Conducting Safe and Ethical Research

  • Division of Social Sciences

Researchers, philosophers and policymakers have developed ethical codes governing research on human subjects. Many of these policies were developed in response to notorious violations of subjects’ rights, such as the Tuskegee syphilis experiment, and have grown out of concern to protect both the researchers and vulnerable populations in particular. Most professional associations nowadays have clear guidelines on how to conduct safe and ethical research, including definitions of who might be considered a vulnerable person and why. For the most part, vulnerable groups are those people who are less able to protect their own interests. This might be someone with ill health, someone who is too young to legally consent to participate or too old to fully understand the consequences of participation, a person of minority status (e.g. a foreign worker or a refugee), or even a person in a hierarchical structure who feels obliged to do something they may not normally want to do.

While the consequences for ethical violations are extremely serious, most of the principles for guarding against such violations are fairly straightforward, such as obtaining participants’ informed consent and minimising potential physical or emotional harm.

In order to protect your research participants and yourself, it is vital that you 1) know the relevant ethical principles and guidelines, 2) design your research in accordance with these, 3) obtain the necessary approval before interacting with your participants, and 4) continuously put good ethical principles into practice. These steps, which are detailed below, should be carried out in conjunction with your capstone supervisor.

Step 1: Educate yourself about why ethics matter in research

The links below contain ethical considerations and procedures for working with human participants.

All students should complete the NIH training module. As part of the approval process (Step 3), students will need to upload a copy of their certificate of completion for the module.

  • NIH training module
    This is a thorough online training course in ethical research procedures, with quizzes and case studies. Allocate 2-3 hours to complete this training programme.

All students should read the Helsinki Declaration and Singapore’s Personal Data Protection Act Overview. Your capstone supervisor will determine whether the other resources are necessary for your project, and may direct you to other sites specifically relevant to your discipline or major.

Students should also read the documents for obtaining ethics approval before starting to design their capstone project, as this process is designed to advise and guide.

    • Helsinki Declaration
      A ground-breaking document first published in 1964 which laid down the foundations for ethical research. Pay particular attention to the section on ‘Informed Consent’ in paragraphs 25 – 32.
    • Personal Data Protection Act
      This legislation governs the gathering and use of personal data in Singapore, and applies to all research involving human subjects at Yale-NUS.
    • APA Ethical Principles of Psychologists
      This page sets out the American Psychological Association’s guidelines for conducting psychology research, and is relevant for research in other disciplines as well.
    • AAA code of ethics
      This is a thorough online training course in ethical research procedures, with quizzes and case studies. Allocate 2-3 hours to complete this training programme.

Step 2: Design your capstone project and assess its likely risks

In consultation with your capstone supervisor, design a capstone project that is consistent with the ethical principles and practices which you have learned.

The following is a set of questions designed to serve as diagnostics of risks and harm that your research may pose on yourself and other human participants. Answering yes to any of these statements would suggest that your research may incur risks on yourself and/or your human subjects, and care is needed in ensuring your research meets necessary standards of ethical requirements.

  • Will my research involve vulnerable groups? [1]
  • Do my research methodology and instruments potentially place my respondents at risk of emotional trauma, physical danger, or distress? [2]
  • Does my research involve any type of deception of human subjects? If so, is this deception justified and harmless? Are there alternative effective ways to achieve the same purpose that would not involve deception? Do I have a mechanism set for a proper debriefing afterwards?
  • Am I collecting and using my subjects’ personal identifying information and sensitive data?
  • Am I distributing any form of payment for those involved in my research?

[1] NUS considers the following as examples of vulnerable populations: students, subordinate populations, medical patients, pregnant women, people with limited citizenship protection (e.g., migrant workers), people engaged in illegal activities, minors, the educationally disadvantaged, people with mental disabilities, victims of violence, people engaged with alternate and risky lifestyles.  Click here for more information.

[2] Examples of real or potential harm include the following: Subjects are observed without their consent while involved in what they would consider a personal/private activity; Subjects are asked questions and their answers are recorded and made public with their personal identifiers; Subjects are asked questions that invoke psychological trauma, anxiety, and distress.

Step 3: Obtain approval

Once you have designed your capstone project, your responsibility is to get the project approved before you can commence with your research.

