FREQUENTLY ASKED QUESTIONS
When To Obtain Human Research Review Board Approval:
- What exactly qualifies as human subjects research?
- How do I know if the research I plan to do requires Human Research Review Board approval or registration
- Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
- Who can consent on behalf of a subject for participation in a research study?
Working With the Approved Protocol:
- Can I share my Human Research Review Board protocol approval with colleagues working on similar projects?
- I'm really busy, can I have my research coordinator or clinic manager respond to requests from the Human Research Review Board on my behalf?
Submitting the Protocol:
- Do I need to list in my protocol application all of the research staff members that might be asked to participate on my approved research project?
- Is there any research-related assistance available to investigators located at the Baptist Health System?
- Why was I given less than a 12 month approval?
- What is the fastest way to find out what happened to my study at a Human Research Review Board meeting?
Q. What exactly qualifies as human subjects research?
A. Any systematic investigation that is designed to develop or contribute to generalizeable knowledge, and which uses living humans or identifiable private information about living humans qualifies as human subjects research. To read the Federal regulations defining human subjects research, obtain a copy from the Human Research Review Board office. The regulations regarding FDA regulated drugs and devices are available on-line at http://www.fda.gov/oc/ohrt/irbs/appendixd.html.
Q. How do I know if the research I plan to do requires Human Research Review Board approval or registration?
A. If the human subject data will be aggregated, analyzed or summarized for publication or presentation of any kind (whether inside or outside the Baptist Health System), it requires Human Research Review Board approval or exempt registration. For an explanation of the different categories of human subjects research and their corresponding requirements for approval/registration, see "What Level of Review Do I Need?".
Q. Is informed consent required even if the data/specimens will be collected from my friends and colleagues?
A. Yes. All research involving interaction with human subjects (including collection of specimens) requires informed consent regardless of who the subjects are. In some cases, written informed consent may be waived. Also, special rules apply to recruiting staff from within one's own department. For more information on informed consent requirements, see "Required Elements of Informed Consent."
Q. Who can consent on behalf of a subject for participation in a research study?
A. If an adult patient is unable to consent on his/her own behalf due to medical incapacity, the patient's legally authorized representative (a court appointed conservator or guardian, an attorney-in-fact pursuant to a durable power of attorney with healthcare proxy) may consent on his/her behalf. Family members (also called "next-of-kin") who do not meet the definition of legally-authorized representative may not provide consent for a related adult to be enrolled in research. If there is no legally authorized representative, and the adult patient cannot consent, the patient may not become a human subject in a medical experiment unless the Federal requirements for waiver of consent have been met or a special surrogate consent exception has been approved by the Human Research Review Board at the time of initial review.
Q. Can I share my Human Research Review Board protocol approval with colleagues working on similar projects?
A. No. The Human Research Review Board approves protocols with the understanding that the work will be conducted only by the Investigators named in the protocol application and/or the FDA form 1572. If your colleagues would like to work on your research project, you may modify your existing protocol to add them as Sub-investigators. Otherwise, they must apply for their own Human Research Review Board protocol approvals. For more information on how to modify an approved protocol, see "Changes (Modifications) in the Protocol".
Q. I'm really busy, can I have my research coordinator or clinic manager respond to requests from the Human Research Review Board on my behalf?
A. Federal regulations require that the Human Research Review Board must communicate directly with the Principal Investigator regarding protocol-related issues. Accordingly, all correspondence and/or application submissions from (or on behalf of) the Principal Investigator must be submitted to the Human Research Review Board over the Principal Investigator's signature. The Human Research Review Board may return any protocol-related correspondence that is received without evidence of the Principal Investigator's approval.
Q. Do I need to list in my protocol application all of the research staff members that might be asked to participate on my approved research project?
A. All research staff members that participate in a Baptist Health System approved research project by performing research procedures must be included on the application as a Sub-investigator, be listed on the 1572, and be listed on the consent form. If the work performed on the research project would allow the staff person to receive credit in publications resulting from the research, then his or her name must be listed on the protocol. If, on the other hand, the staff person's role is part of his or her regular paid duties (i.e., phlebotomist, x-ray technician, research coordinator, etc.) and involvement in the project is limited to performing those duties without contributing to the research endeavor, then such individuals need not be listed as Sub-investigators. If your research team should change once the project is approved, you must submit a modification to your protocol adding the new investigator(s) or removing those no longer involved.
Q. Is there any research-related assistance available to investigators located at the Baptist Health System?
A. Yes, the Human Research Review Board office was established to assist staff with human subject research issues and provide regulatory guidance. It is located in the Referral Clinic, Suite 122 of the Trinity Medical Center.
Vyvette Isabelle, MBA, CIM
Coordinator, Human Research Review Board
Baptist Health System
3201 Fourth Avenue South
Birmingham, AL 35222
Q. Why was I given less than a 12 month approval?
A. It is mandated by Federal regulations that the Human Research Review Board grant approvals for a period not to exceed 365 days. However, the Human Research Review Board has authority to require review more frequently than 365 days when the risks presented by a protocol warrant it.
Q. What is the fastest way to find out what happened to my study at an Human Research Review Board meeting?
A. Call the Human Research Review Board office at (205) 715-5308 following the Human Research Review Board meeting. The Human Research Review Board meets on the second Friday of the month.
Note: This will provide you with the status of your protocol only. Approval/disapproval letters will be sent directly to the Principal Investigator within five (5) working days of the meeting at which the protocol was reviewed. Generally, a copy of the letter to the Principal Investigator will also be sent to the Research Coordinator.