Policy and Procedures (Download )
I.
Institutional authority under which the HSRRC is established and empowered
II.
Purpose of the HSRRC
III.
The principles that govern the HSRRC in assuring that the rights and welfare
of subjects are protected
IV.
The authority of the HSRRC
A, Types of studies that must be reviewed
B. Authority to disapprove, modify, or approve studies
C. Authority to require progressive reports from the investigators and oversee the conduct of the study
V. The HSRRC Organizational Structure
A. Administration of the institution
B. Other committees
C. The research investigators
D. Research Records
E. Closing a Protocol
F. Other institutions
G. Regulatory agencies
VI. The membership of the HSRRC
A. Number of Members
B. Qualification of members
C. Diversity of members
1. Selection and appointment
2. Length of term/service
3. Responsibilities
4. RemovalB. HSRRC Members Selection and appointment
1. Length Term/Service
2. Duties
3. Attendance requirements
4. RemovalC. Training of HSRRC Chair and members
1. Orientation
2. Continuing Education
3. Reference materials (HSRRC Library)D. Compensation of HSRRC Members
E. Liability coverage for HSRRC members
F. Use of consultants
G. HSRRC administrative responsibilities
H. HSRRC Secretary Responsibilities
I. Resources
VIII. Conflict of Interest Policy
A. Conflicts of Interest for HSRRC Members
B. HSRRC Responsibility
C. HSRRC Member Responsibility
B. Reporting, in writing, findings and actions of the HSRRC to the investigator and the institution
C. Determining which studies require review more often than annually
D. Determining which studies need verification from sources other than the investigators
E. Ensuring prompt reporting the HSRRC of changes in research activities
F. Ensuring that changes in approved research are initiated without HSRRC review and approval
G. Ensuring prompt reporting to the HSRRC, appropriate institutional officials the OHRP and FDA of:1. Unanticipated problems involving risks to subjects or others
2. Serious or continuing non-compliance with 21 CFR Parts 50 and 56 or the other requirements of the HSRRC3. Regulatory Improprieties in Research
4. Further Actions
5. Suspension or termination of HSRRC approvalH. Determine which device studies pose significant or non-significant risk
A. Scheduling of meetings
B. Pre-meeting distribution to member’s all information and relevant documentation
C. The review process1. Documentation delivered to HSRRC members
2. Role of any subcommittee of the HSRRC
3. Emergency use notification and reporting procedures
4. Expedited review proceduresD. Criteria for HSRRC approval contain all requirements of 45 CFR 46.101(b) and 110 and 21 CFR 56.110
E. Voting requirements1. Quorum required to transact business
2. Absence or Loss of a Quorum During a Meeting
3. Diversity requirements of quorum
4. Percentage needed to approve or disapprove a study
5. Full voting rights of all reviewing members
6. Proxy votes
7. Prohibition against conflict-of-interest votingF. Further review/approval of HSRRC actions by others within the institution (override of disapproval is prohibited)
G. Communication from the HSRRC1. To the investigator for additional information
2. To the investigator conveying the HSRRC decision
3. To institutional administration conveying HSRRC decision
4. To sponsor of research conveying HSRRC decision1. Criteria for appeal
2. To whom appeal is addressed
3. How appeal is resolved
A. HSRRC membership roster showing qualifications
B. Written procedures and guidelines
C. Minutes of meetings
D. Retention of protocols reviewed and approved consent documents
E. Communication to and from the HSRRC
F. Unanticipated Problems/Adverse Events/Complaints reaction reports
G. Documentation that the HSRRC reviews unanticipated problems/adverse events/ complaints reaction reports
H. Records of Continuing Review
I. Record Retention Requirements
J. Budget and Accounting Records
K. Statements of significant new findings provided to subjects
XII. Information the investigator provides to the HSRRC
A. Professional qualifications to do the research (including a description of necessary support services and facilities)
B. Study protocol information requirements
C. Investigation brochure/advertisements and recruitment incentives
D. Element of informed consent1. Basic Elements of informed consent as found in 45 CFR 46.116(a) and 50.25(a)
2. 45 CFR 46.116(b) and 50.25(b) additional elements of informed consent that should be included where appropriate
3. Proxy Consent
4. Documentation of Informed Consent
5. Waiver or Alteration of Informed Consent
6. Waiver of Written Documentation of Consent
7. Research Involving Audio, Video, Photographic Recordings
8. Research Involving Deception
9. Translated consent documentsE. Control of Investigational Devices
F. Multi-site Study Requirements
G. Requests for changes in study after initiation
H. Reports of all adverse events, unanticipated problems
XIII. Emergency Waiver of Consent
A. University Policy
B. Classroom Project (Exempt)
C. Classroom Project (Expedited or Full Board Review)
D. Categories of sensitive information include information
E. Categories of special subject population
F. Faculty Classroom Project responsibilities and agreements
XVI. Potentially Vulnerable Subject Groups
A. Research Involving Prisoners
1. Review Procedures
2. Issues Related to Consent
3. Issues Related to Confidentiality
4. Issues Related to Content1. Parental Permission
2. Children's Assent
3. Non-Participation
4. School Permissions
5. Minimizing CoercionC. Research Involving Cognitively Impaired Subjects
D. Research Involving Students, Employees and Normal Volunteers
E. International Research
Policy and Procedures
Binghamton University, State University of New York, investigators and their research staff, and the Human Subjects Research Review Office, must share a collaborative responsibility and commitment to maintain the highest ethical standards in our research endeavors.
Binghamton University has established the Human Subjects Research Review Committee (HSRRC) as the institutional review board (IRB) responsible for the institution's obligations to review research involving human research. Researchers are allowed to involve human subjects in their research under the terms and conditions set forth by the Office of Human Research Protections (OHRP) of the Federal Government Department of Health and Human Service (DHHS) and the Food and Drug Administration (FDA). All employees, students, faculty and staff must comply with these regulations, as well as state and local laws, and institutional policies. Failure to comply with the required rules and regulations can result in loss of funding for human subjects research for the entire institution.
