Institutional Review Board Policies and Procedures

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EWC Institutional Review Board

Welcome to the East-West Center Institutional Review Board (IRB) page. This is the administrative unit responsible for federally mandated compliance review and oversight for all research protocols affiliated with the East-West Center that involve the use of human subjects. This may seem very stuffy and dry to you but it is vital that you understand the information and comply with all mandated standards of ethical behavior. Please feel free to contact Ketty Loeb at x7437 or via email at loebk@eastwestcenter.org if you have any questions about the materials provided here.

Whether you are a student, fellow, or another kind of participant at the EWC, if you plan to do any kind of research while you are here, you will need to review these materials carefully and make sure you understand the standards that are required by law. This web page provides the basic information and links to critical resources, but you may prefer to take the online “Social and Behavioral Responsible Conduct of Research, Basic Course” offered by the Collaborative Institutional Training Initiative (CITI). They break the materials into several smaller modules with short quizzes at the end, which allows you to learn the material at your own pace. The website for CITI is https://www.citiprogram.org. You will need to set up an account and list the University of Hawaii (not EWC) as your institution.

Disclosures

The EWC has assured the U.S. Department of Health and Human Services (DHHS) that it will apply CFR Title 45 (Public Welfare), Part 46 (Protection of Human Subjects) and all of its subparts (A, B, C, and D) to all of its human-subject research regardless of source of support.

The Federal-Wide Assurance (FWA) number for EWC is: FWA000040122. This number is renewed every three years.

The EWC Institutional Review Board (IRB) is registered with DHHS as follows:

Name: East-West Center
IRB #1 ID Number: IRB00003085.

This registration is renewed every five years or more often if changes occur in the composition of the committee.

EWC Signatory Official for the FWA: Ralph Carvalho
Human Protections Administrator: Jefferson Fox
Administrative Support: Ketty Loeb (808) 944-7473

EWC IRB Members

Denny Roy, Chair
Laura Brewington
Peter Hershock
Jacob Kowalski

Alternates

Sumeet Saksena
Ketty Loeb

Sections

 

General Information

The East-West Center generally follows the University of Hawaii Policy on Research Involving Human Subjects but uses different forms and personnel to meet its responsibilities. As you click on the various links, please note which forms and documents are specific to EWC and which ones are used by University of Hawaii.

Federal Resources and Regulations

The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research is a seminal report identifying core principles that still guide the research process today. Written in 1978, it is considered a “must read” for new researchers.

The U.S. Department of Health and Human Services (DHHS) Office for Human Research Protections (OHRP) Policy for the Protection of Human Subjects (45 CFR 46)
Subpart A (the Common Rule”)
Subpart B regarding pregnant women, fetuses, and neonates
Subpart C regarding prisoners
Subpart D regarding children

The OHRP website also has sections on differing regulations for international research, conflicts of interest, data coding to protect human subject identities, and many other important topics. All researchers should review this website from time to time as details may change.

If you have questions, please contact Ketty Loeb at (808) 944-7437 or LoebK@EastWestCenter.org.

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Guidelines and Responsibilities

The responsibility of the IRB extends to all research involving human subjects by fellows in the Research Program, staff in the Education Program, students, visiting researchers, and others who are affiliated with the EWC or use EWC staff or students. This responsibility applies to all research involving human subjects regardless of the source of funds supporting the research.

If EWC students conduct research involving human subjects as part of their obligations at the UH (i.e., M.A. theses, Ph.D. dissertations, or other degree requirements), they should follow UH human subject research review and oversight procedures (view the UH procedures). If EWC students conduct research involving human subjects that is outside their obligations to the UH, they should follow EWC IRB review and oversight procedures.

New Applications

Some research conducted at EWC involves human subjects, while other research does not. The investigator should consult the Frequently Asked Questions (FAQ) for definitions of "research" and "human subjects" and to help determine whether his/her work may fall into "exempt" or "expedite" categories not requiring a full IRB review.

  • First step: Determine whether your research involves human subjects
  • Second step: If it involves human subjects, determine whether it falls into the "exempt" category. If it does, prepare a Declaration of Exemption. (If you use this form and it is determined that the research proposal does not qualify for exemption, you will be asked to complete a Full Application.)
  • Third step: if it does not clearly fall into the "exempt" category, prepare a Full Application for New Approval. The Full Application will be given a full review by the entire IRB or, if it qualifies, an expedited review by the IRB Chair or designated reviewer.

