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Institutional Review Board Procedures and Protocols

Types of IRB review and procedures for obtaining each status

Exempt Review

  1. Criteria for Exempt Status

Research is exempt from further IRB review if it entails no more than “minimal risk” and falls in one or more of the following categories. “Minimal risk” means 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.

Exempt research categories:

1. Educational Research

Research, conducted in established or commonly accepted educational settings that specifically involves normal educational practices. This exemption 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.

  1. The research is not likely to adversely impact students’ opportunity to learn required educational content.
  2. The research is not likely to adversely impact the assessment of educators who provide instruction.

2. Educational Tests, Surveys, Interviews, Observation

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:

  1. 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;
  2. 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
  3. 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.

3. Research involving benign behavioral interventions with adult subjects

  1. 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:
  1. 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;
  2. 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
  3. 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.
  1. 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.
  2. 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.

 4. Secondary 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:

  1. The identifiable private information or identifiable biospecimens are publicly available;
  2. 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;
  3. The research involves only information collection and analysis involving the investigator's use of identifiable health information when that use is for the purposes of “health care operations” or “research” or for “public health activities and purposes;” or
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for non-research 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.

5. Research on Behalf of the Government

a. 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.

b. 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.

6. Food Evaluations

Taste and food quality evaluation and consumer acceptance studies:

  1. If wholesome foods without additives are consumed, or
  2. 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.

7. Storage of Secondary Research

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.

8. Secondary Research with Broad Consent

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:

  1. Broad consent for the storage, maintenance, and secondary research use of the identifiable private information or identifiable biospecimens was obtained.
  2. Documentation of informed consent or waiver of documentation of consent was obtained.
  3. 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. 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.
  1. Procedures for Obtaining Exempt Status
  1. Principal investigators of all research that involves human subjects must submit a completed IRB application. The IRB form is accessible through the Office of Sponsored Programs & Research’s Portal site: “Forms and Policies – IRB” section.
  1. The IRB will review the completed IRB application and establish if the proposal is (1) Exempt from IRB review, (2) subject to an Expedited review, or (3) subject to a Full Board review. If exempt, the IRB will notify the principal investigator who can then begin the project.
  1. If the investigator needs to make any change in an approved protocol (e.g., change procedures), a new IRB application must be submitted for review. Prior to implementing any changes, the investigator must obtain IRB approval.

Expedited Review

  1. Criteria for Expedited Review Status

Research activities that (1) present no more than minimal risk to human subjects, and 2) involve only procedures listed in one or more of the following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects. The categories in this list apply regardless of the age of subjects, except as noted.

The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal.

The expedited review procedure may not be used for classified research involving human subjects.

Categories one (1) through seven (7) pertain to both initial and continuing IRB review.

  1. Expedited Research Categories
  1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
  1. 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.)
  2. 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.
  1. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
  1. from healthy, non-pregnant 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
  2. 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.
  1. 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.

  1. 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 subject’s 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.

  1. 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. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
  1. Collection of data from voice, video, digital, or image recordings made for research purposes.
  1. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
  1. Continuing review of research previously approved by the convened IRB as follows:
  1. 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
  2. where no subjects have been enrolled and no additional risks have been identified; or
  3. where the remaining research activities are limited to data analysis.
  1. 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.
  1. Procedures for Obtaining Expedited Review Status
  1. Principal investigators who believe their projects qualify for an Expedited Review should submit the completed IRB application to the Chairperson of the IRB. The IRB application form is accessible through the SU website – Office of Research & Development site’s “Forms and Policies” section.
  1. They should indicate which of the above categories applies to their research. Approval requires the consent of the chairperson and one other member of the IRB. If approval is granted, the Chairperson shall so designate, record, and give notice to the principal investigator within one (1) month. The investigator may not initiate the project until approval is granted.
  1. If the investigator needs to make any change in an approved protocol (e.g., change procedures), a new IRB application must be submitted for review. Prior to implementing any changes, the investigator must obtain IRB approval.
Full Board Review Status
  1. Criteria for Full Board Approval

All research projects not meeting the criteria for Exempted or Expedited Review must be reviewed by the full IRB. This is required when research involves more than minimal risk or the subjects come from special populations such as those with limited civil freedom, children (unless exempt from review), or subjects with limited mental capacity. Principal investigators should be advised that additional protections are mandated for other at-risk groups.

