CEBU DOCTORS’ UNIVERSITY and should not hesitate to give authorship

COLLEGE OF REHABILITIVE SCIENCES credit where there is due.

DEPARTMENT OF PHYSICAL THERAPY GUIDING PRINCIPLES IN CLINICAL RESEARCH:
1. AUTONOMY
RESEARCH ETHICS
Self-determination and capacity of individuals to
RES 1 PT
Prepared by: Jan Ross Therese V. Sarmago, PTRP make decisions affecting their lives and to act
on those decisions
ETHICAL OBLIGATIONS AND RESPONSIBILITIES
OF A RESEARCHER:
• Honesty and integrity in all phases of the 2. BENEFICENCE
research process (beginning with the Refers to the obligation to attend to the well-being of individuals. “Maximize possible
choice of a research question. benefits and minimize possible harm”.

• Set priorities and pursue questions that

are relevant to important health care
issues. 3. JUSTICE
• Do clinical research that is meaningful. Fairness in the research process or the equitable distribution
Should be able to justify a project based of the benefits and burdens.
on the potential scientific value of its
results.
• Obligation to a sound research design
with an appropriate sample. RESEARCH MISCONDUCT:
• Research should be conducted by 1. FABRICATION
competent investigators who have to do The making up of data or results and recording or in reporting
reliable and valid work. research results.
• It is not ethical to involve patient in a
study, with potential risks to them, when
the study has little chance of making a
scientific contribution. 2. FALSIFICATION
• During data collection: Manipulating research materials, equipment, or processes, or
changing or omitting data or results such that the research is not
o Researchers must be careful to
accurately represented in the research record.
minimize the effect of personal
bias in measurement.
▪ Unconscious or purposeful
inaccuracies in 3. PLAGIARISM
measurement The appropriation of another person’s ideas, processes, results, or
▪ Influential interactions words without giving appropriate credit.
between researcher and
subject that alter the
subject’s behavior.
▪ Bias cannot be eliminated USE OF CONTROL GROUPS:
but should be recognized • A basis for experimental comparison.
and controlled as much as • PLACEBO CONTROL GROUP:
possible. When its necessary to compare a new treatment with a no-
o Falsification or misinterpretation of treatment condition. When the purpose of the study is to
data that serve only to hinder the determine whether a particular treatment approach is being
truth and progress. questioned bec. current knowledge is inadequate.
o Statistical procedures should be
appropriate
o Data should not be manipulated *** “DECLARATION OF HELSINKI”***
for the sole purpose of obtaining a A statement of ethical principles for medical research involving
significant result. human subjects, including research on identifiable human material
o All data should be included in the and data.
analysis, and true differences or
the lack of true differences should
be reported. INSTITUTIONAL REVIEW BOARD IN RESEARCH
• Researchers should be aware of potential • Reviews research proposals prior to
conflicts of interest that may lead to implementation to ensure that rights of
misconduct. research subjects are protected.
• The researcher should know who would • Composed of at least 5 members that are
control dissemination of information. fully competent to review the scientific
• The researcher should be clear as to who details of proposed research.
owns the data and who can access it once • Studies the procedure for selecting
the project is completed. subjects.
• The researcher has an obligation to • Ensures voluntary informed consent
publish findings and to be thorough and based on complete and understandable
honest in reporting results. description and conforming to the
• Agreements about authorship should be applicable elements of the “Privacy rule”.
made early in the course of the project • Studies the risk-benefit ratio

This material was developed by Jan Ross Therese V. Sarmago, PTRP for the BSPT Level 3 students enrolled in CDU. Using
this document for other purposes, kindly seek permission via email at jarosarmago@gmail.com
 RISK-BENEFIT RATIO o Waiver or Alteration of the
Requirements for Informed Consent
The ratio of the risk of an action to its potential
Research is conducted w/o obtaining consent from the participant
benefits

It evaluates the ff:

• Risk
Defined as the probability of physical, psychological, social, or economic harm occuring as a o Informed Assent
result of participation in a research study. Both the probability and magnitude of possible harm in
human research may vary from minimal to considerable. The process where by minors agree to participate in clinical trials

• Minimal Risk
Exist where the probability and magnitude of harm or discomfort anticipated in the
proposed research are not greater in and of themselves than those ordinarily
encountered in daily life or during performance of routine physical or psychological
examinations

• Benefit ELEMENTS OF THE INFORMED CONSENT:

Applies to the potential of the research treatment to ameliorate a condition or treated 1. ____________________________________
disease. This can apply to an individual participant or to a population.
- A clear explanation of the reason for doing
the study and why it is important.
- Reason for selecting this particular individual.
EXPEDITED OR EXEMPT REVIEW: 2. ____________________________________
- Expedited review: - A clear detailed explanation of what will be
o Recording data from subjects 18 years done by the individual.
of age or older using noninvasive 3. ____________________________________
procedures routinely employed in - Truthful and inclusive statements of risks that
clinical practice. may result and discomforts that can be
o Moderate exercise by healthy expected.
volunteers. 4. ____________________________________
o Done by at least one designated - Description of potential benefits of the
member of the IRB. individual participant, to the general
o Usually completed in less time that knowledge, or to future administration of
that required for a board review. health care.
- Exempted: 5. ____________________________________
o Surveys, interview, or studies of - Reasonable alternative procedures that might
existing records, provided that the be used in the treatment of this individual
data are collected in such a way that when a treatment intervention is being
subjects cannot be identifies. studied.
o Surveys or interviews will only be 6. ____________________________________
exempted if they do not deal with - Statement in the procedure that ensure
sensitive issues, such as drug abuse, anonymity of the individual in collecting,
sexual behavior, or criminal activity. storing, and reporting information and who will
INFORMED CONSENT: have access to the information.
- Addresses the basic principles of autonomy, - Specific authorization
beneficence, and the subject’s - Information that may be used
comprehension of that information, consent - Purpose
elements, assurance of subject’s voluntary - Authorization must be signed as part of the
nature, and the subject’s competence to informed consent document or as a separate
consent and authorization to use data in a document.
manner specified in the protocol. 7. ____________________________________
- Types of Consent: - A statement that the individual may ask
o Written questions about or discuss participation in the
▪ Standard Written Consent study at any time, naming an individual to
contact.
Participants sign a consent form to indicate that they agree
8. ____________________________________
to participate in a study.
- Participant may refuse or withdraw
participation at any time without prejudice.
9. ____________________________________
▪ Short Form Written Consent - Measures to be taken if injury occurs as a
direct result of the research activity.
Participant signs a shortened, non-english consent
10. ____________________________________
document n a language the participant understands.
- Confirmation that the individual consents to
participate in the research project.
11. ____________________________________
o Waiver of Documentation of Consent - Participant
Participants consent to be in the study, but do not sign sa consent form - Parent or guardian (for the care of minors)
- Assent of minors over age 7
- Witness

-----------------------end of notes-----------------------

This material was developed by Jan Ross Therese V. Sarmago, PTRP for the BSPT Level 3 students enrolled in CDU. Using
this document for other purposes, kindly seek permission via email at jarosarmago@gmail.com