Clinical research is any activity that represents "research" involving "human subjects," as defined by the U.S. Federal Government and the FDA.
As defined by the Common Rule at 45 CFR 46.102(d), the term research means a systematic investigation involving human subjects, including research development, testing and evaluation designed to develop or contribute to generalizable knowledge.
As defined by the FDA at 21 CFR 50.3(c), the term research means an experiment that involves a test article and one or more human subjects.
What is a human subject?
As defined by the Common Rule, the term human subject means a living individual about whom an investigator conducting research obtains 1) data through intervention or interaction with the individual, or 2) information that is both private and identifiable.
As defined by the FDA at 21 CFR 50.3(g), the term human subject means an individual who is or becomes a participant in research, either as a recipient of a test article or as a control.
What is the IRB?
The IRB stands for Institutional Review Board, which is similar to an ethics board, but has to be able to ascertain the acceptability of proposed research in terms of institutional commitments and government regulations, applicable law, standards of professional conduct and practice.
Must be able to promote respect for its advice and counsel in safeguarding the rights and welfare of human subjects
May suspend or terminate approval of a study or investigator as deemed necessary to protect human subjects
May place restrictions on a study or investigators
Mandated to act as the independent entity within the structure of Ascension Genesys Hospital
All decisions by the IRB are binding and cannot be overturned or overruled by any system within Ascension Genesys Hospital
Actions of the IRB, its chairperson, members and administrative staff in matters of human subject protection derive from the authority vested under federal regulations
Why does my research need an IRB approval?
It is both required and recommended.
Government regulations (FDA 21 CFR) and Office of Human Protections regulations (45 CFR 46.102) require that all research involving human research that is NIH funded have an ethics IRB review prior to any enrollment of subjects or data collection.
Ascension Genesys Hospital also requires an IRB review for any research being conducted under the auspice of the Ascension Genesys Hospital Ministry.
Furthermore, IRB review is an added protection to investigators, ensuring that the research is ethical and that proper protections are in place for subjects. Investigators are subject to severe penalties by law for conducting unethical research.
Also an IRB approval letter most likely will be required prior to any research publication or entry to a research forum
What if my research is just a retrospective chart review? Does it still require an IRB approval?
Yes, all research conducted at Ascension Genesys Hospital involving data collection must be reviewed by the IRB. The IRB is the authority in the Ascension Genesys Hospital to determine if projects are exempt from an IRB review. Contact the IRB Office for guidance.
Why do I have to submit my research by the IRB deadline date?
The policies governing the IRB state that the Ascension Genesys IRB and Medical Education Research Committee (MERC) will have a minimum of 1 week prior to the meeting date to review all agenda items. This is a regulatory requirement to provide adequate time for review.
How do I submit my research proposal to the IRB?
All IRB applications and research protocol documents must be submitted electronically to the electronic software system. This website is accessible from any internet-based computer. All IRB forms can be found on the IRBNet webpage.
How long does it take to get an IRB approval letter?
Usually, within 1-2 days after an IRB or MERC meeting an approval letter will be sent.
Why is my research only approved for one year?
Government regulations only allow research to be approved for one year. The IRB expiration date is very important to remember. It is the responsibility of the investigator to request a “continued review” for another year or the research must be “closed out” prior to the expiration date.
What if it takes more than one year to complete my research?
Prior to the expiration date, you must e-submit a continued review form to the IRB. The form is similar to a progress report, giving the status of the research study. It is the responsibility of the investigator to be aware of the expiration date and submit the proper continued review reporting documents to the IRB. If your research study lapses past the expiration date, contact the IRB office immediately. An investigator is subject to penalty by the FDA for research not complying with IRB approval time periods. This is a government regulation that is strictly adhered to.
Can I let a relative or friend help me with my research?
No, only IRB approved investigators or “helpers” may be involved with the research study. Anyone involved must be listed in the IRB application along with a description of their involvement and validation of their training. Human protection training requirements must be verified for all persons involved in collection of data for research purposes. Personal health information is protected by HIPAA regulations and is also strictly adhered to within a research study. No information may be shared with people outside the approved research study personnel or research staff. All computers used must be HIPAA compliant and be password protected.
My research is IRB approved, but I need to make some changes?
Any changes or modifications to already-approved research are required go back to the IRB for review. An addendum/revision form must be completed with detailed description of what is being modified. All modifications to the study must be requested and approved before any changes can be made, including changes to advertisements, posters, pamphlets, collection of data, recruitment, formatting or words in the consent, the inclusion/exclusion criteria or adding more investigators or helpers to the study.
I want to be an investigator on a research study. Do I need Human Protection Training?
Yes, you must complete the CITI training modules. The verification of a training certificate must be submitted with the research application. Click here for the Citi Program.
My research is already approved by another IRB? Do I still need to notify the Ascension Genesys Hospital IRB?
Yes, the Ascension Genesys Hospital IRB has the final authority over all research being conducted at any Ascension ministry location. Contact the IRB Office to determine if the Ascension Genesys Hospital IRB has a federal assurance relationship with an outside IRB.
I am just doing a single “case study.” Does this require an IRB review?
No, a single case study does not require a Ascension Genesys IRB review. However, case studies involving more than 2 subjects - such as when a series of subject observations are compiled in a way to allow possible extrapolation or generalization of the results - constitutes as research that must be approved by the IRB. Additionally, this type of activity must always be reviewed by the IRB when there is intent to publish or disseminate the data or findings. Also, if intent is to display a poster or submit to a research forum, be sure to check the forum requirements.
Who do I contact for help with statistical and data analysis?
Office of Research has expertise and skills in statistical analysis. Contact Jennifer Hella for more assistance at firstname.lastname@example.org
How can I publish my research results in a medical journal?
Contact the Office of Research for assistance with this process. Many Ascension Genesys research study results have been published.
Who do I contact if I have more questions or have problem with e-submitting my research?