Protocol Packet: Submission Checklist

ITEM NO. MANDATORY DOCUMENTS YES NO NA

1 Cover Letter
2 Research Protocol Application Form
3 Protocol Review Assessment Form
4 Informed Consent Form (ICF) Checklist
5 Study Protocol
6. Informed Consent Form in English and Local
Dialect
7 Research participants recruitment procedure (if
applicable)
8 Curriculum Vitae of Study Members
9 Document Receipt Form
10 Site Profile
Cover Letter
 Research Protocol Application Form

HNU-ERB Code:
Protocol Title:

Date of Submission:
1
Type of Study (Basic Research, Survey,
Clinical Trial, etc):
Expected number of participants:

Principal Investigator (Lead Researcher)

Full Name:
Address:
2
Position:
Email address:
Contact #:

Declaration To be Signed by the Principal Investigator

 I am aware of the ethical aspects of this research project.

 I undertake to commit and submit the “Progress Report Form” to the HNU-
ERB.

 I will ensure that changes in approved research protocols are reported

promptly and are not initiated without approval by the HNU-ERB, except
when necessary to eliminate apparent immediate hazards to the
participant.

 I will ensure that all adverse or unforeseen problems arising from the
research project are timely reported to the HNU-ERB.

 I will undertake to provide notification when the study is complete and if it

fails to start or is abandoned.
Signature: Date:

FOR FURTHER INFORMATION, CONTACT:

HNU-ERB Admin Staff

Center for Research and Publications
Bates Bldg., Janssen Heights, Dampas Dist.,
Tagbilaran, Bohol
(038) 5017731 loc.107/5010125 loc 211
[email protected]
 PROTOCOL REVIEW ASSESSMENT POINTS

Please indicate in the space provided below whether

or not the specified assessment point is addressed
by your study protocol. To facilitate the evaluation
TO THE PRINCIPAL INVESTIGATOR of the assessment point, indicate the page and
paragraph where this information
can be found.

Please evaluate how the assessment points outlined

below have been appropriately addressed by the
study protocol, as Applicable by confirming the
submitted information and putting your comments
TO THE PRIMARY REVIEWER in the space provided under “REVIEWER
COMMENTS.” Finalize your review by
Indicating your conclusions under “RECOMMENDED
ACTION” and signing in space provided for the
primary reviewer.

To be filled by the
Applicant
ASSESSMENT POINTS Indicate if the Page and REVIEWER’S
protocol paragraph COMMENTS
contains where it is
specified found
assessment
point
YES NO
SCIENTIFIC DESIGN
1 Objectives
2 Literature review
3 Research Design
4 Sampling Design
5 Sample Size
6 Statistical Treatment
7 Inclusion criteria
8 Exclusion criteria
9 Withdrawal criteria
CONDUCT OF THE STUDY
1 Specimen handling
2 Researchers’ qualification (CV)
3 Suitability of site
4 Duration
ETHICAL CONSIDERATIONS
1 Conflict of Interest
2 Confidentiality and privacy
3 Informed Consent Process
4 Recruitment
5 Vulnerability
6 Assent
7 Risks
8 Benefits
9 Incentives and Compensations
RECOMMENDED ACTIONS
APPROVAL
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVAL
JUSTIFICATION FOR
RECOMMENDATION

PRIMARY REVIEWER:
________________________ _________________
Signature over Printed Name Date

PANEL SECRETARY
________________________ _________________
Signature over Printed Name Date

PANEL CHAIR
________________________ _________________
Signature over Printed Name Date
 Informed Consent Assessment Form

Please indicate in the space provided below whether

or not the specified element is addressed by the
Informed Consent Form (ICF). TO facilitate the
TO THE PRINCIPAL INVESTIGATOR evaluation of the assessment point, indicate the
page and paragraph where the information can
be found.

