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If you have human subjects in your study, you will need IRB approval of the protocols for their protection prior to conducting your research.

Specifically, if you are about to conduct research involving human subjects that will obtain:

  • data through intervention or interaction with the individual;

  • a subject’s identifiable private information;

  • records gathered on human subjects; or

  • samples of human tissue;


You will need IRB approval of all human subjects’ protection protocols before your study begins.

Moreover, if any of your subjects are children or minors (most countries consider subjects less than 18 years to be minors, and NIH considers any subject less than 21 years to be a minor), you should certainly obtain IRB approval.

IRB review assures compliance with Federal regulation (45 CFR part 46) essential to conducting human research, and protects both your subjects’ rights and your institution’s ethical and legal responsibilities. IRB approval may also enhance funding opportunities by promoting the reputation of your organization’s research quality. Compliance with regulatory and ethical responsibilities work together to build a quality research program.  IRB approval is vital for maintaining an effective and efficient human research protection program based on considered ethical and legal decisions.

Click here to learn more about the IRB process with HML IRB


Data collection and subject safety monitoring protocols are critical and required components in protecting human subjects in research.  Researchers should integrate these protocols into their research design and methods, and IRBs should review and approve them -- and when necessary require changes -- to protect participants.

Regulatory criteria for IRB approval of research, from the Department of Health & Human Services, stipulate that a study’s research plan includes protocols for data collection and storage to ensure the safety of human subjects.  Protocols must indicate the method and degree of data collection and monitoring commensurate with subjects’ risks.  The IRB must approve these protocols before the research may begin.  

In general, data and safety monitoring protocols are required for research that involves greater than minimal risk.  However, in some instances the IRB may find written protocols necessary for a particular research project where it may be argued that there is no greater than minimal risk.

For the HML IRB process, investigators should develop and submit data collection and safety monitoring protocols for IRB review.  The Principal Investigator should also submit an annual update of protocols to the IRB annually, and inform the IRB of any changes to protocols as they occur.  All research team members should read data and safety monitoring protocols and be prepared to follow them.

HML IRB has the responsibility to review data collection and safety monitoring protocols and the authorization to determine if they are adequate for the proposed research.  Data collection and safety monitoring protocols should include an analysis of risks and potential benefits. Protocols should also indicate who is responsibile for subjects’ protections (usually the PI), protection measures that will be monitored, methods and frequency of analysis, and who will carry out these activities. Sometimes it is appropriate for data collection and safety monitoring to be independent of the research team to ensure an unbiased analysis. If so, data and safety monitoring personnel should meet periodically to consider what conditions would trigger suspension or termination of the study, and what precautions need to be taken to ensure the validity and integrity of the data.  Protocols should also include mechanisms for reporting routine data collection and safety monitoring status and emerging issues.  These data collection and safety monitoring reports should be sent to the IRB.

If necessary or appropriate, IRB members may question data collection and safety monitoring protocols if they perceive the need for more information.  Furthermore, IRB members may need to review and consider data collection and safety monitoring reports when granting continuing approval of research.

It’s usually best for us to talk before you submit a request for IRB review, so please send us an email or give us a call anytime.

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