|
Institutional
Review Board for Human Subject Research |
|
Policy on
Human Subject Research at |
Adopted
March 1996, Revised March 1999, Revised February 2005
All
correspondence and inquiries related to research involving human subjects may
be directed to the IRB Chairperson:
Chairperson,
Institutional Review Board
c/o
Office of Sponsored Programs, Raubinger Hall 107
Telephone: 973-720-2852; FAX: 973-720-3573
Contact
Information
IRB Chairperson, 2004-2005:
Dr. Stephen
Betts
Associate
Professor, Department of Marketing and Management,
Phone: 973-720-2789;
Email: bettsb@wpunj.edu
IRB
Administrator:
Martin B. Williams
Director, Office of Sponsored
Programs
Phone: 973-720-2852; FAX
973-720-3573; williamsm@wpunj.edu
WPUNJ Responsible Official:
Dr. Nina Jemmott
Associate Vice President for
Graduate Studies & Research
Phone: 973-720-3093;
jemmottn@wpunj.edu
IRB Address:
Institutional Review Board
c/o The Office of Sponsored
Programs
IRB Telephone:
Phone: 973-720-2852
Fax: 973-720-3573
Section
Contact Information
Table of Contents
B. Approval Processes and Actions
1. Review Prior to Submission to the Committee
a. Appendix A: Face Sheet: After preparation of the protocol and prior to its submission to the Committee, the investigator must submit the complete protocol to his/her department chairperson for signature to indicate awareness of the submission and departmental support for the research. For projects involving personnel from more than one department, investigators must submit the protocol to the chairperson of each department. If the any of the researchers are the department chairperson, then their Dean/Vice President will sign the protocol to indicate awareness of the submission and both departmental and college/unit support for the research.
b. Appendix C: Student Research Protocol Review Request: After preparation of the protocol and prior to its submission to the Committee, students must submit the protocol to an appropriate faculty sponsor for signature. This will indicate that the faculty sponsor has reviewed the research, supports the project, and accepts responsibility for the actions of the student in undertaking the project.
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a. Initial Protocol Reviews
1. Faculty, staff and outside investigators submitting a protocol for initial review will use Appendix A: Protocol Face Sheet. WPU undergraduate and graduate investigators, and outside investigators who are undergraduate students, submitting a protocol for initial review will use Appendix C: Student Protocol Review Request.
2. Protocols will be sent to the IRB Administrator who will coordinate the review and all actions concerning all protocols. All protocols are first reviewed by either a member of the IRB Committee (for protocols with Appendix A) or the IRB Administrator (for protocols with Appendix C). If the proposal qualifies for an Exempted or Expedited Review, it is reviewed by that same person, the investigator is notified of the reviewer=s decision and the protocol is sent to the Committee for affirmation. If the proposal qualifies for a Full Committee review, it is reviewed by the Committee at the next regular meeting (or a special meeting is scheduled for the review) and then the investigator is notified of the Committee=s action. The investigator(s) may begin his/her/their research after notification from the IRB Administrator on behalf of the Committee.
3. Faculty and staff protocols are reviewed within 3 weeks of submission. Student protocols are reviewed within 3 working days of submission. These review periods are contingent on the need to request or gather information related to the review. Every effort will be made to review protocols in a timely manner, but no guarantees can be made as to when a particular protocol will be reviewed and they are assigned on a first‑come‑first‑served basis. Investigators are urged to submit their studies as far in advance of a beginning date of their research as possible in order to insure timely review, especially when the submission of an application for funding is contingent on IRB approval. While the Committee wishes to be helpful to all investigators, it cannot make exceptions for last minute requests.
b. Continuing Reviews
All investigators submit Appendix B: Continuing Review Face Sheet for continuing review, adverse reaction, or termination reviews. The Continuing Review Face Sheet and attached materials are reviewed by the IRB Administrator and are then sent to the Committee for review and approval. The investigator(s) may continue his/her/their research pending notification by the IRB unless an adverse reaction or other complication is involved.