Human Subjects research is constantly evolving; therefore this manual will be revised to maintain the most up-to-date ethical standards.
I. Institutional authority under which the HSRRC is established and empowered.
Binghamton University’s Human Subjects Research Review Committee is guided by ethical principles, Federal, State and local laws regarding all research involving humans as subjects. These guiding ethical principles have been set forth by the Nuremburg Code of 1947, the Declaration of Helsinki of 1964, and the Belmont Report Ethical Principles and Guidelines for the Protection of Human Subjects of Research of 1979.
Binghamton University has secured from the U.S. Department of Health and Human Services, Office for Human Research Protections a Federal Wide Assurance (FWA) which is valid from May 14, 2007 through May 10, 2010. The FWA is an assurance of compliance with the federal regulations for the protection of human subjects in research. The Assurance defines the responsibilities of the Institution, the HSRRC, the HSRRC administrative office and staff, and the investigator to protect human research subjects.
The primary responsibility for protecting the rights and welfare of human subjects rests with each individual who initiates, directs, or engages in research. It is the responsibility of Binghamton University HSRRC to insure that the rights and welfare of the human research subjects recruited to participate in research activities conducted under Binghamton University auspices are protected.
III. The principles that govern the HSRRC in assuring that the rights and welfare of subjects are protected.
Binghamton University has established the Human Subjects Research Review Committee (HSRRC) as the institutional review board (IRB) responsible for the institution's obligations to review research involving human research. This committee has been established under an assurance of compliance negotiated with the U. S. Department of Health and Human Services and is governed by the ethical principles outlined in the Belmont Report (The Ethical Principles and Guidelines for the Protection of Human Subjects, 1979)
IV. The Authority of the HSRRC.
All research projects involving human subjects conducted by University faculty, staff and students or done under the sponsorship or auspices of the institution must be reviewed and approved by the Human Subjects Research Review Committee (HSRRC). This includes research involving subjects from outside the university and research which is not funded. This includes the following types of research, (this is not an exhausted list)
B. Authority to disapprove, modify, or approve studies based on consideration of human subject protection aspects.
Actions on Protocols Reviewed by the HSRRC
By regulation, action on protocols that require full HSRRC review may be taken only at convened meetings at which a majority of the members of the HSRRC are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it must receive the approval of a majority of those members present.
The full Committee may act on a protocol in one of four ways:
- it may be approved; i
- t may be approved pending modifications (this may not need to be re-reviewed by the full committee);
- it may be tabled, needing substantial revisions or clarifications (such protocols will need to be re-reviewed by the full committee);
- it may be disapproved (in this case, the study may be re-written to address all concerns and re-submitted for full committee review).
In cases where a study is disapproved - the HSRRC will provide its rationale for the action taken. The investigator may request an appearance before the Committee to present arguments for reversal of the decision or propose a change in the protocol based on the advice and counsel of the Committee.
C. Authority to require progressive reports from the investigators and oversee the conduct of the study.
The HSRRC may require progress reports or summary of findings from the investigator at any time and may determine a need to oversee the conduct of the study. The HSRRC has the authority to observe, monitor or request that an audit be performed to ensure that proper scientific, ethical and regulatory requirements are followed.
Monitoring of ongoing studies may include the following:
- Determining whether the investigator has current, complete copies of all informed consents in his/her files for subjects enrolled in the study
- Determining whether the investigator has a copy of the current protocol and a blank copy of the most recent informed consent document
- Determining whether the investigator has complete and current copies of correspondence from the HSRRC and, if applicable, the study sponsor
- Determining whether the investigator has adhered to inclusion/exclusion criteria
The HSRRC has the authority to determine if a research project should be suspended or terminated for cause. The action will be reported to appropriate institutional officials, the head of any supporting Federal Department or Agency (if applicable), the Office of Human Research Protections under DHHS, and the corporate study sponsor (if applicable). If the project that is suspended or terminated involves a drug, device, or biologic regulated by the Food and Drug Administration, the FDA shall also be notified of the suspension/termination.
V. The HSRRC Organizational Structure
For matters relating to the execution of their duties and responsibilities, the HSRRC staff reports directly to the Authorized University Institutional Official, the Associate Vice President of Research. The following are reported to the Associate Vice President of Research who in turn communicates with the Office of Human Research Protections (OHRP) with the federal Department of Health and Human Services (DHHS)
- Changes in HSRRC membership
- Serious or continuing noncompliance with federal regulations
- Any unanticipated problems involving risks to subjects or others
- Any suspension or termination of HSRRC approval for a project
The HSRRC works in collaboration with other committees and with the campus community as a whole to ensure the protection of human subjects. These committees include, but are not limited to:
- Institutional Official
- Division of Research, Research Development Services
- Office of Compliance and Risk Management
- Biosafety committee
- Radiation safety committee
- Institutional Animal Care and Compliance
The HSRRC communicates to the Principal Investigator and ensures that the following requirements are adhered to:
- All members of the research team comply with the findings, determinations, and requirements of the HSRRC
- Research does not commence until the human subject research conducted under their name has received review and approval by the HSRRC.
- The informed consent document and the informed consent process complies with the HSRRC reviewed and approved document
- Continuing review and approval of the research has been conducted within the requirements set by HSRRC
- No modifications or revisions have been initiated without prior HSRRC review and approval, except when necessary to eliminate apparent immediate hazards to subjects
- No research is continued beyond the HSRRC designated approval period
- Any unanticipated problems involving risks to subjects and any serious adverse events are reported to the HSRRC within 3 business days, or sooner depending on the severity
- Any serious or continuing non-compliance issues are reported to the HSRRC within 5 business days
- Conflict of Interest forms and or conditions must be reported to the HSRRC.
