ETHICS IN RESEARCH - DR.

JESCEL BITO-ONON
1. What is a consent form and what are the considerations in writing the consent
form?

A consent form is a document signed by persons of interest to confirm that they agree
with an activity that will happen and that they are aware of the risks or costs that may come
with it.
Informed consent is the process of telling potential research participants about the key
elements of a research study and what their participation will involve.  The informed consent
process is one of the central components of the ethical conduct of research with human
subjects.  The consent process typically includes providing a written consent document
containing the required information (i.e., elements of informed consent) and the presentation
of that information to prospective participants.  
The consent form has two parts: (a) an information sheet describing the research and the
nature of the participant's involvement in it, and (b) a certificate of consent attesting to the
participant's consent. Both parts should be written in sufficiently large letters and in simple
language so that the participant can easily read and understand the contents. The information
sheet should be written in third person (e.g. "you will meet with the researcher…") whereas
the certificate of consent should be written in first person (e.g. "I have been informed
that…."). Medical terminology should be avoided in writing up the informed consent form.
The information sheet is given or read to each prospective participant. Any questions the
participant may have are then answered and, if consent is given, the certificate is signed by
the participant. If consent is oral, the certificate is signed by a literate witness who was
present when the information was read to the participant and who confirms that the
information was understood, and consent was given freely. The researcher/staff member who
provided the information to the participant also signs the certificate, likewise confirming that
the information was provided and understood, and that consent was voluntary. A signed
certificate of consent must be obtained in this way for each participant admitted to the
research study and a copy of the entire informed consent form must be offered to the
participant.
The consent sheet should include statements that: They have read and understood the
participant information sheet, They have had the opportunity to ask questions and had them
answered, Taking part in the study is voluntary, and there will be no penalty or loss of
benefits if they do not want to participate, If they do to agree to participate in your research
they are still allowed to change their mind and stop at any time, without having to face any
penalties or loss of benefits as a consequence, and If you wish to audio-record their
contribution, then you should ask their permission to do so.
Informed consent documents should be written in plain language at a level appropriate to
the subject population, generally at an 8th grade reading level.  A best practice is to have a
colleague or friend read the informed consent document for comprehension before
submission with the IRB application.
 The informed consent document should succinctly describe the research as it has been
presented in the IRB application.

1. Use the second (you) or third person (he/she) to present the study details.  Avoid use
of the first person (I).  
2. Include a statement of agreement at the conclusion of the informed consent
document. 
3. The consent document must be consistent with what is described in the IRB
application.
4. Indicate that this is a research study to distinguish it from routine care.
5. Clearly state that participation is voluntary and, if applicable, that current care will
not be negatively affected. Stating the voluntary nature of participation at the outset
allows the potential participant to hear the rest of the information in that context and
to hear it when they are most alert. It can be repeated near the end of the information
sheet as well.
6. Explain why the research is being done and why the prospective participant is being
asked to participate.
7. Describe, in sequence, what will happen in the course of the research, giving enough
detail for the participant to gain a clear idea of what to expect.
8. Explain the nature, likelihood and treatment of anticipated risks, discomfort or
adverse effects, including psychological and social risks, if any. Where relevant,
include a comparison with risks posed by standard treatments or drugs, and an
indication of whether the drug or procedure under investigation bears risks equal to,
greater than, or less than the standard. If the risks are unknown or a comparative risk
cannot be given it should be so stated.
9. Explain whether or not the research procedures offer any benefits to the participant or
to others. The research may not offer any benefit to the participant and this should be
stated clearly.
10. Where relevant, explain what will be done with the 'excess' biological samples that
may be taken as part of the research protocol - how soon after the research will they
be discarded or destroyed or for how long will they be stored, how will they be stored
and who will have access to these samples and under what circumstances. Who will
have the responsibility to eventually destroy or discard these samples? Note that if
unused samples are to be stored for future use, further consent is needed from the
participant and perhaps from the community in cases where the research is of a nature
that the community may be involved or affected.
11. State that all records are to be kept confidential. If absolute confidentiality cannot be
guaranteed, explain why this is so. Explain the extent to which the confidentiality of
participant-specific information will be protected during the research and in any
resulting public disclosures at meetings or in publications. Also state which persons
other than the researchers may have access to the records and/or to whom information
may be disclosed. State where and in what form participant-specific information will
be stored, and when, how and by whom it will be destroyed.
12. State that the participant has the right to refuse to participate or withdraw from the
research at any time without their current or future care being affected. State what
alternative treatments or procedures are available for both those who choose not to
participate in the research and for those who withdraw.
13. Explain how you will be sharing the research findings with participants. If you have a
plan and a timeline, state this in the information sheet. You should also state that you
 will be sharing the research findings more broadly and provide information about how
this is to be done, i.e. through scientific reports.
14. Contact information. The name, address and telephone number must be included on
the form of the person(s) to be contacted by the research participant if they have
questions about, or experience any problems during the course of, the research. These
should be persons who are available on site, intimately involved with the research
project and easily accessible to research participants, not chairpersons of ethics
committees or deans of schools or heads of departments.

