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The Institutional Review Board for the Protection of Human Participants

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270.809.2916

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328 Wells Hall, 糖心logo入口, 糖心logo入口, KY 42071-3318

Contents

  1. Preface

    1. Statement of Ethical Principles

    2. Mission

  2. 糖心logo入口 Policy on Human Subjects

  3. Definitions

  4. IRB Structure

  5. Time Needed for Review

  6. Types of IRB Review and Approval

    1. Activities Considered under the Exempt Category

    2. Activities Considered under the Expedited Category

    3. Activities Considered under the Full Review Category

    4. Continuing Activities

    5. Project Closure

    6. Special Regulations

    7. Changes to Proposed Research

  7. Initial IRB Review Process

  8. Procedure for Continuing Review of Projects

  9. Advertising for Human Participants

  10. Activities Involving Other Sites

  11. Internet Research

    1. Required Statement for Internet Research

  12. Conflict of Interest

  13. The Informed Consent Process

    1. Waivers to Obtaining Written Informed Consent

    2. Obtaining Oral Consent by Oral Presentation

    3. Alterations to the Informed Consent Process

    4. Categories of Participants Receiving Informed Consent

      1. Children

      2. Vulnerable and Special Populations

        1. Prisoners

        2. Cognitively Disabled

        3. Fetuses, pregnant women and in vitro fertilization

        4. Students

      3. Other Groups

    5. Notable Risk Projects

    6. Audiotapes

    7. Anonymous Questionnaires

    8. Focus Groups

  14. Retaining and Storing Signed Informed Consent Documents and Data

  15. Deceptive Research

  16. Requests for Student Information: The Buckley Amendment (FERPA)

  17. Research Done on the 糖心logo入口 State Campus by non-糖心logo入口 State Affiliated Personnel or Students

  18. Adverse Event

  19. Problems Reported to the IRB

  20. Misconduct in Human Participants Research

    1. Thesis Research

    2. Faculty, Staff and/or Student Research 鈥� Failure to Obtain IRB Approval

    3. Faculty, Staff, and/or Student Research 鈥� Deviation from Approved Protocol

  21. Reporting Requirement

  22. Examples

    1. SAMPLE Cover Letter

    2. SAMPLE Informed Consent Document

    3. Obtaining Informed Assent from Children and Minors

  23. Guidance for Researchers

    1. Inclusive Demographic Data Collection: Best Practices and Suggested Language

Section 1: Preface

1.1 Statement of Ethical Principles

糖心logo入口 is committed to excellence in teaching, research, and public service and to the conduct of these activities with the highest possible ethical standards. For activities involving humans, 糖心logo入口 is guided by the ethical principles as set forth in the Declaration of Helsinki, and the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research entitled The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research. In addition, the requirements set forth in Title 45, Part 46 of the Code of Federal Regulations will be followed for all applicable Department of Health and Human Services (DHHS) funded research and, except for the requirements for reporting information to DHHS, for all other activity without regard to source of funding.

1.2 Mission

The 糖心logo入口 State Institutional Review Board (IRB) reviews research protocol applications involving human subjects in order to ensure the rights of subjects are protected, including but not necessarily limited to ensuring that the research conforms to the Code of Federal Regulations.

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Section 2: 糖心logo入口 Policy on Human Subjects

Safeguarding the rights and welfare of humans in activities is a general institutional policy, with oversight delegated by the President through the Provost to the Institutional Review Board (IRB). Any research involving humans (including pilot studies) which originates at 糖心logo入口 State or is conducted with the assistance of personnel at 糖心logo入口 State University -- whether the investigator is a faculty member, staff member, student, or administrator -- is subject to review and approval by the IRB. Before the IRB will review any protocol, the principal investigator, and if the PI is a student the faculty mentor, must submit certification of current training in the protection of human subjects in research. This training may be done through a web-based training module, through attendance at a training session or in other ways approved by the IRB. (Researchers should contact the IRB Coordinator for more information and for a current list of approved training modules.) To submit an activity to the IRB, the investigator must file a protocol, or a description of the procedure(s) to be used to gather information from human participants. The IRB must approve the protocol prior to the collection of any data or information from the participants. In order to approve proposed protocols, the IRB shall determine that all of the following requirements are satisfied:

  1. Risks to humans are minimized by using procedures which are consistent with sound research design and which do not unnecessarily expose participants to risk, and whenever appropriate, by using procedures already being performed on the participants for diagnostic or treatment purposes.

  2. Risks to humans are reasonable in relation to anticipated benefits, if any, to participants, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB shall consider only those risks and benefits that may result from the activity (as distinguished from risks and benefits of interventions participants would receive even if not participating in the activity).

  3. Selection of participants is equitable. In making this assessment the IRB shall take into account the purposes of the activity and the setting in which the activity will be conducted.

  4. Informed consent will be sought from each prospective participant or the participant鈥檚 legally authorized representative, in accordance with, and to the extent required by .

  5. Informed consent will be appropriately documented, in accordance with, and to the extent required by .

  6. Where appropriate, the activity plan makes adequate provisions for monitoring the information collected to ensure safety of participants.

  7. Where appropriate, there are adequate provisions to protect the privacy of humans and to maintain the confidentiality of data. Where some or all of the participants are likely to be vulnerable to coercion or undue influence, such as persons with acute or severe physical or mental illness, or persons who are economically or educationally disadvantaged, appropriate additional safeguards will be included in the study to protect the rights and welfare of these participants.

Principles that assist the IRB in protecting the rights and welfare of humans include the following existing codes:

  1. The ; recommendations guiding physicians in clinical research adopted by the World Health Organization, 1964 (5th revision adopted October, 2000).

  2. adopted by the American Psychological Association (current version revised 2010).

  3. (current version revised January 15, 2009).

  4. (April 18, 1979)

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Section 3: Definitions

Assent: agreement by an individual not competent to give legally valid informed consent (e.g. a child or cognitively impaired person) to participate in research.

Children: persons who have not attained the legal age for consent to treatments or procedures involved in research, under the applicable law of the jurisdiction in which the research will be conducted. In Kentucky, the legal age is 18.

Faculty Mentor: for research conducted by students, the 糖心logo入口 faculty member who instructs the student investigator on appropriate research methodology, who ensures that the student investigator has the knowledge and skills necessary to complete the research, who commits to assisting the student investigator with development of the research protocol, and who accepts responsibility for the conduct of the activity, the supervision of participants, and the maintenance of informed consent documentation as required by the IRB. The faculty mentor must certify that the student(s) will conduct the study in an ethical manner that complies with all relevant 糖心logo入口 State policies and procedures.

IRB or Institutional Review Board: the IRB is an administrative body within 糖心logo入口, established by appointment from the Provost of the University, to protect the rights and welfare of human participants in research who are recruited to participate in research activities conducted under the auspices of 糖心logo入口.

IRB Approval: the determination of the IRB that the research has been reviewed and may be conducted at an institution within the constraints set forth by the IRB, the institution, and federal requirements.

Human Research: any systematic investigation using humans, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge (45 CFR 46.102(d)). All classroom activities that involve human subjects and that may be published, disseminated, or presented beyond the class must come before the IRB. The terms research and activity are used interchangeably in these guidelines.

Human Participants: living individual(s) about whom an investigator conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information (45 CFR 46.102(f)).