  1. Activities directed towards pregnant women (45 CFR 46-207)
  2. Activities directed towards fetuses (45 CFR 46.208-210)
  3. Activities directed towards prisoners as subjects (45 CFR 46.301)

Should your research include any of these groups, please read the listed CFR references before preparing and submitting your research application.

  1. Procedures for Obtaining Full Board Review
  1. Principal investigators who believe their projects require a Full Board Review should submit the completed IRB application to the Chairperson of the IRB.
  1. Approval requires the consent of a majority of the Board. If approval is granted, the chairperson shall so designate, record, and give notice to the principal investigator within one (1) month and the investigator may not initiate the project until approval is granted.
  1. If the investigator needs to make any change in an approved protocol (e.g., change procedures), a new IRB application must be submitted for review. Prior to implementing any changes, the investigator must obtain IRB approval.

Informed Consent

The principle of informed consent is central to ethical treatment of human subjects. Under most circumstances the principle of informed consent requires that (1) the subject’s participation in the research be entirely voluntary, and (2) subjects be given sufficient information about the research so that they can make a decision as to whether or not they wish to participate.

Written informed consent should be obtained from each subject who is legally, mentally, and physically able to provide it. Failure of a subject to express an unwillingness to participate does not constitute consent to participate in the project.

For subjects not able to provide informed consent themselves, written informed consent must be obtained from others (e.g., parents, guardians).

If the principal investigator requests a waiver of informed consent, the project is automatically excluded from Exempt status and must receive an Expedited or Full Board Review. The researcher must receive permission from the IRB or the chairperson and one other member (in the case of an Expedited review), if informed consent process is altered or waived.

The IRB may approve a consent procedure which alters some or all of the elements of informed consent or may waive the requirements of written informed consent altogether under the following circumstances:

  1. the research involves no more than minimal risk to the subjects, or
  2. the waiver or alteration will not adversely affect the rights and welfare of the subjects, or
  3. the research could not be practically carried out without the waiver or alteration, or
  4. in cases where the only record linking the subject and the research would be the consent document and the principle risk would be the potential harm resulting from a breach of confidentiality (in these cases, the subjects will be asked whether they want documentation linking themselves with the research; consent forms can be collected separately from the rest of the data), or
  5. in cases where the research presents only minimal risk of harm to the subjects and involves no procedures for which written consent is normally required outside the research context.
  6. In cases where signed, written informed consent is waived, the IRB may require the investigator to provide the subjects with a written statement regarding the purpose of the research.

Written Consent

A copy of the consent form must be included with the IRB application. Essential elements of a written consent form are provided below. A written consent form should include the elements below that are applicable, and it should relate to a specific study. It should not be a “standard” form. It must be written in simple language so as to be easily understood by persons with no medical or scientific background. Potential subjects must be given all information that might reasonably be expected to influence their willingness to participate. Provide two (2) copies of the consent form, one for the subject, parent, or guardian to sign and return, and the other for him/her to keep.

