Application for Initial Ethics Clearance

January 25, 2021

Kindly refer to this post for the more details: Revised Guidelines for Thesis/Dissertation/Capstone Project for SY 2020-2021 | Ateneo de Manila University

ADMUREC Form 1 - Guidelines and Application Form for Ethics Clearance for Research with Human Participants:
For Expedited or Full Review

Application Instructions:
§ Submit the following as SEPARATE PDF FILES together with the application form:
o Research protocol: title, investigators and affiliations, research objectives, significance, brief literature review/conceptual framework, full methods (description of sample, setting, recruitment, inclusion criteria; instruments and procedures), ethical considerations pertinent to the study, research budget
o Participant recruitment materials/letters/scripts/templates
o Informed Consent Forms (ICF) and Assent Forms (if applicable)
o Funding/Grant/Sponsor letter or contract and/or Memorandum of Agreement among collaborating institutions (if applicable)
o Letters from relevant collaborating offices or data collection areas indicating that the proponent can conduct the study in the setting pending ethics clearance, e.g. schools, companies, barangays; note that certain settings may have inherent risks and reviewers may request additional information
o Instruments, questionnaires, interview or FGD scripts and protocols
o 1-2 page CV of Principal and Co-Investigator(s)
o 2 copies of AdMUREC Form 2: Application Submission Checklist
§ Submit the soft copy of the application form and the soft copies of all the attachments in separate PDF files and the hard copy of the application form (only) to the University Research Ethics Office (UREO). The hard copy must have the required signatures.
§ Obtain the official and dated acknowledgment (Ethics Clearance Application Submission Checklist) from the UREO that your application and attachments are complete and had been received by the office.
§ For assistance, contact the UREO (Tel. No.: +63 2 426-6001 ext. 4030 or Email: univresearchethics@ateneo.edu)
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Guidance Notes – please read p. i-ii prior to completing the application form. Do not print or include p. i-ii when submitting the form.

The AdMU Research Ethics Committee (AdMUREC) conducts expedited and full reviews of research with human participants. Check the Guidance Note on Exclusions and Exemptions to determine whether your research is exempt from ethics review. If possibly exempt, complete the Form for Validation of Exemption and submit to the UREO to validate exempt status.

An expedited review is conducted by at least two (2) members of the UREC designated by the UREC Chair, rather than deliberated in a convened UREC meeting with the prescribed quorum. In an expedited process, the assigned reviewers exercise all the authorities of the UREC except that the reviewers may not disapprove the research. A research activity may be disapproved only after full review in a UREC meeting.

Criteria for expedited review

The research protocol may be eligible for expedited review IF:
1) the research activities present no more than minimal risk to human participants, AND
2) the research involves one or more of the activities listed in the categories of research below.

If your project does not fall under any of these categories and/or it presents greater than minimal risk to participants, it will be subject to full review in a convened UREC meeting.

Minimal risk is defined as the probability and magnitude of physical and psychological harm that is normally encountered in daily life, or in the performance of routine medical, dental, or psychological examination of healthy persons. If the risk level of your study is greater than this, then it may be “greater than minimal risk”.

    Category 1: Clinical studies of drugs and medical devices only when condition (a) or (b) is met:
(a) Research on drugs for which the national drug registration authority (i.e. Food and Drug Administration or FDA) has approved the drug for distribution or (ii) the filing and submission of applications as indicated in FDA Circular 2014-009 is not required. (However, research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product should undergo full review.)
(b) Research on medical devices which have been cleared/approved for marketing by the FDA and the Bureau of Health Devices and Technology (BHDT) and the medical device is being used in accordance with its cleared/approved labeling. (However, FDA requires researchers to comply with ISO 14155:2011 for medical device investigations.)

    Category 2: Collection of blood samples by finger stick, heel stick, ear stick or venipuncture in amounts and frequencies in accord with the age, weight, health of the participant (e.g. from healthy, non-pregnant adults who weigh at least 110 pounds: the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week)

    Category 3: Prospective collection of biological specimens for research purposes by non-invasive means. Examples include: Hair and nail clippings; Deciduous teeth or permanent teeth if routine extraction; Excreta and external secretions (including sweat); Uncannulated saliva; Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings

    Category 4: Collection of data through non-invasive procedures routinely employed in clinical practice, not involving general anesthesia or sedation, and excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must have been cleared/approved for marketing and use. Examples include:
        o     Physical sensors that are applied either to the surface of the body or at a distance, and do not involve input of significant amounts of energy into the participant or an invasion of the participant's privacy;
        o     Weighing or testing sensory acuity;
        o     Magnetic resonance imaging;
        o     Electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography;
        o     Moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

(Studies intended to evaluate the safety and effectiveness of medical devices are not generally eligible for expedited review, including studies of cleared medical devices for new indications. Refer to FDA and ISO 14155:2011 for additional guidance.)

    Category 5: Research involving materials (existing data, documents, records, or specimens) that are collected for non-research purposes (such as medical treatment or diagnosis). (However, if these sources are publicly available or if the information is recorded in such a manner that participants cannot be identified, the study may be exempt for review; refer to Guidance Note on Exclusions and Exemptions.)

    Category 6: Collection of data from voice, video, digital, and/or image recordings

    Category 7: Researches on individual or group characteristics or behavior (including but not limited to research on   perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (However, refer to Guidance Note on Exclusions and Exemptions for possible exemptions of such studies from review.)

ADMUREC Form 1 - Ethics Clearance Application for Research with
Human Participants: For Expedited or Full Review

Project Title:

Principal Investigator:	Ateneo ID (e.g., 10011):

University Status: (Faculty, Staff, Graduate Student, etc.):
School / Department / Center:
Email Address:
Telephone Number: Mailing Address: Guidance Note: Undergraduate student research is reviewed by department-level ethics reviewers; consult adviser or Department Chair for forms and procedures.

Faculty Adviser, if PI is a student:	Ateneo ID (e.g., 13250):

Email Address:	Telephone Number:

School and Department:

Mailing Address:

Is there anyone you wish to include in correspondence related to this study (e.g., a study coordinator, etc.)?

Name:	Ateneo ID (e.g., 12450):

University Status: (Faculty, Staff, Student, etc):	Role in this study:
School / Department / Center:
Email Address:
Telephone Number: Mailing Address: