Informed Consent

1. For all research involving humans, the investigator must obtain the voluntary
informed consent of the prospective research participant (after being informed about
the nature, purpose, and procedures of the study, and potential risks and benefits of
participation). In the case of an individual who has diminished capacity to give informed
consent, the permission of a legally authorized representative in accordance with
applicable laws must be obtained .

The types of informed consent are:

An adult subject, capable of giving permission to participate in a research study, can

provide consent. The subject must be 18 years of age and competent to make the
decision to participate.

When children/minors are included in research, the parent/guardian must sign a

parental permission/consent document. Some situations require permission from at
least one parent, while other situations require permission from both parents. In some
cases, it may be necessary to waive the requirement to obtain parental permission.

Assent is a child's affirmative agreement to participate in research. If the subject is 7-17

years of age, assent must be obtained. The assent form must be written at the
appropriate reading level of the youngest subject in the age range and use simple
terminology.

Verbal consent still contains all elements of written consent, however, the participant
has verbally read the elements and verbally agrees to participate.
A "short form" is generally used when there is a language barrier and an English IRB-
approved consent is orally translated in the subject's native language. (P17)

An information sheet may be used as a form of consent in certain circumstances where

a signature could compromise the participant or in studies where signed consent is not
required by regulations (research procedures involving minimal/ no risk).

A waiver of documentation of informed consent can be obtained when the written

consent is the only link to the study and record of subject's name could compromise the
participant. In this case a verbal or information sheet can be used, or the consent may
be read to the subject.

2. A waiver of elements of informed consent may be obtained from the IRB for some
research projects that could not practically be done without an alteration to the required
elements .

Undue coercion and influence. The researcher must be mindful of implicit undue
coercion to participate in studies and address this in the informed consent process,
such as in the following situations:

When students are "required" to participate in faculty research; to be part of the subject
pool; and other contexts wherein participation in studies is graded. In such cases,
students must be presented with alternative requirements or projects that are
equivalent in effort and merit to participation in studies. The benefit of research
participation must not be so large as to remove students' freedom to voluntarily decide
to participate.

When students are enjoined or required to collect data for faculty or for a class; to
recruit a certain number of participants for a grade. In such cases, students may
circumvent the informed consent process to obtain a grade or benefit in their classes.
Students must be trained and supervised by faculty or senior researchers in the
necessity of the informed consent process, and the number of participants recruited
must not be the basis of a grade or class benefit.
Soliciting the participation of prisoners and other institutionalized persons, or of
indigent groups. The marginalized status of these samples, and their restricted
autonomy, make them vulnerable to coercion. Researchers must take more care to
uphold their autonomous right to decide to participate in a study. (P18)

In situations where certain persons act as gatekeepers (e.g., barangay officials;

community leaders) for the group or community to participate, and can therefore be a
source of coercion, researchers shall find a way of ensuring that individual respondents
still have the freedom to decide to participate.

For example, researchers are to solicit the informed consent of both the gatekeepers
and the individuals, emphasizing that the latter's decision does not automatically follow
from the former's consent (Association of Social Anthropologists.)

3.. The potential uses of the data must be discussed with research participants.

3.1. Their consent should be obtained for the future use of the material (e.g., recordings,
photographs, field notes].

3.2. There should be a mention regarding documentation through taking of photos and
recording of the interview and that these might be displayed in publications and
conferences/fora (National Ethical Guidelines for Health and Health Related Research,
2017).

4. To protect the rights of indigenous peoples (IPs) and to see to it that individual as
well as community wellbeing are attended to, the informed consent process may be
waived in specific research contexts, such as:
4.1. Waiving of informed consent

Archival research involving publicly available documents

Research that uses the method of naturalistic observation (often described as "covert"
method) in data collection. Naturalistic observation does not necessitate informed
consent if the activities or behaviors observed are public in nature such that any person
can observe them without violating principles of confidentiality or privacy.

