Research

Institutional Research Ethics Committee

NU Institutional Research Ethics Committee (hereinafter –IREC) is a constant body overseen by Research Council and has the status of “subcommittee” that is responsible for oversight of ethical standards while conducting human subject research at the University. IREC primary role is to safeguard the rights and welfare of all human subjects who participate in research studies conducted by NU (hereinafter - NU) faculty members, staff and students. In compliance with NU IREC Bylaws, NU IREC Procedures and other NU institutional policies regarding research ethics, all research projects involving human subjects or human material have to be reviewed and approved by the NU IREC. All biomedical, social and behavioral research projects conducted by the faculty, the staff and students of the University are subject to the Policies and Procedures of the NU IREC.

NU IREC has the authority to disapprove, modify, or approve protocols based upon consideration of human subject protection. It also requires progress reports from the investigators at least annually and oversees the conduct of the study.

Section 1 – Bylaws and Procedures

Section 2 – Committee Membership

The Committee is composed of the following members:

1) The Chair nominated by the Provost;

2) 1 (one) representative from each school of the University, nominated by the Dean of the corresponding School;

3) 1 (one) representative of the Private Institution "National Laboratory Astana", nominated by the General Director;

4) One (1) representative of the Faculty Senate appointed in accordance with the internal procedures of the Senate;

5) 8 (eight) members nominated by Provost according to their competencies;

6) An independent expert who is not an employee or relative of an employee of the University, nor does he or she has a professional relationship with the University.

The Committee reserves the right to propose additional members to the Committee on the recommendation of the Chair with in order to share the workload associated with membership.

The Deputy Chair is elected by the Committee from among its members. The Deputy Chair shall act as Chair if the Chair is absent or declares a conflict of interest with the PI and / or the Initiator.

Members of the Committee are appointed for a three-year term, after which they can be reassigned for a similar period.

The Chair and members of the Committee have the right to voluntarily step down from membership in the Committee with a notification to the Chair and the Secretary of the Committee one month before the planned withdrawal.

Section 3. School-based IREC

Section 4. CITI Training

NU requires its ethics committee members, principle investigators, and all participating staff to complete the relevant Collaborative Institutional Training Institute (CITI) web-based training program.

Access the CITI training and click on “New Users Register Here”; this will take you to the Course Registration page.

Select “NU” from the dropdown list of Participating Institutions.

Enter your name and NU issued email address for CITI training.
For best results, use your NU email address as the “Preferred Email”.

Once you have provided the registration information, you’ll be led through a series of screening questions to determine which training modules are appropriate for your specific research program.

NOTE: If you have recently completed CITI training at a different institution, you can add NU as a participating institution to transfer your training credit. Follow the instructions on the CITI site for adding an additional institution and changing your Username and Preferred Email. If you have completed ethics training that you think may substitute for completing the CITI program please provide a record of your training to the Office of the Provost (Research Division) for consideration.

Section 5. IREC Handbook: A Guide to Conducting Human Subject Research

I. Human Subject Research at a Glance

II. Ethical and Regulatory Framework

III. Institutional Research Ethics Committee

IV. What is/isn’t Human Subject Research?

V. Types of IREC Review

VI. Informed Consent in Human Subjects Research

VII. Tips for Expedited Research

VIII. What Investigators Need to Know About the IREC Review Process

IX. Investigator Reporting Responsibilities after IREC Approval

X. What do the Reviewers Want? Things to Consider When Submitting a Human Subject Research Application

XI. Tips for Better IREC Submissions

Full version of IREC Handbook: A Guide to Conducting Human Subject Research

Section 6. IREC Forms and Templates

Appendix A. IREC Application Form (.docx, .pdf)

Appendix B: Written Informed Consent Form Template

Appendix C: Informed Consent Form Template for Internet Surveys

Appendix D: Oral Consent Script

Appendix E: Assent Form Template

Appendix F: Request for Continuing IREC Approval Form

Appendix G: IREC Protocol Amendment Form

Appendix H: Adverse/Unanticipated Event Reporting Form

Appendix I: IREC Consultation Form

Appendix J: Glossary of Common IREC Terminology

Appendix K: Request for Deferral of IREC Oversight Form

Appendix L: Confidentiality Agreement Form

Appendix M: Written Informed Consent Form For Genetic and/or Biobank Research

Section 7. The list of requirements for submission of application to IREC:

The NU IREC handles a number of different types of applications, including:

7.1 Standard application is used for any study that is being considered for initial review and approval:

7.1.1 IREC Protocol Form in English

7.1.2 Written Informed Consent Form in English and in the official language(s) of the country, where the project will be held

7.1.3 Informed Consent Form for Internet Surveys in English and in the official language(s) of the country, where the project will be held (in case necessary)

7.1.4 Oral Consent Script in English and in the official language(s) of the country, where the project will be held (in case necessary)

7.1.5 Assent Form in English and in the official language(s) of the country, where the project will be held (in case necessary)

7.1.6 CITI training certificate or any other relevant certificate, which shows that you passed a course on human ethics subjects. All research project members have to be CITI Certified.

7.1.7 All study related materials should be included with the protocol form. Any document referenced within the protocol form should be attached in this section.

Below is a list of commonly attached documents, that have to be submitted in case of their existence in English and in the official language(s) of the country, where the project will be held:

Recruitment materials (flyers, email, oral scripts)
Letters of support or approval from outside organizations
Surveys/questionnaires
Visual stimuli that will be presented to participants
Debriefing Documents
Grant Proposals.

7.2 Request for Continuing IREC Approval Form - the IREC reviews all research that is greater than minimal risk at least annually.

7.3 IREC Protocol Amendment Form is used to request approval of any change to the currently-approved protocol and/or consent process. These are only considered after a study has received initial review and approval as a new study.

7.4 Reportable Events Form - application is used to submit problems, unexpected events related or possibly related to the research that places subjects or others at a greater risk of physical or psychological harm. These unanticipated events must be reported promptly in accordance with IREC policy using this form.

7.5 IREC Consultation Form. IREC members are available to consult with faculty and students regarding their research projects. If it has been determined that your project requires IREC review and you would like assistance navigating the IREC submission process, please use this form.

All applications should be submitted to IREC Secretary resethics@nu.edu.kz