Membership
The IRB is a standing committee governed by the by-laws of the FacultySenate.
a) The IRB is composed of Two (2) Co-chairpersons appointed by the Provost, four (4) faculty members (each representing a different school of the University) elected by Faculty Senate, the Research Integrity Officer, a designee of the Provost, a student government representative and a community representative. The IRB also maintains a list of qualified internal and external consultant-members to be utilized as needed. IRB members do not participate in Board reviews of research or in investigations of allegations of scientific misconduct in which they have a self-interest.
b) Elected faculty members will be appointed for a three (3) year term. Members may be reappointed at the end of their term to consecutive terms if they are willing to serve and their attendance and participation in previous terms has been satisfactory.
c) Unexpired terms due to resignation, disability, relocation, etc., will be filled by alternate(s) as appointed by Faculty Senate.
d) Qualifications for membership are based on a number of factors. Included in the list of qualifications, but not limited to, are:
Interest in the Board
A sincere interest in supporting SFU in protecting human subjects from risk due to research activities
Sound character
Member of SFU Teaching Faculty
Appropriate experience, education and credentials to represent varied elements of the community at large
Other factors that are given consideration are the applicant's experience with other IRBs and with the research process.
External members are chosen based upon the above, with the exception that they are not required to be a member of the Teaching Faculty.
Subcommittee appointments
The Chairperson will have the prerogative to create and dissolve any necessary subcommittees as she/he deems necessary.
Meeting schedule and deadlines
Meeting Schedule and Deadlines
The IRB will meet once in the month of September in order to review IRB policies and receive relevant educational updates. The IRB chair is responsible for promptly responding to all incoming IRB proposals and keeping track of them. After that first meeting the IRB will only meet as needed, such as when Full Review IRB proposals are submitted or other important business arises.
All researchers submitting an IRB proposal to the IRB committee for review should expect to allow a minimum of 2 weeks before learning of the IRB’s decision regarding their protocol.
Applications for expedited or exempt review may be submitted to the IRB at any time. They will be reviewed on a first come, first served basis. Applications that are determined to need a full committee review, the Chairperson will schedule that meeting in a timely fashion and assure that all members of the committee have access to the applicants materials.
Records
Copies of any federal or state reports filed by the IRB will be sent to the Grants and Foundations Offices in the Development Office.
POLICIES AND PROCEDURES
A. Ethical principles
1. Ethical principles and issues for the use of human subjects in research
The current regulations in 45 CFR 46 are based on The Belmont Report, which was developed in the 1970s by the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research. The report presented three basic ethical principles. These principles of respect for persons, beneficence, and justice remain as essential requirements for the ethical conduct of research involving human subjects. Respect for persons recognizes personal dignity and autonomy of individuals and protection of those that have diminished autonomy. Beneficence includes an obligation to protect individuals from harm by minimizing risks of harm and maximizing benefits. Justice requires that the burdens and benefits be distributed fairly.
In addition to The Belmont Report, SFU also is guided by the ethical principles regarding research involving human subjects as presented in The Nuremberg Code and the World Medical Association Declaration of Helsinki: Recommendations Guiding Medical Doctors in Biomedical Research Involving Human Subjects.
In addition to the aforementioned principles, the IRB will be considering the following ethical issues in determining the nature of the risks and extent to which the benefits of the study justify exposing the subjects to risk:
a) Voluntary participation: Participation of human subjects must be voluntary, i.e., must occur as a result of free choice, without compulsion or obligation, based upon disclosure of relevant information in a clear, concise, and understandable way. The researcher must take care to avoid coercing their participation.
b) Inducement to participate: Subjects are frequently offered some form of incentive or reward for their participation, e.g., earning extra credit points from their professor, small gifts or prizes, a chance to win money in a lottery. In general, inducements are allowable as long as they are minimal and are not more attractive to some subjects than to others. The primary ethical issue involves the extent to which an inducement might be sufficiently large enough to cloud the person's judgment about whether or not participation in the study is in their own best interest.
