The CSP Institutional Review Board oversees all compliance requirements at Concordia University, St. Paul related to research under one coordinated unit. Our policies, procedures, and guidelines are designed to support the responsible and ethical conduct of research at Concordia University, St. Paul and ensure adherence to all laws and regulations guiding research. We recognize the increasing burden of compliance requirements on researchers and work to provide assistance to decrease this burden wherever possible.
Major areas of compliance responsibilities include human subject protection, biological and chemical safety, responsible conduct of research, conflict of interest, research misconduct, and data security and facility access.
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.
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 protected]). 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.
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.
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.
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.
- Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
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.
This section provides the necessary documents to effectively plan, conduct, and carry out University research. Please refer to the “Policies and Procedures” tab information regrading the requirement for the IRB review process. Relevant forms are found below.
Please send all forms to [email protected]
The Collaborative Institutional Training Initiative (CITI Program) at the University of Miami is a leading provider of research education content. Their web-based training materials serve millions of learners at academic institutions, government agencies, and commercial organizations in the U.S. and around the world. CSP has chosen to subscribe to the CITI Program for all its online Research Based Training.
Anyone who is required to take CITI courses must first create an account within the CITI website or affiliate themselves with CSP if they already have an existing CITI account.
All Key Research Personnel must complete the online CITI Training Program prior to IRB approval of a new or continuing review application.
Key Personnel is defined as the Principal Investigator, other investigators and research personnel who are directly involved in conducting research with study participants or who are directly involved with handling private information related to study participants during the course of a research project. Key Personnel also include faculty sponsors who provide direct oversight of research with study participants or research using study participants’ private information.
CITI instructional modules are organized by “Learner Groups.” Select the Learner Group that most closely reflects the main emphasis of your work. The Learner Groups include:
- Biomedical Researchers & Staff: Investigators/staff submitting to the Medical IRBs
- Social & Behavioral Researchers & Staff: Investigators/staff submitting to the General IRBs
- Basic Scientists/Investigators who work with coded or identifiable data but who do not have contact with research participants
- General Campus IRB Committee Members
- Medical IRB Committee Members
- Other University officials (e.g., Associate Vice Presidents, Deans, Research Administrators),
Most users complete the Basic training in approximately 4.5 hours. You are not required to complete the training all at once. You may stop and start anytime. Just remember your user name and password.
The Concordia University, St. Paul Graduate Policies Committee (GPC) and the Institutional Review Board (IRB) have adopted a University-wide initiative to standardize our approach to research and ethics and working with human subjects. The program is known as the Collaborative Institutional Training Initiative (CITI for short). The program involves the certification of faculty and students in general research and ethics for working with human subjects. The CITI program is a self-paced course that covers the historical development of human subject protections, as well as current information on regulatory and ethical issues. The GPC believes that this standardization will raise awareness of the importance of working with human subjects and add a consistent measure to our understanding. The certification is good for three years. Please go into the CITI site to register and learn more about the program. The average learner spends approximately 4.5 hours to complete the course.
In order to complete any Basic Course you must first ADD the required course to your profile/main menu. To do this, you must be logged into your CITI account and follow these steps:
- On the CITI homepage, click on the “Register” option in the upper right corner.
- In the text entry box search for “Concordia University – St. Paul”, agree to the Terms of Service, and Continue to Step 2.
- Enter the appropriate personal information to register as a Learner.
- Answer the questions as applicable.
- Click Submit.
Once you click submit, all courses chosen will now appear on your Main Menu screen. To access each course, simply hover over each course title to enter the course. Instruction will prompt you to navigate through each course.
- On the CITI homepage, click on the “Register” option in the upper right corner.
CITI training must be renewed every 3 years (most courses) for all Key Research Personnel. The Refresher Course is comprised of cases and scenarios or summaries of the important concepts for modules in the Human Research Basic Course. Depending upon your Learner Group, you will either complete the pre-selected refresher modules, or the 2 pre-selected modules and 5 additional modules of your choice. Each module will require about 5-10 minutes to complete.