Although regulations require that all human subjects' research records be retained for three years following the completion of the research [45.115(b)], we recommend that records be maintained in the investigator's files for a minimum of six years or an indefinite period following completion of the study. The investigator must maintain all research records (including a copy of the entire protocol, consent form, amendments, and copies of signed consent forms for each research participant (if applicable) in the lab or office of the investigator.
If the investigator leaves Binghamton University, the records must be kept at the University in the Human Subjects Research Review office or with a designated investigator. The HSRRC office must be informed of this transfer of records prior to the investigators departure. The records will be accessible for inspection and copying by authorized representatives of the DHHS and FDA and/or the university.
When a student graduates, or otherwise leaves the University, the faculty advisor is then responsible for retaining the human subject documentation. Students may retain the original, but a copy of all research documentation must be maintained in the areas listed above.
Closure of a protocol should occur when the research is permanently closed to the enrollment of new subjects, all subjects have completed all research-related interventions, all research activities and data analysis is complete. A protocol Closure Form can be found on our website: http://humansubjects.binghamton.edu
All research that is being conducted in collaboration with another institution must receive approval from the other institutions IRB, if one exists. If the collaborating institution does not have an IRB then a letter of permission from an individual who has authority must be obtained. If the research will be conducted in an educational environment, permission must be obtained from the Superintendent of the School District. All letters of permission must be received by the HSRRC office before research can commence. This may also include research sponsors, other IRB’s with which we have a review relationship, and community and special-interest advocacy groups.
These collaborating institutions must provide a letter of understanding that outlines that all applicable laws and regulations will be abided by and adhered to.
Binghamton University’s Human Subjects Research Review office is required to communicate with Federal, State and local authorities all information that is outlined in the Federal Guidelines. We also strive to maintain positive and productive relationships with regulatory agencies, local and state legislators.
VI. The membership of the HSRRC.
The HSRRC shall have
at least five members, with varying backgrounds to promote complete and
adequate review of research activities commonly conducted at Binghamton
University.
The HSRRC will consist of individuals who have expertise in the areas of research reviewed and have sufficient expertise and diversity to evaluate ethical issues involved in research, as well as one non-scientist, and one person who is not affiliated with the university.
The HSRRC will not have a member participate in the HSRRC’s initial or continuing review of any project in which the member has a conflicting interest, except to provide information requested by the HSRRC.
The HSRRC will invite individuals with competence in special areas to assist in the review of issues which require expertise beyond or in addition to that available on the HSRRC. These individuals may not vote with the HSRRC.
The HSRRC Chairperson in collaboration with the Administrator will identify those areas of research which member’s expertise is required. Recommendations for appointment to the HSRRC are requested from individuals in the research community. Community members may be identified through various sources and depending on the area of expertise required. The Administrator conducts an initial contact to gauge the willingness of the individual. Individual names of those that express an interest and desire are forwarded to the Institutional Official. The Institutional Official appoints the individual.
The HSRRC membership will not consist entirely of men or entirely of women, but will include qualified persons of both sexes. The HSRRC will not consist entirely of members of one profession.
Binghamton University HSRRC is constantly evolving and changing to ensure that the committee has the expertise to professionally evaluate the research protocols and to ensure the protection of human subjects.
Our board members represent a wide range of professionals and laymen. These include a Physician, Attorney, Chaplain, Professors in various fields, a community advocate, a prison advocate. The compilation of varying backgrounds brings to the committee the ability to assess risk from differing perspectives.
The HSRRC has called on in the past, those individuals who are expert in a field that the committee does not have experience in.
The Chair has direct responsibility for assuring that the HSRRC operates in full accordance with regulatory requirements and the highest ethical standards. The Chair works with HSRRC staff, committee members, institutional officials, and investigators to ensure that the rights and welfare of research participants are adequately protected, and that the benefits of the research justify the risks to the research participant.
The Chairperson is appointed by the Institutional Official (Associate Vice President for Research)
The Chair of the HSRRC is appointed usually for a three-year term.
The chair should play a leadership role in establishing and implementing HSRRC policy. As a primary representative of HSRRC decisions, the HSRRC Chair should have shared authority over all HSRRC policy and procedures in collaboration with the Institutional Official and HSRRC Administrator.
- The Chair should represent the HSRRC in discussions with other segments of the organization.
- The Chair should represent the organization in discussion with federal authorities.
- The Chair should review all protocols presented to the full committee. The HSRRC Chair is expected to have read each full committee protocol and to communicate with other reviewers so that important HSRRC issues are identified or resolved before the full committee meeting.
- The Chair should direct the proceedings and discussion of the full committee meeting. This includes keeping the discussion focused on important HSRRC issues and seeing that the full-committee meeting process is both efficient and effective.
- The Chair should vote at full committee meetings.
- The Chair should have an in-depth understanding of the ethical issues, state law, institutional policy, and federal research regulations that are applicable to studies that are reviewed by the HSRRC.
- The Chair is not expected to be the only, or ultimate, authority on compliance issues. The HSRRC administrator or other members of the HSRRC organization also take responsibility for compliance verification.
- The Chair should assist HSRRC administration in the drafting of letters from the HSRRC to researchers regarding HSRRC decisions.
- The Chair should review and sign HSRRC response letters in a timely fashion
- The Chair should review and make decisions about responses to condition for HSRRC approval of research in a timely fashion. This task is shared with the HSRRC administrator.
- The Chair should serve as the reviewer for research that is reviewed by exempt or expedited process. This task is shared with the HSRRC Administrator.
- The Chair should represent the HSRRC in defending or discussing HSRRC decisions with researchers.
- The Chair should investigate instances of non-compliance in collaboration with the Director of Compliance and the Institutional Official and develop a plan of action to address the non-compliance and oversee monitoring any remedial action
- The Chair should review all unanticipated problems/adverse events/complaint forms. Take appropriate action as needed regarding revision or status of the protocol and informed consent
- Report as needed to the Institutional Official
The Institutional Official is empowered to remove the Chair, at any time, for cause in consultation with the President and Vice President of Research.