Application Process

The EWC uses two application forms for IRB reviews:

1. Full Application for New Approval  is for all new applications that require full or expedited IRB review (more on these terms below).

2. Declaration of Exemption is for proposals that the researcher believes will qualify for exempt status. Although it is called a “declaration,” it is in fact a request from the researcher asking the IRB to confirm that the project is exempt.

Whichever form you use, you must also include a draft informed consent form using the UH samples and the OHRP checklist. If the research will involve anyone under the age of 18, a separate assent form and possibly parental consent is required. Additional documents such as sample survey or interview questions help to clarify the role of human subjects in your project.

Researchers submitting a new application that requires full or expedited IRB review should send one signed hard copy of the Full Application, draft informed consent form(s), and other relevant documents (e.g., sample survey or interview questions) to Ketty Loeb in JAB 3016 and also email them as attachments to LoebK@EastWestCenter.org.

Researchers submitting a new application that they believe is exempt should send one signed hard copy of the Declaration of Exemption Application, draft informed consent form(s), and other relevant documents (e.g., sample survey or interview questions) to Ketty Loeb in JAB 3016 and also email them as attachments to LoebK@EastWestCenter.org.

Approval of New Applications

Approvals of full application may take 3–4 weeks since it takes time to convene the full IRB committee and obtain a decision. Applications for expedited review usually take 1–2 weeks depending on the availability of the IRB Chair. Exempt review decisions are made by the Human Subjects Administrator or the IRB Administrator and can usually be made in less than a week. All approvals are valid for only one year and must be renewed when the approval period expires.

Application for IRB Renewal or Changes

Researchers requesting to continue their project with no changes in protocol must submit (1) a written status update to Ketty Loeb and (2) a request for renewal to the IRB prior to the expiration of their current approval. In addition to the Status Report and request to renew, researchers should submit a copy of their original application and informed consent forms. Projects that were given expedited or exempt approvals initially will be renewed on the same terms.

Sometimes researchers find that they need to change some part of their research protocol. For example, they may decide that they need to interview children, not just their parents. When this occurs, the researcher must promptly submit a Full Application for New Approval and receive an IRB determination before changing how s/he interacts with human subjects. Researchers requesting a change of protocol must submit to the IRB a signed hard copy of the Full Application and an explanation why the change is sought. In addition, researchers should submit a copy of their original application, informed consent forms, and new consent forms if needed. Any protocol changes such as the example above may trigger the need for a full IRB review.

Reporting Unanticipated Problems

Similarly, if in the course of conducting research project, a researcher experiences any unanticipated situations involving human subjects, s/he must report them to the IRB (and possibly the funder or other federal agencies) immediately. For example, the researcher planned to interview husbands and wives separately about their views on child rearing practices. S/He anticipated that some interviewees would say they disagree with their spouses and demonstrate some degree frustration or anger, but a large proportion of the women became extremely distressed and broke down crying. This outcome was not anticipated and clearly caused psychological stress for the women. The researcher needs to stop interviewing and determine how to gather the desired information in a less stressful manner; the proposed changes will then be submitted to the IRB for review following the process described in the preceding paragraph.

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Exempt and Expedited Research

Federal guidelines allow institutions to streamline their IRB procedures when the research presents a minimal risk or harm to the subjects and conditions to protect subjects’ identities are met. The lowest level of IRB review for these kinds of research is called “exempt” and requires review only by the IRB Administrator. The next level, “expedited” review also presents a minimal risk to the subjects but identifies specific categories of activities eligible for this review; it requires only the Chair of the IRB committee to review the application. See below for more details.

Exempt Research

A great deal of the research conducted at the East-West Center falls into the exempt category for IRB review. Researchers should review the Categories of Research Eligible for Exempt Approval to find out what kinds of research qualify for exempt status. See also exemption Decision Tree. Exempt research still requires that researchers be fully responsible for the protection of human subjects. Supporting documents must include a brief description of the proposed research, a statement regarding how the human subjects will participate, and an explanation of how the projects meets the eligibility criteria for exempt status.