Informed Consent: a person鈥檚 voluntary agreement, based upon adequate knowledge and understanding of relevant information, to participate in research or to undergo a diagnostic, therapeutic, or preventive procedure. In giving informed consent, subjects may not waive or appear to waive any of their legal rights, or release or appear to release the investigator, the sponsor, the institution or agents thereof from liability for negligence (45 CFR 46.116; 21 CFR 50.20 and 50.25).

Minimal Risk: the probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

Permission: the agreement of parent(s) or guardian(s) to the participation of their child or ward in research.

Principal Investigator: the lead researcher, suitably qualified by education, training and experience to direct a particular well-defined protocol; the person who takes direct responsibility for the design of and completion of a research project. The Principal Investigator (PI) is directly accountable for protecting the dignity, rights, safety and well being of the research subjects and for ensuring the collection of high quality, accurate data that is obtained in accordance with IRB approval and university procedures and guidelines. The PI may enlist the assistance of other qualified personnel to help with data collection but s/he is ultimately responsible for the conduct of the research project.

Prisoner: any individual involuntarily confined or detained in a penal institution.

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Section 4: IRB Structure

The IRB consists of a minimum of five members with varying backgrounds to promote complete and adequate review of research activities commonly conducted by the institution. All appointments to the IRB shall be in accordance with 45 CFR 46.107 and same is incorporated here in as if copied word for word.

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Section 5: Time Needed For Review

The full IRB meets monthly during the academic year. Meeting dates for each semester are available at the beginning of each semester from the Office of Sponsored Programs. IRB applications (new or updated) for the full board (Level 3 review) must be submitted for review by the published due date prior to the scheduled board meeting for consideration by the Full Board Review process. The IRB鈥檚 disposition of the application is forwarded to the applicant within 1 to 2 weeks of the IRB meeting. Any required revisions must be submitted and approved by the IRB. The initial review will determine whether revisions need to go to the full Board or whether they may be reviewed by a subcommittee.

New or continuing projects considered under the Level 1 or 2 categories will be considered as they are received. Level 1 and 2 projects generally require 1-2 weeks for review and notification from the date of receipt. Any required revisions must be submitted and approved and are generally acted upon within 1 to 2 weeks.

The IRB cannot and will not review protocols for projects that are already in progress or that have been completed.

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Section 6: Types of IRB Review and Approval

It is the policy of 糖心logo入口 that the IRB will utilize Department of Health and Human Services (DHHS) criteria for all activities involving humans. According to DHHS, research can be categorized into three types of activities, and there are three types of review. The 糖心logo入口 IRB has affirmed the letter and spirit of the DHHS criteria by requiring that review of research from the DHHS Level 1 category be handled by the IRB Coordinator or the IRB Chair. For this level of review, the research must belong to one or more of the activities defined under Section 6.1 below. For activities to be considered for Level 2 review, the research must belong to one or more of the activities defined under Section 6.2 below or be a minor change to a previously approved protocol. Minor change is defined as a change that does not increase or alter the risks to the subject as determined during the initial approval process. An example would be a change to a data collection tool or the addition of a data collection process in which no additional procedures are required of the participant and the level of risk is not increased. Level 2 research is reviewed by a subcommittee of the IRB. Research that does not fall within the scope of the Level 1 or Level 2 categories must be reviewed by the full Board as a Level 3 study. The investigator is responsible for identifying the category s/he feels is appropriate. The IRB must concur with that selection. It is the researcher鈥檚 responsibility to contact the IRB Coordinator if help is needed in making this determination. Final determination of the correct category for a research activity will be made by the IRB.

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6.1 Activities Considered under the Level 1 Category

Activities involving no more than minimal risk to participants and in which the only involvement of humans will be in one or more of the following categories will be reviewed by the IRB as Level 1 application. This category does not apply to research involving prisoners, fetuses, pregnant women, or human in vitro fertilization. In order to establish an individual activity as Level 1, the principal investigator must complete the Application for Approval of Investigations Involving Human Participants. Final determination of the correct category for a research activity will be made by the IRB.

The following six categories of activities are to be considered within the Exempt review category process. The investigator must select one of the following activities that fits his/her research and submit an application for Exempt approval to the IRB for review.

  1. Activities conducted in established or commonly accepted educational settings, involving normal educational practices, such as 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.

  2. Activities involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey or interview procedures, or observation of public behavior unless:

    1. information obtained is recorded in such a manner that the human participants can be identified, directly or through identifiers linked to the participant; and

    2. any disclosure of the participant鈥檚 responses, if they became known outside the endeavor, could reasonably place a participant at risk of criminal or civil liability or be damaging to the participant鈥檚 financial standing, employability, or reputation.

    Research in Category that involves children cannot be considered Exempt unless such studies involve (a) educational tests (research with children that involves educational tests is Exempt), or (b) observation of public behavior when the investigator does not participate in the activities being observed.

  3. Activities involving the use of educational tests (cognitive, diagnostic, aptitude, or achievement), survey or interview procedures, or observation of public behavior that is not exempt under Category 2 of this section if:

    1. the participants are elected or appointed by public officials or candidates for public office, or

    2. federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

  4. Activities involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that participants cannot be identified, directly or through identifiers linked to the participants. Existing data is also defined as data that exist at the time the research is proposed or will exist in the future for non-research purposes.NOTE: Chart reviews conducted at covered entities may require HIPAA authorization or waiver.

  5. Research and demonstration projects which are conducted by or subject to the approval of Federal Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (a) public benefit or service programs; (b) procedures for obtaining benefits or services under those programs; (c) possible changes in or alternatives to those programs or procedures; or (d) possible changes in methods or levels of payment for benefits or services under those programs.

  6. Taste and food quality evaluation and consumer acceptance studies, (a) if wholesome foods without additives are consumed or (b) 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 of the Food Safety and Inspection Service of the U.S. Department of Agriculture.

For research that is not funded by a federal agency, the following categories of Level 1 review are also available for studies with no greater than minimal risk activities:

  1. Research that does not conform to a specific exempt category under 45 CFR 56:

  2. online surveys, in-person focus groups, and /or interviews involving minors as long as the information collected does not place the individual at greater than minimal risk

  3. behavioral games

  4. studies requiring performance of tasks that incur no risk

Research where activity is limited to study of existing or prospective identifiable data:

  1. medical record reviews where data is extracted from records

  2. data analysis of publicly accessible information already collected from court records

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6.2 Activities Considered under the Expedited Category

Activities involving no more than minimal risk to participants and in which the only involvement of humans will be in one or more of the following categories, will be reviewed by the IRB as a Expedited application. In order to establish an individual activity as Expedited, the principal investigator must complete the Application for Approval of Investigations Involving Human Participants. Final determination of the correct category for a research activity will be made by the IRB.

The following nine categories of activities are to be considered within the Expedited review category process. The investigator must select one of the following activities that fits his/her research and submit an application for Expedited approval to the IRB for review.

  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 () 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), or

    2. Research on medical devices for which (i) an investigational device exemption application () 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.

  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:

    1. 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

    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.

  3. 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 gum base or wax or by applying a dilute citric acid 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.

  4. 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鈥檚 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.

  5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis). NOTE: Such research conducted at covered entities may require HIPAA authorization or waiver.

  6. Collection of data from voice, video, digital, or image recordings made for research purposes.

  7. 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.

  8. 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.

  9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories one (1) through eight (8) under Level 2 review 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.

