General Topics
1. What is an IRC (Institutional Review Committe)?
Any research that is done in Nepal has to be reviewed and approved by NHRC (National Health Research Council). To make this review process easy and quick, NHRC has recognized IRC in our Lumbini Medical College to review all research conducted in the College, and to set forth institutional policy governing such research. The IRC has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. The IRC primary role is to ensure the protection of human participants as subjects of research at LMC.
2. When am i supposed to submit the proposal/protocol to the IRC?
Proposal/protocal for all research that is intended to be conducted in the LMC must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
3. I am just doing a simple survey; do I need to submit my proposal/protocol to the IRC?
Yes, if the study meets the definition for research. NHRC states that all research being conducted under the auspices of this institution (LMC) is subject to review and approval by the IRC. Written approval from the IRC must be in place before any interventions or interactions with human participants actually begin.
4. I am not collecting any identifying information in my research project. Do I need to submit my proposal to the IRC for review?
Yes, if your research project involves active data collection. ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
5. Do research projects conducted by LMC (Medical/Nursing) students need IRC approval?
Yes. Projects conducted by LMC undergraduate and graduate, medical or nursing students need IRC approval, if the project fits the definitions of “research” and “human participants”. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes.
6. I will be collaborating with another institution. Do I need to submit to IRC-LMC and the other institution?
If you are a member of the LMC faculty or staff, or a LMC student, and you are the person responsible for the conduct of the study (Principal Investigator), you must get IRC-LMC approval to conduct your research regardless of where the research takes place. Investigators should contact the IRC office whenever collaborative research is occurring. Separate applications for each institution may be necessary. In such cases, IRC will forward such protocol/proposal to NHRC to finalize the approval.
7. I am planning to do an oral history project; do I need to submit my proposal to the IRC?
Researches that involve the collection and use of oral histories or life histories may meets the definition of ‘human subjects research’. Such research requires an application to the IRC office.
8. I am developing case studies; do I need to submit my proposal to the IRC?
Studies that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, meets the definition of ‘human subjects research’ and requires review by the IRC office.
9. Does journalism require IRC review?
The reporting of current events, trends, newsworthy issues or stories about people or events generally does not meet the definition of ‘human subjects research’ and therefore requires no application to the IRC office. However, reporting intended to draw conclusions may require review by the IRC.
10. When may I begin data collection for my study?
You must receive written approval from the IRC before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRC approval.
11. How long will it take for me to obtain approval to do my study?
That depends on the nature of your study and timing of your submission of protocol/proposal. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow about 2 weeks for IRC review. Research projects that involve greater than minimal risk to participants will need to go to the full board for review, which is scheduled once every month. For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study. We will regularly inform you about the deadline of protocol/proposal submission to be reviewed by the full board on that month. If you just miss that deadline, it may take a longer period for approval of your study.
12. Can the IRC approve a project “retroactively?”
No. There is no provision that allow for IRC approval of research that has already been conducted.
13. Who can I talk to if I have a question about my research project?
The IRC staff is available to provide assistance to investigators who are engaged in research with human participants. You can also explore the IRC website for detailed information about the IRC Standard Operating Procedures (SOPs), policies and procedures, forms, meeting schedule and other important information. Your can call to IRC office (ext: 888) or write to us at contact@irclmc.edu.np for any assistance.
13.1 I do not belong to LMC. Still I want to collect data from LMC as a part of my research. What should i do?

We are sorry. Currently, LMC does not permit research work in LMC for the outsiders (Non LMCians). Lets hope, the policy will be changed in near future.

Application Process

14. I don’t know where to start to write a protocol. What needs to be included?
Every new protocol submitted to the IRC must include completed and signed forms available at www.irclmc.edu.np/forms/. For more information contact the IRC office for assistance, www.irclmc.edu.np/contact-us/
15. Are there “sample” protocol submissions available for research projects?
Unfortunately, not at this time. The IRC staff is available to answer questions about the IRC review process and to assist investigators in the preparation of protocols. On the IRC website there are several IRC policies that can guide the researcher in determining IRC requirements in approving a protocol. The IRC also encourages researchers to consult with colleagues and/or faculty advisors who have done research at LMC for advice in preparing research protocols. We may have a “sample” protocol in near future.
16. What does the IRC look for in an application? Are there standard criteria for evaluation?
The IRC evaluates every research protocol according to the evaluation checklist based on ethical principles. Basically, this means the IRC considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.

Consenting Process

17. What does ||informed consent|| mean? What are its essential components?
Fully informing participants of the risks, benefits, and procedures involved in a study is a standard requirement in research with human participants. Ethically and legally, consent is not considered to be “informed” unless the investigator discloses all the facts, risks, and discomforts that might be expected to influence an individual’s decision to willingly participate in a research protocol. This applies to ALL types of research including surveys, interviews, and observations in which participants are identified, and other experiments, such as diet, drug and exercise studies. For more information please go through the informed consent section of SOP.
18. Are there different types of informed consent? What are they?
The informed consent process can take on various forms:

