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Frequently Asked Questions on Research Ethics Review of Graduate Student Research

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Would you like to know how the 2022 NEGRIHP answers the following research ethics FAQs?

1. What is research? What is research involving human participants?
2. What is a research protocol?
3. What should be included in a research protocol?
4. What does it mean for participants to have informed consent?
5. What do REB members assess when reviewing research protocols?
6. What’s the difference between a “researcher” and an “investigator”?
7. Who is a “qualified” researcher?
8. Are undergraduate students “qualified researchers?
9. What are the key responsibilities of a researcher?
10. What are the responsibilities of the research adviser?
11.What is the difference between a “technical review” and an “ethics review?
12.What are the responsibilities of REB in a research ethics review process?
13.What types of reviews are done by the REB?
14. What studies may be categorized as “EXEMPT from review”?
15. What types of studies may be categorized under “DELEGATED REVIEW?
16. What is minimal risk in the context of research involving human participants?
17. Is it okay to conduct a study that has more than minimal risk?
18. Studies that involve vulnerability issues will pass through a FULL (PANEL)
REVIEW. What is vulnerability, and who are the vulnerable groups?
19. Do I need to consider any vulnerability issues when researching with people?
20. Is it really necessary to consider sex and gender in designing, implementing,
and reporting research involving human participants?
21.Is there a way by which I can effectively integrate sex and gender considerations
into my research?

Click and download the file below.
Research Ethics FAQs and answers from the 2022 NEGRIHP (As of April 2024)

What type of research requires REB review?

All research involving human participants requires an ethics review. Research ethics review is done to protect human research participants in all areas of research that relate to their health and in the context of existing and emergent challenges that face all research stakeholders (NEGRIHP, 2022). In the PNHRS Law, health is defined as “optimal state of physical, mental and social well-being and the ability to function at the individual level.”

If the research involves human participants (i.e., survey respondents, participants in key informant interviews and focus groups, presence in field observations), the principal investigator should apply for ethics review and approval BEFORE the study begins.

My research will use secondary data (i.e., meta-analysis). Should I still apply for REB review?

Please refer to this link for the types of review. Some researches that use secondary data of human participants may be exempted from review. However, an exemption can only be issued by the REB. Thus, it is still required to be submitted for review. 

My research will be conducted online (i.e., survey). Should I still apply for REB review?

Yes, all research involving human participants requires ethics review. 

I have already started my data collection. Can I still apply for REB review?

No,  research ethics approval should be secured BEFORE the conduct of the study (including participant recruitment). In the UPLB REB FORM 2(B)_Registration and Application Form Section 3.3, the start date of the study includes the start of recruitment. 

How do I apply for a REB review?

  1. Have an approved research proposal (Guidance Committee Approval). It is recommended that the research proposal/protocol includes the following (refer to Appendix K of  NEGRIHP 2022 pages 334-342 for more information):
    1. Justification of the need for the study and proposed methods.
    2. Description of the recruitment process.
    3. Description of the dissemination plan for research results.
    4. Detailed description of all procedures.
    5. Measures to address all the elements of research ethics (see NEGRIHP 2022 page 31-47).
    6. Information on the protection of the research participants and staff. This includes a detailed procedure of the informed consent process.
  1. Complete a Basic Research Ethics Training module that provides a certificate of completion. Here are recommended courses that are free, online, and self-paced:
TCPS 2 CORE 2022  (Course of Research Ethics)Based on Canada’s Tri-Council Policy Statement: Ethical Conduct for Research Involving Humans (TCPS 2)Nine modules
Essential Elements of Ethics11 ModulesDesigned for clinical researchers and ethics committee members
  1. Prepare all documentary requirements for REB application. Click here for the list of documents. 

Prescribed UPLB REB FORMS  must be filled out correctly, completely, and neatly. If not applicable, kindly indicate “N/A”

  1. Submit complete documents to [email protected] and one (1) set of printed copies to the 2nd Floor, Graduate School International Student and Cultural Center, University of the Philippines Los Baños. Click here for more information.  
  2. Check your email for notice of acknowledgment, clarifications, and recommendations. 
  3. Conduct your research upon receipt of approval from REB.
  4. Submit post-approval documents as necessary.
  5. Report any adverse events to the REB.
  6. Submit the final report and receive ethical clearance from REB.