In cases where students may earn extra credit points from their professor, other options to earn extra credit besides research participation must be available. Researchers must not do the recruiting in their own classes (although they may have one of their colleagues or research students recruit for the study in their own classes), nor should their names be associated with the recruitment procedures if recruitment will take place in their own classes. This guards against the students' perception that they may be expected to participate in a study that their own professor is conducting in order to stay in good terms with that professor.
A second issue involves the extent to which the subjects can reasonably choose not to participate, especially in a case where subjects are approached in a large group (e.g., class) and asked to participate without standing apart from their peers. This is particularly a problem if participation involves a sensitive issue. For example, if the study focuses on AIDS and a person chooses not to participate, it might be interpreted that the person has AIDS. In such cases, the researcher/recruiter would need to demonstrate that this concern has been recognized and addressed (e.g., by providing a means for all potential subjects to appear as if they are participating even if they are not).
c) Informed consent: All subjects must be properly informed about what the participation will entail. This should be initiated in the recruitment process by having the subjects read and sign an informed consent form before participating in the study. It also is crucial that researchers ensure to the best of their ability that the potential subjects understand what is being communicated to them. Consent must be given freely with the subject understanding the nature and consequences of what is proposed. Consent also is an ongoing process, not just a single occurrence. Researchers must inform subjects and/or guardians of any important new information that might affect their willingness to continue in the study.
Federal law stipulates that a person must be 18 years or older to give legal consent for his/her own behalf. Subjects under the age of 18 years may participate in research only with the signature of their parent or legal guardian in addition to their own signature. This also applies to the completion of anonymous questionnaires, since persons under 18 are not permitted legally to make the informed choice to participate. Children should have the information about participation in the research explained to them in language that they can understand (by their parent), and, if possible, they should sign their consent.
d) Identification and minimizing of risks: Virtually all research involves some risk, even though it may be slight (e.g., embarrassment over a performance on a task). A risk may be of a physical, social, and/or psychological nature. The IRB will consider the extent to which the researchers have attempted to identify the potential risks to the subject and the extent to which those risks have been minimized as much as possible without interfering with the validity of the research. In cases where there is a possibility of more than minimal risk to the subject, approval will depend on the benefits of the research, the expertise and prior experience of the researcher(s) in conducting this type of research, the level of inducement to participate, the extent to which the subject is fully informed of the possible risks, and the availability of compensatory treatment or follow-up designed to alleviate any negative consequences from participation. A research procedure may not be used if it is likely to cause serious and lasting harm to subjects (e.g., health problems).
e) Fairness: The research should be designed to treat all individuals fairly. The selection of subjects must be based upon fair procedures and not overburden, overuse, or unfairly favor or discriminate against any subject pool.
f) Deception: In some types of research it may be necessary to withhold some pertinent information from subjects when disclosure of such information would likely impair the validity of the study. In all such cases, subjects should be told that they are being invited to participate in research in which some features will not be revealed until the research is concluded. Complete nondisclosure of information about the study or its purpose is only justified when the research solely involves observation of a person's behavior in locations where the person might reasonably expect that his/her behavior could be observed by another. In any research that involves incomplete disclosure, the following conditions must be met: 1) there are no undisclosed risks to subjects that are more than minimal; 2) there is an adequate plan for debriefing subjects, when appropriate; and 3) incomplete disclosure is truly necessary to accomplish the goals of the research. Truthful answers should always be given to direct questions about the research; this may include telling the subject that revealing certain information may impair the success of the study.
g) Confidentiality/Anonymity: In all research involving human subjects, it is important to assure the subjects of the confidentiality of their responses. This is especially important in cases where the study involves asking the subjects personal questions about themselves or obtaining other information that might put the subject psychologically at risk, if the information was made public. Total anonymity (e.g., where the subject's name or face is never associated with his/her responses, even to the researcher) is preferable, especially in the case of extremely sensitive or personal information. This generally means that the subject must be able to provide information in complete privacy and to submit the information in such a way that it is mixed in with other subjects' data before it is retrieved by the researcher. Where it is necessary to have the subjects' names or identification numbers associated with their responses (e.g., in order to collate several sets of responses by the same subject), the subjects need to be told who will see their data and specifically how this information will be kept confidential.