Please evaluate how the elements outlined below

have been appropriately addressed by the Informed
Consent Form (ICF), as applicable by confirming the
submitted information and putting your comments
in the space provided under “REVIEWER
COMMENTS.” In your comments, ensure that
TO THE PRIMARY REVIEWER vulnerability, recruitment process, and process of
obtaining informed consent are always
assessed in the context of the study protocol and
the participant. Finalize your review by indicating
your conclusions under “RECOMMENDED ACTION”
and signing in space provided for the primary
reviewer.

To be filled by the Applicant

ASSESSMENT POINTS Indicate if the Page and REVIEWER’S
protocol paragraph COMMENTS
contains where it is
specified found
assessment
point
YES NO
1 Statement that the study
involves research
2 Statement describing the
purpose of the study
3 Study-related treatments
and probability for random
assignment
4 Study procedures including
all invasive procedures
5 Responsibilities of the
participant
6 Expected duration of
participation in the study
7 Approximate number of
participants in the study
8 Study aspects that are
experimental
9 Foreseeable risks to
participant
10 Risks from allowable use of
placebo
11 Reasonably expected
benefits; or absence of
 direct benefit to
participants, as applicable
12 Expected benefits to the
community or to society,
or contributions to
scientific knowledge
13 Description of post-study
access to the study product
or intervention that have
been proven safe and
effective
14 Alternative procedures
or treatment available
To participant
15 Compensation or insurance
or treatment entitlements
of the participant in case of
study-related injury
16 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
17 Compensation (or no plans
of compensation) for the
participant or the
participant’s family or
dependents in case of
disability or death resulting
from study-related
injuries
18 Anticipated expenses, if
any, to the participant in
the course of the study
19 Statement that the
participant is voluntary,
and that participant may
withdraw anytime without
penalty or loss of benefit
to which the participant is
entitled
20 Statement that the study
monitor(s), auditor(s), the
HNU-ERB, and regulatory
authorities will be granted
direct access to
participant’s medical
record for purposes ONLY
of verification of clinical
trial procedures and data
21 Statement that the 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
22 Description of policy
regarding the use of
genetic tests and familial
genetic information, and
the precautions in place to
prevent disclosure of
results to immediate
family relative or to others
without consent of the
participant.
23 Possible direct or
secondary use of
participant’s medical
records and biological
specimens taken in the
course of clinical care or in
the course of this study
24 Plans to destroy collected
biological specimen at the
end of the study; if not,
details about storage
(duration, type of storage
facility, location, access
information) and
possible future use;
affirming participant’s right
to refuse future use, refuse
storage, or have the
materials destroyed
25 Plans to develop
commercial products from
biological specimens and
whether the participant
will receive monetary or
other benefit from such
development
26 Statement that the
participant or participant’s
legally acceptable
 representative will be
informed in a timely
manner if information
becomes available that
may be relevant to
willingness of the
participant to continue to
participation
27 Statement describing
access of participant to the
result of the study
28 Statement describing
extent of participant’s right
to access his/her records
(or lack thereof vis à vis
pending request for
approval of non or partial
disclosure)
29 Foreseeable circumstances
and reasons under which
participation in the study
may be terminated
30 Sponsor, institutional
affiliation of the
investigators, and
nature and sources of
funds
31 Statement whether the
investigator is serving only
as an investigator or as
both investigator and the
participant’s
healthcare provider
32 Person(s) to contact in the
study team for further
information regarding the
study and whom to contact
in the event of study-
related injury
33 Comprehensibility of
language used
RECOMMENDED ACTIONS
APPROVAL
MINOR MODIFICATIONS
MAJOR MODIFICATIONS
DISAPPROVAL
JUSTIFICATION FOR
RECOMMENDATION

PRIMARY REVIEWER:
________________________ _________________
Signature over Printed Name Date

PANEL SECRETARY
________________________ _________________
Signature over Printed Name Date

PANEL CHAIR
________________________ _________________
Signature over Printed Name Date
 (This template is for research interventions that use questionnaires, in-depth
interviews or focus group discussions.)