What are common reasons why a research ethics application may be returned to the researcher for amendment or revision?

  1. The application form was not properly filled out. Some entries were unanswered (e.g., missing signatures).
  2. Some of the necessary documents (e.g., informed consent forms in English and relevant local language, research protocol) were missing. 
  3. The reviewers need further information about some aspects of your study. 
  4. The informed consent forms were poorly written. Ask: Is the Information Sheet and Informed Consent Form written in plain language?  (R. Eagleson explains that a document in plain language has “clear, straightforward expression, using only as many words as are necessary, avoids obscurity, inflated vocabulary and convoluted sentence construction.”) For further guidance, check the UPLB REB Guideline 003 Guidance on the Informed Consent Form (ICF) and Template.
  5. The risks involved in the study were underestimated or not properly assessed. Please check UPLB REB Guideline 002 Guidelines on the Assessment and Mitigation of Risks in Research Involving Human Participants. The NEGRIHP 2022 is particularly helpful in identifying circumstances of vulnerability that may arise in conducting research activities  (pages 91-93) and addressing risks to people involved in research (pages 97-97).
  6. The risk mitigation measures are inadequate. DO NOT JUST CITE or write a general statement. Provide adequate details of good practice strategies as adapted/translated/applied to your specific research project.

The recommended Basic Research Ethics training is not based on Philippine social realities. Do you have an equivalent online course?

The courses cited above are recommended for a number of reasons. First, they are most accessible, free, and self-paced. While they are not directly related to the realities of research in the Philippines, they cover universal ethical principles of respect for autonomy and dignity, concern for welfare, and justice. The UPLB REB intends to develop a similar training course adapted to our university setting.

For now, the single most important resource that you need to be aware of is the NEGRIHP 2022. 

You can download an advanced copy of the NEGRIHP here.

We recommend that you read the General Guidelines (pages 13-82) and any of the Special Guidelines (e.g., social research, children, person disabilities, older persons, uniformed personnel, etc.) that may apply to your proposed project.

How long will the review process take?

The length of review depends on the completeness of submitted documents, the type of review, and the speed of resubmission of revised documents. Below are the timelines of the different types of review. Note that these are for every submission and will restart upon resubmission.

  1. Exempt from review – ten (10) working days upon receipt of acknowledgement letter
  2. Delegated review – sixteen (16) working days upon receipt of acknowledgement letter
  3. Full board review – twenty-four (24) working days upon receipt of acknowledgement letter

How long is the validity of an ethics clearance?

Research ethics clearance issued by UPLB REB is valid for one year. If the study is extended, the clearance may be renewed by applying for continuing review before the expiration of the earlier ethics clearance.

I am very much interested in researching sensitive topics (e.g., illegal activities, child abuse, traumatic experiences, sexual behavior etc.). Can that be approved?

Research involving more than minimal risk must undergo a full board review. Approval will be based on:  justification of the need for the study, measures to address all ethical considerations, mitigation of risks for both the participants and the researcher, and qualification of the researcher.  

For social research on sensitive topics, the NEGRIHP 2022 (p.97) says:

The researcher shall have the necessary expertise and competency to undertake the study (e.g., education, training, and experience in the use of the specific method and subject matter). Competency shall also include sociocultural sensitivity to the population and community under study and awareness of the ethical issues involved. 

You may need to demonstrate your competency to carry out the study to minimize risks for people involved, avoid re-traumatizing participants, or exposing researchers to secondary trauma. Moreover, as of December 2022 and with a Level 1 PHREB accreditation, the UPLB REB can only approve research involving no more than minimal risk to participants and researchers.

I have secured a research ethics approval for my dissertation. However, I would like to change some of my methods. What should I submit?

As stated in your approval letter, only the accepted protocol version is approved. Any planned changes (even minor) must be reported and approved by the REB. You may submit UPLB REB 3(B)_Protocol Amendment Form to report changes in the study.