h) Debriefing: In most cases, it is desirable for subjects to be debriefed after their participation in the study (e.g., given further information about the study and given a chance to ask questions). There are three cases in which debriefing is required: first, when the research has involved incomplete disclosure; second, when subjects may be left with a misleading or potentially harmful perception or inaccurate information; and third, when compensatory treatment or follow-up is needed. Such debriefing should not be treated as a substitute for informed consent prior to and during the subject's participation in the research.
In some cases, debriefing may not be possible immediately after the study due to concern about other potential subjects finding out about a deceptive aspect of the study that would preclude further data collection. In these cases, debriefing statements or descriptions could be offered to the subjects at a later date through the mail or other means. In rare instances, debriefing may itself pose a social or psychological risk to a subject; in which case it may be in the best interest of the subject to forego the debriefing procedure. In most cases, however, this can be avoided by disclosing to the subjects prior to their participation that some harmful information may be uncovered in the course of the study. This would fall under the obligation to disclose any risks that are more than minimal (see Deception).
i) Compensatory follow-up: In cases where some physical or psychological harm might result from the subjects' participation, plans for compensatory treatment or follow-up counseling should be provided.
2. Potential risks which may require full review
A risk is a potential harm (injury) associated with the research. Minimal risk is defined in the federal regulations as "The risks of harm anticipated in the proposed research are not greater considering probability and magnitude than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests." Examples of risks:
a) Psychological: May be experienced during the research situation and/or later, as a result of participation in the research.
• depression
• loss of self-esteem
• feelings of stress
• guilt
• anxiety
• fear
• confusion
• embarrassment
• invasion of privacy
b) Social:
• negative effects on standing in group or community
• overt hostile reaction by others
• reduced opportunity for communication
• diminished access to otherwise available roles
• lost or endangered membership in groups
c) Physical:
• illness
• injury
• minor discomfort (e.g., temporary dizziness, headaches, or pain)
• stress related to exercise or other physical activity
d) Economic:
• loss of present or future employment
• loss of opportunity for career advancement
• loss of eligibility for insurance
• cost relating to participation in research (including cost for research-related injuries)
e) Legal:
• criminal prosecution
• civil lawsuit
B. Categories of review
1. Exempt from full IRB review
All research involving human subjects that is exempt from full or expedited IRB review must include a process that assures the research protocol meets and maintains minimum standards for informed consent and confidentiality of data. The researcher must complete an application and submit it to the Department/Program Director or designated representative(s) for review. No researcher may review his or her own application. If the researcher is a Department/Program Director, he or she may have the application reviewed by any IRB member. As explained in Section II, one copy of the application and appropriate signed documents must be filed with the IRB.
Research activities in which the only involvement of human subjects will be in one or more of the following categories are exempt from a full or expedited review. Another stipulation is that the information on these subjects is recorded so that subjects cannot be identified directly or through identifiers linked to the subjects.
a) When educational research meets the following conditions, it is exempt from IRB review and does not require consent from parents. The researcher and/or institution, however, may want this consent. The assent of a child should be obtained whenever possible.
i) The research is conducted in established or commonly accepted educational settings involving normal educational practices. Examples are research on regular and special education instructional strategies or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
ii) If the research involves educational tests (cognitive, diagnostic, aptitude, achievement), this information must be recorded so that subjects cannot be identified, directly or through identifiers linked to the subjects.
iii) The research procedures do not represent a significant deviation in time or effort from those educational practices already existing at the research site.
iv) The research procedures do not involve an increase in the level of risk or discomfort compared to normal, routine educational practices. For example, studies in which parenting practices are criticized or teachers' jobs may be jeopardized are not exempt from review.
v) Provisions are made to ensure the existence of a non-coercive environment for those students who choose not to participate.
