FAQ
- What is the purpose of the PSI Research Ethics Board (REB)?
- What type of training will researchers receive?
- What type of studies does the Research Ethics Board review?
- Who submits research studies to the PSI REB for review?
- How long will the review process take?
- What does the REB look for when deciding whether or not a study will be approved?
- For how long will REB approval be effective?
- If you want to change something in your study, must you notify the REB?
- If someone participating in your study has an unexpected or negative reaction, what do you do?
- What happens if you fail to comply with REB policies and federal regulations regarding the use of human subjects in research?
1. What is the purpose of the PSI Research Ethics Board (REB)?
PSI's REB provides ethical guidance on the adequacy of proposed research studies regarding the protection of potential human participants. PSI's REB follows three commonly accepted ethical principles:
- Respect for persons: protecting the autonomy of all people, including those with reduced autonomy
- Beneficence: maximizing the benefits of research to participants, while minimizing risks of research to participants
- Justice: fairly distributing the costs and benefits amongst research participants
In addition to providing an ethical review of research prior to its commencement, PSI’s REB will follow up regularly (at least once a year) with research studies that have been approved. The REB’s review is independent of the sponsor, the researchers, and any undue influence.
No research studies may be initiated until the PSI REB has given your protocol full approval with no further revisions. You must wait to receive this approval in writing before initiating your research. Verbal approval is not acceptable. (See Section III & Figures 3, 4 & 5 in REB Toolkit Chapter 1).
2. What type of training will researchers receive?
The REB provides three online training options to ensure that all PSI researchers are well-versed in research ethics. Researchers should incorporate the principals discussed in the online training courses during the planning and implementation of all PSI studies. The REB recommends the use of the NIH online ethics training. Since this course is only offered in English, the Family Health International Ethics Training module is recommended for training modules in French, Spanish, and Portuguese. For a training module in Chinese, please use Collaborative Institutes Training Initiative (CITI) Ethics Training.
Every Regional Researcher, Health Area Principal Investigator, and other key personnel (e.g. Research Manager or Research Advisor, staff at a local research agency or sub-contracting organization) are required to complete the online training the first time they provide oversight or collect data for a research study that is being reviewed by the PSI REB. It is expected that all Senior Managers on the Research and Metrics Team and DC-based Researchers will also receive training. Researchers and key personnel must only complete the online training once (See Section III, step four in REB Toolkit Chapter 1). The REB office will maintain a file of all researchers’ and other key personnel’s certificates of completion.
Upon completion, please submit your certificate to the REB Office. When possible, please send an electronic copy of your certificate to research (rebcoordinator@psi.org).
If electronic submission is not possible, please mail a copy of your certificate to:
Research Ethics BoardPopulation Services International
1120 19th St. NW, Suite 600
Washington DC 20036
In addition, guidance materials are available for researchers on establishing and maintaining high ethical standards in conducting research involving human participants.
3. What type of studies does the Research Ethics Board review?
The REB will review all studies that qualify as research under the following definition: a systematic investigation including research development, testing and evaluation designed to develop or contribute to generalizable knowledge. A human subject is defined as "a living individual about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual or (2) identifiable private information.
Non-research studies will not be reviewed. For example, quality improvement (QI) studies which typically aim to improve the quality of repetitive systems for high volume production or service delivery will not be reviewed. Established methods include identifying problems, proposing and implementing a solution, measuring the change expected to occur as a result of the solution and modifying the solution based on data gathered through monitoring activities.
See Section I, Step II in REB Toolkit Chapter 1 for details on how to determine if your study is considered research or non-research, such as quality improvement.
3a. Who determines if a study is "research" or "quality improvement"?
Regional Researchers determine if a study qualifies as research or quality improvement (QI) and Health Area Principal Investigators (PI) approve this decision (see Figure 2 in REB Toolkit Chapter 1). Research studies must comply with specific policies and regulations designed to protect human subjects and privacy rights, as outlined in the PSI Research Ethics Board policies and procedures manual. QI studies are not subject to research policies and regulations.
In some cases it may be difficult for the Regional Researchers and Health Area PIs to determine if a study is research or QI. Since this determination may have a significant impact on the study design, procedures, and regulatory compliance, Regional Researchers and Health Area PIs are urged to seek guidance from the REB by contacting the PSI REB Coordinator (REBcoordinator@psi.org) when a study’s category is unclear.
4. Who submits research studies to the PSI REB for review?
Regional Researchers submit study applications to the PSI REB after finalizing documents with input from Research Managers/Research Advisors and obtaining approval from the Health Area PIs (see Figure 2 in REB Toolkit Chapter 1).
Partner organizations or organizations separate from PSI with Ethics Boards or IRBs may also rely on the PSI REB if there is an agreement in effect between the organization and PSI. In this case, it is still the responsibility of the Regional Researcher to submit study applications.
4a. How do I submit a new study for REB review?
Once it is determined that a study involves "research," you can begin filling out the submission form application. You must answer all required questions and attach all additional materials. Please refer to REB Toolkit Chapter 2 for instruction on completing the new study submission forms.
When submitting a study for REB review, ensure that all documents are completely filled out and that all necessary attachments are included in order to avoid delays in the study review process. Please see Figure 4 in REB Toolkit Chapter 1 and REB Toolkit Chapter 2 for documents to include.
