Institutional Review Board
Co-Chairpersons: Veronica Feeg, Ph.d., R.N., F.A.A.N. (516.323.3653)
and Kathleen Maurer Smith, Ph.d.
Veronica D. Feeg, Ph.d., R.N., F.A.A.N.
Gitenstein Professor, Molloy College Division of Nursing
Associate Dean, Director of the Ph.D. Program
Assistant Dean, Director of the Center for Nursing Research and Scholarly Practice
1000 Hempstead Avenue
Rockville Centre, NY 11571
Kathleen Maurer Smith, Ph.D
Dean, Division of Social Sciences
Associate Dean of Graduate Academic Affairs
1000 Hempstead Ave. P.O. Box 5002
Rockville Centre NY 11571-5002
COMMITTEE MEMBERS: 2012 - 2013
Veronica D. Feeg, Nursing Division
Kathleen M. Smith, Social Sciences Division
Normadeane Armstrong, Nursing Division
Lorraine Emeghebo, Nursing Division
Sam Carpentier, Education Division
Meritta Cullinan, Social Sciences Division
Maureen Sanz, Natural Sciences Division
John Carpente, Humanities Division
Elisa Rapaport, Humanities Division
Nancy O'Donnell, Helen Keller Institute (Outside, Community Representative)
Stella Manne (Ex-Officio)
PRESENTATION APRIL 9, 2013
I. Description of Molloy College Institutional Review Board (IRB)
The Institutional Review Board (IRB) is "a committee whose primary responsibility is to protect the rights and welfare of research subjects and to function as a kind of ethics committee focusing on what is right or wrong and on what is desirable or undesirable." (IRB Member Handbook, Third Edition, 2011).
Molloy College Institutional Review Board (IRB) serves to protect human subjects enrolled in research conducted by faculty, students or administrative personnel at the College. IRB approval ensures that subjects have been adequately informed and consented to participate in all research (a) conducted by or under the direction of a Molloy College employee; (b) utilizing Molloy property, personnel, students or facilities; or (c) utilizing the institution's non-public information to identify or contact human research subjects or prospective subjects. Procedures and forms to apply for IRB approval will be available online. Submissions of documents can be emailed directly to the IRB (firstname.lastname@example.org). Any questions can be directed to Kathleen Smith (email@example.com) or Veronica Feeg (firstname.lastname@example.org).
II. The Role and Function of the Molloy Institutional Review Board
Molloy College's Institutional Review Board has been constituted to ensure the safety, rights and welfare of all human subjects enrolled in research authorized by the college.IRB approval must be obtained for the following:
1. All research conducted by or under the direction of a Molloy College employee, whether the research is funded or non-funded, or
2. Any research conducted by, or under the direction of a Molloy College employee utilizing Molloy property, personnel, students or facilities, or
3. Any research that utilizes the institution's non-public information to identify or contact human research subjects or prospective subjects.
It is the responsibility of the IRB to:
1. Ensure that the risks of research to a subject are minimized and are outweighed by the potential benefits to participants and or to society by the importance of the knowledge to be gained.
2. Require that adequate and appropriate informed consent is obtained from subjects
3. Monitor compliance by researchers of agreed upon protection of human subjects through periodic review
4. Guarantee that all research under its purview conforms to the Department of Health and Human Services Regulations for the protection of human research subjects, to all federal, state and local laws, and to the principles and guidelines of the Belmont Report of the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research (April 18, 1979).
5. Review annually or at its discretion all ongoing human subject research conducted under the purview of Molloy College.
Researchers must submit an application for approval to the IRB and must not include human subjects in the research until approval has been given. Thereafter, review applications must be submitted annually or when requested, until research is completed. Any changes in the research scope or mode of inquiries to subjects must be reported and receive additional approval by the IRB before implementation. A copy of the research results must be supplied to the IRB Chair for record purposes.
III. Categories of Review
Research involving human subjects has been divided into three separate categories, each of which will be reviewed by a different process.
1. Exempt (determined by an IRB member)
2. Expedited (requires review by several IRB members, not full Board)
3. Full Review (must be reviewed by all IRB members)
The final decision about which category a particular project is in rests with the Institutional Review Board. The agencies that fund research may require the submission of an Institutional Assurance. Researchers should ensure that the information submitted to the IRB is sufficiently detailed to allow a determination of the category of exemption to be made. The grant agency and number (if known) should be provided. IRB reserves the right to review any project, even if it falls within the exempt categories, and to overrule any departmental approval involved, if necessary. Departments should refer all projects to the IRB.
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from IRB review.
a. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
b. Research involving survey or interview procedures, except where any of the following conditions exist:
(1) Responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects.
(2) The subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and
(3) The research deals with sensitive aspects of the subject's own behavior, such as, illegal conduct, drug use, sexual behavior, or use of alcohol.
c. Research involving the observation (including observation by participants) of public behavior, except where any of the following conditions exits:
(1) Observations are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects.
(2) The observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability, and
(3) The research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
d. Research involving the collection or study of existing data, documents, records, pathological specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subject cannot be identified, directly or through identifiers linked to the subjects.
Research, which involves no more than minimal risk and falls within the categories listed below, will be reviewed by expedited review. 'Minimal risk' means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than in those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.
Researchers should submit their applications to the IRB. The researcher should ensure that the project is scientifically sound and that the procedures and likely risks are adequately described. When IRB acceptance of the Expedited category has been obtained, the original plus three copies of the application should be submitted to the IRB.
Expedited review will be carried out by at least three members of IRB including:
(1) a member from a related discipline;
(2) a scientific member;
(3) a non-scientific member.
Researchers will be notified if the IRB approves; such approval is valid for a period of 12 months, unless otherwise specified. Expedited categories includ:
a. Collection of: hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth if patient care indicates a need for extraction.
b. Collection of excreta and external secretions including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
c. Recording of data from subjects 18 years of age or older using non-invasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing, sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography.
d. Collection of both supra and subgingival dental plaque and calculus, provided the procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic and aseptic techniques and using "universal precautions".
e. Voice recordings made for research purposes such as investigations of speech defects.
f. Moderate exercise by health volunteers.
g. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
h. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects' behavior and the research will not involve stress to subjects.
i. Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
All other research, i.e., non-exempt, non-expedited, will be reviewed by the Committee at one of its monthly meetings. Dates of meetings can be obtained from the IRB Chairperson of Molloy College. The application should be submitted to the IRB Chair on the first day of the month for determination of status and at least 10 days prior to a Committee meeting for Full Board Review. Applications submitted after this time will be reviewed at the following meeting.
If the research is externally funded, or external funding is being sought, three copies of the full grant application should also be submitted. If possible, IRB applications should be submitted early enough so that the Institutional Assurance can be submitted with the grant application.
Researchers will be sent a copy of the IRB approval and any Institutional Assurance submitted. IRB approval is valid for one year, unless otherwise specified.
IRB POLICY DOCUMENT (Revised Feb 9, 2011)
IRB APPLICATION FORM (PDF)
IRB APPLICATION FORM (WORD)
IRB APPLICATION GRADUATE EDUCATION STUDENTS
IRB APPLICATION GRADUATE STUDENTS IN CLASS (SHORT FORM)
IRB APPLICATION UNDERGRADUATE STUDENTS IN CLASS (SHORT FORM)
IRB APPLICATION STUDENTS NON-CLASS RESEARCH FULL APPLICATION
INFORMED CONSENT GUIDANCE