What is an IRB proposal?
Institutional Review Board (IRB) is understood because of the ethics review committee. US requirements sometimes govern the contents and elements of an IRB application, whether or not you submit the applying to an ethics board someplace else.
All J-PAL-funded projects require to clear IRB review at MIT or cede authority to a different host institution. The IRB( institutional review board) research proposal could be a description of your study plan and this could be submitted within the required format.
What is Included in the IRB Proposal?
The IRB research proposal includes the research hypothesis, study background, design and methodology, data analysis, study procedures, also details about the topic population, recruitment, inclusion/exclusion criteria, consent process, benefits, risks, privacy and confidentiality, compensation, and cost.
It is important to style 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 subsequent step is to urge IRB approval.
IRB approval is critical before you start conducting research. you will be able to visit the IRB proposal submission form for more details.
What to submit for IRB approval
UTRMS-IRB online application
Study proposal document
Consent forms (if applicable)
Recruitment materials (if applicable)
Data aggregation instruments (surveys, interview questions )
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 the forms, templates, and guidance documents are available on the IRB Forms page and Study-specific materials will be provided by the researcher.
Preparing the proposal
This information is required for preparing the proposal
1. Research objectives and purpose
Try to add a short purpose or scientific background to the study. don’t 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 fully and submit the consent form exactly as you intend 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’ll have to use the IRB-stamped form.
- Data handling is a crucial risk of study participation. confirm you’ve got good procedures for both physical moreover as electronic data protection, including storing data in locked files and clearly stating the timeline and process for storage of non-public information.
- Besides, ensure you describe within the assent form to whom and the way the subject’s data are accessible. State clearly which particular information won’t be shared with others. this can be totally important if you propose to publish the study data.
- Deception and debriefing: The IRB will need a close explanation if you would like to save lots of information from subjects. Some journal referees have rejected papers that they fancy containing unnecessary cunning. If you are doing use dissimulation, the IRB will likely require that you simply declassify subjects then and explain actuality 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 can’t use more subjects than you originally planned to enroll in unless you submit a reform.
If you’re undecided about the ultimate subject numbers, provide an approximate bound estimate. Remember, there’s no penalty for surveying fewer subjects than stated, but IRBs don’t wish to see approved subjects exceeded.
For an RCT, try and Describe the choice method for treatment and control groups.
give a detailed explanation about all the potential risks for the topics and the way you’re guarding against them.
IRBs will read this very closely and that they may come up with risks that you simply feel are remote. you will be required to safeguard in in our own way against such identified risks.
Any risks and benefits you identify you wish to say in your consent form
Procedure for consent
Normally, a consent form is written, signed consent is required from all study subjects. Consent flow diagram for research involving is tougher so you must consult with your IRB on the procedures. counting on the age of the kid ( seven or older) children have to give assent to study procedures that involve them, though the strategy of obtaining assent will vary looking on age. additionally, parents must consent to research involving their children. If the study includes more risk, both parent’s consent could also be required. MIT requires that research involving minors have written consent of a parent and therefore the suitably documented ascent of the minor if the kid is already over seven years old.
The requirements for 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 is basically used for unspecified future with identifiable data. There are exceptions required for written consent. These could also be important if the written consent procedure prevents subjects from participating in the research.