5. How long will the review process take
Depending on the type of review (exempt, expedited, full board), the time process varies.
The following time estimates apply for submissions that are complete and for which no additional information or modifications are required:
- Exempt Determination.......7 business days
- Expedited Review..............7 business days
- Full Board Review..............14-28 business days
Please see Figure 6 in REB Toolkit Chapter 1 for a detailed timeline of study reviews.
Research studies will undergo different review processes depending on a number of issues, including the target population, the study design, and data collection procedures. If vulnerable populations or high risk behaviors are included in the research design, the study is likely to require a full board review. Regional Researchers can request an exempt or expedited review when submitting application materials to the REB, however the REB makes the final determination on categorizing research.
Exempt and expedited studies are reviewed on a rolling schedule, and thus have shorter turn around times. Studies that must undergo a full board review often take longer since they must be reviewed at the convened monthly REB meeting.
Regional researchers will receive a notice via email when a study application has been reviewed and approved.
5a. What can delay the REB review process?
Delays can occur in the review process if the submission forms are not complete or modifications are required. In such cases the REB will send letters requesting additional information or changes (e.g. more detailed information on the consent procedures). Once the REBs requests have been fulfilled, you can expect an approval from the REB within seven days for exempt and expedited reviews. If your response to the REB’s request is submitted after the deadline for full board studies, your application will be reviewed at the convened REB meeting for the following month.
6. What does the REB look for when deciding whether or not a study will be approved?
In order for the REB to approve a proposed study, the researcher ensures that the following issues related to commonly accepted ethical principles are addressed in the study design (see Figure 1 and Appendices D & C in REB Toolkit Chapter 1).
Respect for persons (individual autonomy)
Risks to participants are minimized;
- Informed assent and/or consent will be appropriately documented;
- Informed assent and/or consent will be sought for each prospective participant or the participant?s legally authorized representative;
- Adequate provisions to protect the privacy of participants and to maintain the confidentiality of data;
- Safeguards have been included to protect the rights of all participants and special provisions are made for participants who may be vulnerable to coercion or undue influence.
Beneficence (maximize benefits and minimize harm)
- Risks to participants are reasonable in relation to anticipated benefits to participants;
- Adequate provision for monitoring the data collected to ensure the safety of participants.
Justice (equitable distribution of research benefits and risks)
- Selection of participants is equitable.
In many cases, both the PSI REB and a local Ethics Board or IRB located in the country where the study is being conducted are required to review a research study. Researchers must submit copies of local Ethics Board or IRB approval letters before the PSI REB will finalize approval, unless an agreement is in place to defer review to the PSI REB (see Section II step one in REB Toolkit Chapter 1).
When research studies take place at sites that do not have an Ethics Board or Institutional Review Board, investigators must provide assurance and documentation that the site has agreed to host the research activities and also provide contact information for relevant parties and officials related to the conduct of the study (see Section II steps 1 & 2 in REB Toolkit Chapter 2).
7. For how long will REB approval be effective?
REB approval for research studies is valid for a maximum of one year. All research studies must be reviewed before the expiration date of approval, but no less than annually. The approval period is determined by the REB and is based on the level and degree of risk involved in the research.
7a. If REB approval of your research will expire before you finish your study, what must you do to maintain REB approval?
With the exception of research studies that are determined to be exempt from the regulations, the REB is required to conduct continuing review of research at intervals appropriate to the degree of risk, but no less than once a year. For research involving no more than minimal risk (see Section IV, Step one Items 13a and 13b in REB Toolkit Chapter 2), the approval period is generally one year.
Researchers will be notified by REB staff when their study is due for continuing review, no less than three months prior to the expiration date for research approval. In order for the study to continue, the researcher must submit the Application for Continuing Review of a Research Study. The approval notification from the REB will specify the date that the approval expires. Continuing review reminders will be sent to Regional Researchers at least eight weeks prior to the expiration date of the REB approval.
8. If you want to change something in your study, must you notify the REB?
Any proposed changes in the research study that deviate from the original submission must be approved by the REB prior to implementation, except when necessary to eliminate apparent immediate hazards to the subjects. Changes may include changes in investigator, study design, questionnaires, and study closure. The researcher must submit a completed Application for Modification of a Research Study Form in order to obtain approval for any changes.
9. If someone participating in your study has an unexpected or negative reaction, what do you do?
Investigators must promptly report to the REB any unanticipated problems in research involving risks to study participants or others. Researchers should submit the Adverse Events Submission Form to the REB within 10 days of the event.
10. What happens if you fail to comply with REB policies and federal regulations regarding the use of human subjects in research?
Non-compliance with PSI policies and US Federal regulations regarding human subjects research may be considered scientific misconduct. If non-compliance is alleged, the organizational official (Steven Chapman, CTO) will initiate an investigation. Any alleged non-compliance with professional standards in the conduct of research is a matter for investigation and may result in disciplinary action. A finding of research misconduct requires that:
- There be a significant departure from accepted practices of the relevant research community;
- The misconduct be committed intentionally, knowingly, or recklessly; and
- The allegation be proven by a preponderance of evidence.
If any PSI personnel are reported to have engaged in research misconduct, the organizational official will initiate an investigation into the matter and appropriate corrective actions determined.
If you have any questions related to the above please contact the PSI REB Coordinator, (REBcoordinator@psi.org).
