Research

Institutional Review Board

The Department of Public Health commits to protecting the rights and welfare of all the participants in research studies.

An Institutional Review Board is a committee established to review and approve research involving human subjects. The aim of an IRB committee is to make sure that the research conducted is in accordance with the international and national research and ethical guidelines.

The Department’s Institutional Review Board (IRB-PH) consists of five members, four experts with extensive experience in research in social sciences and one community representative. For more information about IRB-PH, please visit: Overview & Information section.

To obtain the ethics approval from the IRB-PH, an application must be submitted for consideration of the IRB committee. For more information about developing and submitting an application, please visit: Investigator’s Guide section.

For any supplementary information regarding IRB-PH, please visit the FAQs section or write us an email at irb@publichealth.ro.

Overview & Information

The Department of Public Health IRB (IRB-PH) has been approved by the U.S. Department of Health and Human Services (HHS), for use through November 12, 2021. For detailed information, please click here.

IRB-PH Application Review Time

The IRB-PH decision time can vary depending on the type of necessary review: exempt, expedited, full. However, there is a maximum time-frame of 6 (IRB-PH pane review time) + 1 (IRB-PH administrator time) weeks.

IRB-PH Roster

Chairperson

Cristian Meghea, PhD – CV / Biosketch

Members

Laura Alicu – CV 
Cristian Litan, PhD – Biosketch
Florin Oprescu, MD, PhD – CV
Anca Simionca, PhD – Biosketch

Administrator

Petru Sandu, MD, PhD(c) – CV / Biosketch

Investigator’s Guide

In order to obtain the Department of Public Health IRB approval for developing a research project involving human subjects, an application must be submitted in advance.

Please use the document below as a primary source for IRB-PH Standard Operating Procedure and Human Subjects Research Policy Guidance.

IRB-PH Application Form
WHO Informed Consent Templates

Resources

In order to assist you in acquiring a knowledge base in regards to the recent history and importance of responsible conduct of research, please find bellow a number of resources covering some of the landmark documents, which set the current framework of research ethical conduct.

The Declaration of Helsinki
The Belmont Report
The Nuremberg Code

Process for submission and review of applications

Department of Public Health Institutional Review Board (IRB-PH) approval or determination of exemption must be obtained prior to any subject recruitment or data collection.

New study applications that are likely to need full IRB review must be submitted to IRB-PH no less than 6 weeks prior to the next regularly scheduled meeting of the appropriate IRB. IRB-PH reserves the right to determine when a study application is ready to be considered by the full IRB and will schedule it on the next appropriate meeting agenda accordingly.

Renewal/continuing study applications that need expedited or full IRB review must be submitted no less than 6 weeks prior to their expiration date and/or the date of the next appropriate full IRB meeting.

All applications are reviewed in chronological order of receipt, with the exception of protocols that require full IRB review at a convened meeting of the IRB-PH, and continuing studies that must be reviewed by their expiration date.

The IRB-PH panel meets online periodically, as well as in accordance to the needs. All applications are given an initial assessment within maximum 1 week after receipt in the IRB-PH, in order to determine the type of review needed. Depending on the result of this assessment, the review process may take another 3 to 6 weeks to complete.
Researchers are urged to submit applications in a timely manner to allow adequate time for review.

Researchers who are applying for an International grant are reminded that the funding agency may require the IRB-PH to certify its approval of the research application for the grant. In such situations, researchers should submit their protocol for human subjects review at the same time that they apply for the grant. Time allowance should also be made for projects that require additional review and approval from other IRBs.

Types of Review

New Research Applications are given one of the following types of review

Applications for Determination of Exempt Status are reviewed by IRB-PH panel and the IRB-PH Chair. This review process may take minimum 3 weeks.

The research may be approved as Exempt, or it may be found to not qualify for Exempt Status and be re-assigned to a different level of review. There are no deadlines for submission of Exemption requests. However, you should submit your Exempt Status application at least 3 weeks prior to the planned start date of your research. Approved exemptions do not need annual review, provided there are no changes to the protocol.

