HealthEast Institutional Review Board
Database Application Form
1Project Title:
2Contact Information (Please indicate primary contact person)
a.Application Date:
b.Principal Contact(s):
Mailing Address:
Telephone:
FAX:
Email:
c.Please indicate the training or education completed in the protection of human subjects or human subjects records:
3Subject Population
a.Anticipated date of project: Start date: End date:
b.Please estimate the number of subjects to be involved:
Nationally: Locally: Age range of subjects: to
Total number of subjects: (or)
Anticipated number of subjects per year:
4Study Design/Protocol (In answering the following questions, it is important that you provide a complete response).
a.What are the objective(s)/purpose of the proposed database?
b.List any data elements that would normally not be collected as part of standard clinical care but would be collected and maintained in this database for research purposes.
c.Will this research use solely existing data or specimens?
NO YES – Are those data or specimen publicly available?
d.Will information be recorded by the investigator in such a way that it can be linked to the subject?
NO YES
5Risk (The following items are criteria the IRB must use when determining if your database can be approved under current regulations.)
a.Risks to subjects are minimized:
Note any procedures that will be utilized to prevent or minimize risks or discomforts. If risks are limited to privacy and confidentiality issues, skip to question (b.)
b.When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data. (HIPAA requirements)
1)If you are proposing contact with subjects with whom you do not have an ongoing professional relationship, describe procedures that will be employed to minimize subjects’ feelings of invasion of privacy.
2)How will paper and electronic data be secured (i.e., coded, locked, password protected, etc.)?
3)Where and for how long will it be stored?
4)Who will have access to the data? And why is this access necessary?
5)Provide a brief description of the protected health information which is necessary for the research.
6)Describe an adequate plan to destroy the patient identifiers at the earliest opportunity within the bounds of the study (or) describe why it is necessary to retain the identifiers as a critical component of the study.
7)Describe how you will assure that the protected health information will not be reused or disclosed to any person or entity.
c.Risks to subjects are reasonable in relation to anticipated benefit.
Will the research in its entirety, involve greater than “minimal risk” as described in CFR 46.102(i)? Explain why you feel the potential benefits offered by this research database outweigh the risks to subjects. In answering this question, consider that risks may be physical, psychological, sociological, economic and legal. Consider non-therapeutic personal benefits such as the attainment of valuable information. Also consider potential benefits to society (e.g., advancement of knowledge).
6Selection of subjects is equitable. Be particularly cognizant of the special problems of research involving vulnerable populations such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
a.Potential subjects will come from what sources and what means?
(Note exclusion of any population (e.g., race, gender, ethnicity, age, pregnant, childbearing status, etc.) and provide medical and/or scientific justification for such exclusion)
7Informed consent will be sought from each prospective subject or the subject’s legally authorized representative and appropriately documented or consent is waived by the IRB.
a.Is it practicable to conduct the research without the waiver?
NO YES
If No, please explain why?
b.In your opinion, will the waiver of informed consent adversely affect the subjects’ rights or welfare?
NO YES
Please answer why you think so:
c.One of the following must be attached (Please place an X before one):
A draft of a written consent document that contains all the required elements.
A request for waiver of informed consent.
(If your study plans to use or disclose protected health information, you will need to provide a brief description of the protected health information you plan to use or disclose.)
A request for waiver of documentation.
(i.e., obtain verbal consent only) of informed consent
d.Will pertinent information be provided to subjects later if appropriate?
NO YES – please describe how such information will be provided and how will you identify patient that should be provided pertinent information?
8VERIFICATION OF APPLICATION
I certify that the information furnished concerning the procedures to be taken for the protection of human subjects is correct. I will seek to obtain prior approval for any substantive modification in the proposal and will report promptly any unexpected or otherwise significant adverse effect in the course of the study.
______
Signature of Principal Investigator/Principal ContactDate
Page 1 – IRB Database Application
Last Modified: 12/26/2018