vi) The research does not involve sensitive topics (e.g., sex education).
vii) The institution grants written approval for the research to be conducted.
b) When the research involving the use of surveys, interview procedures, or observation of public behavior is not part of educational research as defined in "a", but meets the following conditions.
i) Information on these subjects is recorded so that subjects cannot be identified directly or through identifiers linked to the subjects.
ii) Disclosure of subject responses outside the research setting would not place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation.
iii) There is no risk associated with a breach of confidentiality.
iv) The research does not deal with sensitive or highly personal aspects of the subject's behavior, experiences, or attitudes (e.g., substance abuse, detailed health history, sensitive demographic data).
v) The research does not involve children (subjects under 18 years of age).
c) The research involves the collections or study of existing data, documents, records, pathological specimens, or diagnostic specimens which either are publicly available or will be recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects.
d) Research that involves taste and food quality evaluation and consumer acceptance studies where only wholesome foods without additives are consumed or that involves only a limited amount of consumption of a food additive at or below a level approved by the Food and Drug Administration, Environmental Protection Agency, and/or the United States Department of Agriculture.
2. Expedited Review/Minimal Risk
Applications that qualify for expedited review are read by either the chair of the IRB or an experienced IRB member designated by the IRB chair. These research activities involve no more than minimal risk and only include involvement of human subjects in one or more of the following categories (carried out under standard methods). Also, previously approved (within one year or less) research with only minor changes qualifies for the expedited review.
a) Collection of hair and nail clippings, in a non-disfiguring manner; deciduous teeth; and permanent teeth, if patient care indicated a need for extraction.
b) Collection of excreta and external secretions, including sweat, uncannulated saliva, placenta removed at delivery, and amniotic fluid at the time of rupture of the membrane prior to or during labor.
c) Recording of data from subjects 18 years of age or older using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance and do not involve input of matter or significant amounts of energy into the subject or an invasion of the subject's privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, encephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (e.g., x-rays, microwaves).
d) Collection of blood samples by venipuncture. In patients not exceeding 450 milliliters in an eight-week period and not more often than two times per week, from subjects 18 years of age or older and who are in good health and not pregnant.
e) Collection of both supra- and subgingival dental plaque and calculus, provided the procedure is no more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques.
f) Voice recordings made for research purposes such as investigations of speech deficits.
g) Moderate exercise by healthy volunteers (as defined by the American College of Sports Medicine).
h) The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
i) Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the researcher does not manipulate subjects' behavior and the research will not involve stress to subjects.
j) Research on drugs or devices for which an investigational new drug exemption or an investigational device exemption is not required.
For all non-exempt research protocols that entail even a very small possibility of research-related injury of any kind, the following Medical Care Language must be included in the informed consent form:
In the unlikely event you become injured as a result of your participation in this study, Saint Francis University will make every effort to assist you in obtaining medical care. The costs of this medical care will be billed to you or your insurance company. If you want more information about this, please contact [Insert primary investigator’s name] at [Insert phone number/e-mail address].
3. Full Review/Greater than Minimal Risk
Unless research qualifies for exemption from full IRB review or expedited IRB review as previously described, it requires full review by the IRB. Federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. Research involving these subjects, sensitive behavioral research, research involving deception, or research that is harmful to the subjects automatically requires full IRB review.
For all non-exempt research protocols that contain even a very small possibility of research-related injury of any kind, the following Medical Care Language must be included in the informed consent form:
In the unlikely event you become injured as a result of your participation in this study, Saint Francis University will make every effort to assist you in obtaining medical care. The costs of this medical care will be billed to you or your insurance company. If you want more information about this, please contact [Insert primary investigator’s name] at [Insert phone number/e-mail address].
C. Special categories of research
1. Student research
These same policies and procedures apply to student research. Instructors are responsible for screening student research projects and determining if they require approval by the IRB or Department/Program Director. If a project is assigned for the purpose of producing generalizable results that may be presented outside of the class, or published, or may involve risk to the subjects, the researcher must comply with these policies and procedures. Submission of an application and appropriate approval must occur prior to initiating the research (e.g., data collection).
