Guidelines for Ethical Clearance

Introduction

The IRB is a board comprised of academics and professionals from various disciplines. The board is responsible for the ethical review of all applications submitted by AUIB staff or external researchers/investigators. Through its inclusion of members from a variety of disciplinary backgrounds, the IRB ensures that the proposed research follows appropriate, consistent, and comprehensive ethical standards.

The IRB’s primary mission is to provide guidance and oversight regarding ethical practices in research activities. To fulfill this role, the IRB ensures that all policies, procedures, and actions align with ethical principles and standards. The IRB also reviews and addresses complex ethical issues that may arise in specific research studies. To this end, the IRB relies on ethical guidelines that emerged from the Belmont Report, the Declaration of Helsinki, and the Nuremberg Code. To guarantee that the rights and welfare of human research participants are protected, as required by national and international regulations, the IRB can approve, reject, or request adjustments to research proposals submitted for approval.

The mandate of the IRB at AUIB is to ensure that research in the natural and social sciences is conducted following ethical principles. To support AUIB researchers and their affiliates in their pursuit of knowledge, the IRB prioritizes the welfare and autonomy of human participants and animals and emphasizes the use of informed consent and appropriate ethical guidelines.

Applying for Ethical Clearance

To apply for ethical clearance, please request the application form at CRD@auib.edu.iq

All Principal Investigators (PI) for research must complete the application form and ensure all relevant documents are attached. Failure to provide all the information required with the documents will result in a delay in approval.

IRB application review

IRB application review can be expedited, exempted, or requiring a full board review.

An expedited review will be conducted in the following cases:

• Research on a medical device that uses a cleared/approved medical device in accordance with its cleared/approved labeling.
• Research study that uses finger sticks, heel-stick, or ear sticks for blood sample collection (for adults, not more than 450ml per 8-week period and not more than twice per week. For children or participants below 50kg, not more than 50mL or 3mL per kg per 8-week period and not more than twice per week).
• Research study involving non-invasive collections of biological specimens such as buccal swabs, nail clipping, etc.
• Research study involving materials/data already collected. This can include literary, social, and cultural research.
• Research study in which data is collected from recordings made for research purposes.
• Research study on group characteristics or behavioral study not involving manipulating/stressing the subjects or altering their behavior.
• Research study using questionnaires, surveys, interviews, netnography, focus group discussions, participant observations, oral history, or quality assurance procedures. This should pose a low risk to the research participants and should not be used on vulnerable populations as described in Section III D.

A proposal is exempted from review in the following cases:

• No human/animal participant is involved in the research.
• Oral History projects insofar as (i) they collect and use information about specific individuals themselves, (ii) they do not collect nor use identifiable information about living individuals to produce generalizable knowledge, and (iii) they are not conceived to inform policy.

Any other research proposal that does not cover the above will have to go through a full board review.

Application Evaluation

All applications will be reviewed by the board members and a response will be given within 10 working days. It will be evaluated according to the following principles:

• The risk to participants in the research must be within the established ethical and scientific guidelines.
• All participants have formally provided their informed consent and the proof of this consent is attached with the application.
• Confidentiality is maintained throughout the research process and data is secured and stored with the upmost security possible.
• All participants are selected in a fair manner and based on appropriate criteria.
  
• Applicants whose IRB applications are not approved have to take into account the board’s recommendations in the comments section for revision and resubmission. The IRB Chair will inform the applicants if their IRB application has been approved or requires amendments.
• In conducting interviews with children and families or discussing personal issues, a specific procedure shall be in place that will guide the collection of sensitive data, personal information, criminal acts, and emergency situations.

Reporting and Record Keeping:

Researchers and research teams must retain all relevant materials, particularly material related to informed consent and ethical approvals. All such documentation must be handled in a way that protects the identity and confidentiality of the participants. All such records or documentation must be retained for a minimum of two years following the finalization and conclusion of the research project and its outcomes. The IRB can demand an accounting or order a review/inspection of this documentation, without advance notice. The researcher or research team must be prepared to submit for review, explain and justify their complete records and their implementing actions, to the IRB.

Researchers and research teams must promptly notify the IRB in the case of adverse events, unanticipated problems or outcomes, or any digression or exception contrary to the determinations and decisions made by the IRB. All instances of non-compliance must be reported promptly and with full disclosure. Researchers and research teams must provide reports, periodically and on demand, to the IRB. The IRB reserves the right to demand additional information or clarifications.

Compliance and Enforcement:

Should the IRB determine that a researcher or research team is in non-compliance with the IRB rules and guidelines, or with IRB determinations, decisions, and agreements, the IRB can order the immediate cessation of all activities related directly or indirectly to the research project in question. In such circumstances, the IRB should provide the researcher or the research team with timely remedies and mitigation measures, as necessary in particular circumstances. The IRB can further recommend to the university that disciplinary measures be taken against the individuals involved in non-compliance or any incident resulting from non-compliance. Researchers and research teams are responsible to follow and maintain for proper conduct in their research project, and for acting with due diligence, mindful of the principle of prudence, and carrying out their research project in full respect of the conditions imposed by the IRB.

As soon as the IRB is made aware of the allegations of misconduct or of non-compliance, or made aware of adverse or unanticipated events, the IRB shall convene to determine the known facts of the situation, shall undertake necessary measures to ascertain and investigate all aspects of the situation, shall demand full-accounting from the researcher or research teams involved, and shall take all necessary actions in order to maintain that the researcher or research team implement necessary measures to safeguard research participants, remedy harm, prevent further harm and uphold the ethical standards detailed in their agreement with the IRB. As a regulatory body, limited to determining and enforcing ethical standards for researchers, the IRB has no power or responsibility to remedy situations that emerge from the actions, non-compliance, or misconduct of the researchers who operate under its guidelines.

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For access to the forms or further information, please do not hesitate to contact the Center for Research and Development (CRD) at CRD@auib.edu.iq