New protocols should be submitted at least 14 calendar days prior to the regular monthly meeting (SOP 7).
The committee meets every 2nd Thursday of the month (SOP 18).
The following are the deadlines for reports submission:
a. Adverse Events (AEs) – within 24 hours of the event (SOP 12-B)
b. Serious Adverse Events (SAEs) – within 24 hours of the event (SOP12-B)
c. Suspected Unexpected Serious Adverse Reactions (SUSARs) -if center specific, within 2 weeks and if not center specific, within 4 weeks after the event has come to the attention of the Principal Investigator (SOP 12-B)
d. Protocol deviations – within 4 weeks from the detection of the protocol deviation (SOP 11)
e. Protocol violations - within 4 weeks from the detection of the protocol violation (SOP 11)
The Annual Progress Report must be submitted at least 4 weeks before the expiry date of the approval (SOP 5).
As stated in CDUHREC FORM 19, the following are the review fees effective 10 October 2024:
a. New clinical trial application – Php60,000.00
b. Major/Substantial Amendment – Php15,000.00
c. Annual continuing review – Php15,000.00
d. Undergraduate & residents-in-training clinical research – Php2,000.00
e. Pharmacokinetic fee – Php30,000.00 f. SJREB-approved clinical trial – Php5,000.00
o Respect for Persons: Protecting autonomy and treating participants with dignity.
o Beneficence: Maximizing benefits while minimizing harm.
o Justice: Ensuring fair selection and treatment of participants.
Key guidelines include:
o CIOMS International Ethical Guidelines for Biomedical Research Involving Human Subjects 2016
o WHO Standards and Operational Guidance for Ethics Review of Health-Related Research with Human Participants 2011
o National Ethical Guidelines for Research Involving Human Participants 2022
o Philippine Health Research Ethics Board Standard Operating Procedures 2020
It is the process of providing participants with comprehensive information about the study, including risks, benefits, and alternatives, and obtaining their voluntary agreement to participate.
Yes, participants have the right to withdraw at any time without any penalty or loss of benefits.
Risks to participants are minimized by conducting thorough risk-benefit analyses, implementing safety monitoring, and using protocols approved by ethics committees.
Extra care is required to ensure these groups (e.g., children, pregnant women, or economically disadvantaged individuals) are not exploited. Additional safeguards include obtaining guardian consent or assessing risks uniquely.
Data collection should respect participant consent, avoid unnecessary procedures, and prioritize participant privacy and safety.
Participant confidentiality is maintained by:
o Anonymizing or pseudonymizing data.
o Encrypting records and limiting access to authorized personnel.
o Complying with privacy laws like the Data Privacy Act of 2012.
Yes, data from previous studies can be reused if the data is anonymized and the reuse aligns with the original consent and with CDUHREC approval.
Researchers must have a protocol in place to inform participants and provide appropriate medical referrals.
The CDUHREC evaluates the trial’s ethical aspects, ensuring participant safety, proper consent, and adherence to regulations before and during the study.
Using placebos may withhold effective treatment. Such trials are ethical only if no standard treatment exists or withholding treatment poses minimal risk.
Compensation is ethical if it is reasonable, does not coerce participation, and is clearly explained in the consent process.
Research should provide potential benefits to participants or contribute valuable knowledge, with minimal risk or discomfort.
Researchers must address privacy, potential misuse of genetic data, and implications for family members.
The following are necessary when conducting medical studies involving children:
• Parental or guardian consent is mandatory.
• Child assent is sought when appropriate.
• Risks must be minimal unless the research offers direct benefits.
The study must provide immediate medical care and, if applicable, compensation for injuries. Ethical oversight ensures these protocols are in place.
Researchers (Principal Investigators) must disclose financial, personal, or professional interests that could bias the study, and measures should be taken to mitigate their impact.
The following are considered unethical medical research:
• Coercion or lack of informed consent.
• Misrepresentation of risks.
• Conducting studies without ethical approval.
• Fabrication, falsification, or plagiarism in reporting.
GCP ensures the design, conduct, and reporting of clinical trials meet high ethical and scientific standards, safeguarding participant rights and data integrity.
International research must comply with local and international guidelines (e.g., the Declaration of Helsinki) and respect cultural and legal norms of the host country.
Violations can lead to study suspension, funding withdrawal, legal consequences, or damage to a researcher’s reputation.