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a. Committee Review of Exempted and Expedited Protocols
The investigator will be notified after the initial reviewer makes his/her determination and, if approved, may begin their research. All approved exempted and expedited protocols are reviewed by the full Committee at its next meeting. The Committee may affirm or change the reviewer=s determination. The investigator will not be notified if the Committee affirms the initial determination. The investigator will be contacted by the IRB Chair and Administrator if the Committee does not affirm the initial determination to discuss the decision, the issues involved, if the research is to be temporarily suspended or terminated, what is required to obtain the approval of the Committee, and a date for fulfilling any requirements or answering any questions or concerns.
b. Full Committee Review Process
(i) After a protocol has been identified for full Committee review it is placed on the agenda of the next regular committee meeting, the investigator is notified that the protocol will receive a full Committee review and when the meeting will take place. If the next regular meeting has not been scheduled, a meeting will be scheduled.
(ii) A list of all protocols for full Committee review is sent to each Committee member. A copy of each protocol is sent to the IRB Chairperson and at least one additional Committee member who, with the IRB Chairperson, are assigned as primary reviewers. The primary reviewers are responsible for recommending the IRB to: 1) approve the protocol as submitted; 2) approve the protocol contingent on specific revisions; 3) table the protocol for substantive change and resubmission to the Committee, or 4) disapprove the protocol. (Note: Descriptions of these choices follow.) At the Committee meeting, each protocol is discussed by the entire Committee. The Committee may ask the investigator or other individuals to attend the meeting to discuss the research and/or provide information to the Committee on the area of research, research methodology or other issues related to the protocol. The Committee then determines if it will accept or not accept the recommendation of the primary reviewers. If the primary reviewers' recommendations are not accepted, the Committee may determine the disposition of the protocol according to the above (1, 2, 3, or 4). The IRB Chairperson will notify the investigator in writing of the action as soon as possible after the determination is made. Activities related to each action will proceed as follows:
(1) Approval as submitted: The investigator will be sent an approval notice including a statement of his/her responsibility to report adverse reactions and request Committee review of modifications or revisions to the protocol. The investigator will also be informed of his/her responsibility to submit a summary of the project every twelve months for continuing review or more often if requested by the Committee.
(2) Approval contingent upon specific revisions: The investigator will be sent a notice describing the revisions requested with specific reply-by date. After revising the protocol and/or consent form and/or testing instrument, the investigator will return one copy with the revisions underlined or highlighted to the IRB Chairperson. If the revisions are deemed satisfactory by the primary reviewers, an approval notice will be sent to the investigator. If the investigator disagrees with requested revisions, he/she may present in writing the reasons to the IRB Chairperson. The Chairperson will review this response and if necessary request the investigator to appear at the next Committee meeting to answer questions and discuss relevant matters. The investigator will be notified in writing of the Committee's final decision.
(3) Tabled for substantive change: The investigator will be sent a notice describing the reason for tabling IRB decisions and outlining revisions or clarifications necessary for reconsideration with a specific reply-by date. The primary reviewers will discuss the Committee=s concerns and requests with the investigator and the investigator may request to appear at the next Committee meeting to discuss the protocol, the Committee=s decision and relevant matters. The investigator will submit his/her response to the IRB Chairperson for distribution to and review by the Committee.
(4) Disapproval: The investigator will be sent a notice describing the reasons for disapproving the protocol. Disapproval of the protocol usually occurs when the Committee determines that the risk of the procedures outweighs any benefit to be gained. The investigator may discuss the Committee's review with the Chairperson and/or submit a revised protocol for review at the next scheduled meeting. The investigator may request to appear at the next Committee meeting to discuss the protocol, the Committee=s previous decision and relevant matters during the Committee=s discussion of the revised protocol.
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Many agencies which fund research require certification by an authorized official of the institution that research involving human subjects as described in the application has been approved by an IRB. The University will provide the sponsor with appropriate documentation of the Committee's approval. The review of research that falls under either the Exempted or Expedited review categories should be completed prior to the preparation of documentation and submission of the proposal. For research that will require a full Committee review, a preliminary review and recommendation for approval by the IRB Chairperson and one additional IRB Committee member is required prior to institutional endorsement and submission of the proposal. Full Committee review and approval is required prior to beginning the research whether or not the research is funded.