However, if observations are recorded in such a way that the individuals involved are
identifiable, then informed consent may be necessary depending on the nature of the
study (i.e., if risks to participants are plausible). Moreover, use of this method requires
that the researcher provide:

a thorough justification for the use of naturalistic observation; a plan for how the data
collected will be used; a mechanism to ensure confidentiality and anonymity of
observed individuals and their data. (19)

4.2. Waiving of signed informed consent. By default, informed consent is documented

via a signature of the participant or his/her legal representative on the informed consent
form (ICF). Documented informed consent may be waived (with the approval of the
ethics review committee) if:

The research presents no more than minimal risk for which informed consent is
normally required;
The only record linking the participant to the research would be the informed consent
document and the principal risk to participants would be the potential harm resulting
from breach of confidentiality;

The researcher shall provide other evidence that the informed consent process was
undergone and that consent was obtained (e.g., appropriate witness signs a document
to attest)

4.3. Waiving some elements of the informed consent. Some or all of the elements in the
informed consent may be waived or altered (with the approval of the ethics review
committee) if all these conditions are met:

The research presents no more than minimal risk;

The waiver or alteration will not adversely affect the rights and welfare of the
participants;

The research cannot be practicably carried out without the waiver or alteration; and

The participants will be provided with additional pertinent information after their
participation (whenever appropriate).

5. The researcher shall fully disclose information to the potential research participants
about the research that can serve as basis for their decision to participate or not to
participate. Information to be disclosed must include specific details about the research
procedures (e.g., the number of interview sessions and the length of time involved),
foreseeable risks and benefits, and how privacy will be safeguarded.
6. Where there is a psychological or social intervention that is being tested that is, as
yet, of uncertain benefit (e.g., responsible conduct of testing [RCTs) or pilot studies),
researchers shall indicate this and its foreseeable risks and outcomes (whether positive,
negative, or no effects) in the informed consent form. This is to forestall any
unwarranted assumptions of benefits of the social intervention, which may induce
individuals or communities to participate . (P20)

7. Withholding of information or using deception. Withholding information or using

deception in the informed consent process may be necessary in order to control biased
responses of participants (i.e., demand characteristics, good subject d characteristics,
good subject phenomenon . This, however, may be done in situations deemed
necessary by the researcher.

7.1. Deception is an unethical practice in research.

7.1.1. "Deception in Psychological Research-a Necessary Evil?" mentioned two types:

active deception or deception by commission where a researcher blatantly misleads the

participant about some aspects of the investigation and passive deception or deception
by omission as when a researcher purposely withholds relevant information from the
participant.

He explained though that in spite of moral, methodological and disciplinary criticisms,

there are theoretical and social advances that may be achieved as well as avoidance of
misleading findings that might result from a study had participants not been deceived.

It is a necessary evil often required to provide the necessary technical illusion and
increase the impact of a laboratory or field setting, such that the experimental situation
becomes more realistic and reduces the effects of participants, motives and role
playing behavior
7.1.2. When the use of alternative procedures such as role play, simulation or virtual
reality option has been explored and not one of them will be as effective, only then can
deception be used as a last resort but it needs to be justified.

7.2. For researches involving deception (Michael Cheng-Tek Tai, 2012): (P21)

7.2.1. (its) use must be justified in the protocol to show that the research cannot be
performed in the absence of deception and the benefits of the research will sufficiently
outweigh any risks that deception may create;

7.2.2. research participants cannot be deceived about significant aspects of the

research that would affect their willingness to participate or that would cause them
physical or emotional harm; and

7.2.3. in exceptional cases where the withholding of information is justified by minimal

risk and significant benefits from the research, debriefing must be performed as soon
as appropriate. In no case shall withholding of information result to irreversible harm.

A debriefing script must be included in the protocol and should include a detailed
description of the ways in which deception was used and why; when and by whom the
debriefing will be administered should also be included; and

7.2.4. true "informed consent" cannot be given if the true nature of the research is
deceptively presented. This situation is dealt with administratively via a waiver of
portions of the information consent regulations.