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6.3 Activities Considered under the Full Review Category

Any research or training project involving the use of humans which does not fall into the Exempt or Expedited Review categories must be submitted to the IRB for a Full Board evaluation. For new activities, the principal investigator must complete and submit the Application for Approval of Investigations Involving Human Participants. For continuing activities, investigators should use the Project Update and Closure Form.

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6.4 Continuing Activities

Exempt, Expedtied, and Full Review activities may only be approved for a maximum of a twelve-month period. Any such activities that continue beyond the approval period must be submitted to the IRB for continuing review. Federal regulations (45 CFR 46) require this review to occur on or before the approval end date of the previous IRB review. All activities that were submitted for IRB review, whether Exempt, Expedtied, and Full Review, must be reported on at least annually to the IRB until the research is completed. The IRB may require that a protocol be reviewed more often than annually if, for example, it determines that the research involves more than minimal risk or if there is concern that initial results of the research may change the risk/benefit analysis (45 CFR 46.103(b)(4)(ii)). Each year (or more frequently if required by the IRB) for the duration of the project, a Project Update and Closure form must be submitted to and processed by the IRB no later than the anniversary of the latest approval date. The Project Update and Closure Form must be processed in sufficient time for review and approval to occur. If ongoing research is not approved for continuation by the end of the approval period, then all data collection and subject recruitment must immediately stop and the entire protocol will need to be submitted as a new application for review. Failure to submit the Project Update and Closure Form within the stated time frame will result in the closure of the study due to noncompliance and the 糖心logo入口 State IRB will no longer accept responsibility for oversight of the research. Refer to Section 8 for additional information on continuing review of projects.

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6.5 Project Closure

When the research study has been completed, the Project Update and Closure form must be submitted to the IRB Coordinator. Failure to do so will result in the closure of the study due to noncompliance and the 糖心logo入口 State IRB will no longer accept responsibility for oversight of the research. The Project Update and Closure Form is due for review by the IRB by the closing date stated in the most recent approval letter.

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6.6 Special Regulations

Special regulations apply to activities involving fetuses, pregnant women, human in vitro fertilization, prisoners, and children. Any activities involving these populations may have specific regulations governing their conduct. Investigators should refer to the specific federal regulations () or contact the 糖心logo入口 State IRB Coordinator.

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6.7 Changes to Proposed Research

No changes may be made to an approved protocol without the prior approval of the IRB except when the change is necessary to eliminate immediate hazards to the participants (). If changes are required, the researcher must submit an Application for an Amendment to a Previously Approved Protocol form to the IRB and the change must be approved at the appropriate level before it may be implemented. Minor changes to a previously approved Full Review protocol may be reviewed by the IRB subcommittee. Minor change is defined as a change that does not increase or alter the risks to the subjects as determined during the initial approval process. An example would be a change to a data collection tool or the addition of a data collection process in which no additional procedures are required of the participant and the level of risk is not increased. In the case where change is necessary to eliminate immediate hazards to the participants, the researcher must notify the IRB immediately and submit the Application for an Amendment to a Previously Approved Protocol form within 3 calendar days of the change. The IRB will then review the change and make a decision on whether to allow the project to continue and whether further changes to the protocol are required to protect the rights and welfare of the subjects.

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Section 7: Initial IRB Review Process

  1. The principal investigator prepares the IRB application packet (protocol form and all relevant attachments) according to IRB guidelines and submits the following hard copies to the IRB Coordinator:

  • One original for Exempt Review

  • One original for Expedited Review

  • One original for Full Reivew Review.

The signed protocol form must be submitted as a pdf document and all attachments must be submitted as editable Word documents to msu.irb@murraystate.edu.

  1. The complete application packet is submitted to the IRB in the Office of Sponsored Programs by the published date prior to a scheduled IRB meeting for a Full Review or at any time during the academic year when classes are in session for a Exempt and Expedited Review. NOTE: The IRB office is closed during the summer and no applications will be reviewed during that time.

  2. The application is logged in and receives a unique identification number. The principal investigator (or faculty mentor if the PI is a student) is notified of the number and receipt of IRB application.

  3. A Technical Review is conducted to determine that the IRB application is complete and contains all required information and signatures as set forth in the application form. Incomplete application packets will be returned to the principal investigator with a memo stating deficiencies. Once corrected, the application may be resubmitted for review and will be reviewed under the schedule stated in Section 7.B.

  4. Complete IRB applications will be reviewed by the designated category on the application as follows:

    1. Exempt Review: the IRB Coordinator or IRB Chair reviews the project and makes a decision on the application. The decision by the IRB Coordinator or the IRB Chair to decline a Exempt protocol must be reviewed by the full Board. A summary of all projects accepted for Exempt review is recorded in the minutes of the IRB monthly meeting.

    2. Expedited Review: an IRB subcommittee reviews the project and makes a decision on the application. A list of all protocols is submitted to the full Board. A summary of all projects accepted for Expedited review is recorded in the minutes of the IRB monthly meeting. The decision by the subcommittee to decline a Expedited protocol must be reviewed by the full Board.

    3. Full Review: All IRB members review the application at the monthly IRB meeting. The principal investigator and/or the faculty mentor (if the principal investigator is a student) will be asked to be present to respond to IRB inquiries. In the case when IRB members are sponsors for a student application or are themselves an applicant or where there is a conflict of interest, those members may not vote on those applications.

  5. The IRB disposition of the application is forwarded to the applicant by the IRB Coordinator within one to two weeks following the IRB meeting. If the applicant is a student, communication will be sent only to the faculty mentor, who has the responsibility to transmit the IRB response to, and work with, the student. The final disposition of the protocol will also be reported to the University administration via the Provost鈥檚 office representative who serves as a non-voting ex officio member of the IRB. Review of all approved projects involving humans will be required at least annually by the IRB. A Project Update and Closure Form must be submitted for IRB review by no later than one week before the anniversary of the approval date given in the latest letter. Refer to Section 6.4 and Section 8 for a discussion of the continuing review process. When a project has been completed, the principal investigator must officially notify the IRB that the project has been closed by submitting a completed Project Update and Closure Form no later than one week before the anniversary of the approval date given in the latest letter. Refer to Section 6.5 for a discussion of project closure.

  6. Appeal of IRB Determination: If a protocol has been approved pending or if the vote on a protocol has been deferred, the Principal Investigator (PI) or faculty mentor if the PI is a student may submit a written request for reconsideration to the IRB Coordinator. The PI may also submit any additional information for review if desired. The Coordinator shall submit the written request for review along with additional information, if any, to the subcommittee which reviewed the protocol originally or if the original protocol was last reviewed by the full Board, to the full Board. If the subcommittee does not approve the protocol upon reconsideration, the PI or faculty mentor if the PI is a student may submit a written request for full Board review. In conjunction with a full Board review, the Coordinator or PI or faculty mentor may also submit a written request for a meeting between the full Board and the PI and/or faculty mentor if it is believed that such will enhance the approval process. The decision of the full Board will be final. Under no circumstances will a subcommittee be asked to meet with the PI and/or faculty mentor as this would be a breach of confidentiality for those members.

As required by Federal guidelines, there is no appeal process for a declined protocol. The IRB鈥檚 decision is final. The IRB will provide the investigator (or faculty mentor if the PI is a student) with a statement setting forth the reasons that the protocol was denied and providing the PI (or faculty mentor if the PI is a student) an opportunity to respond in person or in writing. If the PI chooses to do so, s/he may then make appropriate changes to the protocol and resubmit the project as a new protocol for IRB review.Under no circumstances may any entity of the University allow a protocol to be conducted when it has been declined by the IRB. However, the University administration may decline to allow a protocol approved by the IRB to be conducted if it is determined that this action is in the best interest of the University.