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Part IV. Special Classes of Subjects and Special Considerations
A. Federally Stipulated Special Classes of Subjects
Federal regulations provide specific requirements for three classes of subjects. Any research involving these classes of subjects must be reviewed by the full committee unless the specific exemptions for each class are met. The primary reviewers and the Committee will refer to the appropriate subpart of 45 CFR Part 46 during its consideration of the protocol.
4. Fetuses and Pregnant Women (45 CFR Part 46, Subpart A). Exemptions for Fetuses: None. Exemptions for Pregnant Women: Exempted Review items as described in Part III.A.1e and Expedited Review items as described in Part III.A.2.e, f and g only if there are no biomedical elements to the research plan.
5.
Children and Minors (45 CFR Part 46, Subpart B). Exemption for Children
aged 0 to 13 Years: Exempted Review items as described in Part III.A.1e . Exemptions for Minors aged 14 to 15 Years:
Exempted Review items as described in Section 13 (A) (1) and Expedited Review
items as described in Part III.A.2.e, f and g if there are no biomedical
elements to the research plan and the research does not collect sensitive
personal information and/or request the subject to undertake an activity that
may elicit a significant negative psychological or physical response. [Note: In
3. Prisoners (45 CFR Part 46, Subpart B). Exemptions: None.
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B.
7. Individuals with Limited Ability to Voluntarily Participate in Research.
For the subjects who may perceive that their ability to participate freely and honestly is limited because of their specific personal circumstances and the subject of the research, the Committee will work with investigators to insure that all possible concerns are addressed prior to the approval of a protocol. Subjects in this group may be: (a) residents of a hospital, nursing home or other health care facility when the focus of the research is on the quality of their care, the type of procedures or tests they are receiving or have received, or the facility=s staff; (b) employees of a business when the focus of the research is on the workplace, the employer or other employees; (c) students in a course or class when the investigator is the instructor and the subject of the research is not related to the course or exempt as per Part III.A.1.e. In these cases, additional safeguards will be used to shield responses from all individuals except the investigator and other project staff, to separate informed consent statements from testing instruments, and by avoiding questions or opportunities which require subjects to specifically identify individuals or situations.
2. WPUNJ Students or Employees as Research Subjects
a. For students and instances where WPUNJ faculty or staff use WPUNJ students in research studies, the following guidelines are intended to (1) protect students from unintended coercion or unequal benefit from participating in research that involves face-to-face interviews or testing, observation in a controlled location, or a similar activity that is beyond the scope of an anonymous survey, and (2) encourage students to voluntarily participate in Aresearch activities@ with option of providing extra credit. These guidelines do not supercede any course requirements, are not intended to restrict any faculty member=s freedom to make assignments or conduct their classes, offer extra credit, or infringe on any aspect of achieving the goals of individual courses unless these activities are in clear contradiction to the University=s IRB Policy.
A WPU faculty person may include students who are currently in his/her classes in research he/she is undertaking within the following contexts:
(i) Controlled, out-of-classroom, laboratory-based research
(a) The professor will offer equal credit to his/her students in his/her class who: (a) participate in a research study for not more than 3 hours during the semester; (b) completes a ungraded short paper or other appropriate academic activity related to research as determined by the professor; (c) attends a research colloquium; and (d) other options.
(b) The professor will recruit students in his/her classes as he/she would recruit other students or WPUNJ employees to be employees. These activities may include: (a) a publicly posted notice Volunteers register by calling the investigator, or (b) direct recruitment in his/her class, by other faculty in their classes, or individually as opportunities are presented. Volunteers may register on-the-spot or contact the faculty researcher directly later on. Recruitment posters or announcements will include information taken from the informed consent statement.