  • Signed informed consent is the standard expectation in research with human participants. This is in the form of a document with the elements of informed consent, signed and dated by the participant and kept as a record by the researcher.
  • In research with children (individuals under 18 years old), assent of the child and parental permission are standard requirements.
  • In research with patients with mental disorders, guardian permission are essential
19. What do the terms “consent” and “assent” mean? Aren't they the same thing?
Both consent and assent involve informing potential participants about the research and its risks and benefits, and documenting their understanding and agreement to participate. The reason the different terms are used has to do with the age of the participants. In research involving adults, “consent” is obtained from individuals to participate in the study. In research involving minors, a parent must give permission to allow the child to participate in the research, and children who are able to understand information about participation are asked to “assent” or agree to participate as well.
20. Do I always have to obtain the informed consent of research participants?
In general, yes. The IRC-LMC is responsible for ensuring that basic ethical principles are abided by in all research.
21. What is signed informed consent?
Used most commonly, signed informed consent allows prospective participants to document their agreement to take part in research activities by signing and dating the consent document.
22. I am not collecting any identifying information. Do I still need an informed consent form?
Yes.
23. What is ||implied|| consent?
Implied consent is the tacit indication that a person has knowingly agreed to participate in research by performing a research activity or task. By completing the research task (e.g., completion of a questionnaire, interview, survey, etc.), the participant has provided consent to participate in the research. There are a number of instances where this type of consent is helpful. For example, you wish to mail out a survey. The survey does not ask for any identifiable information. The cover letter accompanying the survey could be written in such a manner as to serve as the “implied” informed consent form. The letter would need to contain a statement indicating that completion and return of the survey implies consent to participate in the research.
24. How is the consent process handled for Internet-Based research?
For Internet-based surveys, it is sometimes appropriate to use implied informed consent. Participants would still need to be presented with the consent information, but would be informed that their consent is implied by submitting the completed survey.

Trainings

25. What are the IRC requirements for training?
All investigators and research staff in LMC are expected to participate the training in the ethical conduct of research with human participants and update it regularly. IRC-LMC will be conducting or arranging for such training once or twice yearly. Additionally, investigators and research staff must be qualified by training and experience for the research they will be conducting. It is important to understand that the responsibility for the welfare of participants lies with the principal investigator, even when participants have given consent. Investigators and research staff must have the necessary training and expertise to

  • Ensure the rights, welfare and safety of participants are protected
  • Comply with regulations concerning IRC review and approval, including
    • Informed consent requirements
    • Reporting requirements
    • Maintenance and retention of records (keep complete files during and 5 years after research ends)
  • Supervise research conduct
  • Apply relevant professional standards that are applicable to the research
26. Who is required to complete the human participants training?
All faculty, students, and staff proposing to use human participants in research under the auspices of LMC are expected to complete the human participants training.
27. Does the Institutional Review Committee Office provide any other training for investigators about the IRC?
Yes. The IRC office staff strives to provide information and assistance to investigators and research staff in several ways. Several times throughout the year the IRC may hold formal seminars to help educate the research community about different IRC and human research topics. Arrangements can be made to have IRC staff present informational sessions for small groups which can be tailored for the needs of a specific group. The IRC staff is available during LMC business hours to answer your questions about the IRC process and provide assistance with any human subjects.

Life-cycle of Protocol

28. When should a modification (amendment) to an approved research study be submitted?
Any and all changes to an approved research study must be submitted for review and approval prior to implementing the change(s) into the research study.
29. What do I have to do if I need to amend my approved research study?
Investigators with approved projects must submit an Amendment application if there are significant changes involving any of the study protocols, study design, informed consent procedures, or principal investigator team. The administrator and chair of IRB review all amendment applications, and assign them to either expedited or full committee review. Amendment application form will be uploaded in the form section of www.irclmc.edu.np
30. Does approval of an amendment to an approved research study extend the original approval date?
No. The expiration date of the original approval is not changed by the review and approval of an amendment.
31. After my approved protocol has passed the one year expiration date what do I do?
If IRC approval of the human research expires, all study procedures related to the protocol under review must cease, including recruitment, advertisement, screening, enrollment, consent, interventions, interactions, and collection of private identifiable information. Continuing human research procedures is a violation of regulations. You need to receive continued approval from the IRC in order to continue research.
32. How do I obtain continued approval (renewal) for my research study?
It is the responsibility of the principal investigator (PI) to ensure continued approval of his or her human participant research study. If approval is allowed to expire, all research on the study must cease until renewed approval is granted. Progress of approved research must be reported, in the manner prescribed by the IRC, on the basis of risks to participants, no less than once a year.

Adverse Events/ Unanticipated Events

33. In the case of a potential unanticipated problem involving risks to participants or others, when is the principal investigator expected to report this occurrence to the IRC?
Serious adverse events must be reported to the IRC immediately, with a written report by the principal investigator (PI) following within 24 hours of the PI’s becoming aware of the event. Serious adverse events are (1) death of a research participant; or (2) serious injury to a research participant. All other non-serious unanticipated problems should be reported to the IRB within 2 weeks of the first awareness of the problem by the Protocol PI or another researcher. Prompt reporting is important, as unanticipated problems often require some modification of study procedures, protocols, and/or informed consent processes. Such modifications require the review and approval of the IRC.
34. Can the IRC temporarily or permanently discontinue a research project as result of an unanticipated problem involving risks to participants or others?
Yes. If an unanticipated problem poses a risk(s) to the participants or others, the IRC may temporarily discontinue a research project until a thorough investigation has been conducted. Dependent on the investigation, the IRC may request changes to a research study or permanently discontinue the research study.
35. Can the IRC request revisions to the approved research study and the informed consent form as a result of an unanticipated problem?
Yes. As a result of the IRC’s investigation of the unanticipated problem, revisions to the approved research study and the informed consent form may be requested.