The Chair and Administrator review and identify areas in which expertise is required. The Administrator obtains the willingness of the individual to serve on the HSRRC prior to recommending the prospective member to the Institutional Official.
Members serve a one-year term and can be re-appointed at the end of their term. Members may resign at any time by submitting a letter of resignation to the Chair of the HSRRC.
- The HSRRC members are responsible for completing initial and ongoing educational requirements regarding protection of human subjects
- Identifying any conflicts of interest at HSRRC meetings and removing themselves from the discussion and voting
- Reading all material provided to them and being informed and prepared for the meeting
- Conducting reviews as requested
- Being an active member of the HSRRC and attending the meetings on time, participating in the discussion and planning to stay the length of the meeting
The HSRRC Members in accepting their appointments are informed of the scheduled meetings and it is their responsibility to make every effort to attend each meeting. In the event that a member is not available for a period of three consecutive meetings in one semester or five meetings in a one year period they will relinquish their membership of the committee.
The Institutional Official may remove members from the HSRRC prior to the end of their appointment. The HSRRC member removal may occur in the event that the member does not fulfill their duties or responsibilities in reviewing protocols or has displayed inappropriate behavior and has affected the conduct of the meeting. Members cannot be removed based on their voting record, or in an attempt to alter the HSRRC membership to obtain approval for protocols.
C. Training of HSRRC Chair and members
The HSRRC members are required to complete the on-line Collaborative IRB Training Initiative educational program. The CITI human subject’s research educational program consists of a Basic Course of 17 modules for Biomedical investigators and 11 modules specifically prepared for Investigators conducting Social / Behavioral research
The HSRRC Administrator will review with the new member the procedures for obtaining materials and the various forms used. This includes reviewing access to Blackboard and the ability to retrieve documents.
As part of their continuing education, the membership blackboard is used to post information regarding “current “hot topics”.
All information is stored on the HSRRC organizational blackboard. The committee members are free and encouraged to submit educational findings regarding human subjects for distribution through Blackboard postings.
The Office also has access to IRB Ethics and Human Research and The Hastings Center Report. These publications offer issues and or concerns that are relevant to human subjects research. Articles are often shared and discussed among the HSRRC.
Binghamton University’s Human Subjects Research Review Committee is a completely volunteer group of individual who are donating their time and expertise for the benefit of Binghamton University’s research environment.
Section 17 of the NYS Public Officers Law provides that the NYS Attorney General will defend employees should they become involved in litigation if such litigation pertains to an incident involving their duties as long as the employee(s) did not intentionally engage in wrong doing. This protection is also extended to SUNY Associates and volunteers expressly authorized to participate in a state-sponsored volunteer program. Evidence of this authorization includes a volunteer appointment record in accordance with campus procedures and an oath of office executed by the SUNY Associate or other volunteers.
The HSRRC will call on consultants to provide to the HSRRC the additional expertise or cultural diversity that may arise. The consultant shall be both unbiased and knowledgeable about the research and has the ability to provide an opinion to the HSRRC in layman terms. The consultant may submit a written report that will be distributed to the HSRRC or may attend a meeting and submit the report then and be available for questions, but must leave the meeting before a vote is taken.
- Serve as the primary resource for investigators regarding the administrative review requirements for human research protocols
- Understand, interpret and document compliance with Federal and State research regulations
- Perform preliminary review of all research applications and determine protocol status and identify problems and issues on the submission based on Binghamton University’s, the Federal Government Guidelines and New York State Laws
- Approve protocols based on Federal criteria for Exempt and Expedited protocols
- Track pending applications and advise investigators on the status of their protocols
- Identify and track approved research protocols, including implementing office-established procedures to assist investigators in complying with conditions imposed by the committee
- Issue approval notices based on conditions imposed by the committee
- Design and create all databases and mail merge documents pursuant to Federal Guidelines
- Supervise the updating of all databases and maintain correct records of confidential research protocols
- Supervision and train the HSRRC Specialists and student assistants
- Create and modify all forms and applications required for protocol submissions
- Create and modify Human Subjects Research Review Website: http://humansubjects.binghamton.edu/
- Update and revise Policy and Procedures pursuant to Federal Policy 45 CFR 46.116(b) (5). And 21 CFR 56.
- Provides secretarial support to the HSRRC
- Transcribing minutes
- Updating databases
- Filing
- Creating Blackboard folders and on-line documentation
- Assist HSRRC members with computer problems
- Coordinates all HSRRC meeting schedules and dietary needs
- Serves as the organizational representative during formal regulatory Human Subjects Research Review quality assessments of research protocols
- Provides assistance (internal and external) on matters concerning research at Binghamton University and Federal requirements.
The HSRRC administrative offices are located in the ITC Alpha building rooms 2204 and 2205.
VIII. Conflict of Interest Policy
Binghamton University’s policy dictates that HSRRC members will not review, participate in the discussion of, or vote upon any research protocol for which they have a conflict of interest. No HSRRC member can take part in the initial or continuing review of a protocol in which they have a conflict of interest other than to provide requested information.
Binghamton University policy prohibits HSRRC members from reviewing, participating in the discussion of, or voting upon any research protocol for which they serve as principal investigator or co-investigator.
Binghamton University policy prohibits HSRRC members from reviewing, participating in the discussion of, or voting upon any research protocol when they serve as principal investigator, co-investigator in which the committee member holds a financial interest, meaning anything of monetary value, including but not limited to, salary or other payments for services (e.g. consulting fees or honoraria); equity interests (e.g. stocks, stock options, or other ownership interest); and intellectual property rights ( e.g. patents, copyrights, and royalties from such rights).
