This section serves as an outline of the process needed to effectively plan, conduct and carry out University research. Relevant policies and guidance that support the services provided by the Human Subjects Review Committee can be found in this section.
The IRB Committee serves as a source of information regarding human subject research, and will make decisions regarding the compliance of proposed research projects using human subjects. The IRB Committee will review research projects initiated by faculty, staff, and students. Additionally, the IRB Committee will review and approve the implementation of research studies being conducted by individuals or groups external to the University community, but using members of the University community as subjects.
Under the terms of voluntary compliance with federal standards regarding human subject research, all research involving human subjects will be reviewed for compliance prior to application for funding or the initiation of the research project. Both faculty and student projects are subject to compliance review if human subjects are involved.
Human subject – a living individual about whom an investigator (whether professional or student) conducting research: (i) Obtains information or biospecimens through intervention or interaction with the individual, and uses, studies, or analyzes the information or biospecimens; or (ii) Obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
Research – a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge. Activities that meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities. For purposes of this part, the following activities are deemed not to be research:
(i) Scholarly and journalistic activities (e.g., oral history, journalism, biography, literary criticism, legal research, and historical scholarship), including the collection and use of information, that focus directly on one specific individual about whom the information is collected.
(ii) Public health surveillance activities, including the collection and testing of information or biospecimens, conducted, supported, requested, ordered, required, or authorized by a public health authority. Such activities are limited to those necessary to allow a public health authority to identify, monitor, assess, or investigate potential public health signals, onsets of disease outbreaks, or conditions of public health importance (including trends, signals, risk factors, patterns in diseases, or increases in injuries from using consumer products). Such activities include those associated with providing timely situational awareness and priority setting during the course of an event or crisis that threatens public health (including natural or man-made disasters).
(iii) Collection and analysis of information, biospecimens, or records by or for a criminal justice agency for activities authorized by law or court order solely for criminal justice or criminal investigative purposes.
(iv) Authorized operational activities (as determined by each agency) in support of intelligence, homeland security, defense, or other national security missions.
Procedures for Obtaining Approval for Projects Involving Human Subjects
No research can be initiated prior to formal written approval from the Human Subject Review Committee.
Faculty and students planning to initiate research involving human subjects may discuss the concept of the proposed project with members of the IRB Committee in order to obtain advice and guidance in preparing the research proposal. Questions concerning the review process or elements of the proposal can also be discussed.
Completed applications should be submitted via email to the chair of the Institutional Review Board (IRB) Committee for action (email@example.com). Application forms can be found on the “Forms” link of this website. Research proposals must be received by the chair of the IRB Committee a minimum of 30 days prior to the initiation of the research project. Notification of approval will be sent to the principal investigator. For student researchers, the approval will be sent to the faculty advisor, who will then forward the approval notice to the student or students implementing the research project. If any changes are made to the research protocol after approval, the Principal Investigator must complete, and have approved, a Request for Modification form detailing the proposed changes.
In order to approve research covered by this policy the IRB shall determine that all of the following requirements are satisfied:
(1) Risks to subjects are minimized: (i) By using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and (ii) whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2) Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
(3) Selection of subjects is equitable. In making this assessment the IRB should take into account the purposes of the research and the setting in which the research will be conducted and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons.
(4) Informed consent will be sought from each prospective subject or the subject’s legally authorized representative to the extent required by §46.116.
(5) Informed consent will be appropriately documented, in accordance with, and to the extent required by §46.117.
(6) When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) When appropriate, there are adequate provisions to protect the privacy of subjects and to maintain the confidentiality of data.
(8) When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects.
Completing the Protocol Application
Using the Human Subjects Review Application, provide the following information in the evaluation criteria grid:
- Subjects: Describe the population and sample, and the sampling procedure for the research. Indicate efforts that will be made to assure equitable selection. When vulnerable populations are involved, describe why they are necessary. If subjects are to be paid, describe the circumstances.
- Purpose Statement: Provide the purpose statement of the research
- Methods, Procedures, and Analysis: Describe in detail:
- the research methods;
- the procedures of the study, and
- proposed plan for data analysis
- Risks: Describe any potential risks to the subjects –physical, psychological, social or legal—and assess the likelihood and seriousness of those risks. If the methods of research create potential risks, describe other methods, if any, that were considered and why they will not be used. Describe the procedures to ensure confidentiality standards for minimizing potential risks.
- Benefits: Describe the anticipated benefits of the research to the individual subjects, to the particular group or class from which the subject population is drawn, and/or to society in general.