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Section 8: Procedure for Continuing Review of Projects

All research that has been approved by the IRB must be reviewed at least annually regardless of whether the research was classified as Exempt or Expedited or Full Review. NOTE: The IRB may require that a protocol be reviewed more often than annually if, for example, it determines that the research involves more than minimal risk or if there is concern that initial results of the research may change the risk/benefit analysis.

If the approved research activity or data analysis will continue beyond the end date as stated in the most recent approval letter, an application for continuing review of the project must be submitted to the IRB (using the Project Update and Closure Form) at least one week before the expiration date for Exempt or Expedited protocols or by the deadline for the next full Board meeting before the expiration date for Full Reivew protocols. The principal investigator should complete this application. If the investigator is a student, the student鈥檚 faculty sponsor must approve the application. The application for continuing review should be filled out on the IRB website and then saved and printed. One signed paper copy of the form must be submitted to the IRB for inclusion in the file and one pdf copy of the signed form and one copy of the attachments as Word files must be submitted to the IRB via email for dispersal to the appropriate reviewers. A Word file copy of the latest approved consent form or cover letter, if required for the research, must also be submitted for updating.

The IRB disposition of the application for continuing review is forwarded to the applicant by the IRB Coordinator within two weeks following the IRB meeting. If the applicant is a student, communication will be sent only to the faculty mentor, who has the responsibility to transmit the IRB response to, and work with, the student. NOTE: If the research approval expires before the application for Project Update and Closure is processed, the principal investigator and/or the faculty sponsor must resubmit the entire protocol for the review and approval process. Adverse events must be reported to the IRB in writing immediately following any such occurrence; reporting of such events cannot be delayed until application for continuing review. Continuing review is handled in the same manner as the initial IRB review. Refer to Section 7 for more information.

Failure to complete the Project Update and Closure Form in the stated time frame will result in the closure of the study due to noncompliance and the 糖心logo入口 State IRB will no longer accept any responsibility for oversight of the research. All subject recruitment and data collection on the study must stop immediately and cannot resume until the principal investigator has completed and submitted to the IRB a new Application for Approval of Investigations Involving Human Participants and that application has been reviewed and approved.

The IRB may choose to conduct targeted audits of studies to insure that no material changes have occurred since previous IRB review (45 CFR 46.103(b)(4)(ii)). In such cases, the IRB Coordinator will notify the Principal Investigator (or the faculty mentor if the PI is a student), by official letter of the upcoming audit and request that necessary records be made available for review. A report of the audit findings will be presented to the IRB at the next full Board meeting or sooner if deemed appropriate by the IRB Coordinator should the audit indicate the need to take immediate actions to address any issues that could affect the subjects鈥� informed choice to participate in the research.

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Section 9: Advertising for Human Participants

Advertising for prospective participants must receive prior approval of the IRB. Coercive statements or grossly liberal compensation must be avoided and risks and benefits must be mentioned.

Recruitment materials must include:

  1. Title of the study

  2. Name of the PI

  3. Clear statement that this is research

  4. Contact information for interested individuals

When appropriately worded, the following items should be included:

  1. Condition being studied and/or the purpose of the research

  2. Primary criteria that will be used to determine eligibility for the study

  3. Time or other commitment required of the subjects

  4. Location of the research

  5. Potential direct or societal benefits

Recruitment materials for studies involving remuneration cannot include emphasis on compensation (e.g., bold type, larger font, etc.)

Once approved by the IRB, recruitment material cannot be altered or manipulated in any way without subsequent IRB approval.

Recruitment using social media ads that are size limited (e.g Facebook, Twitter, etc.) must be linked to a page or document that contains all required recruitment elements.

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Section 10: Activities Involving Other Sites

Some research activities collect data from other sites or in collaboration with other organizations. In the instances when this occurs, the IRB must have a letter of approval from the cooperating institution(s). The approval letter must include the following items:

  • The individual giving approval is the person signing the letter and is in a position to authorize the commitments being made in the letter.

  • The letter must be on the cooperating institution's letterhead or must give the name and address of the institution in the body of the letter.

  • Any expectations by the cooperating institution as a result of the research must be itemized in the letter.

  • An indication of the understanding of the uses of the data collected, the data collection measures, and the handling of the data must be evident.

The IRB expects the permission letter to be included as part of the application. Research may not begin at a site until the investigator places a copy of the site permission letter on file with the IRB Coordinator.

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Section 11: Internet Research

Safeguarding the rights and welfare of humans in activities is a general Institutional policy, with oversight delegated by the President through the Provost to the Institutional Review Board (IRB). Any research involving humans that originates at 糖心logo入口 State University -- whether the investigator is a faculty member, staff member, student, or administrator -- is subject to review and approval by the IRB. This restriction applies to all activities that include the collection of data for research purposes, even when this collection occurs via the Internet. To submit an activity to the IRB, the investigator must use the Application for Approval of Investigations Involving Human Participants to file a protocol containing a description of the procedure(s) to be used to gather information from human participants. The IRB must then approve the protocol prior to the collection of any data or information from the participants. In order to use the programs provided by the Center for Teaching, Learning and Technology (CTLT) office which facilitate survey research, an applicant must provide CTLT with an approval statement from the IRB. Compliance with University regulations is a matter of professional ethics.

The use of the Internet as a medium for research continues to increase. While it provides many advantages, it can also complicate the process of human subjects protection. Research using electronic communication cannot be promoted as anonymous, even if attempts are made to secure the transmission of data. In addition to interception of data, there exists the possibility of spyware that can track keystrokes on computers and/or electronic surveillance of employee computer use. Please contact the IRB to discuss how to best handle the process of informed consent for internet research. In most cases, written documentation of informed consent can be waived, but it should be recognized that no guarantees can be made regarding the tracking or interception of subject responses by third parties.

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11.1 Required Statement for Internet Research

All consent statements for online survey research which involves sensitive information or for which disclosure of the participants鈥� responses could place them at any risk must include the following information:

All responses from online participants will be treated confidentially and stored on [state how stored (e.g., secure server, encrypted hard drive, encrypted file, unencrypted hard drive, etc.)]. However, we are unable to guarantee the security of the computer on which you choose to enter your responses. Information (or data) you enter, and websites you visit online can be tracked, captured, corrupted, lost, or otherwise misused.

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Section 12: Conflict of Interest

As a part of the informed consent process, a researcher is ethically responsible for notifying the IRB and potential research subjects of any possible conflict of interest. Conflict of interest may occur where 1) the researcher has a personal economic interest in the outcome of the study, 2) the researcher acts as an officer or a director of any outside entity that has financial interests in the outcome of the research study or 3) the researcher is recruiting potential subjects from persons over whom the investigator holds significant influence or power (i.e., students within the researcher鈥檚 own classroom, employees in the researcher鈥檚 workplace where the researcher is in a position of administration, etc.)

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Section 13: The Informed Consent Process

Every person (faculty, staff, student, or administrator) at 糖心logo入口 must obtain the informed consent of any participant. Obtaining the informed consent of participants is a matter of professional ethics in every discipline at the University. A sample consent document is included in these Procedures and Guidelines. The IRB strongly suggests that investigators use the sample as the structure for their consent forms.