Binghamton University HSRRC members with these types of conflicts of interest shall recuse themselves from the final discussion and vote of all such studies. All conflicted members must recuse themselves and leave the room for the vote
When a member, or a member’s spouse, relative or partner, is an investigator on a study to be reviewed, HSRRC members must recuse themselves from the review, discussion of, and vote on the protocol.
HSRRC members are provided guidance about potential conflicts of interest through Binghamton University’s policies, given to all members upon their acceptance of HSRRC membership, and throughout their tenure on the board. These policies are also available on the website: http://humansubjects.binghamton.edu
Every HSRRC meeting agenda includes language that prompts members to leave the room during the discussion and vote if they have a conflict of interest, including financial interest, related to a study on the agenda
Abstentions of Committee members, who have a conflict, from the deliberation and the vote are noted in HSRRC minutes.
It is the responsibility of every member including those who are unaffiliated members, to recuse themselves from the discussion and the vote if they have a conflict.
HSRRC members conflict of interest includes, but is not limited to the following, if the HSRRC member
The HSRRC Chair or an individual who possess the qualification and is a current member of the HSRRC will review each application for compliance with federal and state regulations and institutional policies. The Chair or designee will determine if the protocol is eligible for exempt/expedited review.
Applications that qualify for exempt/expedited review are reviewed for approval by the Chair or a designated member of the HSRRC. If the chairman or designated member of the HSRRC question the approval of the protocol, they will communicate their questions to the Principal Investigator. Comments, questions and the request for additional information will be returned to the Principal Investigator in writing. All comments, questions and additional information must be addressed by the Principal Investigator before the protocol can be approved.
In the event that the Chair or the Chair designee does not have the expertise required to assess a protocols risk criteria - that protocol will be reviewed by three members of the committee one of which will have expertise in the research area. The three members have the option of approving the protocol, approval with revisions or requiring a full board review. The approval options can only occur if all three committee members agree on approval. In one committee member requires full board approval, the protocol will be placed on the agenda for full board review.
By regulation, action on protocols that require full HSRRC review may be taken only at convened meetings at which a majority of the members are present, including at least one member whose primary concerns are in nonscientific areas. In order for the research to be approved, it must receive the approval of a majority of those members present.
Applications that require full board review will be added to the HSRRC meeting agenda. The following material required for the complete protocol review will be placed on the HSRRC blackboard for the committees review.
- The full protocol or grant application
- Proposed informed consent
- plans for subjects safety monitoring and data storage
- All recruitment/advertisement brochures
- All surveys, questionnaires and interview outlines
- A copy of all media (photographs, videos, web shots, etc.)
- All required additional committee reviews and approvals
- Permission and other HSRRC approvals
Scientific Evaluation
In "high risk" studies the scientific validity will be evaluated based on the following OHRP Guidelines:
Institutional Review Board Guidebook: Chapter III: Basic IRB Review
"[I]f a research study is so methodologically flawed that little or no reliable information will result, it is unethical to put subjects at risk or even to inconvenience them through participation in such a study."
Full Committee Actions
The Full Committee may act on a protocol in one of four ways:
- it may be approved
- it may be approved pending modifications (this may not need to be re-reviewed by the full committee)
- it may be tabled, needing substantial revisions or clarifications (such protocols will need to be re-reviewed by the full committee)
- it may be disapproved (in this case, the study may be re-written to address all concerns and re-submitted for full committee review).
Once a project is approved, no protocol or consent form changes, amendments, or addenda may be made without re-review and approval by the HSRRC.
Attached to the standard approval memo is the final approved version of the consent form with the HSRRC approval stamp.
Continuing review is a federally mandated requirement. All research studies approved by the HSRRC must be reviewed at least annually. The expiration date is stamped on each page of the consent document. As a courtesy, a notice that the continuing review report is due will be sent via e-mail to the Principal Investigator at least one month prior to the study expiration date. Please note that an investigator should not depend solely on HSRRC notification as a prompt for submitting a request for renewal. It is the responsibility of the Principal Investigator to complete the continuing review report form and return all requested items to be reviewed at the HSRRC meeting in order to ensure that the review process is completed on time. The following should be submitted to the HSRRC office for continuing review:
- A completed Human Subjects Research Review form
- A current copy of the consent form with HSRRC approval stamp
- Summary of findings
- Copies of all recent publications
- Copies of all current investigational device brochures (if applicable)
- Protocol closure Form (if applicable)
B. Reporting, in writing, findings and actions of the HSRRC to the investigator and the institution.
Exempt/Expedited Research
If the protocol is complete and meets the regulatory definition of minimal risk, it will be approved as an expedited and/or exempt protocol. The Principal Investigator will receive an approval memo via e-mail, along with their consent form date stamped - the protocol must note that the research will last longer than one year to receive the stamp.
Full Board Review Research
Written notification of actions taken at the HSRRC meeting is e-mailed to the Principal Investigator after each meeting.
In cases where a study is disapproved - the HSRRC will provide its rationale for the action taken. The investigator may request an appearance before the Committee to present arguments for reversal of the decision or propose a change in the protocol based on the advice and counsel of the Committee.
C. Determining which studies require review more often than annually.
In certain circumstances, determined at the time of initial or continuing review, the Committee may stipulate that continuing reviews should take place more frequently than once a year (for example, high risk protocols or protocols with a high risk; potential benefit ratio).
If special reporting requirements are set as a condition of approval, the investigator must submit the required information, when designated, to determine whether changes have occurred in the risk: benefit ratio.
D. Determining which studies need verification from sources other than the investigators
The Committee may request additional information from sources other than the principal investigator in order to assess the completeness and accuracy of information submitted and to verify that no material changes have occurred since the last HSRRC review. These situations may include the following: complex projects involving unusual levels or types of risks to subjects; projects conducted by investigators who previously have failed to comply with requirement of the federal regulations or the requirement of the HSRRC; and projects where concern about possible material changes occurring without HSRRC approval have been raised, based upon information provided in continuing review reports or from other sources.
