A limited number of biomedical procedures are used in human participant studies on the Ithaca campus. These procedures must be conducted in a manner that assures the safety and privacy of participants. Many such procedures must be conducted in specialized spaces on campus, to ensure that research support is appropriately provided, with trained and qualified personnel conducting the procedures. For detailed information on working with these facilities or conducting any biomedical research on campus, please review IRB Policy #19.
General Guidance for Preparing an IRB Application with Biomedical Procedures
When submitting an IRB application involving biomedical procedures, follow the steps and include the information and documents described below:
Questions 2.3.1-220.127.116.11 are specific to biospecimens collected during biomedical procedures
- 2.3.1 Provide additional details about biospecimens or physiological data collection
- Please select any and all biospecimens that you are collecting. If selecting "other", please describe what you are collecting
- Please select the appropriate category for how you are collecting these specimens
- IRB Policy #19 contains a list of non-invasive medical and physiological procedures
- If selecting "other" please describe how you are collecting the biospecimen, including devices you are using
- 2.3.2 Describe the storage, handling, transportation, and disposal procedures for biospecimens
- Be sure to describe how the sample will be stored, what precautions will be taken during handling, how the samples will be transported, and proper disposal of the specimen
- Institutional Biosafety Committee (IBC) approval may be needed in order to collect biospecimens. Please contact the Cornell IBC for guidance. If you are working under an IBC MUA please provide the number in this section.
- 2.3.3 Do you plan to use any biospecimens for commercial profit?
- Please select the appropriate response. Most basic scientific researchers would respond with a "no" answer. If you are planning to collect biospecimens for commercial profit, the IRB will work with you to develop appropriate informed consent language
- 2.3.4 Do you expect to generate any clinically relevant results from you research?
- This question addresses whether your samples may generate clinically relevant diagnostics
- 18.104.22.168 If so, your consent should explain whether or not you will disclose this information to the participant. The IRB can advise during the review process on how to best address any concerns
- 2.3.5 Do you have plans to include whole genome sequencing in your research?
- This specifically relates to any whole genome sequencing that you are planning, based on samples provided by your research participants
- If you answer "yes", your consent must clearly communicate this information
- 2.4.1 Provide details of biospecimen collection
- Please include the SOPs you will be using for the collection of the samples and describe who will be collecting and handling the specimens. All research personnel will need to have IRB basic training and, if working with blood, blood borne pathogens training.
- 2.4.2 Provide a sequential list of all study components
- Please describe how long it will take for the participant to complete the study.
- Please include the time estimate for the consent, the procedure, and any follow up visits
- This gives the IRB an idea of the total commitment required from participants
- Please describe how long it will take for the participant to complete the study.
- 2.4.3 Where will the biospecimens be collected?
- Cornell University only permits certain biospecimens to be collected on campus, in approved facilities. Please see below for specific biomedical procedures and samples that must be collected at approved facilities.
- For all other specimens, please describe your plans for collection. If working with international collaborators, please include a letter of support and a full description of the facility in which samples will be collected
- 2.4.4 If samples will be collected at multiple sites, will the same protocol be followed at each site.
- If not a multisite study please answer "no"
- If yes, provide a detailed description of what will happen at each site
If you are planning to analyze already-collected biospecimens, you will need to complete section 3 of the application. Below is specific guidance for filling out the IRB application for this kind of study.
- 3.1 Are you conducting this kind of research
- Please answer "yes" to either question 2 or 3, depending on whether the samples you will receive will be de-identified or not.
- 3.2 Select all types of secondary data/materials from living individuals you are using in this study:
- Please select the biospecimens you are analyzing in the study
- If you select "other", please describe in detail what the specimen is.
- 3.3 Please provide a brief description of the biomaterials and their source
- Please describe where you are getting the samples from. Include a letter of support or other documentation that indicates you have access to the samples, such as a Data Transfer Agreement.
- 3.4 Please describe if the provider is imposing any restrictions to your use of these specimens
- 3.8 Please describe how you will store the biospecimens
- 3.9 Was anyone on your research team involved in the original collection of these data or biospecimens?
- Please answer and, if "yes", describe in detail
- 3.10 Was any part of the original data/biospecimen collection effort funded by Cornell, or supported by Cornell Faculty, staff, or students?
All IRB applications involving active collection of specimens must include a consent form. Below please find a general biomedical consent form template that can be adapted for your needs. Note, if your application involves blood draws or fMRI, specific consent forms for these procedures need to be used. You can find these consent templates in the section below concerning specific biomedical procedures.
Guides and Templates for Specific Biomedical Procedures
Review the guidance below before you start planning for blood draws for research. It contains useful links and resources that will help to make the application and review process go smoothly and fast. We strongly recommend that researchers use the research support services for blood draws offered by Gannett Health Services or the HMRU.
The standard, IRB-approved consent language and standard operating procedures (SOP) for blood draws are provided in the templates below. Researchers are welcome to edit the templates for their project, but are encouraged only to make those changes to standard language that are truly necessary, as any material changes will need to be reviewed by Occupational Medicine and the IRB, and may add additional time to the protocol approval process.
- Editable Standard Operating Procedure and Take Home Sheet: Venipuncture (to be used only if blood draws are not being done at Cornell Health Services)
- Editable Consent Form: Venipuncture
The standard, IRB-approved consent language and standard operating procedures (SOP) for capillary blood draws (also known as finger sticks) are provided in the templates below. Researchers are welcome to edit the templates for their project, but are encouraged only to make those changes to standard language that are truly necessary, as any material changes will need to be reviewed by Occupational Medicine and the IRB, and may add additional time to the protocol approval process.
The Cornell MRI Facility (CMRIF) is a university-wide resource located on the ground floor of Martha Van Rensselaer Hall. To help you understand how studies in the CMRIF are reviewed, a process outline is provided below.
For all scans with human participants performed in the CMRIF, use this IRB protocol application cover sheet and consent form template. You should edit the consent template for your project, but only make those changes that are truly necessary; any material changes will need to be reviewed by Occupational Medicine and the IRB, and will add additional time to the protocol review process.
Additional resources—such as SOPs and an IRB application template—are available through the CMRIF website.
Contact the Human Metabolic Research Unit (HMRU) for guidance on urine sample collection, pregnancy testing, and respiratory tracking studies.
Contact the IRB office for guidance on conducting research involving fecal sample collection and blood pressure measurements.
Contact the EEG lab for guidance on EDA (ElectroDermal Activity), Bioelectrical Impedance, ECG/EEG, and eye-tracking studies.
Cornell Facilities for Biomedical Procedures