Purpose of the MCCC IRB
The purpose of Monroe County Community College’s Institutional Review Board (IRB) is to protect the welfare of human subjects used in research.
The basic principles of the MCCC IRB are as follows:
A. The basic principles that govern the IRB in assuring that the rights and welfare of subjects are protected are contained in Ethical Principles and Guidelines for the Protection of Human Subjects of Research (“The Belmont Report”), and The National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, April 18, 1979 [see www.hhs.gov/ohrp/regulations-and-policy/belmont-report/].
B. Therefore, the following principles apply to all research, including student projects, involving human subjects at Monroe County Community College to ensure that adequate safeguards are provided:
- Subjects’ legal rights will be respected; their rights to privacy, dignity, and comfort will also be considered in approving proposed research.
- Risks to subjects must be reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result.
- Adequate provision(s) must be made for all facilities, procedures, and professional attention necessary for the protection of the individual as a research subject.
- Adequate provisions should be made for recruiting a subject population that is representative of the population base in terms of gender and minority representation unless scientifically justified.
- Research involving human subjects must be supervised by qualified persons, including health care professionals for medical research.
- Participation of a human subject in research must be voluntary and the right to withdraw at any time must be provided. Information provided to gain subject consent must be adequate, appropriate, and presented in lay language appropriate to the subject population.
- All research programs that involve human subjects must be reviewed by and must receive approval of a formally constituted review prior to their initiation or prior to initiating any changes to the protocol. Continuing research programs are subject to periodic review, to be carried out no less often than once a year.
- The IRB reviews all projects and programs involving human subjects in accordance with Procedures, applicable federal regulations, and sponsor policies and guidelines.
- The IRB provides continuing advice and counsel to personnel engaged in activities involving human subjects.
- The IRB has approval authority of human subject protocols, and can disapprove, modify, or approve studies based upon consideration of any issue it deems relevant to human subject protection. Research that has been approved by the IRB may be subject to further appropriate review and approval or disapproval by the Vice President of Student Services. However, the Vice President of Student Services may not approve research if it has not been approved by the IRB.
- The IRB has authority to require progress reports from the investigators and oversee the conduct of the study.
- The IRB has authority to suspend or terminate approval of a study, or to place restrictions on a study, when this is deemed to be in the best interests of the subjects in that study.
- The IRB has authority to observe the informed consent process as practiced by any investigator or authorized person in any approved protocol especially in cases where the consentee is from a vulnerable population.
- The IRB has the authority to access and to make copies of records related to any research approved by the IRB (or another body under an IRB Authorization Agreement), regardless of the location of those records, for any reason. Where feasible, appropriate notice will be given of the need to review, copy or duplicate records while being sensitive to causing the least inconvenience or disruption of ongoing research.
Monroe County Community College holds a Federalwide Assurance (FWA) through OHRP. As part of this Assurance, MCCC agrees to consider all research involving the use of humans as research participants as being subject to federal regulations regardless of the source of funding if one or more of the following apply:
- The research is sponsored by this institution or
- The research is conducted by or under the direction of any employee of this institution (unless the research is conducted at another institution with which MCCC has an “IRB Authorization Agreement” as specified in MCCC’s FWA), or
- The research is conducted by or under the direction of any employee of this institution using any property or facility of this institution, or
- The research involves the use of this institution’s non-public information to identify or contact human research subjects or prospective subjects.
In some instances, students may be involved in course activities such as questioning, participation in minimally physically stressing classroom exercises, observing, and/or interacting with other individuals. The course instructor is responsible for determining whether such activity is classified as those kinds of activities that require Institutional Review Board (IRB) approval. If the instructor has any doubt concerning the classification of these activities, he/she is encouraged to complete the Exempt Review Application for approval and submit it along with the protocol and any accompanying consent form(s), cover letter(s), and/or questionnaire(s) in order to obtain the guidance of the IRB regarding these activities.
No or Minimal Risk:
Under the auspices of the IRB, the IRB Chair will review Exempt Review Applications eligible for “exempt” (see below) or expedited review or, if significant risk is inherent in the study, refer the petition to the IRB for full board review.
Under federal regulations, certain types of research are exempt from federal policy unless the appropriate federal agency heads have determined otherwise. Exempt types of research include:
- Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
- Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
- Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
- Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
- Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
The IRB Chair, not the Principal Investigator (PI), shall make the determination as to whether a project is or is not exempt. To obtain an exemption, an investigator must fill out an Exempt Review Application citing the specific exemption category and providing justification for the exemption.
Under federal regulations certain types of research qualify for an ‘expedited’ review. These are activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures specified in federal regulations. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on the list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
The list of categories of research that may be reviewed by the IRB through an expedited review is as follows:
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
(a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
(b) Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
- Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
(a) from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amount drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
- Prospective collection of biological specimens for research purposes by noninvasive means.
Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.
- Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)
Examples: (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.
- Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from federal regulations for the protection of human subjects. This listing refers only to research that is not exempt.)
- Collection of data from voice, video, digital, or image recordings made for research purposes.
- Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from federal regulations for the protection of human subjects. This listing refers only to research that is not exempt.)
- Continuing review of research previously approved by the convened IRB as follows:
(a) where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions; and (iii) the research remains active only for long-term follow-up of subjects; or
(b) where no subjects have been enrolled and no additional risks have been identified; or
(c) where the remaining research activities are limited to data analysis.
- Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two through eight do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.
Principal Investigators (PIs) seeking an exempt or an expedited review must submit one original of the Exempt Review Application or the Expedited Review Protocol Summary Form to the IRB Chair at least eight days prior to any proposal deadline in order to provide time for review and processing. The Institutional Research (http://www.monroeccc.edu/institutionalresearch/index.htm) website has forms and links to those categories of research that may qualify for exemption or expedited review.
The IRB Chair may recommend a protocol to the IRB for expedited review, for expedited review pending recommended changes/clarifications, or for review by the full board. The IRB Chair will inform the PI of its actions. Any disagreement between the PI and the IRB Chair must be resolved by the IRB.
If it is determined that one of these protocols require IRB review, it will be returned to the PI with comments for revision and submission to the full board. Upon receipt of the material from the PI, the IRB Chair will distribute copies to each IRB member. The PI will be notified of the IRB decision by the Chair.
More Than Minimal Risk
Any research determined to be ineligible for exempt or expedited review will be subject for full-board review. Research that presents more than minimal risk to participants is considered subject for full-board review.
Protocols for full-board review must be submitted three weeks prior to the proposal deadline. The PI will submit to the IRB Chair one original and the required number of copies of the Full Review Protocol Summary Form. In the form the investigator assures the IRB that he/she will follow the principles, procedures and guidelines established in the present document and agrees to allow the IRB access to pertinent records or research. In addition, the investigator should present any information that will aid in evaluating the proposal for compliance with this policy.
The PI must be available to discuss the protocol and/or consent forms at the discretion of the IRB.
“These forms are appended to the IRB Applications posted above but can be accessed here separately. Applications submitted without all required supporting documentation will be returned to the PI for revision.”
For additional information regarding the protection of human subjects in research, please access the links provided below or contact the Office of Institutional Research, Assessment and Evaluation.