IRB is the acronym for Institutional Review Board for Human Participants. Any institution that receives federal funding to conduct research with human participants, such as Concordia University, is required to establish an IRB to review all research that directly or indirectly involves human participants, and to set forth institutional policy governing such research. Concordia University IRB operates under a charge.
The IRB for Human Participants has the authority to review, approve, disapprove or require changes in research or related activities involving human participants. Research reviewed by the IRB may also be subject to other review and approval or disapproval by officials at Concordia University. However, those officials may not approve research that has not been approved by the IRB for Human Participants. The IRB primary role is to ensure the protection of human participants as subjects of research at Concordia University.
According to Concordia University Policy, research is defined as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.” Activities which meet this definition constitute research for this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.
Human Subjects are defined as 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.
Intervention includes both physical procedures by which information or biospecimens are gathered (e.g., venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.
Interaction includes communication or interpersonal contact between investigator and subject.
Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place, and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (e.g., a medical record).
Private information must be individually identifiable (i.e., the identity of a participant is associated with the information or may readily be ascertained by the investigator) in order for obtaining the information to constitute research involving human subjects.
Identifiable private information is private information must be individually identifiable for which the identity of the subject is or may readily be ascertained by the investigator or associated with the information
All research projects that will involve human participants must be submitted for review and approval before beginning the study. This includes proposed research involving existing data and previously collected human fluid and tissue samples, as well as any advertising or other recruitment procedures.
Yes, if the study meets the definition for research with human participants, as explained above. Concordia University’s Federalwide Assurance (FWA) with the U.S. Department of Health and Human Services states that all research being conducted under the auspices of this institution is subject to review and approval by the IRB. Written approval from the IRB must be in place before any interventions or interactions with human participants (e.g., recruitment) actually begin.
Yes, if your research project involves active data collection. Federal regulations and Concordia University policy require that ALL research involving intervention or interaction with human participants, regardless of whether or not identifying information is being collected, must be submitted for review prior to beginning the research study.
However, if your research project involves use of existing information collected from human participants (e.g., secondary datasets, existing biological samples), but there are not any identifiers linking individuals to the data/samples, then the activity may not require IRB review.
Yes. Projects conducted by Concordia undergraduate and graduate students need IRB approval, if the project fits the definitions of “research” and “human participants” as described above. If the project is to be used in classroom setting only to teach research methods, the project may not constitute human participant research. However, this means that at no point during or after the conclusion of the course can the results or the data be used for publication, presentation or other research purposes. Therefore, students should discuss these limitations with their instructor or faculty advisor so that they can determine whether IRB review is necessary.
No. The Federal Regulations do make certain categories of research exempt from IRB review. However, Concordia University policy does not allow investigators to self-exempt their human participant research projects. Instead, determining if a project is exempt from IRB review is an administrative review process handled by the IRB staff.
If you are a member of the Concordia University faculty or staff, or a Concordia University student, and you are the person responsible for the conduct of the study (PI), you must get Concordia IRB approval to conduct your research regardless of where the research takes place. Investigators should contact the IRB office whenever collaborative research is occurring. Separate applications for each institution may be necessary; however, in order to avoid duplicate review, an IRB Authorization Agreement may be arranged with the other institution to establish one IRB as the designated IRB to review and approve the research.
Yes. If you are a member of the Concordia University faculty or staff, or a Concordia University student, and you are the person responsible for the conduct of the study (PI), you must get Concordia IRB approval to conduct your research regardless of where the research takes place.
The use of deception in research is not prohibited by either the federal regulations or Concordia. However, because at some level the use of deception in research violates the trust that the participant puts in the researcher, this method should be considered carefully. Deliberate deception of participants may occur only in situations where withholding information about the nature of the study is necessary to ensure valid results, and never to get participants to do something that they would not do if the information was fully disclosed to them.
Researchers should describe for the IRB the method, rationale and the process of informing participants of the purpose of the research as early as is feasible – preferably at the conclusion of an individual’s participation (but no later than at the conclusion of data collection) to permit participants to withdraw their data. Additionally, researchers should provide a justification for the deception techniques and document that there are no equally effective non-deceptive techniques available.