The investigator must ensure that the circumstances under which consent is sought will provide the participants (or their representative) with sufficient opportunity to consider whether or not to participate. The circumstances must also minimize the possibility of coercion or undue influence that might be experienced by the participants. Many times the situation of the participants may be inherently coercive; i.e., their freedom of choice may be restricted by the nature of their employment, their age, associations with certain groups, or their mental or physical capacities. Restriction of freedom of choice may also occur due to confinement in a mental hospital or in a jail, penitentiary, or correctional institution. Participants in any of these categories are not excluded; rather, the investigator must make special efforts to ensure that potential participants are given every opportunity to exercise free choices in consenting to participate.

The consent document is not meant to be merely a legal record of the consent process, nor is it meant to be the only communication between the investigator and the prospective participant. On the contrary, the document should be one part of the total process. Broadly, the informed consent document communicates to the prospective participant:

  • purpose, procedures, risks and benefits of the activity

  • the participant鈥檚 rights in participating

  • the freedom to decline to participate without any jeopardy

  • contact information should the participant have questions about the conduct of the research pertaining to their rights as a participant

If applicable, the alternative treatments available will be explained. The individual will also be given the opportunity to obtain further information and answers to questions related to the study. The consent form should serve as a written summary of the exact information that was presented to the prospective participants before their agreement to participate in the study. As such, it will provide a useful reference for both the subject and the investigator. Participants agreeing to the study sign the consent form. If the consent form is multiple pages, participants must initial each page. Participants must be given a copy of the consent form to keep. It is the responsibility of the researcher to ensure that informed consent documents are written with vocabulary and a reading level comprehensible to the researcher鈥檚 target population.

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13.1 Waivers to Obtaining Written Informed Consent

Under certain circumstances, the use of written consent documents may be waived by the IRB. Requests for waiver must be fully justified by the investigator when submitting an application to the IRB. The IRB may waive the requirement for the investigator to obtain a signed consent form for some or all of the subjects if it finds either:

  1. The only record linking the participant and the activity would be the consent document and the principal risk would be the potential harm resulting from a breach of confidentiality.

  2. The activity presents no more than minimal risk of harm to participants and involves no procedures for which written consent is normally required outside of the activity context. This type of waiver applies especially to anonymous interviews (including face-to-face and telephone interviews) wherein the investigator鈥檚 sole knowledge of the identity of the interviewee would come from the consent document (45 CFR 46.117(c)).

Waiver of written consent procedures does not imply waiver of the investigator鈥檚 responsibility to obtain consent from the participant. In all cases, the investigator must provide the participant with a statement of the study that includes all relevant elements of informed consent. It is the recommendation of the 糖心logo入口 State IRB that, wherever practicable, when written documentation of consent is waived, a cover letter be submitted to participants which outlines the purpose and procedures of the project with a statement such as 鈥渃ompletion of the survey and/or return of the questionnaire indicates consent to participate in the study.鈥� A sample cover letter may be found at the end of this document.

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13.2 Obtaining Oral Consent by Oral Presentation

If oral presentation is necessary due to limited literacy or language comprehension, the participant or his/her legal representative will be asked to sign a short form stating that the basic consent form elements have been orally presented. Both the short consent form and the oral presentation must be approved by the IRB. It is the researcher鈥檚 responsibility to ensure that the language used in the short consent form and the oral presentation is comprehensible to the target population. A witness must also be present for this presentation and must sign both the short form and a written summary of the oral presentation as does the investigator. The participant or his/her legal representative must be furnished with a copy of both signed documents.

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13.3 Alterations to the Informed Consent Process

  1. The IRB may approve a procedure that does not include or that alters some or all of the elements of, or dispenses with, informed consent if the activity is to be conducted by or subject to the approval of state or local government officials and is designed for the purpose of studying, evaluating, or examining: a) federal, state, or local benefit of service programs that are not themselves research programs, b) procedures for obtaining benefits or services under these programs, c) possible changes in or alternatives to these programs or procedures, or d) possible changes in methods or levels of payment for benefits or services under those programs; and e) if the research could not be carried out practicably without the waiver or alteration (45 CFR 46.116(c)).

  2. The IRB may approve a procedure that does not include or that alters some or all of the elements of, or dispenses with, informed consent if: a) the activity involves no more than minimal risk to the participants; b) the waiver or alteration of normal consent procedures will not adversely affect the rights and welfare of the participants; c) the activity could not practicably be carried out without the waiver or alteration; and d) whenever appropriate, the participants will be provided with additional pertinent information after participation (45 CFR 46.116(d)).

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13.4 Categories of Participants Receiving Informed Consent

Except as otherwise determined by the IRB, every participant who is a physically and mentally able adult must provide consent to participate in the activity prior to the start of that activity. The ideas of mental and physical normalcy revolve around the ability of the participant to provide truly informed and voluntary consent. Variations from this norm may be a function of age or the circumstances of the participant.

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13.4.1 Children

Obtaining permission to conduct research involving children -- that is, persons under 18 years old -- requires special attention to the child鈥檚 age, his/her ability to understand what is asked of him/her, and his/her relationship to parents or guardians. In all cases, the investigator must demonstrate respect for the rights of the subject within the proposed consent procedures, which should be developmentally appropriate to the age and circumstances of the subject. Unless waived by the IRB, if the participant is a minor then written parental/guardian permission must first be obtained. A sample parental/guardian permission form is found in the Tips for Informed Consent Section. For children with parental permission, an assent form must be signed by those child participants capable of reading and understanding a simplified version of the permission form signed by the parent or guardian. The child's assent form must be separate from the parental permission form. As part of the IRB protocol application, the researcher must submit a copy of both the intended assent form and the parental permission form. For those participants who are too young to read an assent form, but who would be capable of understanding an oral explanation of the procedures, a copy of the oral explanation to be given must accompany the request for IRB approval, and be signed by the individual responsible for the oral explanation. The age, maturity, and psychological state of the participants must be taken into account by the principal investigator when creating an assent form or an oral presentation to obtain oral assent from such participants. Investigators should carefully review for additional specific requirements for permission by parents or guardians and for assent by children. View sample assent forms.

Parental Permission: Parental (or legal guardian) permission in writing is required for all minors, under the age of 18, who participate in research activity.

Adolescent鈥檚 Written Assent: A child鈥檚 written assent is needed (in addition to parental permission) when the child is considered old enough to read and comprehend a well-constructed assent form. However, the investigator should use supplementary verbal explanations wherever needed.

Child鈥檚 Assent: For children who can read but may not comprehend an assent form, the investigator should provide an explanation in a form the child can understand (in addition to parental permission). A conversational question-and-answer setting is often necessary to achieve this goal. In addition, the child鈥檚 assent should be positive, that is, not merely lacking in dissent. If the child is old enough to render a signature, investigators are required to obtain a signed assent form.

Very Young Children: For children who cannot read (e.g., infants, toddlers, or preschoolers) the investigator should give explanations that match the level of understanding. In many instances, the children鈥檚 nonresistant behavior may be interpreted as assent, but the investigator must use special care to discontinue the participation of children who appear to experience undue stress from the activities procedures. A verbal script must be submitted as part of the protocol.

Wards of the State: Children who are wards of the state may participate in activities only under very limited circumstances with the appointment of an advocate for the child for the duration of the activity.