- Costs to Subjects: If the investigation involves the possibility of added expense to the subject or to a third party, such as an insurer – for example longer hospitalization, extra laboratory tests, travel, times missed from work or school – indicate how this is justified. Be sure this is mentioned in the consent form.
- Informed Consent: Describe the method of obtaining informed consent (if needed), the person (s) who will be responsible for obtaining it, and where the informed consent forms will be stored. Be sure to include all elements of an informed consent. (See guidelines below for basic elements needed). When children are subjects for research “Assent” from the child and “Permission” from a parent or legal guardian must be obtained.
- Deception: If deception is used in the study design, explain why it is necessary and how subjects will be debriefed.
- Privacy: Describe how the research design protects subject rights to decide when, where, to whom and to what extent their attitudes, beliefs, and behaviors will be revealed.
Basic Elements of Informed Consent
The following information must be communicated in writing to all research subjects. Additional consent may be required when children are involved in the research. When subjects are from populations for who English is a second language it may also be necessary to prepare consent forms in the first language of these parties. Research involving special populations may be required to include additional information
The following are the minimum required elements of informed consent. Additional information may be included at the discretion of the investigator:
- A concise and focused presentation of the key information that is most likely to assist a prospective subject or legally authorized representative in understanding the reasons why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
- Statement identifying yourself and your affiliation with Concordia University;
- Invitation to participate in the study as part of a research project:
- Explanation of the purpose of the research, the expected length of time of the subject’s involvement, a description f the procedures to be followed, and the identification of activities which are experimental in nature;
- Description of any benefits to the subject or others which may reasonably be expected from the research;
- Description of compensation for participation (money, extra course credits, etc.);
- Statement describing the subject’s anonymity and of the extent to which confidentiality identifying the subject will be maintained;
- Names, addresses, and phone numbers of the people to contact for answers to questions about the research, and the office to contact for questions about the rights of research subjects (chair, IRB Committee, 641-8723);
- Assurance that participation is voluntary and that the subject may withdraw from the process at any time;
- If collecting private information or identifiable biospecimens include one of the two following statements about future research:
(i) Identifiers might be removed and the de-identified information or biospecimens used for future research without additional informed consent from the subject; or
(ii) The subject’s information or biospecimens will not be used or distributed for future research studies even if identifiers are removed.
- Child Assent Form: Required for those who are not of legal age for consent. This form must be signed by a parent or guardian. The child assent form must be brief and contain language appropriate to age level. Only the following elements need be present on the child assent form.
Statement of the purpose of the research Description of the procedures to be applied to the minor; Description of the potential risks and discomforts associated with the research; Description of any benefits to the minor; Statement that the minor does not have to participate if he/she does not want to; Statement that the minor is free to withdraw at any time; Statement that the minor should discuss whether to participate with his/her parent or guardian prior to signing the assent form; Statement that the parent or guardian of the minor will be asked to consent on behalf of the minor; Offer to answer all questions; Simplified concluding assent statement.
Research Qualifying for Expedited Review: 46.110(b)
Certain research projects may qualify for expedited review by the IRB Committee. The guidelines for classifying this type of research are subject to ongoing review and may change from time to time based on new information or changes in the social context in which research is conducted. Research activities subject to expedited review will involve no more than minimal risk to human subjects. This means the risk of harm anticipated in the proposed research are no greater, considering both probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. Categories of such research that may meet the requirements for expedited review fall into one or more of the categories listed below and are implemented through standard methods and practices.
- 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.)
- 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:
- from healthy, nonpregnant adults who weigh at least 110 pounds. For these subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or
- 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 the HHS regulations for the protection of human subjects).
- 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.
- Continuing review of research previously approved by the convened IRB as follows:
- 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
- where no subjects have been enrolled and no additional risks have been identified; or
- 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 (2) through eight (8) 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.
Research Qualifying for Exempt Review: 46.104(d)
Concordia University recognizes there are broad categories of research which do not use living human subjects or which present little or no risk of harm to subjects. These research projects will be exempt from review by the IRB Committee. The University has an interest in tracking these research projects and the faculty, staff, or students who initiate such a research project must still complete a protocol form and submit it to the chair of the IRB Committee. If the chair concurs with the non-exempt request the proposal will be recorded and the approved application returned to the researcher.