The Research Ethics Committee will be using a new platform called myYaleNUS, which creates a way for students to submit their forms online as a PDF upload and complete two forms we’ve developed online. The submission will be reviewed by supervisors and the HOS, and the REC will review cases as necessary. We hope this will streamline what is otherwise a cumbersome paper-trail process.

The onus is on the student to compile their various forms into a single PDF to upload.

Students will first do a “self-audit” form (RESCUE) and determine whether the project involves human subjects, which will indicate further forms to be completed. If no additional risks are determined by the RESCUE, students will submit it for approval on myYaleNUS. The student’s supervisor and Head of Study will then review it.

If the research project has the potential to incur a higher level of risk, such as 1) emotional, mental, physical and/or psychological risks on the human subjects, 2) placing student researchers at risk due to the nature of the questions examined or methodologies implemented, and/or 3) involving payments, deception, and use of human bodies, students will need to complete a human subjects clearance form (CHSER) to provide additional information. The CHSER will need to be submitted to myYaleNUS, along with other supporting documents, and approved by the REC in order for research to commence. Studies that may present more complex risks for either the researcher or human subjects will undergo a thorough review from the REC. This committee will handle such cases ad hoc and return with approval or comments for review within 2-3 weeks.

Flowchart for Ethical Review Process

  1. Work through the following checklist with your supervisor
  2. If completion of the RESCUE indicates further action is required, you must complete some or all of the forms listed below:

    There is no deadline for the completion of these forms. Students are advised to submit forms as early as possible to flag complex cases that may need to go to the REC, and to enable projects to be approved by their supervisors before research commences.

  3. Once the supervisor and the Research Ethics Committee are satisfied with the above, students will be notified and research can commence.

TIMELINE

In the following section, we lay out the timeline for students to complete the steps outlined above.

The Research Ethics Committee will review complete submissions to the Safe and Ethical Review Process on an ad hoc basis. In general, it will take up to 3 weeks for your research to receive approval.

Yale-NUS students will be assigned to capstone supervisors in Semester 2 of Year 3. Students who wish to conduct capstone research during the summer after Year 3 will need to begin consultation, design their research project, and initiate the ethical review process with their supervisor in Semester 2 of Year 3.  They can commence research activities once their proposed projects have been endorsed on myYaleNUS by their supervisors, Head of Study, and REC. The end of finals will be the last chance to have this research approved.

If a student’s project requires additional review, as determined by the RESCUE and CHSER, the REC may request additional information and suggest necessary changes to the proposed study before granting approval. The process of committee review, revision of study, and granting of approval pending revision may take up to 2-3 weeks.

Students planning on conducting field research and collecting data during the summer and winter breaks should work with their supervisors to ensure that they complete the necessary forms well in advance of their field research start date.

Students intending to publish their capstone research would need to submit additional forms for review by NUS IRB, with their supervisor as the Principal Investigator.

STUDENTS’ YEAR SEMESTER 1 SEMESTER 2
Year 3
  • Not Applicable
  • Week 13
    Students who plan to conduct capstone research over summer will need to submit forms to myYaleNUS for review by their supervisors and the REC. Once approval has been granted, research can commence. REC will not review applications submitted once recess week begins.
Year 4
  • Ongoing
    Students submit their RESCUE Form and any additional forms to myYaleNUS. Once approval is granted, research can commence. As a rule of thumb, students should submit their applications 2-3 weeks in advance of when they hope to conduct their research, minimum.
  • Ongoing
    Yale-NUS Research Ethics Committee will review capstone projects cases that require additional scrutiny. Once approval has been granted by the committee about 2-3 weeks after submission, research can commence.
  • Week 13
    Last chance to submit applications if students hope to conduct research over winter break. REC will not review applications submitted once reading week begins.
  • Ongoing
    Students submit their RESCUE Form and any additional forms to myYaleNUS. Once approval is granted, research can commence. As a rule of thumb, students should submit their applications 2-3 weeks in advance of when they hope to conduct their research, minimum.
  • Ongoing
    Yale-NUS Research Ethics Committee will review capstone projects cases that require additional scrutiny. Once approval has been granted by the committee about 2-3 weeks after submission, research can commence.
  • Week 13
    Final draft of capstone due.

 

Step 4: Continued vigilance

Remember that conducting an ethical research project is an ongoing process. Ensure that procedures are explained, consent is obtained, and confidentiality is maintained. If changes are to be made to the research protocol, you must consider the ethical implications and have the changes approved if necessary.