Additional Ethical Policy Considerations for the Review of Particular Sectors or

Situations
A. Research with indigenous peoples (IPs) (2011)

In undertaking a research on IPs, the NCIP Administrative Order #1, Series of 2012
entitled Indigenous Knowledge Systems and Practices (IKSP) and Customary Laws (CLs)
Research and Documentation Guidelines of 2012 provides a substantive guide to social
scientists to practice ethical behavior. It includes the operating principles that should be
followed, the scope and coverage of the projects and activities included as well as the
procedures, processes and methods that should be carried out through the course of
the study. ( 22 )

The National Ethical Guidelines for Health Research (2011) also stipulates particular
ethical rules of conduct in carrying out research for IPs:

1. Informed consent (pp. 92-95)

1.1. Research involving IP populations must maintain compliance with standard

elements of free and prior informed consent such as competence, disclosure,
comprehension of information disclosed, voluntariness, signification of consent (in the
form of assent, signature, etc.), but must include special considerations for IP values
and concepts, especially alternative decision making processes which may involve two
interrelated processes here: community approval for the study to proceed on one hand
and individual consent to participate on the other hand. The first may be required by the
IP communities for the second to proceed.

1.2. Balance must be sought between community approval and individual informed
consent so that the former does not compromise the latter. If a member of the
community feels compelled to consent because the community has already approved
the study, then such autonomy could be seen as compromised. However, if community
approval was arrived at after several community meetings, discussions, consensus
taking, where members freely participated, community approval could be seen as the
representation of the members' decision.
1.3. Community consultations are required for approval to conduct the study prior to
approaching individual members for consent.

1.4. Other documents may be considered in lieu of the standard informed consent form
(e.g. IPRA requirement of a MOA).

2. Respect for People

2.1. The researcher must demonstrate knowledge and appreciation of community

traditions through the inclusion of appropriate social preparation phase of the study.

2.2. The researcher should acknowledge and maintain respect for elders, which is a
highly valued tradition in indigenous communities. (P23)

2.3. The researcher should respect sacred places and rituals, including request of
communities to conduct rituals as part of the community's decision making whether or
not to allow the study.

2.4. The research design should not violate traditional practices. Methods like field
observation could potentially trespass certain sacred places or taboos. Researchers
should use alternative methods, and if there is none, to explain why field observation
must be done and how the benefit outweighs the risk of harm that these methods could
create.

2.5. Conceptualize and conduct research with cultural minorities as a partnership,

carefully avoiding hierarchies in research interaction.

3. Justice
3.1. The research plan should include explicit description of access and benefit sharing
(ABS) and describe how the researcher will ensure that the community will have access
to or get a fair share in whatever benefits will accrue from the study.

3.2. Information about ABS should be disclosed during the solicitation of individual
consent and community consultations.

3.3. ABS agreements should be formalized as stipulations in a contract or memoranda

of agreement between the IP community and other parties.

3.4. Community ownership of traditional knowledge should be acknowledged in any

report in any medium.

B. Research with people affected by emergencies and disasters (pp. 89-91)

1. Integrity of the research

1.1. Researchers must demonstrate familiarity with the community's situation and their
cultural beliefs and practices. (24)

1.2. The researchers have the responsibility to identify the specific vulnerabilities of the
research population relevant to the study and the mechanisms that are being put in
place to address them.

1.3. Collecting personal data on traumatic experiences should not be allowed unless
clearly justified in the protocol; it must be understood however that in many instances,
people themselves want to talk about these as a form of therapy.
1.4. Group methods should be used with much caution because confidentiality and
anonymity cannot be guaranteed (in all types of research), and in security situation, this
takes greater importance.

2. Informed choice

2.1. The researcher must consult the community and secure its permission before
approaching individuals for their informed consent.

2.2. The research team must identify factors that serve as barriers to the freedom of
individual members of the subject population to give consent and provide effective
mechanisms to address them.

3. Community participation

In research involving people in emergencies or disasters, the participation of subjects is

of prime importance. The highest possible degree of participation is advised. The study
design should describe the involvement of the research participants in the study.

4. Privacy/non-disclosure of information

4.1. The withholding or non-disclosure of pertinent information must be justified in the

context of protecting the research participants from specific harm or risks and must be
done according to the Ethical Guidelines for Social Research approved by the Ethics
Review Committee. (25)