If the chair of the IRB Committee does not agree that the project should receive an exempt classification, then the project will be submitted to another member of the IRB Committee. If the second reader agrees with the researcher, then the project is exempt. If the second reader also declines to give an exempt from review classification, the proposal is turned back to the researcher with suggestions for revision to the project which would allow for an exempt classification, or the researcher may submit the project for review under another classification. The following categories of research are exempt from formal review by the IRB Committee:
- Research, conducted in established or commonly accepted educational settings, that specifically involves normal educational practices that are not likely to adversely impact students’ opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies, and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
- Research that only includes interactions involving educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior (including visual or auditory recording) if at least one of the following criteria is met:
(i) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(ii) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(iii) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination.
- (i) Research involving benign behavioral interventions in conjunction with the collection of information from an adult subject through verbal or written responses (including data entry) or audiovisual recording if the subject prospectively agrees to the intervention and information collection and at least one of the following criteria is met:
(A) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained, directly or through identifiers linked to the subjects;
(B) Any disclosure of the human subjects’ responses outside the research would not reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, educational advancement, or reputation; or
(C) The information obtained is recorded by the investigator in such a manner that the identity of the human subjects can readily be ascertained, directly or through identifiers linked to the subjects, and an IRB conducts a limited IRB review to make the determination.
(ii) For the purpose of this provision, benign behavioral interventions are brief in duration, harmless, painless, not physically invasive, not likely to have a significant adverse lasting impact on the subjects, and the investigator has no reason to think the subjects will find the interventions offensive or embarrassing. Provided all such criteria are met, examples of such benign behavioral interventions would include having the subjects play an online game, having them solve puzzles under various noise conditions, or having them decide how to allocate a nominal amount of received cash between themselves and someone else.
(iii) If the research involves deceiving the subjects regarding the nature or purposes of the research, this exemption is not applicable unless the subject authorizes the deception through a prospective agreement to participate in research in circumstances in which the subject is informed that he or she will be unaware of or misled regarding the nature or purposes of the research.
- Secondary research for which consent is not required: Secondary research uses of identifiable private information or identifiable biospecimens, if at least one of the following criteria is met:
(i) The identifiable private information or identifiable biospecimens are publicly available;
(ii) Information, which may include information about biospecimens, is recorded by the investigator in such a manner that the identity of the human subjects cannot readily be ascertained directly or through identifiers linked to the subjects, the investigator does not contact the subjects, and the investigator will not re-identify subjects;
(iii) The research involves only information collection and analysis involving the investigator’s use of identifiable health information when that use is regulated under 45 CFR parts 160 and 164, subparts A and E, for the purposes of “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b); or
(iv) The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearch activities, if the research generates identifiable private information that is or will be maintained on information technology that is subject to and in compliance with section 208(b) of the E-Government Act of 2002, 44 U.S.C. 3501 note, if all of the identifiable private information collected, used, or generated as part of the activity will be maintained in systems of records subject to the Privacy Act of 1974, 5 U.S.C. 552a, and, if applicable, the information used in the research was collected subject to the Paperwork Reduction Act of 1995, 44 U.S.C. 3501 et seq.
- Research and demonstration projects that are conducted or supported by a Federal department or agency, or otherwise subject to the approval of department or agency heads (or the approval of the heads of bureaus or other subordinate agencies that have been delegated authority to conduct the research and demonstration projects), and that are designed to study, evaluate, improve, or otherwise examine public benefit or service programs, including procedures for obtaining benefits or services under those programs, possible changes in or alternatives to those programs or procedures, or possible changes in methods or levels of payment for benefits or services under those programs. Such projects include, but are not limited to, internal studies by Federal employees, and studies under contracts or consulting arrangements, cooperative agreements, or grants. Exempt projects also include waivers of otherwise mandatory requirements using authorities such as sections 1115 and 1115A of the Social Security Act, as amended.
(i) Each Federal department or agency conducting or supporting the research and demonstration projects must establish, on a publicly accessible Federal Web site or in such other manner as the department or agency head may determine, a list of the research and demonstration projects that the Federal department or agency conducts or supports under this provision. The research or demonstration project must be published on this list prior to commencing the research involving human subjects.
- 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.
- Storage or maintenance for secondary research for which broad consent is required: Storage or maintenance of identifiable private information or identifiable biospecimens for potential secondary research use if an IRB conducts a limited IRB review and makes the determinations.
- Secondary research for which broad consent is required: Research involving the use of identifiable private information or identifiable biospecimens for secondary research use, if the following criteria are met:
(i) Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained);
(ii) Documentation of informed consent or waiver of documentation of consent was obtained;
(iii) An IRB conducts a limited IRB review and makes the determination that the research to be conducted is within the scope of the broad consent; and
(iv) The investigator does not include returning individual research results to subjects as part of the study plan. This provision does not prevent an investigator from abiding by any legal requirements to return individual research results.