IRB & Ethical Protocol
Overview
The Institutional Review Board (IRB) is a critical component in ensuring the ethical conduct of research involving human subjects. Established in response to historical ethical violations, IRBs are mandated to protect the rights, welfare, and well-being of research participants. IRB is an independent body which reviews the workplan before implementation to ensure it all.
Human Subject Training
Human subjects training is essential for researchers and staff involved in studies that include human participants. This training ensures that all personnel understand the ethical principles, regulatory requirements, and best practices for protecting the rights and welfare of participants.
⭐Note: According to the organization’s policy any individual who has access to more than 10% data with PII must have human subject training certification.
Who Should Complete the Training?
- Principal Investigators (PIs): Responsible for the overall conduct of the study.
- Research Staff: Including co-investigators, study coordinators, research assistants and data analysts.
- Field Staff: For enumerators, field supervisors, field monitoring officers, and field managers a separate session on human subjects must be held every training session.
Frequency of Training
- Initial Training: Required before beginning any research involving human subjects.
- Refresher Courses: Typically required every 2-3 years to ensure ongoing compliance and awareness of any regulatory updates.
- Training Programs and Resources: By completing human subjects training, researchers and staff can ensure that their studies are conducted ethically and in compliance with all relevant regulations, thereby protecting the rights and welfare of participants. Few training and certification programs are given below:
Data Encryption & Confidentiality
ARCED ensures that all confidential data is protected from unauthorized access. This includes data with personally identifiable information (PII) or data shared under confidentiality agreements.
Transferring and Sharing Confidential Data:
- Encryption in Transit: All data transferred over the internet must be encrypted to prevent interception. Established services like SurveyCTO, Survey Solutions, OneDrive, and Dropbox handle this automatically.
- Email: Never use email for transferring confidential data as it cannot ensure complete encryption.
- Encryption at Rest: Data stored on servers must be encrypted before being sent and remain encrypted to prevent unauthorized access by server administrators. At ARCED we use veracrypt to encrypt raw data. Please go through how to go with the flow to see how it works.
Transferring and Sharing Confidential Data:
- One-way Transfer: Services like SurveyCTO and ODK use asymmetric encryption (public/private key pairs). Only IRB-listed individuals should have access to the private key.
- Two-way Transfer: For services like Dropbox, G-drive, OneDrive, email, WhatsApp, and SMS, use symmetric encryption. Share the encryption key separately using a password manager.
Storing Confidential Data:
- Backup: Principal Investigators (PIs) should save unaltered raw data in a G-drive folder, which should not be synced or shared.
- Local Storage: Any confidential data stored locally must be encrypted. De-identify data by removing direct and indirect identifiers when possible.
- Data Security: Always keep confidential data encrypted and decrypt it only when needed. Use the dedicated encrypted data folder for local storage and manually encrypt it using a symmetric encryption tool.
Fundamental Principles
According to the Belmont report the three fundamental principles for IRB are as follows:
- Respect for Persons: This principle emphasizes the autonomy of individuals and the need to protect those with diminished autonomy. It requires obtaining informed consent and ensuring voluntary participation
- Beneficence: Researchers must maximize potential benefits while minimizing possible harms. This principle mandates a thorough risk-benefit analysis to ensure the well-being of participants.
- Justice: This principle focuses on the fair distribution of the benefits and burdens of research. It ensures that no group is unfairly burdened or excluded from the potential benefits of research.
In a far more general manner, we can say IRB is important to protect rights & welfare which translates into:
It requires obtaining informed consent, ensuring voluntary participation, and safeguarding personal information. Researchers must clearly explain the study, its risks, and benefits, and obtain written consent from participants. Additionally, personal identifiable information (PII) must be encrypted to protect participants’ privacy.
This principle mandates a thorough risk-benefit analysis to ensure the well-being of participants. Practical steps include implementing robust data protection measures, conducting regular risk assessments, and providing participants with access to support services if needed.
Researchers must ensure equitable selection of participants, avoid exploiting vulnerable populations, and distribute the benefits of the research fairly. This includes making the findings accessible to all participants and stakeholders.
IRB Application
When to Apply for for IRB?
IRB (Institutional Review Board) approval is required when conducting research involving human subjects to ensure ethical standards are met and participants’ rights and welfare are protected. Here are some guidelines on when IRB approval is needed and when it might not be:
When IRB Approval is Required
1. Human Subjects Research: Any research involving living individuals where data is obtained through intervention, interaction, or identifiable private information.
2. Behavioral and Social Sciences Research: Studies involving surveys, interviews, or observations of human behavior.
3. Biomedical Research: Research involving biological samples, medical records, or genetic information.
4. Educational Research: Studies conducted in educational settings involving students or teachers.
5. Research with Vulnerable Populations: Studies involving children, prisoners, pregnant women, or individuals with impaired decision-making capacity
When IRB Approval May Not Be Required
1. Program Evaluation/Quality Improvement: Activities aimed at improving programs or services without the intent to contribute to generalizable knowledge.
2. Case Reports: Descriptions of individual cases without systematic investigation or generalizable conclusions.
3. Oral History Projects: Interviews conducted to document historical events or personal experiences without systematic investigation.
4. Publicly Available Data: Research using data that is publicly available and does not involve interaction with individuals.
5. Classroom Projects: Student projects conducted solely for educational purposes without the intent to contribute to generalizable knowledge.
💡Tip: Plan for IRB application beforehand.
Who Applies for IRB?
Your Project Investigator (PI) is the primary applicant for IRB approval. But we need to mention the CO – PIs as well)
💡Tip: Collect the information about IRB meetings beforehand, search in their website.
What Do You Do Then?