If you have any questions, please consult your supervisor.

All the best for your research!

FAQs

1. What counts as “research”?

The NUS IRB defines “research” as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalisable knowledge”. Research that will need to be reviewed for safety and ethics is likely to be based in a laboratory, or in the field or involve human subjects. Independent research projects that are undertaken by students and are not part of a Professor’s laboratory or research programme will also need to go through the Yale-NUS Safe & Ethical Research Review Process. For example, most capstone projects should proceed only after the researcher has completed, with their supervisor, the Yale-NUS Safe & Ethical Research Review Process.

2. Does my research need to go through the Yale-NUS Safe & Ethical Research Review Process?

Students at Yale-NUS are doing research all the time, but not all of that research needs to go through a thorough Yale-NUS Safe & Ethical Research Review Process. Currently, only capstone research is subject to this process. All students conducting capstone research using human subjects will have to submit the RESCUE form to initiate this process. For students whose projects will incur risk, additional forms will need to be completed and approved, often with expedited review. In rare cases that may have higher levels of complexity and risk, the Research Ethics Committee may require students to have their project reviewed by the NUS-IRB. This will likely result in a much longer review period.  The REC recommends that students design capstone projects that entail only minimal risk.

3. What is the definition of “human subject”?

By “human subject” we mean a living human being from whom you as a researcher will collect data through interaction, intervention, experiment with the individual; and/or personally identifiable information.

4. How can I apply for approval from the Yale-NUS Research Ethics Committee?

As outlined in the flowchart in Step 3, all students undertaking the capstone project in the Division of Social Science will submit their proposed research for ethical review using the Research Ethics and Safety Checklist for Undergraduate Experiments (RESCUE) form. If the RESCUE form indicates that additional specification and assessment are needed, then students will submit the necessary additional forms for further approval. The student’s supervisor, Head of Study, and Research Ethics Committee reviews all applications, some with expedited review. Information on submission is provided in the specific forms listed in Step 3.

5. What documents do I need to submit?

All students writing a capstone in the Division of Social Science will need to submit the RESCUE form. Students in other divisions conducting capstone research with human subjects will also need to submit the RESCUE form.  Students for whom the RESCUE form stipulates further specification and assessment will need to submit additional forms as per the instructions listed in the RESCUE form.

6. When do I need to complete forms and gain final approval for my research?

Once students have consulted with their capstone supervisors and attained their supervisors’ approval of their capstone project design, they will submit the RESCUE form and thus initiate the ethical review process, as well as determine additional forms that may be needed. This may be done as early as Semester 2 of Year 3, and in an ongoing process through Year 4. Students who are planning to conduct research involving human subjects over the summer following the completion of Year 3 will need to submit necessary documents by Week 13 of Year 3 in order to provide the Yale-NUS Research Ethics Committee (REC) 2 weeks for review before Reading Week begins.

The REC will review capstone project designs for cases of higher complexity and risk on a rolling basis. The process of committee review, revision of study, and granting of approval pending revision may take up to 2-3 weeks.

For further information, please consult the timeline provided in Step 3 above.

7. How long does the Yale-NUS Research Ethics Committee take to review a project proposal?

The REC strives to review all submissions in a timely manner.

The review process may take up to 2-3 weeks depending on the nature of the project, the completeness of information included in the initial forms, and the likely risks of the project. The timeliness of the review also depends on the timeliness of approval from the student’s supervisor and Head of Studies, as well as the promptness of the student’s response to any inquiry raised by the REC. Please also note that it is the student’s responsibility to regularly check the Student360 portal for any updates to their application, and to do any necessary follow-ups in a timely manner.

8. Does interview work I do for class assignments need approval from the Yale-NUS Research Ethics Committee?

For class assignments that involve interviewing human subjects, students will need to attain their instructor’s approval on their list of interview questions, but they will not need to initiate the ethical review process by the Yale-NUS Research Ethics Committee.

9. Do all independent student research projects need approval from the Yale-NUS Research Ethics Committee?

At present, only capstone research projects involving human subjects are required to undergo the Safety and Ethical process. Independent student research projects that are not covered by a faculty member’s IRB approval may require approval from NUS-IRB.

10. I did some human-subjects research for a class assignment and got some interesting findings. I would like to write a paper based on my class assignment. Is that allowed?