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13.4.2 Vulnerable and Special Populations

Besides children, numerous other types of subjects require special attention when obtaining informed consent. In all cases, the guiding principle is respect for the rights of the potential participant. The contains an important section on the application of its standards to informed consent. Every investigator should carefully examine this material.

Among the types of participants for which the investigator should have special concern in obtaining informed consent are the following:

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13.4.2.1 Prisoners

Obtaining the informed consent of prisoners to participate in an activity requires attention to their circumstances. The activity should not provide the prisoners with advantages that would outweigh their ability to weigh the risks involved in the activity. Moreover, the consent form should make it clear to prisoners that participation will have no effect upon their parole or treatment. Investigators proposing research that involves prisoners should allow additional time for the review process in order that a prisoner representative can be included in the IRB review (as required by ).

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13.4.2.2 Cognitively Disabled

The use of patient advocates appointed or approved by the IRB is necessary to guard patient interests. For research involving adults who have been determined to have or are suspected of having a limited capacity to provide informed consent (which may include, but is not limited to, the elderly), a process for determining the competency of the research subject will be required. For research that meets the IRB standards for Exempt or Expedited, the IRB may allow competency to be determined by the researcher through a series of question and answer discussions with the potential research participant. However, for research that requires Full Review or for Exempt or Expedited research that the IRB determines involves a population in which competency to consent is of particular concern (e.g., including but not limited to nursing home residents, Alzheimer鈥檚 patients, elderly patients in a Veterans Administration hospital), and/or the nature of the study is believed to be such as to indicate that an independent investigation of competency is warranted, a qualified third party, such as a speech pathologist, physician or psychologist who is not a member of the research team, may be required to determine competency for informed consent.

It is the responsibility of the researcher to determine if a potential participant has been declared legally incompetent. If this has been done, permission to enroll the potential participant in a research study must be sought from the legal guardian.

In cases where a potential participant has not been declared legally incompetent but said person displays signs of incompetency, consent/assent must be obtained from that person (unless comatose or otherwise totally mentally incapacitated) and must also be obtained from the person(s) who normally make decisions concerning the care and well-being of the potential participant, such as next of kin, health care surrogate, if applicable, or person with Power of Attorney for such decisions. If after obtaining what was believed by the researcher at the time to be informed consent from the participant, information gleaned during the course of the research indicates an issue as to the individual鈥檚 mental capacity such that informed consent is not obtainable from the participant, the researcher must obtain consent from the person(s) who normally make decisions concerning the care and well-being of the potential participant, such as next of kin, health care surrogate, if applicable, or person with Power of Attorney for such decisions.

If the potential participant refuses his/her consent/assent, it is ethically unacceptable to enroll this person in a research study regardless of the consent of a care-giver, health care surrogate or person with Power of Attorney.

In any case wherein informed consent has been obtained from one other than the potential participant, a copy of the document indicating legal guardianship, Power of Attorney, health care surrogate, or other such documentation granting authority to the individual providing consent to make such decisions for the participant shall be retained by the researcher and placed in the research file.\

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13.4.2.3 Fetuses, pregnant women, and human in vitro fertilization

Regulations require for the conduct of activities involving fetuses, pregnant women, and human in vitro fertilization. Among the recommendations are systems for monitoring the acquisition of informed consent as well as other aspects of the activity.

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13.4.2.4 Students

Universities, and the association of investigators with them, provide investigators with a ready pool of research subjects: students. To protect students against coercion when research is conducted in the classroom setting, the 糖心logo入口 State IRB has determined that there must be a defined break between when the class period finishes and when the research begins. During the class time, the researcher and/or faculty member may announce that the study will take place, give potential subjects information about the study, including purpose and time commitment, and answer any questions that the potential participants might have. However, the research itself can only be conducted at the end of the class period. At the end of the class period, students must be given a short break (for example, 2-5 minutes) to allow uninterested persons time to leave. At the designated time, the researcher may return to the classroom to administer the study to those students who have voluntarily chosen to return/remain and to participate. (Please note: Faculty members may not specifically recruit members of their own classes to participate in their research projects unless special measures are taken to avoid coercion. Someone other than the faculty member must obtain the informed consent of the students if the faculty member intends to use his/her own students as research subjects and/or the identity of those who choose not to participate must be protected until such time as the teacher/student class relationship has been completed. The person who will invite the students to participate in the study must have certification of training in the protection of human subjects in research on file in the IRB office and must be identified on the protocol approval form. In all cases, the IRB will work with the researcher(s) to design a recruitment and informed consent process that provides adequate protection for participants in human subjects in research.)

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13.4.3 Other Groups

Other groups, such as the elderly, the economically disadvantaged, the very sick, and the institutionalized are described as vulnerable populations by the Belmont Report and are therefore provided similar protection when used as participants. (See Section 13.4.2 above.)

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13.5 Notable Risk Projects

When an activity involves greater than minimal risk, the participant needs a reasonable enumeration of the risks in order to decide whether or not to participate. The list should not be constructed either to minimize real risks or to overstate them. Projects with risks should also list protection measures used to lower the risk potential or to ensure safety while the subject encounters the risks. If a project presents one or more risks, an injury clause needs to be included in the consent document.

Although the regulations specifically mention only the preceding special categories of participants, the overall intent is clear. Whenever the potential participants of research have special features or circumstances that might alter their ability to render informed and voluntary consent to participate in activities, the investigator has special responsibilities. There is no way to anticipate every situation. Therefore, investigators must use extreme care to respect the rights of potential participants in developing the means of obtaining their informed consent. The IRB may choose to conduct targeted audits of studies to insure that no material changes have occurred since previous IRB review (45 CFR 46.103(b)(4)(ii)). In such cases, the IRB Coordinator will notify the researcher (or the faculty mentor if the researcher is a student) by official letter of the upcoming audit and request that necessary records be made available for review. A report of the audit findings will be presented to the IRB at the next full Board meeting or sooner if deemed appropriate by the IRB Coordinator should the audit indicate the need to take immediate actions to address any issues that could affect the subjects鈥� informed choice to participate in the research

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13.6 Audiotapes

Voice recordings are considered identifiable information; therefore, an investigator cannot promise anonymity to subjects participating in a project where they will be audiotaped. In addition to any signed consent documents, it is also recommended that the audiotape record both verbal permission of the participant and information advising the participant that his/her identity will be associated with the information he/she provides. Oral history and ethnography provide good examples of interview methods holding generally minimal risk but which also may make use of audiotapes that will not be erased at the conclusion of the immediate activity.

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13.7 Anonymous Questionnaires

Many types of survey research use anonymous questionnaires returned by mail or placed in drop-box locations. A participant is anonymous only if his/her identity remains individually unknown to the investigator. Where the identity is known but held secure from being known by others, the investigator is said to be maintaining the confidentiality of the identity. With anonymous questionnaires, the investigator may fulfill the requirements of informed consent by providing the participant with a cover letter or set of instructions that includes the following items, as applicable:

  • An explanation of the activity, its purpose and duration of participation time.

  • A statement indicating anonymity.

  • Indication that the return of the questionnaire will constitute the participant's consent to participate.

  • A statement of voluntariness must be included.

  • Contact information should the participant have questions about the conduct of the research or his/her rights as a participant.