Any planned revisions to the project after an exemption has been granted must be submitted for IRB-PH review before the changes are implemented.

Projects judged not to require full IRB review and not to be exempt are reviewed and approved by a sub-IRB.

This review process may take up to 4 weeks before a review decision is made and the researcher notified. Eligibility for this type of review is determined by the IRB-PH Chair.

Certain projects require full IRB review, such as:

  1. most physiological or medical research;
  2. certain research involving vulnerable subject populations (e.g., children, prisoners, pregnant women);
  3. research where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subject’s financial standing, employability, insurability, reputation, or be stigmatizing, and there is a reasonable risk that confidentiality could be violated, or the consequences of a loss of confidentiality would be severe.

Studies that previously required full IRB review, and were not determined by the IRB to be minimal risk, will again need full IRB review for renewal/ continuation of IRB-PH approval. Full IRB review takes places at the monthly IRB-PH meetings.

Such applications should be submitted no less than 2 weeks prior to a scheduled meeting date Notification of the review decision is sent to the applicant as soon as possible following the meeting date, generally within a week. However, it may take up to 4 weeks before receiving a detailed letter regarding the IRB’s decisions.

Renewal / Continuing Research Applications (Anual Review Required)

Projects that have been approved and issued an expiration date must obtain renewed IRB-PH approval in order to continue beyond the time of expiration. As a courtesy, a renewal notice with instructions will be emailed to all researchers approximately 6 weeks before the approval is due to expire. The deadline for submission will be included. 

However, please NOTE: It is the researchers’ responsibility to ensure that the application for renewal is submitted in a timely manner. The continuing review process may take up to 6 weeks before notification of decision is sent to the researcher. Continuing studies that require full IRB review will be considered at the next available IRB-PH monthly meeting. As with new studies requiring full IRB review, notification of the review decision is sent to the applicant as soon as possible following the meeting date, generally within a week. However, it may take up to 4 weeks before receiving a detailed letter regarding the IRB’s decisions.

Research determined Exempt by IRB-PH is not subject to annual renewal.

Amendment Aplications

Amendment applications must be submitted for all proposed revisions of:

  • Currently approved protocols
  • Protocols being submitted for continuation approval which include major modification
  • Projects previously granted exempt status by IRB-PH

The researcher must submit revised documents for review and approval prior to implementing the proposed changes to the study. In many cases, amendment requests can be reviewed and approved by the IRB-PH Chair or sub-IRB. In situations where the changes might increase risks to subjects, full IRB review may be required.

Researchers will be notified of the review status generally within 4 weeks after submission of amendment requests.

What to Submit

Forms Required for IRB-PH Submission

New Exempt

Submit 2 copies, typed and collated – with original signatures:

  1. IRB-PH Application Cover Sheet
  2. Request for Determination of Exempt Status Form
  3. Protocol Narrative Form
  4. Informed consent materials for all adult subjects (written form and/or verbal script)
  5. Assent materials for minors (written form and/or verbal script) and parental consent/permission form
  6. Certificate of Completion of a human subjects/research ethics course or training (required for graduate and undergraduate students listed as Lead Investigator or Key Personnel)
  7. Surveys, interview guides, and any other data collection instruments
  8. Recruitment materials (e.g., advertisements, letters, flyers, scripts for verbal recruitment).
  9. Additional Documents (if applicable):
    • Letters of permission from off-site institutions/participating data collection sites (e.g., permission from school administrator, data sharing agreement, etc.)
    • IRB approvals from collaborating institutions
    • Copy of grant proposal

Applications for exempt research involving the use of de-identified and pre-existing data generally do not need to include a protocol narrative or consent materials; instead, a description of the dataset(s) and content, where/from whom it will be obtained, data security/storage measures, and other information as requested on this form should be provided.

New Non-Exempt. Expedited or Full Board review level is determined by IRB-PH after submission.