2. What are tips in anonymizing quantitative data?

The best way to protect your participant's privacy may be not to collect certain
identifiable information at all. The second best is anonymization which allows data to be
shared whilst protecting participant’s personal information.
Anonymization is the process of turning data into a form that does not identify
individuals. Because social science is concerned with society and human behavior, an
anonymization strategy to protect the identity of participants is critical to ethical research. As
with consent, planning anonymization before undertaking data collection produces both
better informed consent and a less resource-intensive process of data anonymization.

The following are the tips in anonymizing a quantitative data:

1. Remove direct identifiers, e.g. personal information such as names and addresses
2. Aggregate or reduce the precision of variables that might be identifiable
3. Generalize text variables to reduce identifiability
4. Restrict continuous variables to reduce outliers
5. Pay particular attention to anonymizing relational data, for example, some
anonymized variables may become identifiable when considered in combination,
combining location with special educational needs

Procedures to anonymize any research data that are destined for sharing or archiving
should always be considered together with appropriate informed consent procedures

3. What are the tips in anonymizing qualitative data?

Anonymizing qualitative research data can be challenging, especially in highly

sensitive contexts such as catastrophic brain injury and end-of-life decision-making.
Anonymization of qualitative data can be particularly complex, and is not simply a
matter of removing personal information such as names or addresses, or of using pseudonyms
You do not need much of somebody’s life history to work out who they are, if you know
them, or if they are distinctive in some way. A distinctive event or combination of
descriptions in a qualitative account could make somebody recognizable.

The following are the tips in anonymizing a qualitative data:

1. These concerns can mean that qualitative data may need some editing to ensure their
anonymity. When the data editing is complete, researchers should take care that:
2. The editing has not distorted their data or changes what the data is telling you, for
example, deleting all possible identifiers from text or sound recordings is a simple but
blunt tool that creates data that are confidential but may be unusable.
 Qualitative data that undergo anonymization are the following
1. People’s names
2. Places
3. Religious and cultural backgrounds
4. Occupation
5. Family relationships
6. Other potentially identifying issues

