1. What are the duties and responsibilities of a principal investigator?
The principal investigator (PI) is responsible for the ethical conduct of the research project. The PI has to submit all the mandatory reports in a timely manner to the Medical Research Center. The PI is responsible for the conduct of a research project from the research design to the manuscript preparation.
2. Do my IRB forms need to be signed by the PI?
Yes. All IRB forms require the signature of the PI and all the team members who are involved in the study. Additionally, all initial applications (new applications) require the signature of the PI(s) and the PI's Department Chair (or the person the PI reports to).
3. How do I know if I need to submit my human subject research for review and IRB approval?
To assist you in determining if your study requires IRB review, the MRC recommends submitting the completed application to the corresponding staff in MRC for a decision.
To help determine if your project is considered human subjects research as defined by the Food and Drug Administration (FDA) and may require IRB review, please forward your application to email@example.com
. This would include research involving drugs, biologics, medical devices, and dietary supplements. If your research does qualify as “Human Subject Research” under FDA criteria, you are required to submit your IRB application to the MRC.
4. How can I request assistance with the forms, IRB process, or my study submission?
We welcome your calls or emails at any point during your research process to answer any questions you may have. The MRC staff are available to meet with you Sunday to Thursday between the hours of 7am and 3pm to discuss your project or in-process paperwork either in person or by phone.
To discuss your project in more detail, please request a 30 minute appointment in our office between 7am and 3pm.
5. What are the types of research that can be conducted in HMC?
a. Observational research
1. Naturalistic observation: where the researcher studies and records behavior in a natural setting with no attempt to influence behavior.
2. Participant observation: where the researcher participates in the group while recording its behavior – participation could be active or passive e.g. cross sectional studies.
3. Archival research: where the researcher gathers information from existing records e.g. retrospective studies.
b. Correlational research: where the researcher focuses on the degree to which two variables are related - like case control or cohort studies
c. Experimental research: where the researcher conducts experiments on an experimental group and a control group and studies the changes in the dependent variable based on the independent variable.
6. How much time should I allow for an IRB approval of my research?
We request that your Exempt or Expedited application and other documents be submitted to this office for review at a minimum of four weeks prior to your anticipated research start date. We cannot guarantee that we can accommodate your deadlines if you allow less time for IRB review. This approval timeframe assumes that all CITI training is complete, and all proper and completed paperwork has been submitted with the application. Missing information will delay the approval process.
Please check with your PI and/or Department's Administrative Office prior to submitting to our office to ensure you are within the guidelines.
7. What services are available from the Medical Research Center at HMC for a researcher?
The Medical Research Center (MRC) is the executive wing of the IRB at HMC. Researchers can seek the help of the MRC staff in the design of research proposals, for statistical analysis, financial help and advice on ethical issues related to research.
8. What if I want to make changes to my study after I have IRB approval?
All changes to IRB approved Expedited and Full Board studies require modification approval prior to implementing any approved changes. Please submit a request form, indicating the change(s) you are making, and the justification. Changes to the protocol would include, but are not limited to: additions/removal of PI(s)/Co-I (s), changes to procedures, or even additions/deletions/changes to a survey or questionnaire.
Exempt studies require modification approval only when: the changes may increase the risk to subjects, there is a change in PI, or when you want to start collecting identifiers.
9. When can I close my study with the MRC?
An IRB approved study can be closed in the MRC when all data collection and subject interaction has been completed and all private identifiable information has been stored, de-identified, or destroyed in accordance with IRB approved protocol. This is applicable to all Expedited and Full Board studies. Please submit the Closure Form when these criteria have been met.
10. Can I submit a hand written form?
No, hand written forms are not accepted by the MRC. All of our forms are downloadable word documents and must be typed. The signatures of the PI, Co-I and PI’s Department Chair, Medical Director (If needed) are the only acceptable hand written elements for our forms.
11. What does the study expiration date mean?
After the approval of Expedited and Full board studies a continuing renewal of the study must occur at least annually. The expiration date is generally one year from the approval date. You are first notified of your expiration date in your initial approval letter. If your study is expired you will receive a notification from MRC and ALL research activities must be stopped.
To avoid your study expiring, the continuing review request form must be completed, signed by the PI and submitted to MRC at least 30 days prior to the expiration date. As a courtesy, MRC will send you two reminders, 60 and 30 days prior to the study expiration.
If your study expires but you wish to continue the study you must complete a new application and re-submit your study documents as a new study.
12. Does a Quality Assurance/Quality Improvement (QA/QI) project that involves research need to be reviewed by an IRB?
Yes, in some cases IRB review is needed if the project meets the definition of human subject research. If your project involves research and a QA/QI component, use the standard IRB initial application form. If you are uncertain if your project qualifies as QA/QI project please contact MRC.
13. Is my research retrospective or prospective, and what is the difference?
Retrospective research is information that is already collected (already exists-or is "on the shelf") prior to the study submission.
Prospective research is information that has not yet been documented or collected at the time of study submission.
Please review the informative slides in the E-training and Development section
14. CITI Training
In order to conduct human subject research at MRC there are certain education or training requirements that must be met. HMC has partnered with the Collaborative Institutional Training Initiative (CITI) to provide that training. Note: CITI training must be complete and up-to-date for study approval.