  1. Elements of the Consent Form

A consent form must include the following:

  1. A simple, descriptive title of the research project (optional);
  2. Name and telephone number of the principal investigator or faculty advisor;
  3. A statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject’s participation, a description of the procedures to be followed, and identification of any procedures which are experimental;
  4. A description of any reasonable foreseeable risks or discomforts to the subject;
  5. A description of any benefits to the subject or to others which may reasonably be expected from the research;
  6. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  7. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained;
  8. For research involving more than minimal risk, an explanation as to whether any compensation or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
  9. An explanation of whom to contact for answers to pertinent questions about the research and research subjects’ rights, and whom to contact in the event of a research-related injury to the subject;
  10. A statement that subjects may contact the Institutional Review Board at any time during this study, if they feel their rights have been violated;
  11. A statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which he or she is otherwise entitled;
  12. Signature of the subject indicating consent (signature of parent or legal guardian for subjects who cannot legally represent themselves);
  13. When appropriate, a simply worded consent form for children who can read and write should be prepared for their signature (this is in addition to the consent form signed by the parent or guardian; see following section for additional information about research with children).
  1. Additional Elements of Informed Consent

When appropriate, one or more of the following elements of information shall also be provided to each subject:

  1. A statement that the particular treatment or procedure may involve risks to the subject (or to the embryo or fetus, if the subject is or may become pregnant) which are currently unforeseeable;
  2. Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regard to the subject’s consent;
  3. Any additional costs to the subject that may result from participation in the research;
  4. The consequences of a subject’s decision to withdraw from the research and procedures for orderly termination of participation by the subject;
  5. A statement that significant new findings developed during the course of the research which may relate to the subject’s willingness to continue participation will be provided to the subject;
  6. The approximate number of subjects involved in the study.

NOTE: Stevenson University recommends that if video or audiotaping is part of the data gathering procedure, an additional statement be added to the effect: “This information may be used for multiple purposes (i.e., instruction) and will be archived for future use.”

  1. Children as Research Subjects
  1. Children (under 18 years in age) are permitted to be research subjects if:
  1. there is no greater than minimal risk, or
  2. an intervention or procedure holds out the prospect of direct benefit for the individual subject, or a monitoring procedure is likely to contribute to the subject’s well-being, or
  3. there is only a minor increase over minimal risk and the intervention or procedure is likely to yield generalizable knowledge about the subject’s disorder or condition which is of vital importance for the understanding or amelioration of the subject’s disorder or condition, and
  4. the intervention or procedure presents experiences to subjects that are reasonably commensurate with those inherent in their actual or expected medical, dental, psychological, social or educational situations.
  1. Consent by Parents or Guardians
  1. According to the federal regulations on the Protection of Subjects, for research falling under categories 1a and 1b above, the permission of one parent is sufficient.
  2. Permission from both parents is required for category 1c above unless one parent is deceased, unknown, incompetent or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
  3. The IRB requires parental consent to be written.
  1. Children’s Assent

In addition to parental permission, federal regulations require, in most instances, that a child who is sufficiently mature to comprehend his/her participation in the research project be offered the opportunity to give “Assent,” which means a child’s affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Under some circumstances, written assent may be appropriate but, generally, verbal assent will be sufficient. When a written form is used, it should contain a simple explanation of the research project, including possible benefits, risks and safeguards. A copy of the assent form should be included in the proposal. There is no requirement of securing a child’s assent if the research holds out a prospect of direct benefit that is important to the health or well-being of the child and is available only in the context of research.

Investigator Responsibilities

  1. General Responsibilities

The IRB requires that all investigators, whether faculty members, staff members, graduate students or undergraduate students, comply with both internal and federal regulations regarding the protection of human subjects and the appropriate administration of protocol activities. Researchers, in turn, have the responsibility of staying abreast of policies to remain within compliance. Failure to do so will result in the investigator losing his or her capability to perform as the individual responsible for the administration of the research protocol.