Some research involving the collection and use of oral histories or life histories meets the federal definition of ‘human subjects research’ and requires an application to the IRB office, while other research using the same methods does not. The IRB Chair can be consulted to help determine the appropriate process.
Studies that use multiple case studies to draw conclusions that are applicable in a generalizable context, or to address a hypothesis, meets the federal definition of ‘human subjects research’ and requires review by the IRB office. Other case studies may not require IRB review.
The reporting of current events, trends, newsworthy issues or stories about people or events generally does not meet the federal definition of ‘human subjects research’ and therefore requires no application to the IRB office. However, reporting intended to draw conclusions may require review by the IRB.
You must receive written approval from the IRB before beginning participant recruitment, data collection, or data analysis. A memo will be sent to you via e-mail when your project has IRB approval.
That depends on the nature of your study and the characteristics of the people you intend to recruit. Research projects that involve only minimal risks are eligible for expedited review, for which you should allow at least 4 weeks for IRB review.
Research projects that involve greater than minimal risk to participants will need to go to the full board for review. For applications requiring full board review, you should allow at least 4-6 weeks for review and approval of your study.
Compliance with 45 CFR 46.115(b) requires that all records relating to IRB approved research be retained for a minimum 3 years after closure of the project. Records may be preserved in hard-copy, electronic or other media form, and must be accessible for audit purposes.
No. There is no provision in the federal regulations that allow for IRB approval of research that has already been conducted. If data was collected for purposes that the IRB determines to be non-research (e.g., program evaluations for library or educational programs not initially intended to be used for research), IRB approval can be sought for the data analysis going forward.
Payment or incentive based procedures may be provided to subjects. However, all human subjects research projects that offer compensation for participation must comply with Concordia University Business Services procedures and policies as well as Institutional Review Board (IRB) review and approval to ensure the compensation amount does not exert undue influence on a subject’s decision to participate. The nature, amount, and method of payment or other remuneration should not constitute excessive enticement to participate (i.e., the payment should not serve as sufficient inducement for the subject to volunteer). The IRB will consider the impact participation poses on the daily life of the potential subject. For example, the IRB will consider compensation of subjects for inconvenience posed by the research, such as: the time required to participate; travel involved and/or parking costs; lost time from work, and babysitters, etc. Investigators should include provisions in the protocol for addressing these concerns, especially for research that poses little or no direct benefit for the subjects.
In some instances it is acceptable for the researcher to recruit students as long as they will have no knowledge of who decided to participate. The purpose of this measure is to remove the teacher as much as possible from the participants without compromising the data collection. If students will be offered extra credit as compensation for participation in a study, an alternative extra credit option must also be available if study participation is declined.
The Application Process:
Every new protocol submitted to the IRB must include completed and signed forms for the correct submission type (available under IRB Forms)
The IRB evaluates every research protocol according to the ethical principles described in the Belmont Report (http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.html). Basically, this means the IRB considers whether the risks and benefits of a study are acceptable and managed appropriately, and whether individuals being asked to participate are adequately informed about the research and its possible risks.
Considered another way, investigators could look at their plans from the point of view of a subject, or an observer concerned about responsible research. Who are the subjects and how are they recruited? Could they be lured or coerced to participate? Is it through an institution that may have responsibilities toward them (e.g., a school or hospital) and should be consulted? Do they understand, in advance, what they are agreeing to participate in and give their consent willingly? What will they actually do, and what is done to them, during the study? Is it possible that the experience might be injurious, painful, uncomfortable, needlessly boring, embarrassing, offensive, or otherwise stressful? Might there be long-term consequences? Could the subject be endangered, compromised or embarrassed if information collected leaked out? There are many possible considerations, but they should not be difficult to understand if one assumes the subject’s perspective. The IRB’s role is to look at the study from this perspective and to ensure that proper precautions are taken to protect individuals when they agree to participate in research.
Contact & Membership
203 Thompson Hall
Email: [email protected]