(c) The amount of optional credit toward a student=s final grade point average for participating in one of the three research activities would be up to the discretion of the professor. The IRB suggests a rate of 1 credit/100 credits toward the student=s final average for the class.
(d) Students would not be penalized beyond not receiving their extra credit for not Ashowing up for a scheduled research appointment, for not completing a paper or for not attending a colloquium.
(ii) In-class or classroom-based research.
(a) When the identification of students is a required part of the study, students must be fully informed of the study and be provided with an appropriate method for not participating in the study, such as not completing but handing in a survey with a cover page masking answers. No course credits will be offered for participation and no penalties will be assessed for non-participation. Survey or other responses will remain sealed until the end of the semester.
(b) When the identification of students is not a required part of the study, students must be fully informed of the study and be provided with an appropriate method for not participating in the study, such as not completing but handing in a survey with a cover page masking the unanswered survey. No course credits will be offered for participation and no penalties will be assessed for non-participation. A WPU faculty person may non include students who are currently in his/her classes if the research involves an issue that may affect the faculty=s perception of that student (such as sensitive issues like sexual attitudes or behaviors, racial attitudes, mental health, the use of alcohol or illicit drugs, or illegal activity). Additional confidentiality safeguards may be required by the IRB based on the research plan and need to identify individual student=s data.
b. For employees, the same concerns and process in paragraph 2 (a) of this section applies. The IRB encourages the use of employees in research undertaken at WPUNJ.
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C. Other Special Considerations
Subjects can be harmed psychologically in the course of a survey or interview study as well as in manipulative experimental situations. It requires sensitive anticipation to avoid these apparently innocuous intrusions. Subjects are often asked to reveal unpopular attitudes, such as resentments toward some social group, or possible demeaning social characteristics, such as low income or receipt of welfare payments. The subjects may be led into admissions or behaviors that in later reflection they find to be deviant, immoral or unjust. Such research situations should be designed carefully, to provide a supportive context, and only carried forward if the threats to subjects= comfort are essential and severely minimized.
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2. Medical Records and Chart Review
Studies which involve only chart and record review sometimes pose significant risk to patients. The most common breach of confidentiality is exposure of possible embarrassing information without the knowledge or consent of the patient. Such studies may also lead to recruitment of patients into future non‑therapeutic studies in a manner which may provoke the patient to ask how his/her record was revealed to someone not part of his/her therapeutic team. The present policy is to require review of studies involving chart review or data collection and analysis:
a. When the possibility of contacting patients or their physicians is contemplated.
b. If identifiable information will be collected or disclosed to anyone other than the investigators. An expedited review should be requested for studies in this category. (See Part III.A for studies eligible for expedited review).
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3. Residual Body Fluids, Tissues and Recognizable Body Parts
Studies which utilize residual bodily fluids, tissues and/or recognizable body parts from clinical laboratories, pathology laboratories, or other clinical or hospital settings which may or may not be personally identified or linked to a subject must be reviewed. Investigators conducting research of this nature should be familiar with the policies regarding recognizable human body parts and the promulgated standard entitled, "Occupational Exposure to Blood borne Pathogens." Information in this regard may be obtained by contacting the IRB Chairperson. Expedited review of such studies may be authorized if all of the following circumstances exist:
a. The fluid, tissue or body part is obtained in a procedure that is entirely predicated
on clinical grounds or donated through the Gift Registry.
b. Consent has been obtained for the procedure.
c. Extra fluid or tissue is not removed, and the materials used for research is that
remaining after clinical use.
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4. Emergency Approval for Medical Care
Nothing in these regulations is intended to limit the ability to provide emergency first aid or limit the authority of a physician to provide emergency medical care, to the extent the physician is permitted to do so under applicable federal, state, or local law. Questions concerning emergency approval should be directed to the IRB Chairperson.
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5. Research Involving Administration and Use of Ionizing Radiation
To comply with regulations of the U.S. Nuclear Regulatory Commission, any use of radiation or radioactive materials requires approval by the University. Information in this regard is available from the IRB Chairperson. In addition to submission for full Committee review, all protocols involving ionizing radiation for other than clinical management must be approved by a cooperating sponsoring institution with a nuclear license.