2. Cooperative research with other institutions
Cooperative research is research where at least one of the principal investigators is affiliated with SFU AND at least one of the principal investigators is affiliated with an external organization or institution. In this case, one institution may agree to delegate responsibility for initial and continuing review of all or a portion of the research activity to another IRB. This can occur if the other institution agrees to abide by the reviewing IRB decisions. Any research activity, which SFU researchers do not delegate to another IRB, must comply with the policies and procedures of the SFU IRB and have SFU IRB approval.
Researchers and SFU IRB need to bear in mind the following when contemplating the use of another institution's IRB to review its protocols: local laws, institutional policies and constraints, professional and community standards, and population differences. Researchers should seek IRB counsel prior to engaging in cooperative research involving the use of human subjects.
The agreement for IRB review of cooperative research must be documented in writing using the Letter of Authorization Agreement form. Copies of the completed agreement, with all appropriate official signatures, must be furnished to all parties to the agreement and to the governing IRB. No matter what the agreement, each researcher is responsible for safeguarding the rights and welfare of human subjects.
If the external institution is delegating the SFU IRB to be responsible for reviewing the IRB proposal, then no further action is needed. If SFU is delegating IRB review to the external institution, then the SFU IRB chair must update SFU’s Office of Human Research Protection (OHRP) Federal Wide Assurance (FWA) form, found at http://www.hhs.gov/ohrp , by listing all relevant external institutions’ FWA numbers on it. The updated SFU FWA form must then be submitted to OHRP for approval.
3. International research
Procedures for reviewing research in foreign countries may differ from those set forth in this document and in federal regulations. Such international standards as the Nuremberg Code and Declaration of Helsinki present broad policies, but are not considered sufficient for an institution having an assurance with a federal agency such as DHHS. Because of the varied policies and procedures involved with conducting research in foreign countries, it is best that researchers discuss research projects with the IRB during the planning phase of the project.
4. Research using special populations
Federal regulations require that IRBs give special consideration to protecting the welfare of particularly vulnerable subjects. For example, the DHHS requires additional safeguards for research involving fetuses, pregnant women, and human in vitro fertilization (45 CFR 46, Subpart B), prisoners (45 CFR 46, Subpart C), and children (45 CFR 46, Subpart D). If faculty, staff, or students are associated with research involving fetuses and in vitro fertilization, they should consult with the IRB chairperson and/or the Vice President for Academic Affairs. Some of the federal regulations, state, and local laws need to be strictly adhered to concerning these areas. For example, in some instances the DHHS requires approval by their Ethical Advisory Board prior to conducting a study.
Research involving any of the other special populations must follow all requirements as indicated in 45 CFR 46. The remainder of this section concentrates on some aspects of research involving children, incapacity, and AIDS/HIV-related research studies.
a) Research involving children: The special vulnerability of children makes consideration involving them as research subjects important. Special procedures are required for research involving children except for research that is conducted in educational settings as described on page 6 of the document. Whenever feasible, appropriate studies should be conducted on non-vulnerable populations or older children before young children are involved as research subjects.
What constitutes minimal risk is central to the IRB's consideration of research involving children. The IRB also must determine that adequate provisions have been made for getting the permission (assent) of children and the permission (informed consent) of their parents or guardians. The IRB's policy regarding obtaining consent and assent is as follows:
i) In most situations, parental consent is required if the research involves minors (under the age of 18). Unless requirement is waived by the IRB, a parent or guardian must complete an informed consent form.
ii) Unless the requirement is waived by the IRB, assent is required from all children. In most situations, a written form should be used to document assent. The form should include a simplified version of the contents of the informed consent. This explanation should be written so as to be understandable to the child. If the child's developmental ability does not enable him or her to understand the written explanation, documented oral assent is appropriate.