  1. Specific Responsibilities
  1. Investigators are responsible for completing the CITI Program training prior to initiating a new protocol or renewing an existing one.
  2. Investigators are responsible for ensuring that all research involving human subjects is submitted to and approved by the IRB prior to initiation of the research. Investigators have the primary responsibility for protecting the rights and welfare of human research subjects. In addition, they are expected to be knowledgeable about the requirements of the federal regulations and institutional policies and procedures for the protection of human subjects.
  3. Investigators are responsible for complying with all IRB policies, decisions, conditions, and requirements. Investigators are responsible for ensuring that the research is implemented as specified in the approved IRB protocol.
  4. Investigators are responsible for obtaining and documenting informed consent for each participant and providing a copy of the IRB-approved consent form to each subject, unless the IRB has specifically waived this requirement.
  5. Investigators are responsible for ensuring that assent from research participants who are minors (18 years of age and under) is obtained and documented.
  6. Investigators are responsible for reporting progress of approved research to the IRB, as often as and in the manner prescribed by the IRB, but no less than once per year.
  7. Investigators are responsible for promptly submitting to the IRB any modifications to a protocol or consent form of an approved protocol.
  8. Investigators are responsible for promptly reporting any injuries, adverse events, or other unanticipated problems involving risks to participants.
  9. Investigators are responsible for maintaining a protocol file that includes all correspondence between the IRB and principal investigator and retaining copies of signed consent forms. The files must include:
  1. All correspondence between the investigator and the IRB as well as any communications regarding the study from a sponsor.
  2. Copies of the signed Consent Form obtained from all participants or information as to where these documents can be found.
  3. Any data derived from the study.
  4. Progress reports.
  5. Reports of all adverse incidents and any follow-up to adverse incidents.
  6. Current contact point for the investigator (address and telephone number) should the investigator no longer be associated with SU.

Non-Compliance

  1. Minor Protocol Deviations
  1. Investigators are responsible for conducting human research with participants in compliance with federal regulations and SU policies and procedures. Failure to comply with these administrative regulations may result in the loss of an individual investigator’s ability to conduct research but can also affect the ability of all others at SU to perform human participant research. Non-compliance with regulations may be seen as protocol deviations.
  1. Deviations generally do not have substantive effects on the safety or well-being of research participants; do not affect the value of the data collected (meaning the violation does not confound the scientific analysis of the results); do not result from willful or knowing misconduct on the part of the investigator(s); and do not violate any ethical principles. Deviations are often caused by an investigator failing to communicate effectively with the IRB. When such instances are discovered, the IRB will act promptly to halt the research to ensure remedial action regarding compliance with federal and institutional human participant protection requirements.
  1. Common deviations in investigator compliance include:
  1. unreported changes in the IRB-approved protocol or consent documents.
  2. misuse or non-use of the IRB-approved informed consent documents.
  3. lapse in obtaining approval for continuing review.
  4. failure to obtain IRB approval prior to starting research activities.
  5. failure to file protocol modifications.
  1. Deviation Reporting Procedure
  1. Investigators can almost always avoid protocol deviations by being aware of the IRB requirements and following the approved protocol. If a protocol deviation does occur, an investigator must submit report to the IRB for review immediately upon discovery. This report will serve as the documentation for modifying the particular protocol; investigators must await IRB approval before implementing anticipated changes or modifications.
  1. Following the review of the report, the IRB chair will notify the investigator in writing of the need to meet to discuss the deviation and develop a plan to avoid such actions in the future. The results of the meeting will determine what must be done (if anything) to correct the conditions that lead to the deviation and what (if anything) must be communicated to the research participants. Participant enrollment may be suspended pending resolution of the problem or concern. The IRB chair will present a summary of the deviation, process, facts, and conclusions at the next scheduled convened IRB meeting.
  1. Protocol Violations
  1. Protocol violations emerge when there is a variance in a research study between the protocol that has been reviewed and approved by the IRB and the actual activities being performed. Reports may come from a variety of sources: participants, community members, research staff, etc.
  1. Reporting of violations will be made, in writing, to the IRB chair; all reports will be held in the strictest of confidence and discussed within the confines of the fact- finding committee.
  1. Examples of protocol violations:
  1. Modifications of protocols are unapproved by the IRB that caused substantive harm to research participants
  2. Modifications of protocols that cause damage to the scientific integrity of the data collected
  3. Modifications of protocols which result in willful or knowing misconduct on the part of the investigator
  4. Modifications of protocols that impact on ethical principles
  1. Investigative Procedure for IRB Protocol Violations
  1. Incidents of alleged or known protocol violations may be investigated by the IRB via the following steps:
  1. The IRB chair will create a fact finding committee, composed of:
  1. the IRB chair
  2. the designated Human Research Protections Administrator
  3. two or more representatives from the PI’s department or discipline, and
  4. a representative from the SU legal counsel.
  1. This committee will analyze all information gathered regarding the protocol violation and compare it to the approved protocol. When necessary, the committee will consult with experts in the specific discipline of research in order to make definitive, unbiased and educated decisions regarding the violation. A conclusion will then be made regarding the seriousness of the violation.
  1. If the hearing committee finds any of the protocol violations criteria noted above, the IRB chair will immediately suspend the protocol. The IRB chair may suspend the protocol in advance of the hearing if, in the chair’s assessment, the conditions in 45 CFR 46.113 have not been met and warrant an emergency protocol suspension). If suspension of the protocol results from harm to the enrolled research participants, the IRB chair will request that the PI’s department chair assign PI duties to another qualified person. In this situation, the official action will be the suspension of the investigator (45 CFR46.109[d]).
  1. Depending on the nature or the seriousness of the violation, the committee may elect to direct the IRB to audit all protocols that involve the investigator in question. If the findings of the hearing committee support research misconduct, the Executive Vice President for Academic Affairs/Provost will be notified. A summary of the violation, process, facts, and conclusions will be presented at the next scheduled IRB meeting. The IRB chair will notify the investigator in writing with copies to the PI’s department chair, the appropriate dean, and the Officer for Human Research Protections. If an investigator disagrees with the findings or requirements of the committee, investigators have the right to appeal the committee’s decision to the Executive Vice President for Academic Affairs/ Provost.