No, we cannot review cases “retroactively.” Following the standards of the NUS IRB, studies involving human subjects will need to go through a review process and research activity can begin only after the approval is sought and given. However, if you would like to publish Yale-NUS REC approved research after receiving approval, the NUS IRB will issue a “Statement of Concurrence” to allow you to publish the research.

11. I’ve heard that NUS has an Institutional Review Board (IRB) that approves human subjects research. What is the relationship between the Yale-NUS Research Ethics Committee and NUS IRB?

The Yale-NUS Research Ethics Committee (REC) is the College’s internal committee tasked with reviewing matters pertaining to research done by students at Yale-NUS. The NUS-IRB is an independent NUS-wide review board responsible for reviewing the safety and ethics of research projects done at NUS, including Yale-NUS. NUS departments have DERCs (Departmental Ethics Review Committees), which are department-based and department-run but which are officially “deputised” by the IRB to provide oversight for certain classes of student research. In its role to review the safety and ethics of student capstone projects at Yale-NUS, the REC can be thought of as akin to a DERC.  Student research that is approved by the REC does not need to be reviewed by NUS-IRB, however, if students wish to publish the results of an REC-approved project, they must contact NUS-IRB to request a Statement of Concurrence that will allow publication.

All Yale-NUS faculty who conduct research involving human subjects with the intention to publish their results in academic journals will need to submit documents for review by the NUS IRB prior to beginning data collection. With regards to students conducting research with faculty as part of the faculty’s larger research project, the faculty will be responsible for submitting necessary documents to the NUS IRB and will act as the designated Principal Investigator (PI) of the project. Submissions to NUS IRB for publishable research projects can be done directly, without going through the REC.

12. When can I start my research study?

You can start research as soon as you receive approval from the Research Ethics Committee. This will generally be granted after 2-3 weeks of submitting your application. Projects with minimal risk will be completed through an expedited review. Other projects will have more thorough reviews and the REC may request more information or clarification. Please consult the flowcharts on Step 3 for more information.

13. If I have any questions about the ethics of my research, who can I talk to?

You should consult with your supervisor.

14. Do I always need to have written consent from my research participants?

You must always obtain consent from your research participants before collecting data.  Usually this consent should be documented in writing using a form similar to the sample Informed Consent Form provided on this page.  However, in certain cases it may be appropriate to collect consent via oral or digital response. For example, it would be appropriate to collect oral consent if you are doing a survey where the only potential risk to participants is if their identity was revealed on a written consent form.  Digital documentation of consent may be acceptable for research done on mTurk or another online forum.  If you would like to request a waiver of written signed consent, you should indicate that in your CHSER form.  However, even if you do not collect a written consent form, you are still expected to provide participants with all of the necessary information that they require to be able to decide if they want to participate, and they must consent before participating.

15. What happens if I change my research design or research question midway through my fieldwork? Do I need to tell the my supervisor or the Yale-NUS Research Ethics Committee?

To the extent that the information collected from, interaction and intervention with human subjects are also changed as a result of modifications in your research design, you will need to submit an amendment to your initial documents and attain further approval from your supervisor, or (in complex cases) the Research Ethics Committee (as determined by your supervisor).

16. What do you mean by “minimal risk”?

Ideally, your project should involve no risk on yourself or your participants. The NUS IRB defines that a risk is minimal where the probability and magnitude of harm or discomfort anticipated in the research are not greater, in and of themselves, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (Click here for more details).

17. For my capstone, I would like to collect and analyze non-identifiable data based on publicly-available tweets on Twitter. Does that count as human-subjects research?

Foremost, it is human subjects research if the data you access contain personally identifiable information. If your project involves de-identified, publicly available data tweets, you do not need to submit documents for review as long as you and your supervisor work together to take proper measures to ensure anonymity.

18. My capstone research uses data that my faculty supervisor collected as part of an NUS IRB-approved project. Do I still need to get clearance from the Yale-NUS Research Ethics Committee?

If your capstone project uses data collected by your faculty supervisor as part of an NUS IRB-approved research project, you will not need to submit additional documents for review by the Yale-NUS Research Ethics Committee, provided that you are not collecting additional data from human participants. If your capstone project requires additional data collection involving human subjects, you will need to submit additional documents for review.

19. Who should I contact if I have questions regarding my ethics application?

Please direct any inquiries to researchethics@yale-nus.edu.sg.

Update: 24 May 2017