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Special Classes of Subjects
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.
1. 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.
2. 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 New Jersey, individuals who have reached the age of 16 have reached the Aage of majority.@] All children and minors must assent to their participation in research along with their parent/guardian=s approval for their participation; children aged 7 to 15 years must also be involved in discussing the Informed Consent Statement and must sign the statement along with their parent/guardian to indicate their assent to participate.
3. Prisoners (45 CFR Part 46, Subpart B). Exemptions: None.
B. William Paterson University Stipulated Special Classes of Subjects
1. 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.
C. Other Special Considerations
1. Sensitivity of Questioning
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.
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).
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.
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.
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.
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.