b) Research involving subjects with incapacities: Incapacity refers to a person's mental status and means inability to understand information presented, to appreciate the consequences of acting (or not acting) on that information, and to make a choice. Persons with incapacities who either have been adjudicated to lack the capacity to give informed consent or have been judged by the researcher to lack the capacity cannot participate as research subjects unless proxy consent is obtained by their legally authorized representative. The assent of these persons must be obtained whenever possible. Depending on their situation and the research being planned, durable power of attorney may be requested from the IRB.
c) AIDS/HIV-related research: A paramount concern in HIV research is confidentiality. Breaches of confidentiality could have severe adverse consequence such as loss of employment or insurance coverage, or criminal charges. For example, if identifiers are not needed, they should not be recorded. If they are recorded, they should be separated, if possible, from the data, and combined with the data only when necessary. It also has been suggested that no lists should be retained identifying those who elected not to participate.
The procedures for obtaining informed consent need to be accurate and complete. Subjects should be informed of exactly what information will be recorded and whether any state laws require disclosures of information.
5. Waiver of documented informed consent
The IRB may waive the requirement for documentation of informed consent by the subject or his/her representative in certain circumstances. Documented consent may be waived if:
a) The research is conducted by a governmental body to evaluate its program.
b) The research could not be practicably carried out with conventional consent requirements.
c) The research involves no more than minimal risk to the subjects. (The statute defines "minimal risk" as meaning that the "risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.")
d) The rights of the subjects are not adversely affected.
e) The subjects are supplied with pertinent information about their participation subsequently wherever appropriate.
Investigators who feel their protocols qualify may request such a waiver from the IRB stating, in writing, the reasons for the request.
Questionnaire studies which qualify for waiver of documentation of consent should include the following statement at the end of the questionnaire:
"By completing this questionnaire, I indicate my consent to participate in the study. I understand confidentiality will be maintained."
D. Follow-up procedures
1. Continuing review and annual update
Non-exempt applications are approved for a maximal period of one year. For research projects that continue beyond one year, it is the responsibility of the researcher to submit an annual update; researchers should submit a Request for Annual Update (page 28) to the IRB. The first update is due 12 months following the date the application was approved. If the IRB determines that a project requires review more often than annually, the researcher will be notified. Projects can be updated annually for a maximum of five years. Continuation of projects beyond five years requires resubmission.
2. Revision and resubmission
If an application has been disapproved, the applicant may revise the proposal and resubmit it to the IRB. Every attempt will be made to resolve the identified problem(s). The IRB, however, retains final authority over whether or not an application can be approved.
3. Reporting changes in research protocol
Any change in a protocol that affects the human subjects must be approved by the IRB prior to implementation, except where an immediate change is necessary to eliminate a hazard to the subjects. Researchers should submit a Request for Change in Protocol (page 29) to the IRB. If the change in the protocol requires changes in the consent form, attach the new consent form to the Request for Change.
4. Reporting injury to subject
If a subject sustains an injury during research, the principle investigator must assist the subject in obtaining medical care and must notify the SFU IRB committee of the injury within 48 hours using the Injury Report form.
5. Reporting finalization of project
The researcher must submit an End of Project Report to the IRB when the project is complete. All federally funded research projects must submit copies of ALL, SIGNED consent forms along with their End of Project Report for compliance with Office of Human Research Protection regulations.
E. Scientific misconduct
Each institution which receives or applies for a research, research-training, or research related grant or cooperative agreement under the Public Health Service Act must submit an annual assurance certifying that the institution has established administrative policies as required (42 CFR Part 50, Subpart A), and that it will comply with those policies and the requirements of the Final Rule (54 FR 32446, August 8, 1989). The University will inform its scientific and administrative staff of IRB policies and procedures and the importance of compliance.