You do the application on behalf of your PI.
What Should You Study Before an IRB Application?
On the followings you should have complete idea:
1. Research Proposal
2. Study Design
3. Pre-Analysis Plan
4. International IRB application (If there’s any)
How Many IRB Applications Can There Be?
International & Local IRB
International IRB is the one which the PI applies himself/herself/themself. Generally if your PI is a faculty of any university he/she/they apply for IRB in their respective universities.
Since we usually work with universities from abroad, an IRB approval from there is necessary but as we are conducting the research in a different country, it can be Bangladesh or any other country. We need a local IRB approval to conduct the field. Because you will be needing this to get authorization from local authorities that you may need to deal with. Secondly, to publish any research paper based on this study will require IRB approval, as its a prerequisite for any journal. To align with the law of data security & privacy IRB approval is an absolute necessity..
💡Tip: You must communicate with your superior and confirm whether there is any local IRB approval for the study you currently working on.
💡Tip: Before starting the local IRB application make sure your study has already obtained the international IRB approval.
Same Study but Multiple Surveys
A study can have multiple aspects and approaches. For each time you are contacting any human subjects. It is mandatory to have IRB approval. But if one survey has multiple rounds you do not need to worry about as many as IRB approvals. We only take it once.
💡Tip: Check your project budget and make sure every required IRB application is budgeted in it, if you love your salary.
How to Prepare an Application?
Contents: For an local IRB application you will get all the content from the international IRB application and the research proposal.
Budget: After taking approval from your PI & Senior Management Team. You have to contact the Accounts department before applying for an IRB so that they can take their necessary preparations for the invoice.
Where Do You Apply?
For the local IRB we always apply to the IRB of Institute of Health Economics, University of Dhaka.
Application Template
Here you will find the application form template. Apart from that there are few things that you need to email them. Collect the email IDs from your supervisor.
Other Required Documents
Following documents you have to submit too:
1. Consent form in both Bangla and English before making the consent form please read through the IPA consent form checklist.
2. Principal Investigators’ CVs
3. Survey Instruments/Tools
4. Research Proposal/Protocol
💡Tip: Don’t trust humans blindly! Are you a human? Then you know the drill.
💡Tip:Always and always review the IRB application form with your supervisor. For any confusion consult it with you PI. Know that IRB applications are very sensitive. You do not want to put a bad (read noob) impression out there.
💡Tip: Never forget zipping!
What Do I Do After the Application?
Don’t take a rest yet. You are just halfway through. There are still some continuations of work. Let’s go through that now!.
Feedback
After applying for an IRB. The board will give feedback on the whole application. You have to prepare answers for it. Then you share it with your PIs. And let them know you have written down the probable responses, after reviewing the responses if the PIs give you a go-go, send it to the IRB in the same email thread. Now wait for their approval or feedback. If it’s feedb
Unexpected Events
If you have come this far, I know for sure you have gotten the IRB approval. Congratulations!
But now after obtaining IRB approval, it is crucial to maintain ongoing communication with the board, especially when unexpected events occur. These events can include adverse events, unanticipated problems, or protocol deviations. The following guidelines outline the process for reporting such events:
- Adverse Events (AEs): Any unfavorable or unintended event related to the research, such as abnormal laboratory findings, symptoms, or death.
- Serious Adverse Events (SAEs): Events that result in death, life-threatening situations, hospitalization, significant disability, or congenital anomalies.
- Unanticipated Problems: Incidents that are unexpected, related to the research, and suggest that participants are at greater risk than previously known
- Unexpected Changes in Survey Timeline: Suppose you had planned a survey during the July of 2024, but you couldn’t perform if due the unrest & mass revolt.
Amendments
Amendments to an IRB-approved protocol are necessary for several reasons, ensuring the research remains ethical, scientifically valid, and compliant with regulatory requirements. Here are some key reasons why amendments are made:
Enhancing Participant Safety
- Addressing Adverse Events: If unexpected adverse events occur, amendments may be needed to modify the protocol to enhance participant safety.
- Implementing New Safety Measures: As new information becomes available, additional safety measures may be required to protect participants.
Modifying Study Design
- Refining Procedures: Amendments can help refine study procedures to improve data quality and study efficiency.
- Adjusting Sample Size: Changes in the estimated effect size or variability might necessitate adjustments to the sample size to ensure the study is adequately powered.
Adapting to Practical Challenges
- Recruitment Issues: If the study faces challenges in recruiting participants, amendments might be needed to modify inclusion/exclusion criteria or recruitment strategies.
- Logistical Adjustments: Practical issues, such as changes in study sites or personnel, may require protocol amendments.
Incorporating New Scientific Knowledge
- Updating Interventions: New scientific findings might suggest changes to the intervention or control conditions to ensure the study remains relevant and scientifically sound.
- Adding New Measures: Incorporating new outcome measures or assessment tools that have become available since the original protocol was approved.
Regulatory Compliance
- Meeting Regulatory Requirements: Amendments may be necessary to comply with new regulations or guidelines issued by regulatory bodies.
- Addressing IRB Feedback: The IRB may request changes to the protocol based on their review to ensure the study meets ethical standards.
Correcting Errors
- Clarifying Protocol Details: Amendments can clarify ambiguous protocol details or correct errors in the original submission.
- Updating Documentation: Ensuring all study documents are accurate and up-to-date.
Then you have to apply for an amendment again, then you can continue your field work.
Renewal
IRB approval is typically valid for one year. Researchers must submit a renewal application before the expiration date to avoid a lapse in approval.
✨ Fun Fact: Many of these are yet to be in the practice of the local IRB. So chill out and wait for the time when they will be like us and will adhere to best practices.
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