|
Resources or Quick Links
HSRB Membership Roster
For All Inquiries:
Office of Research Subject Protections
George Mason University
4400 University Drive, MS 4C6
Fairfax, VA 22030
Email:hsrb@gmu.edu
|
Human Subjects Frequently Asked Questions
What is the Human Subjects Review Board (HSRB) and why does it exist?
How are members appointed to the HRSB?
Must Mason have an HSRB?
Why would it be cumbersome if we followed the Code of Virginia rather than the federal regulations?
What are the responsibilities of the HSRB?
What authority does the HSRB have?
Can an HSRB decision be appealed?
Are all studies reviewed by the full board?
What is the difference between full board review, expedited review and exempt?
What determines whether a study is exempt, expedited or goes to the full board?
Do I need to submit an application for exempt research?
How long does the human subjects review process take?
Must investigators obtain training in the protection of human subjects?
What is the Human Subjects Review Board (HSRB) and why does it exist?
The HSRB, often called an Institutional Review Board or IRB, is an independent, administrative body established to protect the rights and welfare of human research subjects recruited to participate in research activities conducted under the auspices of the institution.
How are members appointed to the HRSB?
Members are appointed to the HSRB by the Institutional Official of the University. The President has designated the Vice President for Research and Economic Development as the Institutional Official for carrying out the University's human research protections program. The HSRB consists of at least five members of varying backgrounds. HSRB members should have the professional experience to provide appropriate scientific and ethical review. The HSRB must have at least one scientist member and at least one member whose primary concerns are nonscientific. Additionally, there must be at least one member who is not otherwise affiliated with the institution (a community representative) and a prisoner representative for studies involving prisoners as subjects. The Mason HSRB has 12 members that include a prisoner representative.
Must Mason have an HSRB?
As a recipient of federal funds for research, Mason is required to have a Human Subjects Review Board (HSRB) that meets federal requirements to review research protocols involving human subjects and to evaluate both risk and protection against risk for those subjects.
As well, Mason is required to register with the federal Office of Human Research Protections (OHRP) through a process called a FederalWide Assurance. In this Assurance, Mason is given the option to designate whether the University and the HSRB will follow federal regulations for only federally funded research or for all research. Mason has chosen to follow federal regulations for all research conducted. The rationale for the decision, is that the Code of Virginia would need to be followed in lieu of federal regulations and the Code of Virginia would not allow Mason's HSRB to conduct expedited reviews of research.
Why would it be cumbersome if we followed the Code of Virginia rather than the federal regulations?
Last fiscal year the HSRB received 390 applications to review. We were able to review 90% as "expedited" reviews or were "exempt," leaving only 10% to go before the full HSRB for review. That means that those "expedited" protocols didn't require full board reviews, and as a result the reviews were handled by one member of the Board. Thus, the investigators with expedited reviews were able to begin their studies very rapidly. The Code of Virginia doesn't allow for expedited reviews. So, the HSRB would become a tremendous bottleneck in getting protocols approved were we to switch from federal regulations to state regulations.
What are the responsibilities of the HSRB?
In accordance with Title 45 of the Code of Federal Regulations, Part 46.111, in order to approve research, the HSRB must determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the HSRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The HSRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the HSRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disable persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject's legally authorized representative, in accordance with, and to the extent required by §46.116.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(8) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
It is the function of the HSRB to 1) determine and certify that all projects reviewed by the HSRB conform to University policies and procedures and the regulations and policies set forth under the Common Rule regarding the health, welfare, safety, rights, and privileges of human subjects; and 2) assist the investigator in complying with federal and State regulations.
What authority does the HSRB have?
The HSRB has the authority to suspend, place restrictions, or terminate approval of research activities that fall within its jurisdiction that are not being conducted in accordance with HSRB requirements or that have been associated with unexpected adverse events. The HSRB has the authority to observe or have a third party observe the consent process and the research if the HSRB determines it to be indicated.
The HSRB jurisdiction extends to all research (funded and not funded) involving human subjects conducted at Mason, as well as research conducted elsewhere by Mason faculty, staff, and students.
The HSRB makes its independent determination whether to approve or disapprove a protocol based upon whether or not human subjects are adequately protected.
Research that has been reviewed and approved by the HSRB may be subject to review and disapproval by officials of the institution. However, those officials may NOT approve research if it has been disapproved by the HSRB.
If the HSRB chair, member, or staff person feels that the HSRB has been unduly influenced by any party, corrective action will be taken to prevent additional occurrences.
Can an HSRB decision be appealed?
If an expedited reviewer of an HSRB makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator may appeal, in writing, for review by the convened HSRB.
