What is an IRB proposal?
Institutional Review Board (IRB) is known as the ethics review committee. US requirements sometimes govern the contents and elements of an IRB application, even if you submit the application to an ethics board somewhere else.
All J-PAL-funded projects require to clear IRB review at MIT or cede authority to another host institution. The IRB( institutional review board) research proposal is a description of your study plan and this should be submitted in the required format.
The IRB research proposal includes the research hypothesis, study background, design and methodology, data analysis, study procedures, also details about the subject population, recruitment, inclusion/exclusion criteria, informed consent process, benefits, risks, privacy and confidentiality, compensation, and cost.
It is very important to design your research protocol to account for risks to human subjects. The study proposal is improved by recruitment materials, consent forms, and data collection instruments. After writing your proposal and developed the expanded materials, the next step is to get IRB approval.
IRB approval is necessary before you begin conducting research. You can visit the IRB proposal submission form for more details.
What to submit for IRB approval
As per the New Study submissions must include:
- UTRMS-IRB online application
- Study proposal document
- Consent forms (if applicable)
- Recruitment materials (if applicable)
- Data collection instruments (surveys, interview questions, stimuli, etc.)
- Other forms or documents utilized with human subjects
Review submissions must include:
- UTRMS-IRB continuing review application
Modification submissions must include:
- UTRMS-IRB modification application
- Revised IRB proposal or other documents impacted by the proposed research modification
- Newly developed documents that support the proposed research modification
All the forms, templates, and guidance documents are available on the IRB Forms page and Study-specific materials will need to be provided by the researcher.
Preparing the proposal
This information is required for preparing the proposal
- Research objectives and purpose
Try to add a brief purpose or scientific background to the study. Do not add a comprehensive literature review. Make this agreeable to a well-educated layperson.
2. Procedures of the study
- Make sure you Submit all the interview guides, survey instruments, and recruitment materials you want to use, and provide translations.
- Try to Describe the consent procedure in full and submit the consent form exactly as you plan on using it. Waivers or alterations of consent may require additional materials. Once approved, the agreement form can’t be changed without a correction so it’s worth putting some work into this. You may need to use the IRB-stamped form.
- Data handling is An important risk of study participation. Make sure you have good procedures for both physical as well as electronic data protection, including storing data in locked files and clearly stating the timeline and process for storage of personal information. Besides, make sure you describe in the assent form to whom and how the subject’s data will be accessible. State clearly which particular information will not be shared with others. This is totally important if you intend to publish the study data.
- Deception and debriefing: The IRB will need a detailed explanation if you need to save information from subjects. Some journal referees have rejected papers that they consider to contain unnecessary cunning. If you do use dissimulation, the IRB will likely require that you declassify subjects then and explain the true study purpose to them.
3. Study participants
Describe exclusion/inclusion criteria and explanation.
- Are you working with unsafe populations (children, pregnant, mentally disabled, or developmentally challenged individuals), and if so, why?
- you cannot use more subjects than you originally planned to enroll in unless you submit a reform. If you are not sure of the final subject numbers, provide an approximate upper bound estimate. Remember, there is no penalty for surveying fewer subjects than stated, but IRBs do not like to see approved subjects exceeded.
- For an RCT, try to Describe the selection method for treatment and control groups.
give a detailed explanation about all the potential risks for the subjects and how you are guarding against them.
- IRBs will read this very closely and they may come up with risks that you feel are remote. You may be required to safeguard in another way against such identified risks.
- Any risks and benefits you identify you need to mention in your consent form
Procedure for informed consent
Normally, a consent form is written, signed consent is required from all study subjects. Consent procedures for research involving is more difficult so you should check with your IRB on the procedures. Depending on the age of the child ( seven or older) children have to give assent to study procedures that involve them, though the method of obtaining assent will vary depending on age. In addition, parents have to consent to research involving their children. If the study includes more risk, both parent’s consent may be required. MIT requires that research involving minors have written informed consent of a parent and the suitably documented ascent of the minor if the child is already over seven years old.
The requirements for informed consent have changed with the addition:
- “Key information” to be presented at the initial of the consent form
- New consent elements
- Changes to waiver criteria and documentation.
- A “broad consent” option for unspecified future use of identifiable data.
There are exceptions required for written consent. These may be important if the written consent procedure prevents subjects from participating in the research.