Frequently Asked Questions
What is the IRB?
IRB stands for “Institutional Review Board”. The IRB is a committee established to review and approve applications for research projects involving human subjects. The primary purpose of the IRB is to protect the rights and welfare of the human subjects.
What is a human subject?
Under the DHHS regulations “human subject” means a living individual about whom an investigator (whether professional or student) conducting research:
- obtains information or biospecimens through intervention or interaction with living individuals and uses, studies or analyzes the information or biospecimens; or
- obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Who can be the Principal Investigator (PI) of a study?
Maroof International Hospital IRB policy requires the principal investigator of a study to be a Maroof faculty member or designated senior staff of one of the non-MIH entities covered under the Federal Wide Assurance.
How can participants be recruited?
It is the job of the IRB to make sure that the selection of subjects for a study is equitable. Each protocol submitted to the MIH IRB for review must explain how subjects will be identified and recruited for the study. Once the pool of potential subjects is identified, the IRB considers how the investigator proposes to approach those individuals. Any approach to subjects must be non-coercive and the potential subjects must voluntarily participate in the recruitment process. The IRB and the investigator must respect and protect subject privacy, the subject’s right to control access to him/herself. In order to assure that these principles are met, the IRB reviews the study recruitment plan and all recruitment materials to determine how the materials will be used, whether the plan will reach the target audience, and how communication between the investigator and the potential subjects will occur.
Are there requirements for recruitment ads?
All proposed printed advertisements or brochures, web postings, or audio/video advertising, and all communications with primary care physicians, other investigators, or potential subjects informing them about a study must be submitted for IRB review and approval prior to use. These tools are considered to be part of the subject selection and the informed consent process for the study. This includes any recruitment plans, tools, or campaigns that will be undertaken by the sponsor or any contract research organization involved in the research. Any proposed changes (including where the tool will be used) to previously approved recruiting tools must be submitted to the MIH IRB for review and approval before they may be used to recruit subjects for a study.
What does the IRB consider research?
Research means a systematic investigation (including research development, testing, and evaluation) designed to contribute to generalizable knowledge.
Do I need IRB approval to send study data to an outside site?
Yes, you do need IRB approval to send study data to an outside site.
What kinds of IRB review are there?
Types of IRB review include convened, expedited, and exempt review. All applications are submitted through eIRB, the on-line electronic application submission system.
- Convened IRB.(full committee review): Any study involving greater than minimal risk, including studies with vulnerable populations and/or sensitive questions, as well as studies with the possibility of physical risk.
- Expedited IRB. (individual committee member review): Only research involving no more than minimal risk to subjects, including blood sampling in minimal amounts, review of records collected for non-research purposes (such as chart reviews), and survey research.
- Exempt from Continuing IRB Review: Research with very minimal risk to human subjects as determined by regulatory guidelines may be exempted from continuing review at the discretion of the IRB. An exemption is granted by the IRB upon review of the application.
What is exempt research?
Exempt research are projects that meet specific criteria as defined in the Revised Common Rule. Exempt research must initially be reviewed by the IRB to make a determination the project meets the criteria. Exempt research does not require continuing review by the IRB. Examples of exempt research may include educational tests, surveys, or interviews or the use of existing data, documents, or other records. Note that the IRB, rather than the researcher, determines when research is exempt.
What do I need to know about submitting a new application to the IRB?
Any faculty member whose research involves human subjects must submit an application to the MIH IRB. All Principal Investigators must hold a faculty level appointment, senior staff may act as PI by submitting a letter of support from the Department Chair with the new application. Applications should be as complete as possible using the most recently approved templates as applicable. The IRB must approve the application before research can begin. All study team members must complete the required compliance training before the application can be approved. All new applications are reviewed for regulatory and administrative issues prior to being scheduled for IRB review. Time to approval for new applications usually depends on the type of research conducted and timely submission of responses to IRB issues.
How often does the IRB meet?
There are seven MIH IRBs. (IRB 1, 2, 3, 5, 6, & X) meet monthly or when required.
Does the IRB require a complete copy of the grant application with a new application?
Can non-Maroof researchers be on the study team?
Only Maroof hospital faculty members can be the Principal Investigator of a study. Non-Hopkins investigators may be study team members.