E. Ensuring prompt reporting to the HSRRC of changes in research activities
Once the HSRRC has approved a project, it must be carried out exactly as planned. Any changes (i.e subject population, recruitment plans, research procedures, study design, study instruments, study sites, or research personnel) must be approved by the HSRRC prior to implementation.
Researchers planning a change should submit the following to the HSRRC office:
- Modification Form
- One marked copy of the document that will be revised (all changes must be highlighted or underlined)
If the change to the protocol makes it necessary to change the consent document, the following should also be submitted
- One marked copy of the amended consent document, with all changes highlighted or underlined)
- One clean copy of the amended consent document for the HSRRC stamp (note: the expiration date remains the same).
Minor protocol/consent changes may be approved by expedited review. These would be changes that do not adversely alter the overall risk/benefit profile of the study; would not affect the willingness of current subjects to remain in the study; and do not alter the scientific validity of the study design. Changes to the study design, which may increase risk to subjects, may require full committee review. Changes that are perceived to significantly affect the risk/benefit ratio for subjects must be reviewed by the full committee.
F. Ensuring that changes in approved research are initiated without HSRRC review and approval except where necessary to eliminate apparent hazards.
Implementation of any change must not occur prior to HSRRC approval unless the change is required to eliminate an immediate hazard to the subjects. In this case, the HSRRC should be notified as soon as possible of the change.
G. Ensuring prompt reporting to the HSRRC, appropriate institutional officials, the OHRP and FDA of:
Principal Investigators and/or any individual involved in the research must report any problems involving the conduct of the study or patient participation. Any problems involving the recruitment and/or consent processes and/or any deviations from the approved protocol should be reported in writing. Examples of a more serious nature include incidents of a person being enrolled in a study before signed consent has been obtained.
All unanticipated problems/adverse event/complaints must be reported promptly. The Unanticipated Problems/Adverse Event/Complaint form is available on-line at: http://humansubjects.binghamton.edu/Forms.htm
The HSRRC will review all unanticipated problems/adverse event/complaint reports in order to re-evaluate the risks/benefit of the study and/or the appropriateness of the recruitment/ consent process to determine if any changes should be made in the protocol or consent form. If the investigator has already modified the protocol or consent form in response to these events, the appropriateness of these changes is also reviewed.
2. Serious or continuing non-compliance with 45 CFR 46 and 21 CFR Parts 50 and 56 or the other requirements of the IRB
Complaints, Non-Compliance, and Regulatory Improprieties Policy: This policy will ensure that the research environment will be responsive and sensitive to the complaints of our human subject and others and to resolve complaints in a positive and timely manner. This policy preserves the rights of the research subjects to lodge complaints and to be assured that complaints will be taken seriously. This policy also covers the issues of handling non-compliance and regulatory improprieties. Non-compliance and improprieties with regulations as well as violations of safety policies will not be tolerated and will be dealt with according to federal regulations.
A human subject may lodge a complaint with either the principal investigator (PI), the Office of Human Subjects Research (HSRRC), or through the Office of Compliance and Risk Management hot line (OCRM). If the PI receives the complaint first, they will make every effort to resolve the complaint. The PI will then complete the on-line adverse event/complaint form and forward to the HSRRC office. The research subject may contact the HSRRC or the OCRM Office. If the HSRRC receives the complaint they will complete the adverse event complaint form and notify the PI of this action and request a 3-day response.
The subject will be reassured that all means will be taken to inquire into the circumstances and appropriate measure will be taken to address the issue. The subject will also be asked if they would like to receive a follow-up confirmation of the actions taken.
A copy of the complaint and the PI’s response is forwarded to the Chair. If no further action is required the matter will be filed.
If the Chair feels that the issue warrants further action, the HSRRC Administer will research the complaint and the protocol and forward a report to the Chair and the Institutional Official. The issue will then be finalized or forwarded to the full board committee for review.
All complaints will be handled in a confidential manner. Access is limited to only those individuals with a responsibility that requires knowledge of the complaint. (Further action is outlined in Section D).
The HSRRC will monitor performance of specific compliance issues and any non-compliance issues brought to the HSRRC or the OCRM’s attention.
When investigator non-compliance issues are identified, the Administrator will promptly investigate the allegation of non-compliance and corrective action will be taken. The Administrator will make every effort to correct the issue(s) at the administrative level. Within three working days after receipt, the Administrator will explore and research the allegations and request responses by the PI to address the allegations. These findings will be submitted to the Chair. The Chair will ensure that an appropriate response to each complaint/allegation is taken. The Chair will report at the following HSRRC meeting the action(s) taken and if necessary, submit a report to the appropriate officials and/or agencies.
Allegations of serious non-compliance will be reported immediately to the HSRRC Chair, to the Director of OCRM and to the Vice President of Research.
All instances of improprieties in research will be reported to the Director of OCRM. Each instance of alleged impropriety will be evaluated on a case-to-case basis. All effort will be made to correct the impropriety at the administrative level. If the impropriety involves potential harm to others or significant property damage, the appropriate institutional officials will be notified for immediate action pending formal inquiry.
The Administrator will conduct an initial review to determine the nature of the complaint, non-compliance issue or impropriety. During this review, every effort will be exercised to maintain the confidentiality of all parties involved. The Administrator will evaluate the facts gathered and forward all information to the Chair who will take appropriate action. Dependent upon the nature of the event or circumstances, certain actions may occur:
- Further inquiry may be initiated
- Administrative action may be taken (i.e. suspension or termination of the study)
- Details and recommendations forwarded to the appropriate committee Chairpersons (i.e., HSRRC, Radiation, and/or Safety) for consideration in their committee, and action
- Details and recommendations forwarded to the Associate Vice President, Vice President, Provost, General Counsel, and/or the President for action
- Details and recommendations forwarded to the appropriate officials at affiliated institutions for notification, action, and/or follow-up, if applicable
- Other actions as deemed appropriate.