4. What are to be considered if the participants of your research are children?

Children are considered a vulnerable research population because their intellectual and
emotional capacities are limited. They are legally incompetent to give valid informed
consent. Children (typically under 17) cannot provide informed consent.  As such, parents
must permit treatments or interventions. In this case, it not termed "informed consent" but
"informed permission."  An exception to this rule is a legally emancipated child who may
provide informed consent for himself. Some, but not all, examples of an emancipated minor
include minors who are (1) under 18 and married, (2) serving in the military, (3) able to prove
financial independence or (4) mothers of children (married or not). Legislation regarding
minors and informed consent is state-based as well. It is important to understand the state
laws.
When research involves children or people considered to be unable or not competent to
sign for themselves, a consent from a parent or guardian is required. However, children or
others considered to be unable to sign for themselves, should be given the opportunity, where
at all appropriate, to have their permission or concerns recorded as well. This is known as
Assent and there is a separate form for the recording of assent. The age at which assent is
required depends upon local legal requirements or, in their absence, upon both the local
culture and the content of the research. In general, researchers should consider obtaining
assent from children over 7 years with mandatory assent required from the age of 12. Assent
which is denied must be taken very seriously.
When research involves children such as this 9-year-old, investigators and institutional
review boards (IRBs) cannot rely on the conventional concept of informed consent, which
applies to decisions about research participation made by those with the legal and intellectual
capacity to make such choices in their own right. Children usually lack such capacity.
Instead, legal authority to allow a child's participation in research rests with parents or
guardians, who must provide their permission. In addition, with respect for children's
emerging maturity and independence and consistent with federal regulations, investigators—
when appropriate—seek to involve children in discussions about research and obtain
their assent to participation.
Research involving children is divided into two categories: minimal risk research
(classroom observation, curriculum evaluation, and standardized testing analysis) and greater
than minimal risk research (experimental learning techniques, sensitive data collection, and
therapeutic interventions).  Many studies of greater than minimal risk should provide the
prospect of a direct benefit to a child. Otherwise, these studies are approved to use this
vulnerable population as subjects because it presents a reasonable opportunity to further our
understanding, or our ability to prevent, or alleviate a serious problem affecting the health or
welfare of children. These studies may include an intervention or procedure that attempt to
replicate actual, or expected psychological, social, or educational situations.
As the child’s parent or guardian it is your responsibility to ensure your child’s well-being
and safety.  You will be asked to provide informed consent for your child’s participation in
the research study.  Moreover, if your child is able comprehend the research study they too
will likely be asked to assent to participate.  It is important for investigators to acquire the
assent of children to the extent possible as well as the informed consent and permission of
parents. It is the responsibility of the Principal Investigator (leader of the research project) to
provide you with this information.  However, it is your responsibility to ask any questions
you may have about your child’s involvement.
Additionally, here are some items you’ll want to think about while contemplating your
child’s participation:
 What is being asked of your child?
 What are the direct benefits?
 What are the risks?
 Is the data being collected sensitive (i.e. ask about sex, drugs, or criminal behavior)?
 How much time is required?
 Do researchers know my child’s identity?
 How is my child’s identity protected?
 Transportation issues
 Does the study require that your child be removed from class?
 Does my child want to participate?
 What are the advantages (or disadvantages) of participating (or not participating)?

5. Give three research misconduct and explain each.

Researchers are expected to adhere to ethical, legal, and professional guidelines that
structure how research is conducted. The consequences that research misconduct can
have are considerable and potentially disastrous. For one, misconduct can irreparably
erode trust among colleagues. It can erode trust between researchers and funding
agencies, which may make it more difficult for colleagues at the same institution to
receive grants. More importantly, research misconduct can cause the public to lose
confidence in the ability and integrity of researchers.

“Plagiarism is the appropriation of another person's ideas, processes, results, or words

without giving appropriate credit.” Norms can vary within different fields concerning
the proper way in which to attribute credit, so it is crucially important for researchers
to familiarize themselves with relevant citation conventions.

“Fabrication is making up data or results and recording or reporting them.” In other

words, fabrication is the practice of generating data without having performed the
relevant research. Research findings should not be discussed, shared, or published
unless the work has been genuinely undertaken.

“Falsification is manipulating research materials, equipment, or processes, or

changing or omitting data or results such that the research is not accurately represented
in the research record.” Selectively eliminating data points resulting from an intent to
generate a misleading conclusion is one example of falsification.
6. As part of research ethics how would you store data that are in (a) hardcopies and;
(b) computer files?

7. How ethical principles are upholding even after completion of research or during
publication?

8. Give 5 questions will you ask of yourself if you will incorporate ethical principles
before a research process?