Protocol Audits

Stevenson University Audit Procedure

The Human Research Protections Office will examine the following items in the researcher’s protocol file:

  1. the use and retention of an IRB-approved consent form for all participants recruited for the research. A comparison will be made between the number of consent forms signed by participants that are maintained in the researcher’s protocol file with the actual number of participants recruited for the research;
  1. the use of the IRB-approved measures, surveys, questionnaires, etc. A comparison will be made of the forms used in the study with those retained in the Researcher’s protocol file;
  1. copies of protocol correspondence between the investigator and the IRB, including a copy of the investigator’s IRB training certificate;
  1. reports of all adverse incidents and any follow-up to adverse incidents; and
  1. the investigator’s data storage medium will be examined to determine if the appropriate measures are undertaken to ensure confidentiality and minimize risk to participants. Applicable items to be reviewed include the use of a secured location (lock and key system), an updated firewall or virus protection program and secure data tracking systems.
  1. Maintaining confidentiality of data sources is important while the study is active.
  2. Data should be stored in a secured location and identified by code numbers only. A master list must be kept in a separate location from the data, with only the investigator and his/her designee responsible for access to the data.
  3. If audio and video tapes have been used in the study, the recommended length of time for keeping tapes is three (3) years beyond the completion of the study. However, data from audio or video tapes should be transcribed as soon as possible; once accomplished, these tapes should be erased or destroyed.
  4. Signed consent forms and other relevant documents must be maintained and made available for review for at least five (5) years past completion of the research activity for adult subjects and, for minor subjects, at least three (3) years after reaching the age of 18, whichever is longer.
  5. The results of the audit must be kept in the investigator’s protocol file.

References:

Protection of Human Subjects. (2017), 45 C.F.R. § 46, effective 2018.

The Common Rule. (2017). Federal Register, 82(12), 7149-7274.

Approved May 2020
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