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13.8 Focus Groups

Research using focus groups may fall into any of the three levels of review conducted by the IRB (i.e., Exempt, Expedited, Full Review). In all cases, it must be clear that each member of the focus group has been given adequate information on the project in order to make an informed decision on his/her choice to be part of the discussion. Because the very nature of the group setting does not allow for anonymity of responses in the focus group, if the topic to be discussed is sensitive or can in any way cause harm to the participants (including, but not limited to emotional harm or loss of reputation or standing in the community), it may be necessary to ask each participant to sign a certificate of confidentiality. If the meeting is to be audiotaped or videotaped, the guidelines under Section 13.6 must be followed.

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Section 14: Retaining and Storing Signed Informed Consent Documents and Data

Signed informed consent forms are legal documents, and the researcher has legal responsibilities in handling them. They should be stored in a secure location at 糖心logo入口 that is accessible to the University in the event that an inquiry should require an examination of them. The specific location (including room and building) of the documents must be explained in the IRB application. Data that can be linked to a subject should be treated in the same manner as a signed informed consent form. Access to these documents should be limited to those persons who have a need to know their contents, ordinarily the investigator (and co-investigators), a representative of the IRB (usually the Chair), the IRB Coordinator on behalf of the University, and authorized federal officials. In compliance with federal regulations consent documents must be retained for a period of three (3) years following the completion of the research. It is required that any parental permission and assent forms from minors are retained until one (1) year after the minor reaches legal age.

Consent documents become part of the IRB file of a project and, as such, are subject to Federal audit. Therefore, the IRB will review carefully both the content of and the storage provisions for all consent forms.

Data collected from subjects that cannot be linked to a subject do not require the same secured handling as those documents that contain identifying information or which could be linked to a particular individual. This type of data is not required to be stored in a locked location within 糖心logo入口, but the data shall be available for review and certification at any time during the period that the identifying information is held.

An investigator who leaves the University prior to the end of the three-year retention period for consent forms should notify the IRB of this fact, specifying the new location of the consent documents. If consent documents are maintained by a graduate student or research assistant during data collection, they must be turned over to the responsible faculty member after data collection is completed. A change of location within the University that results in a new storage place for consent forms must also be reported to the IRB.

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Section 15: Deceptive Research

Research activities that do not fully disclose the purpose of the research to the subjects are those that are said to be deceptive. Any deceptive research should be carefully weighed in terms of the justification for the need to deceive the subject and alternative methods for conducting the research that do not involve deception. The IRB will decide if the information being withheld from the subjects is an important element in the subject鈥檚 decision to participate. If the IRB decides that the information being withheld is an important element, then the research will not be approved. At a minimum, subjects must be informed in a consent form that full information is not being disclosed to them. Any research involving deception must involve a full debriefing.

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Section 16: Requests for Student Information: The Buckley Amendment(FERPA)

The (FERPA) more commonly known as the Buckley Amendment, deals with primary rights of students. Basically, these rights are 1) the students鈥� right to inspect and review educational records, 2) their right to seek to amend educational records and 3) their right to have some control of the disclosure of information from educational records. The FERPA officer on the 糖心logo入口 State campus must review any research using 糖心logo入口 State University student information before that research is submitted to the IRB for approval. A statement from the FERPA officer outlining precisely which information the researcher may obtain from the student records and how this information may be obtained must be submitted with the protocol for review by the IRB.

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Section 17: Research Performed on the 糖心logo入口 State Campus by non-糖心logo入口 State Affiliated Personnel or Students

The 糖心logo入口 State IRB has no control over research that is accomplished by off-campus (not affiliated with 糖心logo入口 State) researchers through direct collection of data from 糖心logo入口 State personnel or students. However, if a non-糖心logo入口 State researcher involves any 糖心logo入口 State personnel or students in the contacting of potential participants, gathering of data, or dissemination of forms, then the research must come before the 糖心logo入口 State IRB for approval. The IRB cautions subjects who choose to participate in research conducted by non-糖心logo入口 State affiliated researchers to be sure that the research meets all of the requirements of informed consent so that they can be certain that their rights as a research subject are protected.

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Section 18: Adverse Event

Federal Policy requires IRBs to have and follow written procedures for 鈥減rompt reporting to the IRB of any unanticipated problems involving risks to human subjects or others鈥� (). Investigators carry the responsibility for timely reporting of adverse events to the IRB to ensure that the IRB is cognizant of any new information that might affect its assessment of the benefit-to-risk ratio of research study participation and/or the adequacy of research protocol provisions for protecting the welfare of research subjects. To report an adverse event, the IRB investigator must complete the Adverse Event Form and submit it to the IRB Administrator as a signed pdf document, within three (3) calendar days of identifying the adverse event. The IRB Administrator will immediately share the information with the IRB Chair for review and consideration of next steps. A copy of the Adverse Event Form will be sent to the department head or office director of the investigator, to the 糖心logo入口 State Provost, and to the University General Counsel.

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Section 19: Problems Reported to the IRB

In the course of protecting human subjects involved in research, the IRB will respond to any problem or complaints raised directly or by third party reporting, to any member of the Board. When notified of a problem or complaint, the IRB Chair and IRB Coordinator will review the issue and determine appropriate action. If warranted, the 糖心logo入口 State General Counsel may be involved in the investigation and the research may be suspended. Targeted audits of the research may be undertaken if deemed appropriate by the IRB Chair and/or the majority of the IRB.

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Section 20: Misconduct in Human Participants Research

It is the ethical responsibility of all 糖心logo入口 personnel to obtain the approval of the IRB when undertaking any research which involves the use of human participants. Any desired changes to the protocol approved by the IRB shall be resubmitted to the IRB for approval. Moreover, it is unethical and a violation of the IRB鈥檚 policies and guidelines to deviate from the protocol as approved by the IRB in conducting research or to misrepresent information or omit any material information regarding a protocol. In the event that the IRB policies and guidelines are not adhered to and the research is completed, the following procedure has been approved by the Provost:

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20.1 Thesis Research

  1. Upon receipt by the IRB or any member of the IRB of an allegation that thesis research involving human participants has been conducted without IRB approval, the IRB shall issue a letter to the student and faculty sponsor notifying each of the allegation. The letter shall also contain notification of a meeting to be held by the IRB at a specified place, date, and time at which time the student and/or faculty sponsor shall be allowed to present any and all evidence supporting his/her position. The IRB will then render its decision within seven (7) working days of the meeting, setting forth its review of the evidence, findings, and determination. A copy of the IRB鈥檚 decision shall be sent to the faculty sponsor and the student. The IRB鈥檚 decision shall be final.

    1. If it is determined by the IRB that research involving human participants has occurred without prior IRB approval, a letter shall be forwarded to the coordinator of graduate programs indicating that upon presentation of the thesis to the coordinator of graduate programs for signature and approval, the graduate coordinator may sign a form which allows the student to graduate, but the University will not allow the thesis to be bound and placed in the library. If the IRB determination occurs subsequent to the placement of the thesis in the library, a letter shall be sent to the Graduate Admissions office requiring removal of the thesis from the library. Such notifications shall likewise indicate that use of this material in a future publication is unethical because prior approval from the IRB was not obtained as required in the 糖心logo入口 State Guidelines for the Preparation of the Master's Thesis. Both the student and faculty sponsor shall receive a copy of any such notification. If an infraction is found, a copy of the IRB determination shall also be sent to all members of the student鈥檚 thesis committee. If an infraction is found, the faculty sponsor shall also receive a separate letter requiring IRB training or retraining, as the IRB deems appropriate. A copy of the faculty sponsor鈥檚 letter and IRB determination shall be sent to the faculty sponsor鈥檚 department Chair (or Dean if the sponsor is also the department Chair).