[INSTITUTIONAL LETTER HEAD]

Informed Consent Form for [Identity of the particular group of individuals
(e.g., clients, patients, community leaders, service providers) in the project
for whom this consent is intended]
[Name of Principle Investigator]
[Name of Organization]
[Name of Sponsor]
[Name of Project and Version]

PART I: INFORMATION SHEET

INTRODUCTION
Briefly introduce the proponent and concerned organization, emphasize that this is an invitation
to participate in a study/research and that he or she can take time to reflect on whether he or
she want to participate or not. Assure the participant that he or she does not understand some
of the words or concepts, that these will be explained and that he or she can ask questions at
any time.

PURPOSE OF THE RESEARCH

Explain the research question in ordinary, non-technical terms. Use local and simplified words
rather than scientific terms and professional jargon. Consider local beliefs and knowledge when
deciding how best to provide the information.

TYPE OF RESEARCH INTERVENTION

Briefly state the type of intervention that will be undertaken. This will be expanded upon in the
procedures section but it may be helpful and less confusing to the participant if they know from
the very beginning whether, for example, the research involves a vaccine, an interview, a
questionnaire, or a series of finger pricks.

PARTICIPANT SELECTION
Indicate why you have chosen this person to participate in this research. People wonder why
they have been chosen and may be fearful, confused or concerned.

VOLUNTARY PARTICIPATION
Indicate clearly that they can choose to participate or not. State, only if it is applicable, that they
will still receive all the services they usually do if they choose not to participate. Explanation: It
may be more applicable to assure them that their choosing to participate or not will not have
any bearing on their job or job-related evaluations. This can be repeated and expanded upon
later in the form as well. It is important to state clearly at the beginning
of the form that participation is voluntary so that the other information can be heard in this
context. Although, if the interview or group discussion has already taken place, the person
cannot 'stop participation' but request that the information provided by them not be used in the
research study.
PROCEDURES
A.
Provide a brief introduction to the format of the research study and in which part of the study he
or she will be involved.

B.
Explain the type of questions that the participants are likely to be asked in the focus group, the
interviews, or the survey. If the research involves questions or discussions which may be
sensitive or potentially cause embarrassment, inform the participant of this.

In focus group discussions:

Give the location of the FGD, describe the FGD process, inform the participant that there will be
7-8 other persons with similar experiences, that the discussion will be guided by a moderator
who is trained to do so, whether the discussion will be recorded, how confidentiality will be kept
and how long the records will be stored. Give the participant an idea on what topics will be
taken up, that questions the participant has about the study
may also be raised and discussed and that he or she does not have to share any knowledge that
he or she is not comfortable sharing. It is also important for the participant to know that he or
she can still opt out of the study even after the FGD by requesting that his or her participation
not be cited part of the data.

For interviews:
Inform the participant about the location of the interview (or a preferred location of the
participant) and identity of the interviewer. Assure the participant that he or she does not wish
to answer any of the questions during the interview, the interviewer will move on to the next
question; that no one else but the interviewer will be present unless he or she would like
someone else to be there. Describe how the interview will be recorded and
kept confidential. Explain how long the study records will be kept and subsequently destroyed.

For questionnaire surveys:

Describe how the survey will be distributed and collected. Inform the participant that he or she
may answer the questionnaire personally, or it can be read to him or her; answered aloud and
written down by a member of the research team. Assure the participant that if he or she does
not wish to answer any of the questions, this may be skipped and he or she can proceed to the
next question. The information recorded is confidential, name is not included on the forms, only
a number will identify him or her, and no one else except [name of person(s) with access to the
information] will have access to the results of the survey.)

DURATION
Include a statement about the time commitments of the research for the participant including
both the duration of the research and follow-up, if relevant.