The final course of action is entirely dependent upon the nature, severity, and degree of seriousness of the findings. For example, the HSRRC may require special monitoring of the consent process by an impartial observer (consent monitor) to reduce the possibility of coercion and undue influence by an investigator or his staff.
All action taken will be at the institutional level most appropriate for the circumstances. All actions requiring reporting to regulatory bodies outside the university, such as OHRP or FDA, will be by, or at the request of, the Institutional Official for the Human Subjects Research Review committee.
Noncompliance will be reviewed by the committee and will be referred to the Dean of the appropriate college for further action, including disciplinary action.
Failure to report any unanticipated problem, adverse event or complaint is a breach of the conditions under which HSRRC approval is given, and could result in suspension or revocation of approval. If the HSRRC determines that a research project should be suspended or terminated for cause, the action will be reported to appropriate institutional officials, the head of any supporting Federal Department or Agency (if applicable), the Office of Human Research Protections under DHHS, and the corporate study sponsor (if applicable). If the project that is suspended or terminated involves a drug, device, or biologic regulated by the Food and Drug Administration, the FDA shall also be notified of the suspension/termination. Suspension or revocation of approval could result in loss of support by funding agencies and loss of right to publish.
H. Determine which device studies pose significant or non-significant risk.
All device studies require full board review. The Principal Investigator will supply the following information:
- a description of the device
- reports of prior investigations with the device
- the proposed investigational plan
- a description of patient selection criteria and monitoring procedures
- any other information that the HSRRC deems necessary to make its decision.
If human subjects will be in contact with mechanical, electrical or other equipment which might subject them to the possibility of accidental harm or injury the Principal Investigator must have the device reviewed by Binghamton University’s Occupational Health and Safety, and the Authorized Equipment Safety Officer. Both reports will be presented to the HSRRC for review and will include the following information:
- Location of equipment
- description of how the subject will interact with the equipment
- description of potential risks
- description of measure taken to minimize risk
- names of all individual’s authorized to use the equipment and verification of their training
- certification of safety inspection
Non-Significant Risk
Device
If the authorized safety inspection reports do not raise any concerns regarding
human subject safety and the protocol complies with the requisite criteria
[21 CFR 56.111], and with the “abbreviated IDE requirements”
[21 CFR 812.2(b)] and the informed consent complies with [21 CFR parts 50
and 56] the full board will approve the study.
Significant Risk Device
If the authorized safety inspection reports raise concerns regarding human
subject safety, the PI and sponsor will be contacted and informed that the
HSRRC considers the study to be significant risk (SR), and the sponsor must
obtain an Investigational Exemption Device (IDE) from FDA and resubmit the
protocol for review.
The HSRRC informs the board members of the date and times of the scheduled meetings during the initial communication with the potential board member. The other board members are informed of the meeting schedule upon receipt of their appointment letters. The committee members at that time agree to attend the meetings, and in the event that they cannot they inform the HSRRC office immediately. The HSRRC takes into consideration the number of meetings that the board member cannot attend and a decision is made whether or not to ask the board member to recuse themselves for the semester.
B. Pre-meeting distribution to member’s relevant documentation that will be discussed.
Binghamton University’s HSRRC members meeting material is distributed electronically through a web-based system called Blackboard. All protocols and relevant documents are placed on Blackboard eight (8) days prior to the scheduled meeting. The members are informed via email that the materials are available on-line and asked to review the documents and if additional information is required, please submit a request to the administrator and the PI will be contacted for the additional information. The web posted meeting material includes:
- Meeting agenda
- New Research
- Modification Requests
- Continuing Review Request
- Listing of all approved exempt protocols
- Minutes from previous meeting
- Adverse Event/Complaint Reports
- All relevant document for protocol review
- New Business and or topics to be discussed
Receipt of Human Subjects protocol from Principal Investigator-Documentation required:
- Human Subjects Research Review Form (http://humansubjects.binghamton.edu/Forms.htm)
- Consent letter and/or scripts
- Assent letters
- Permission letters
- Letters of invitation
- Advertisements
- Questionnaires
- A copy of all media (i.e. films, video, web shots, pictures, etc.)
- Tests
- Reports from all other committees if applicable (BioSafety, IACUC, Occupation Health and Safety, Electrical/Mechanical Safety, Environmental Safety)
Device studies require:
o A description of the device
o Reports of prior investigations with the device
o Proposed investigational plan
o Description of patent selection criteria
o Monitoring procedure
The HSRRC will take into account the factors listed below when evaluating a proposal for approval:
- Federally mandated education requirements are fulfilled
- Expertise of Principal Investigator
- Level of risk
- Risks to subjects are minimized
- Selection of subjects is equitable
- Require that information given to subjects as part of informed consent.
- Where appropriate, the research plan makes adequate provision for monitoring the data collected to insure the safety of subject
- Where appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data
- Current contact information (Principal Investigator and HSRRC chair) is placed on informed consent.
In the event that the Chair or the Chair designee does not have the expertise required to assess a protocols risk criteria, the protocol is distributed to 3 members of the committee, Initial Review Panel (IRP) (committee members are chosen on knowledge of topic and rotation). The IRP are requested to review the protocol, summarize their findings and return same to the office.
The IRP have the option of approving the protocol, approval with revisions or requiring a full board review. The approval option can only occur if all three IRP members agree on approval. In one IRP member requires full board review, the protocol will be placed on the agenda for full board review.
FDA IDE (device) reporting requirements:
Investigator to Sponsor and HSRRC: FDA IDE regulations require that the investigator notify the sponsor and the IRB of any unanticipated adverse device effect within 10 days of discovery.
Sponsor to FDA, Investigator and HSRRC: The sponsor is required to evaluate the event and report it to the FDA, to all participating investigators, and to all reviewing IRBs within 10 working days of the sponsor’s receipt of the information.