Where can I go for help in preparing an application?
The IRB website provides links to IRB, guideline and policy, Evaluation forms, proposal forms are available on the web page.
What should my application say about risk?
Research subjects may be exposed to physical, psychological, social, and economic risks. Very few studies involve no risk. In minimal risk studies, the risks to participants should be no more than those encountered in everyday life (or during routine physical or psychological tests). The PI must evaluate whether the degree of risk is safe enough for the specific subject population by considering:
1) Who are the research subjects and what kinds of risks do they routinely encounter?
2) Are some subjects more vulnerable than others, and is the risk/benefit ratio worth the exposure?
3) What are possible adverse effects, and can the harm be fixed or prevented?
4) Having taken the obvious steps to reduce or circumvent harm, what, if any, are the remaining levels of risk, possible consequences to certain classes of subjects, consequences to the entire research population, and is the research now “safe enough”?
What is Informed Consent?
Consent is a continuing process that starts before any forms are signed and continues until the individual’s participation is complete. It involves meeting with a potential participant, determining whether s/he is capable of giving consent, discussing the purpose, risks, and benefits of participation, etc. Its goal is to assure that prospective participants can knowledgeably and voluntarily, without coercion, decide whether to participate. Consent is required for every participant unless the consent or one of its elements has been waived by the IRB or the IRB has determined that the research is exempt
What happens after submission?
Your study will be assigned to an IRB Committee. The Research Subjects Specialist (RSS) for that committee will review your application and uploaded documents. If the application is determined “incomplete” by the RSS, it will be returned to you to make revisions. Once you submit the completed application, the RSS will assign your application to the next available meeting. A Consent Form Specialist (CFS) will review your consent form and make necessary changes. Upon review by the IRB Committee additional changes may be requested. You will have the opportunity to accept or reject these changes.
What do I need to know about data?
Maintaining confidentiality is essential to any research in order to protect the privacy and well-being of participants. Whenever possible, research should use data prepared from personal information from which the participant cannot be identified by the recipient of the information. If this is not possible, the amount of personal data stored by researchers should be kept to the minimum necessary to achieve the purpose of the research.
What does it mean to be “de-identified”?
Data that does not include any direct identifiers of the individual or of the individual’s relatives, employers, or household members is considered to be de-identified.
How long does IRB review take?
An expedited or exempt review may take about two weeks. Studies requiring convened review may take three or more weeks. The PI has a significant influence on the length of time between submission and approval. Well prepared applications result in fewer requests for changes raised as issues by the IRB. Rapid response by the PI to the IRB issues speeds the approval process.
What criteria do reviewers apply when looking at my project?
Reviewers look at purpose, methodology, adequate handling of informed consent, whether the research deals with high risk or sensitive issues and, if so, whether the benefits outweigh the risks, and the degree to which confidentiality is both assured and protected.
What delays approval of my IRB application?
Some things that may delay approval of your IRB application include submitting an incomplete application by failing to: complete compliance training, cross-checking information on the consent form against information in the protocol, and proofreading the application and relevant documents.
What are the possible outcomes of IRB Review?
Approved: The PI is notified that the application is approved and does not require modification. This is a rare outcome.
Approved with Administrative Changes: If minor modifications are required by the IRB, the PI must complete the revisions and resubmit the application. In most cases, the modifications will be reviewed and administratively approved.
Tabled: If the proposal generates significant ethical questions, or appears to be scientifically unsound, the study will be tabled and further information will be requested. Studies may also be tabled if the protocol or consent documents are poorly written or do not provide sufficient information. The application will be reviewed at a subsequent IRB meeting once the PI has submitted the revisions.
Disapproved: Applications will be disapproved if they are judged to be ethically or scientifically unsound. Investigators are not advised to resubmit disapproved studies without consulting the IRB. This is a rare – but possible – outcome.
What happens after I receive approval?
You may begin your research upon receipt of the written documentation of IRB approval.
How long is the approval period?
The approval period for any research is no more than one year, less if the proposed research needs more frequent monitoring. Before the end of the approval period, the Principal Investigator must submit a request for continuing review. Even if within the approval period a change in research (amendment) is submitted and approved, the original approval date will stand.