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6. Research Involving Human Blood, Blood Products, Body Fluids or Tissue Specimens
The Occupational Safety and Health Administration (OSHA) promulgated a standard entitled, "Occupational Exposure to Blood-borne Pathogens" that took effect March 6, 1992. The standard, which recognizes unique hazards to health care workers, applies to all laboratories and clinical settings that use human blood, blood products, tissue specimens or body fluids. It requires the employer to provide annual training in the proper handling of blood-borne pathogens. Training is available for University personnel. For more information or to obtain a copy of the University's Exposure Control Plan, please call the IRB Chairperson.
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Part V. Training Certification
15. To insure that investigators and instructors involved in human subject research have an adequate background in the ethical principals and requirements governing research involving human subjects as well as the requirements and processes related to the conduct of human subject research at WPUNJ, investigators and instructors must provide certification of human subject research or research ethics training to the IRB. Certification must be received prior to the acceptance of a research protocol for review. Protocols from students of an instructor who has not been certified will not be accepted. (This is not applicable for students involved in a faculty research project as defined in Paragraph B of this section.)
2. This requirement applies to:
a. Faculty, professional staff and others who are the principal investigator, co-investigators, senior-level project support, or other project support staff who have direct contact with subjects in any manner, with original data collection tools/resources, or with information that identifies subjects.
b. Faculty teaching courses that include instruction related to human subject research and/or requiring students to undertake human subject research that falls under the purview of this policy.
c. Graduate and undergraduate students who are undertaking human subject research for a course that does not normally include human subject research AND when the course faculty is not certified.
d. All members of the IRB, the Responsible Institutional Official, the IRB Chair, and the IRB Administrator.
e. Deans and Department Chairs of academic units that include faculty who are involved in human subject research and/or have courses and/or students that include or undertake human subject research.
f. Vice Presidents, Associate and Assistant Vice Presidents, and Directors of administrative units that include staff who are involved in human subject research.
g. Outside researchers who wish to undertake research on the WPUNJ campus or involving WPUNJ students, faculty, staff or visitors.
16. This requirement does not apply to: (a) Project staff who do not have contact with subjects, original data or identifying information. (b) Undergraduate and graduate students in a course taught by an instructor who has received certification. Certification for undergraduate and graduate students will be the certification of their instructor.
4. To assist investigators, project staff, instructors, students, administrators and others in the fulfillment of this requirement, a training certification program will be developed and maintained. The program will address both Federal and local concerns and requirements. The University will review and accept/reject certification from other institutions. The University will maintain a record of certifications.
5. A certification will remain effective throughout the research period of an approved protocol and for a period of three years following the completion of the investigator=s last research project. A new certification will then be required prior to the approval of a new protocol for research involving human subjects. The three-year time period will insure that investigators are up-to-date with changes to regulations and processes.
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Provided by The Common Rule, the IRB
Guidebook (OHRP, 2001), the previous editions of this policy (1996, 1999),
or were created for this edition. The
definitions are divided into five categories: Human Subject Research and
Research Activities, Researchers and Officials, Research Subjects, Review
Process and Considerations, and Policies.
1. Human Subject Research and Research
Activities
Research: A systematic investigation (i.e., the gathering and analysis of
information) designed to develop or contribute to generalizable knowledge
[Common Rule, 46 CFR 45.102(d)].
Human Subject Research: In clinical or educational institutions,
the boundary between research and experimental and innovative care and teaching
is a complex and controversial issue. However, for the purposes of this policy,
human research is any activity which has the intent of securing information
from humans for the purpose of advancing generalizable knowledge. Such activity
may or may not differ from customary professional or medical practice [Common
Rule, 46 CFR 45.102(f)].