RISKS
Explain and describe any risks that can be anticipated or that are possible. The risks depend
upon the nature and type of qualitative intervention, and should be, as usual, tailored to the
specific issue and situation. If the discussion is on sensitive and personal issues (e.g.,
reproductive and sexual health, personal habits, etc.) or confidential in nature, then there is a
risk of embarrassment, discomfort or fear. Assure the participant that he or she does not have
to answer any question or take part in the discussion, interview, or survey if he or she feels the
question(s) are too personal or if talking about them makes him or her uncomfortable.
BENEFITS
Benefits may be divided into benefits to the individual, benefits to the community in which the
individual resides, and benefits to society as a whole as a result of finding an answer to the
research question. Mention only those activities that will be actual benefits and not those to
which they are entitled regardless of participation.

REIMBURSEMENTS
State clearly that the participants will not receive payments beyond reimbursements for
expenses incurred as a result of their participation.

CONFIDENTIALITY
Explain how the research team will maintain the confidentiality of data with respect to both
information about the participant and information that the participant shares. Outline any
limits to confidentiality. Inform the participant that because something out of the ordinary is
being done through research, any individual taking part in the research is likely to be more easily
identified by members of the community and therefore more likely to be stigmatized. If the
research is sensitive and/or involves participants who are highly vulnerable - research
concerning violence against women for example - explain to the participant any extra
precautions you will take to ensure safety and anonymity.

(The following applies to focus groups)

Focus groups provide a particular challenge to confidentiality because once something is said in
the group it becomes common knowledge. Explain to the participant the group participants
shall be encouraged to respect confidentiality, but that this cannot be guaranteed.

SHARING THE RESULTS

If there is a plan and a timeline for the sharing of information, include the details. The
participant may also be informed that the research findings will be shared more broadly, for
example, through publications and conferences.

RIGHT TO REFUSE OR WITHDRAW

Reiterate that participation is voluntary and includes the right to withdraw. Tailor this section to
ensure that it fits for the group for whom one is seeking consent. Participants should have an
opportunity to review their remarks in individual interviews and erase part or all of the
recording or note.

WHO TO CONTACT
Provide the name and contact information of someone who is involved, informed and accessible
- a local person who can actually be contacted. State also the name (and contact details) of the
local REC that has approved the proposal.
 PART II: CERTIFICATE OF CONSENT

I have read the foregoing information, or it has been read to me. I have had the opportunity to
ask questions about it and any questions I have been asked have been answered to my
satisfaction. I consent voluntarily to be a participant in this study.

Print Name of Participant: _________________

Signature of Participant: ___________________
Date: [MM/DD/YYYY]

If Illiterate
I have witnessed the accurate reading of the consent form to the potential participant, and
the individual has had the opportunity to ask questions. I confirm that the individual has
given consent freely.

Print name of witness____________

Thumb print of participant:
Signature of witness _____________
Date: [MM/DD/YYYY]

STATEMENT BY THE RESEARCHER OR PERSON TAKING CONSENT

I have accurately read out the information sheet to the potential participant, and to the best
of my ability made sure that the participant understands that the following will be done:
1.
2.
3.
I confirm that the participant was given an opportunity to ask questions about the study, and
all the questions asked by the participant have been answered correctly and to the best of my
ability. I confirm that the individual has not been coerced into giving consent, and the
consent has been given freely and voluntarily. A copy of this Informed Consent Form has been
provided to the participant.

Print Name of Researcher or person taking the consent

Signature of Researcher or person taking the consent

Date: <MM/DD/YYYY>
 DOCUMENT RECEIPT FORM

HNU-ERB CODE

Type of Submission □ Initial Review □ Continuing Review

□ Resubmission for re-review □ Renewal
□ Protocol Amendments □ Protocol Termination

If an approved □ Exempted Review

study, level of initial □ Expedited Review
review □Full Review

Protocol Title

Cellphone Number

Email:

College:

Delivery route: □ E-submission □ In-person

Documents submitted: □ Complete □Incomplete, will submit on

Comments

Received by/Sign:

Date Received: