed consent form (ICF)?

"Any information you provide will be protected from any unlawful access."

What statement should be included regarding data security?

If the information is required by law to be released to health authorities

What is the main limit of confidentiality that must be stated?

Information on the communicability of the disease or other things that will affect the health of the majority of people

What kind of information are researchers legally bound to disclose to health authorities?

COVID status was reported to the LGU

What specific information was imperative to report during the COVID-19 pandemic?

Limit the amount or the kind of information

What must be done when providing information to health authorities?

Contact Information

What vital element lists whom to contact for questions?

Student/faculty names and contact information

Whose contact information should be listed for study-related matters?

If there is more than one person to contact, all the names and information must be listed in the ICF

What rule applies if multiple people are contact points?

ASMPH-REC

To whom must ethics-related questions be directed?

Investigating concerns raised to them

What is the responsibility of the ASMPH-REC regarding ethics-related questions?

Address and phone number

What specific contact information of ASMPH-REC should be listed?

Issues pertaining to participants’ rights (e.g., feeling rights were violated)

What kind of issues can participants contact ASMPH-REC about?

Principal investigators or researchers of the study

Who must be asked for study-related questions?

“Do not contact the ASMPH-REC for study-related questions.”

What explicit statement must be included regarding study-related questions?

Minors, persons with disability, compromised mental capacity, etc.

What three examples of vulnerable populations require a separate kind of consent?

Assent

What specific type of agreement is needed for studies involving minors (participants below 18 years of age)?

Non-verbal agreement (i.e., a nod, a verbal assent, etc.)

What is assent?

Authorized guardian or surrogate decision-maker

Who provides consent for prospective participants who may lack mental capacity?

0-7 years old

For what age group is consent from an authorized/legal guardian required, but assent is not applicable?

8-11 years old

For what age group is verbal assent required, and the minor can refuse participation?

12-15 years old

For what age group is verbal assent and/or a simplified assent form required, and the minor can refuse participation?