If the convened HSRB makes a decision that the investigator believes to be unduly restrictive on the proposed research, the investigator should first discuss the matter with the Chair of the HSRB or the Director of the Office of Research Subject Protections, taking care to explain the reasons for believing that the proposed procedures are in compliance with University policy and with Federal regulations. If the issue cannot be resolved satisfactorily by negotiation, the investigator may appeal the decision of the HSRB, in writing. The HSRB will reconsider the appeal based upon the new information provided and will continue to re-review protocols as long as the investigator wishes to appeal.
Are all studies reviewed by the full board?
During the 2006 fiscal year, 389 applications were submitted for HSRB review. Of these only 42 were reviewed by the full board, 235 reviewed by expedited review and 56 exempt.
What is the difference between full board review, expedited review and exempt?
Review procedures for expedited review and full review are similar in several ways:
. The review criteria are the same.
. Both types of review are documented communication processes between investigators and reviewers.
. Expediting reviewers and the full IRB can request modifications to submissions and can approve protocols, continuing reviews, and amendments to approved protocols.
. Expediting reviewers and the IRB will specify when a protocol must be reviewed again. By regulation it must be within twelve months, but shorter review periods may be required.
A key difference between the two processes is that expedited reviewers cannot disapprove a protocol. They must refer protocols they cannot approve to the full IRB. All IRB members must be advised about protocols, continuing reviews, and amendments approved through expedited review procedures. Any member of the IRB may request that such approvals be reconsidered by the full IRB.
Exempt research does not have to be reviewed by the HSRB at all. Instead, the determination of exempt is made by the Office of Research Subject Protections and the only review of the study is by the Office.
What determines whether a study is exempt, expedited or goes to the full board?
Research may be eligible for exemption from the federal regulations if all the activities associated with the research fall into one or more of six categories. Of the six categories, three are frequently used by social and behavioral scientists. They are:
1. Some research conducted in established or commonly accepted educational settings, involving normal educational practices.
2. Some research involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior.
NOTE: This category does not apply to research with children.
3. Some research involving the collection or study of existing data (collected prior to the research for purposes other than the research) if the data are publicly available or recorded by the investigator in such a manner that the subjects cannot be identified.
While these studies do not require review in accordance with the federal regulations, some procedure is necessary to make the determination that they are eligible for exemption. Institutional procedures vary, but the common element is that the institution, not the investigator must make the determination.
To be eligible for expedited review research must meet two criteria:
1. Pose no more than minimal risk to subjects.
"No more than minimal risk" means that "the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests."
2. All of the activities associated with the research fall into one or more of the expedited categories specified in the regulations.
Eligible activities are similar to those for exempt research (some surveys, interviews, and data analysis) with the addition of some minor or non-invasive medical procedures, such as blood pressure readings, weight measurements, MRI use in research and blood draws.
Studies sent to the full board for review typically involve potentially vulnerable populations and/or studies that involve sensitive topics including, but not limited to, illegal behaviors, drug use, alcohol use, other dangerous behaviors and trauma.
Do I need to submit an application for exempt research?
Yes, the Mason human subjects policy requires the Office of Research Subject Protections(ORSP) Office to make the initial determination that a protocol is exempt or nonexempt. Mason faculty, staff and students may not conduct exempt research until they receive exempt notification from ORSP.
How long does the human subjects review process take?
If your research is found to be exempt and informed consent revisions are not required, you should receive an exempt notification letter within 7-10 days after your complete application is received. If your research is found to be nonexempt and qualifies for expedited review, your research will be reviewed within approximately 7-10 days of receiving your complete application. If your research is found to be nonexempt and does not qualify for expedited review, your research will be reviewed by the full board. The HSRB meets once a month. You should receive a response within three days after the HSRB has reviewed your research.
Must investigators obtain training in the protection of human subjects?
The HHS regulations for the protection of human subjects (45 CFR part 46) do not require investigators to obtain training in the protection of human subjects in research. However, an institution holding an OHRP-approved Federalwide Assurance (FWA) is responsible for ensuring that its investigators conducting HHS-conducted or -supported human subjects research understand and act in accordance with the requirements of the HHS regulations for the protection of human subjects. Therefore, as stated in the Terms of the FWA, OHRP strongly recommends that institutions and their designated IRBs establish training and oversight mechanisms (appropriate to the nature and volume of their research) to ensure that investigators maintain continuing knowledge of, and comply with, the following:
. relevant ethical principles;
. relevant federal regulations;
. written IRB procedures;
. OHRP guidance;
. other applicable guidance;
. state and local laws; and
. institutional policies for the protection of human subjects.
Furthermore, OHRP recommends that investigators complete appropriate institutional educational training before conducting human subjects research.
In some cases, other federal requirements regarding training for investigators must be met, such as the National Institute of Health's (NIH) requirement for the training of key personnel in NIH-sponsored or -conducted human subjects research.
|