If you think your research is likely to be eligible for exemption, complete and sign the Declaration of Exemption Application. Send the signed hard copy along with hard copies of draft informed consent form(s) and other supporting documents to Ketty Loeb in JAB 3016 and also email them as attachments to loebk@eastwestcenter.org.

Your application will be reviewed by the EWC Human Protections Administrator, Jefferson Fox, or the IRB Administrator, Ketty Loeb. They are the only two staff members who can approve exempt research.

Expedited Research

Expedited review is also used frequently for EWC research projects. It is similar to the exempt category, but information gathered from the human subjects usually requires a higher level of researcher responsibility to protect. For example, if a researcher makes audio or video recordings that could possibly identify the human subjects; s/he needs to establish security procedures to protect those materials from theft or other intrusions.

Here are the specific categories of activities that qualify for an IRB expedited review.  If your project fits within one of the nine categories, you should complete the Full Application. Send the signed hard copy along with hard copies of draft informed consent form(s) and other supporting documents to Ketty Loeb in JAB 1065 and also email them as attachments to LoebK@EastWestCenter.org.

Your application will be reviewed by the Chair of the IRB committee, Denny Roy, Ph.D. He is the only one who can approve expedited research.

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Forms

If you have questions about filling in the Declaration of Exemption, contact Ketty Loeb at (808) 944-7437 or LoebK@EastWestCenter.org.

http://www.hhs.gov/ohrp/register-irbs-and-obtain-fwas/forms/

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Useful Links

45 CFR Part 46 [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html]

CITI Online Training [https://www.citiprogram.org]

Informed Consent Samples  http://www.hhs.gov/ohrp/regulations-and-policy/guidance/informed-consent/[K. L.2] 

Informed Consent Checklist [http://www.hhs.gov/ohrp/policy/consentckls.html]

Exempt Review [http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.html#46.101(b)

Expedited Review [http://www.hhs.gov/ohrp/policy/expedited98.html]

University of Hawaii Committee on Human Subjects [https://www.hawaii.edu/researchcompliance/human-studies]

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Frequently Asked Questions

What qualifies as "Research" requiring IRB review?

What is the definition of "Human Subject"?

What about research conducted as a class project?

What do I need to do if I want to change something in my research?

Is there someone I can call if I need assistance or have questions?

 What qualifies as "Research" requiring IRB review?

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

What is the definition of "Human Subject"?

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains:

(1) data through intervention or interaction with the individual, or

(2) identifiable private information

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment that are performed for research purposes. Interaction includes communication or interpersonal contact between investigator and subject. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects.

What about research conducted as a class project?

Often students at all levels are required to conduct "research" as part of class responsibilities or activities. Most of this research does not qualify for IRB review. These are the essential questions to be answered:

  • Will this research be published?
  • If yes, the research is required to be reviewed prior to implementation.
  • What will be done with the data/information?
  • If the information is identifiable to an individual or may be used or published in the future, the research may require IRB review prior to being implemented.

If you have any questions about this area please check with IRB staff before conducting or planning "class project" research.

What do I need to do if I want to change something in my research?

Approval to conduct proposed research is given only on the application and protocol as presented or amended at the time of approval. If there are any changes to the research protocol after this approval has been granted these proposed changes must also be reviewed by the IRB before implemented. This includes, but is not limited to, any changes in the selection of subjects, additional questions or additional survey items, changes in the approved protocol or any deletions or additions in the approved consent forms. This applies to research approved by IRB review, expedited review, or exempt approval. If you have any additional questions about this, please contact IRB staff prior to any changes in your research.

Is there someone I can call if I need assistance or have questions?

Yes. If you have questions about any aspect of the application requirements, required forms, or eligibility criteria, do not hesitate to contact Ketty Loeb at (808) 944-7437 or mailto:LoebK@EastWestCenter.org. You may also use the "Contact Us" link to send e-mail inquiries.

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Contact Us

Human Protections Administrator: Jefferson Fox
Phone: (808) 944-7248
Email: FoxJ@EastWestCenter.org

IRB Chair: Denny Roy
Phone: (808) 944-7244
Email: RoyD@EastWestCenter.org

Administrative Support: Ketty Loeb
Phone: (808) 944-7437
Email: LoebK@EastWestCenter.org

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