Submit 3 copies, typed and collated – with original signatures:

  1. IRB-PH Application Cover Sheet
  2. Protocol Narrative Form
  3. Informed consent materials for all adult subjects (written form and/or verbal script)
  4. Assent materials for minors (written form and/or verbal script) with parental permission form, and any other subjects who do not have the capacity to provide consent for themselves
  5. Certificate of Completion of a human subjects/research ethics course or training (required for graduate and undergraduate students listed as Lead Investigator or Key Personnel)
  6. Surveys, interview guides, and any other data collection instruments
  7. Recruitment materials (e.g., advertisements, letters, flyers, scripts for verbal recruitment).
  8. Additional Documents (if applicable):
    • Letters of permission from off-site institutions/participating data collection sites (e.g., permission from school administrator, data sharing agreement, etc.)
    • IRB approval(s) from collaborating institution(s)
    • Copy of grant proposal

Amendment (Applies to all proposed changes to currently approved protocols and to projects previously granted Exempt status by IRB-PH)

Submit two (2) copies of the following materials:

  1. IRB-PH Application Cover Sheet
  2. Study Amendment Form
  3. Additional Documents (if applicable):
    • Copy of previous IRB-PH Determination of Exempt Status letter (if applying for revision/amendment of Exempt protocol)
    • Copy of grant proposal
    • Two (2) updated copies of all new or revised documents and materials (e.g., protocol, informed consent materials, etc.)—one copy with changes highlighted and one “clean” copy without highlights.

Renewal / Continuation (For all previously approved Expedited and Full Board level research projects that are continuing with subject enrollment or data collection, as well as studies that have completed all data collection but are still in data analysis. Reminder: Exempt protocols do not need to be renewed)

  1. IRB-PH Application Cover Sheet
  2. Study Renewal/Continuation Form
  3. Summary of study findings from the past year
  4. Current copy of Protocol Narrative
  5. Current copies of all consent/assent materials
  6. Current copies of all recruitment materials

The Protocol Narrative does not need to be submitted if no changes to the approved protocol on file with IRB-PH are proposed or the study is moving into a “data analysis-only” stage, with no data collection or subject interaction planned for the coming year.

Additional Documents (if applicable):

  1. Any findings/ literature/ other relevant information outside of your study (especially about risks associated with the research) since last approval received
  2. Current IRB approval(s) from off-site institutions/participating data collection sites or collaborating institutions, if applicable.
  3. Certificate of Completion of a human subjects/research ethics course or training if not previously submitted (required for graduate and undergraduate students listed as Lead Investigator or Key Personnel)

Response to Conditions (Investigator response to specific, minor revisions requested by the Full IRB)

Submit the following materials:

  1. One copy of a memo with a point-by-point response to the IRB’s concerns
  2. For any protocol, consent materials, or other documents for which revisions were required, include two (2) copies with your response, one with changes highlighted and one “clean” copy without highlights.

All forms included in the IRB-PH application need to be signed by the lead investigator, than scanned and submitted to the email address: irb@publichealth.ro.

FAQs

What is an IRB?

IRB is the acronym for Institutional Review Board for Human Participants. The IRB primary role is to ensure the protection of human participants as subjects of research at Department of Public Health.

Any institution that receives research funding from funding agencies to conduct research with human participants, such as Department of Public Health, is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research.

The IRB for Human Participants has the authority to review, approve, disapprove or require changes in research or related activities involving human participants.

For what type of research do I have to submit an IRB application?

All Human Subjects Research must receive approval from the IRB. Therefore, if your research meets the definitions of both research and human subjects, you must complete the IRB process. Please click here to verify of your research meet the definitions.

What are the steps I have to take for submitting an IRB application?

There are several mandated steps to receive IRB approval for your research. Click here to review the process.

How long will it take to receive an answer in regards to the IRB decision?

All applications are given an initial assessment within maximum 1 week after receipt in the IRB-PH, in order to determine the type of review needed. Depending on the result of this assessment, the review process may take another 3 to 6 weeks to complete.