The following policies for investigating, resolving, and reporting allegations of scientific misconduct will be followed by SFU:
a) Allegations of scientific misconduct will be received by the Office of Academic Affairs, which will immediately refer such allegations to the IRB for determination if a sufficient basis exists for conducting an investigation. The IRB shall determine within thirty (30) calendar days of receipt of the allegation whether sufficient basis exists for an investigation. The IRB shall report its findings in a written report to the Vice President for Academic Affairs. This report and detailed documentation of the inquiry shall be maintained and held confidential by the Office of Academic Affairs for at least three (3) years, and must be provided to authorized HHS personnel upon request.
b) Upon a finding by the IRB that sufficient basis exists for conducting an investigation, the Vice President for Academic Affairs will (a) initiate a formal investigation; (b) notify the PHS's Office of Scientific Integrity at the National Institutes of Health that an investigation will be conducted; and (c) take appropriate interim administrative action to protect Federal funds and ensure that the purposes of Federal financial assistance are being carried out.
c) Within thirty (30) days of completion of the IRB's inquiry and the finding that sufficient basis exists for conducting an investigation, the Vice President for Academic Affairs will initiate an investigation. An investigating panel of at least three (3) faculty members or researchers will be named by the Vice President for Academic Affairs. The team will include at least one (1) scientist from the discipline in which the misconduct is alleged to have taken place, at least one (1) faculty member or researcher from an outside institution, and the Chairperson of the SFU IRB or another member of the IRB designated by the Chairperson. No individual with a real or apparent conflict of interest will be named to the investigating team. The team will take measures to afford the affected individual(s) confidential treatment to the maximum extent possible and opportunity to comment on allegations and findings of the inquiry or investigation; shall conduct a thorough and prompt investigation; and shall complete its investigation within 120 calendar days of initiation of the investigation. The result of the investigation will be communicated in a written report to the Vice President for Academic Affairs, whose office will maintain the report and documentation to substantiate the investigation's findings for at least three (3) years. The Office of Scientific Integrity (OSI) will be notified of the results of the investigation in a written report that thoroughly documents the investigative process and findings.
d) Finding of the IRB that scientific misconduct by a faculty member has occurred will be handled by the Vice President for Academic Affairs as prescribed in the Faculty Handbook. Should a reasonable indication of possible criminal violation be obtained, the PHS's Office of Scientific Integrity will be notified within twenty-four (24) hours. When allegations are not confirmed, all efforts will be made to remediate any damage to the reputations of persons alleged to have engaged in misconduct.
F. Studies Conducted Without IRB Approval (adapted from policies at the University of California, Santa Barbara)
- Data obtained for human subjects research activities in which SFU faculty and/or students are considered to be engaged is considered to have been collected without IRB approval under the following circumstances:
- With no prior IRB approval
- With no prior letter of determination confirming IRB oversight is not required (checklist)
- With no informed consent from the subjects or their legally authorized representatives
- And when the IRB has not approved a waiver of consent or documentation
- Using procedures that were not previously described and approved in the IRB approved consent document (unless it has been determined to be in the best interest of the subjects enrolled in the study to continue in the research in consultation with the IRB Chair/Designee or Research Integrity Officer)
- After expiration of the IRB approval
- After suspension or termination of IRB approval
- The IRB cannot grant retroactive approval for use of data that was previously collected without IRB approval. Federal regulations allow for IRB approval only when it is prior to the initiation of the research activities.
- The IRB cannot require the investigator to destroy data or prevent the investigator from analyzing or publishing the data collected without prior IRB approval.
- Federal regulations do not state how data collected without IRB approval may be used.
Actions following data collected without IRB approval:
- The investigator must immediately cease all activities involving human subjects.
- Any investigator who discovers they have conducted research involving human subjects without prior IRB review and approval or exemption determination, must report their project promptly to the IRB.
- Investigators should also contact their faculty sponsor if they are a student researcher or notify their department chair if they are a faculty member.
- The investigator must submit in writing a summary of the project to the IRB and why the appropriate approvals were not initially sought and how they will ensure there are no future recurrences.