Classroom-based Research: Demonstrations, exercises, and/or
experiments designed for the exclusive purpose of student education, e.g.
teaching, interviewing by having students interview each other and derive Afindings@, with no intent to generate data whose main
purpose is the advancement and dissemination of generalizable knowledge beyond
the classroom setting is not considered a research activity. However, some
research conducted by students for course assignments may constitute human
subject research when it exceeds the bounds of the classroom and includes
significant contact with subjects outside the confines of the classroom. [WPU-IRB Policy, 1996.]
Research Activities: The activities or procedures involved in
research may be invasive or noninvasive and include placing subjects in various
therapeutic or research situations; removal of body tissues or fluids;
administration or application of chemical substances or forms of energy;
modification of diet, daily routine or service delivery; alteration of
environment; observation; administration of questionnaires or tests;
interviews; randomization of subjects; review of records, or surgical
interventions. [Guidebook, 2001.]
Intervention: Physical procedures by which data are
gathered (for example, venipuncture) or manipulations
of the subject or subject's environment are performed for research
purposes. [WPU-IRB
Policy, 1996.]
Interaction: Communication or interpersonal contact between investigator and
subject. [WPU-IRB
Policy, 1996.]
Surveys: Studies designed to obtain information from a large number of
respondents through written questionnaires, in-person interviews, telephone
interviews, door‑to‑door canvassing, or similar procedures. [Guidebook, 2001.]
Risk: The probability of harm or injury (physical, psychological, social,
or economic) occurring as a result of participation in a research study. Both
the probability and magnitude of possible harm may vary from minimal to
significant. Federal regulations define only "minimal risk." [Guidebook, 2001.]
Minimal Risk: A risk is minimal where the probability and
magnitude of harm or discomfort anticipated in the proposed 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 [Common Rule, 46 CFR 45.102(i)]. Examples: The
risk of drawing a small amount of blood from a healthy individual for research
purposes is no greater than the risk of doing so as part of routine physical
examination. [Guidebook, 2001.] The risk of asking
questions concerning a persons life history or
experience purposes no greater risk than having a conversation on the same
topic.
Adverse Effect: An undesirable and unintended, although not
necessarily unexpected, result of therapy or other intervention (e.g., headache
following spinal tap or intestinal bleeding associated with aspirin therapy). [Guidebook, 2001.]
2. Researchers and Officials
Principal Investigator: The scientist or scholar with primary
responsibility for the design and conduct of a research project. [Guidebook, 2001.]
Investigator or Researcher: An individual who
actually conducts an investigation or study [21 CFR 312.3;.
Guidebook, 2001.]
Research Project Staff: Other project staff involved in the conduct
of a research project. Unlike an
Investigator or the Principal Investigator, project staff
have little direct contact with subjects but may have extensive contact
with the data generated through the research. [Guidebook,
2001.]
Legally Authorized Representative: A person authorized either by statute or by
court appointment to make decisions on behalf of another person; a
guardian. In human subjects research, an
individual or judicial or other body authorized under applicable law to consent
on behalf of a prospective subject to the subject's participation in the
procedure(s) involved in the research [Common Rule, 46 CFR 45.102(c)].
Authorized Institutional Official or Responsible Institutional Official:
An officer of an institution with the authority to speak for and legally commit
the institution to adherence to the requirements of the federal regulations
regarding the involvement of human subjects in biomedical and behavioral
research. [Guidebook, 2001.]
Institutional Review Board or IRB: A specially constituted
review body established or designated by an entity to protect the welfare of
human subjects recruited to participate in biomedical or behavioral research
[Common Rule, 46 CFR 45.102(g), ___.108, ___.109].
IRB Chair: The person elected by the IRB Committee to work with the Authorized
Institutional Official and the IRB Administrator to achieve the effective
implementation of IRB-related policies and regulations.
IRB Administrator: An official of an institution with the
responsibility to (a) insure the effective implementation of IRB-related
policies and regulations, (b) support the activities of the Authorized
Institutional Official, the IRB Committee and the IRB Chair, (c) maintain well
organized and accessible records on IRB Committee activities and meetings,
reviewed protocols, and related information, and (d) distribute information to
the local community to improve and ensure compliance with all appropriate
policies and regulations.