In protocols that are exempt and/or expedited and if the protocol is complete and meets the regulatory definition of minimal risk, it will be approved as an expedited or exempt protocol. The Principal Investigator will receive an approval memo via e-mail, along with their consent form date stamped (the protocol must note that the research will last longer than one year to receive the stamp).
A list of all protocols that have been reviewed and approved as exempt/expedited will be submitted to the HSRRC members at the next convened meeting for review. The HSRRC minutes will contain documentation of the specific categories justifying exemption or expedited review.
If the protocol is not
minimal risk and does not fulfill the exempt/expedited criteria the protocol
will be will be added to the HSRRC meeting agenda for review and the Principal
Investigator will be notified in writing by the Chair or designee of this
decision.
Upon protocol category designation, the following procedures will be followed
Approved
The consent form is stamped with an approval/expiration date and an approval
letter is forwarded to the Faculty Supervisor and the Principal Investigator.
Copies of all documents are placed in the Faculty Supervisor/Principal Investigators
file and in a chronological folder.
Continuing Review
45 CFR 46.110(8) allows
expedited review of previously Full Board Review research under the following
circumstances:
- where the research is permanently closed to all enrollment of new subjects; all subjects have completed all research related activities; the research remains active only for long-term follow-up of subjects
- where no subjects have been enrolled and no additional risks have been identified
- where the remaining research activities are limited to data analysis
- The research does not involve an investigational new drug or device and the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and the HSRR Office has not received any unanticipated problems, adverse events or complaints.
Modifications
45 CFR 46.110(b)(2)
allows for minor modifications to research that required convened review
and approval to be approved through expedited procedures during the period
of approval.
The HSRRC has determined that the Chair will make the final decision of the revision is considered a "minor modification". If the Chair is not available, then all modifications will be reviewed by the full board.
D. Criteria for HSRRC approval contain all requirements of 45 CFR 46.101(b) and 110 and 21 CFR 56.110
All protocols received by the HSRRC will be reviewed for inclusion into the exempt or expedited category. The first assessment will be based on risk and vulnerable populations based on the following criteria: “§45 CFR 46.102(i) 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.”
The protocol will then be reviewed against the exempt criteria outlined in 45 CFR 46.101(b)(1)-(b)(6). If the protocol does not fit the exempt criteria, yet is minimal risk it will be compared against the expedited criteria listed in 45 CFR 46.110 and 21 CFR 5.110.
A quorum of more than
half of the voting membership is required to conduct business
It is strongly recommended that HSRRC members be physically present at the
meeting. If physical presence is not possible, a member may be considered
present if participating through teleconferencing or videoconferencing.
In this case the member must have received all pertinent material prior
to the meeting and must be able to participate actively and equally in all
discussions.
If the quorum is not achieved or lost at a meeting due to members with conflict being excused, early departures, or a loss of a non-scientist, the meeting is terminated from further votes unless the quorum can be restored. Any absence or loss of quorum should be noted in the meeting minutes.
The HSRRC Members consists of individuals that are sufficiently qualified to review research through their experience, expertise, and diversity, including consideration of race, gender, cultural backgrounds, and sensitivity to community issues and/or attitudes.
The HSRRC committee shall consist among other individuals, one member who is not affiliated with the university, one member who is a non-scientist, one member who is a scientist, and one member who is a physician, and is present during the reviewing of FDA regulated studies
The HSRRC may invite individuals with competence in special areas to assist in the review of issues that require expertise beyond or in addition to that available on the HSRRC. These individuals may not vote with the HSRRC.
The approval of a research protocol requires a majority of votes by the HSRRC.
Each HSRRC member has one vote.
Proxy votes are not allowed, written or telephone.
HSRRC members must not vote on a protocol if they are investigators, co-investigators or have any type of consulting or involvement on the protocol or have any other conflict of interest with any person or entity connected to a protocol.
F. Further review/approval of HSRRC actions by others within the institution (override of disapproval is prohibited).
By Federal regulation, institutional officials may not approve research that has not been approved by an HSRRC. Consequently, NIH does not have an appeal procedure if a protocol is not approved by an IRB. PIs may request an IRB to reconsider a decision regarding a human subject research activity. However investigators do not have the option to seek the reversal of an IRB decision by submitting the same protocol to another NIH IRB.
G. Communication from the HSRRC
During the initial review the administrator or coordinator will compare the protocol documents received with our checklist of required documents. In the event that information is missing the investigator will be contacted via email for the documentation.
When the HSRRC Committee members receive the protocol (8 days prior to the meeting) they can also contact the administrator or coordinator and request additional documentation or clarification. At this time the administrator will contact the PI via email and request the additional documentation.
Immediately after the convened meeting the HSRRC Administrator and Coordinator review their notes and the taped meeting to ensure that the committees decisions, request for additional information and/or any other documentation is clearly documented.
Protocol that have been approved: The HSRRC staff will forward an email to the PI notifying them that their research has been approved and the approval documentation is being processed. The HSRRC approved stamped consent forms are attached to this initial email. The approval documents are then generated and sent via mail.
Protocols that have been tabled: The HSRRC staff will compose a draft email outlining the committee’s decision and the committee’s request and/or concerns regarding the study listing the Federal Guidelines that the committee considered in their decision. At this time the draft email will be forwarded to the Chair for review and revision if necessary. After review, the Chair will forward the final draft to the Administrator to distribute to the PI.
The Institutional Official receives a copy of the Minutes of the meeting that include the boards voting decision of all protocols.
All documentation that is forwarded to the PI is carbon copied to the Sponsor.
If an HSRRC Application is disapproved, the reasons for disapproval will be conveyed to the investigator in writing. This letter will include the committee’s decision and concerns regarding the study listing the Federal Guidelines that the committee considered in their decision. The inv