- The summary must include the following information:
- A description of the project (including the dates and location of activities, the human subjects participant population, examples or copies of the survey materials, interview guides, instruments, etc., that were used to collect data)
- A description of the consent process
- A discussion of how the rights and welfare of the participants were not adversely affected (including whether there were any complaints, concerns, complications, unanticipated outcomes or adverse events associated with the research)
- If identifiable data were collected, the disposition of these materials
- Why the appropriate IRB approvals were not initially sought and how the research team will avoid future occurrences
Corrective and Preventative Actions
- Depending on the circumstances leading to the lack of approval, the IRB may require any of the following corrective actions, or any other action as appropriate:
- Warning letter: Issue a letter of warning to the investigator.
- Publications and presentations: If the data are intended for publication, the investigator must disclose to the publication editor that the data was previously collected without prior IRB approval.
- Publications and presentations: Data cannot be described as a part of an SFU IRB-approved study.
- Halt ongoing activities: If the study is on-going, interactions with the human subjects must cease until the IRB has reviewed and approved all the study procedures.
- Modification: If data was collected under an existing study for which the appropriate procedures were not described, some or all part of the protocol may require modification.
- Recollection of data: Data are collected again, but with IRB approval.
- Notification to participants: In some instances, the IRB may require the investigators to notify all participants of the investigator’s lack of compliance with the IRB procedures.
- Reconsent: The participants are provided the opportunity to consent to the use of their data for research purposes, using IRB approved documents.
- Retraining: Require retraining of the investigator and researchers conducting the project.
- Notification to OHRP: If there was any risk of harm to the participants, the IRB will report the incident to OHRP and appropriate officials as required by the Federal Wide Assurance.
- Funding agency notification: If the study is federally funded, then the IRB chairs must notify the funding agency to report that the research was conducted without prior IRB approval to determine applicable reporting requirements.
- Suspension and termination: If, after the IRB has intervened to take corrective action and the investigator initiates a second study without IRB approval, procedures for suspension and termination may be applied at the discretion of the university administration.
- Recommendation of sanctions on data use: Although the IRB cannot impose sanctions on the use of the data, the IRB may recommend that university administration, or other appropriate officials (e.g., SFU Legal) consider the following actions:
- Require that data not be published or presented
- Require data not be used for a thesis or dissertation
- Require that data be destroyed
- Other actions as appropriate
- The IRB chairs, after review by the IRB committee, will send a letter of determination to the investigator detailing any corrective actions.
RESPONSIBILITY
- The investigator is responsible for ensuring they obtain IRB approval prior to initiating activities involving human subjects.
- The investigator is also responsible for notifying the IRB of when a violation occurs and ceasing all activities until the IRB has reviewed a summary of the incident.
- The IRB Chairs, IRB committee, and/or Research Integrity Officer are responsible for receiving and reviewing reports of investigators collecting data without prior IRB approval.
- The IRB chairs will facilitate the initial review of the report and will notify investigators of the IRB decision and any corrective action(s) in writing.
- The IRB chairs and/or Research Integrity Officer are responsible for notifying the university administration, as appropriate.
- The IRB is responsible for reviewing reports of noncompliance with this standard of practice and federal regulations.
PROCESS OVERVIEW
- The IRB chairs and/or Research Integrity Officer will initially receive the reported data collection without IRB approval.
- The IRB chairs will determine whether an approved protocol was in place during the time period in question.
- If an approved protocol does not/did not exist, then the IRB will review the summary of information provided to the IRB chairs.
- The IRB will make a formal determination as to whether the data collected required IRB approval. The IRB will assess:
- Whether the activity constituted research involving human subjects, as defined by federal regulations
- Whether the project was eligible for an exempt determination, expedited review procedures, or full board review
- This determination will also include the category of exemption or expedited review, if applicable
- A risk/benefit analysis of the research to the participants and whether the project posed any risks of harm to the subjects and how those risks (if any) were mitigated by the researcher
- Whether there was any coercion or undue influence to the participants
- Following review and assessment, the IRB may require corrective actions (as described above) and issue a letter of determination to the investigator
- The IRB chairs and/or Research Integrity Officer will follow up on any corrective actions required by the IRB.