  2. A second infraction of this rule by a faculty or staff member shall result in a letter from the IRB requiring additional IRB retraining. A copy of this letter shall be forwarded to the faculty member鈥檚 Chair, Collegiate Dean, and to the Provost. If a staff member, a copy shall be forwarded to the staff member鈥檚 supervisor. If a second infraction is found to have been committed by a faculty member, the board shall recommend to the Provost that s/he send a letter to the faculty member, the faculty member鈥檚 Chair, Collegiate Dean, and departmental graduate faculty recommending suspension of the faculty member from the graduate faculty and/or from supervision of student research for a time certain.

  3. Upon three (3) or more violations of this rule by a faculty sponsor the IRB shall institute an inquiry pursuant to 糖心logo入口鈥檚 Policies and Procedures to Deal with Misconduct in Research.

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20.2 Faculty, Staff, and/or Student Research 鈥� Failure to Obtain IRB Approval

  1. Upon receipt by the IRB or any member of the IRB of an allegation that research on human participants has been conducted by a faculty/staff member or by a student who is sponsored or otherwise supervised by a faculty/staff member without receiving approval from the IRB, the IRB shall issue a letter to the faculty/staff member and student, if applicable, notifying the faculty/staff member and student, if applicable, that an allegation has been made. The letter shall also contain notification of a meeting to be held by the IRB at a specified place, date, and time at which time the faculty/staff member and student, if applicable, shall be allowed to present any and all evidence supporting his/her position. The IRB will render its decision within seven (7) working days of the meeting, setting forth its review of the evidence, findings, and determination. A copy of the IRB鈥檚 decision shall be sent to the faculty/staff member and student, if applicable. The IRB鈥檚 determination shall be final.

    1. If it is determined by the IRB that research involving human participants has occurred without prior IRB approval then a letter shall also be sent to the faculty/staff member and to the student, if applicable, notifying each that no publication or presentation of the research materials or findings outside the classroom shall be allowed. The faculty/staff member shall be required to undergo IRB training or retraining, as the IRB deems appropriate. A copy of the faculty letter along with the IRB determination shall also be sent to the faculty member鈥檚 department Chair (or Dean, if the faculty member is also the department Chair) or the staff member鈥檚 supervisor.

  2. A second infraction of this rule by a faculty or staff member shall result in a letter from the IRB requiring additional IRB retraining. A copy of this letter shall be forwarded to the faculty member鈥檚 Chair, Collegiate Dean, and to the Provost. If a staff member, a copy shall be forwarded to the staff member鈥檚 supervisor. If a second infraction is found to have been committed by a faculty member, the board shall recommend to the Provost that s/he send a letter to the faculty member, the faculty member鈥檚 Chair, Collegiate Dean, and departmental graduate faculty recommending suspension of the faculty member from the graduate faculty and/or from supervision of student research for a time certain.

  3. Upon three (3) or more violations by a faculty or staff member, the IRB shall institute an inquiry pursuant to 糖心logo入口鈥檚 Policies and Procedures to Deal with Misconduct in Research.

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20.3 Faculty, Staff, and/or Student Research 鈥� Deviation from Approved Protocol

  1. Upon receipt by the IRB or any member of the IRB of an allegation that research on human participants has been conducted in a manner other than as specified in the protocol approved by the IRB, that any information included in the protocol, as approved, is incorrect or is such that material information has been omitted form the protocol, or that research has been conducted in such manner as to violate IRB procedures and guidelines and/or any recognized IRB policies, the IRB shall issue a letter to the faculty/staff member and student, if applicable, notifying the faculty/staff member and student, if applicable, that an allegation has been made. The letter shall also contain notification of a meeting to be held by the IRB at a specified place, date, and time at which time the faculty/staff member and student, if applicable, shall be allowed to present any and all evidence supporting his/her position. The IRB will render its decision within seven (7) working days of the meeting, setting forth its review of the evidence, findings, and determination. A copy of the IRB鈥檚 decision shall be sent to the faculty/staff member and student, if applicable. The IRB鈥檚 determination shall be final.

  2. If it is determined by the IRB that any part of a research project was conducted in a manner other than as specified in the approved protocol, that any information included in the protocol, as approved, is incorrect or is such that material information has been omitted form the protocol, or that research has been conducted in such manner as to violate IRB procedures and guidelines and/or any recognized IRB policies, the IRB shall issue a letter to the faculty/staff member and to the student, if applicable, notifying each of the IRB鈥檚 determination. The faculty/staff member shall be required to undergo IRB training or retraining as the IRB deems appropriate. Depending on the severity of the breach of protocol, potential penalties may also include, but are not limited to, a letter of reprimand, prohibition of publication or presentation of the research materials or findings outside the classroom, recommendation that the faculty member be suspended from the graduate faculty and/or from supervision of student research for a time certain, and/or institution of an inquiry pursuant to 糖心logo入口 State Policies and Procedures to Deal with Misconduct in Research. Should the IRB determine that the faculty/staff member is engaging in a pattern (three (3) or more) of deviating from approved protocols, providing inaccurate information to the IRB, omitting from protocols material information, or otherwise violating IRB procedures and guidelines and/or any recognized IRB policies, even if such deviations, inaccuracies, omissions, or violations are minor in nature, the IRB reserves the right to treat such pattern as a basis to pursue an inquiry under 糖心logo入口鈥檚 Policies and Procedures to Deal with Misconduct in Research. A copy of any determination by the IRB shall be forwarded to the faculty member鈥檚 department Chair (or Dean if the faculty member is also the department Chair) or the staff member鈥檚 supervisor. Should the IRB recommend that a faculty member be suspended from the graduate faculty and/or from supervision of student research, a copy shall also be forwarded to the Provost, Collegiate Dean, and departmental graduate faculty.

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Section 21: Reporting Requirement

The IRB Coordinator shall promptly report to the IRB, the Provost and the University General Counsel any unanticipated problems involving risks to subjects or others, any serious or continuing non-compliance, and any suspension or termination of IRB approval. As required by the federal regulations (45 CFR 46.103(b)(5)), the Office for Human Research Protections (OHRP) will be notified of such issues involving research studies that are funded by any agency of the Department of Health and Human Services as required in OHRP's and Other funding agencies will be notified as required in their guidance documents. If the report is the result of serious or continuing non-compliance, the IRB reserves the right to treat such as a basis to pursue an inquiry under 糖心logo入口鈥檚 Policies and Procedures to Deal with Misconduct in Research as outlined in section 20.3.2 above.

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Section 22: Examples

22.1 SAMPLE Cover Letter
(for online surveys or when a signed consent form is not required)

The following elements are required but should be presented in words and a format that the researcher is comfortable with and that are understandable to the research population.

Cover Letter/Online Survey Consent Template

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22.2 SAMPLE Informed Consent Document
(when a signed consent is needed)

(Note: This format is suggested by the IRB. This form is intended only as a guide.)

When using as a parental permission form, change "you" references to "your child" or similar wording.

Signed Consent/Parental Permission Template

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22.3 Obtaining Informed Assent from Children or Minors

Parents, legal guardians or a legally authorized official must sign a permission form permitting minors to participate in activities.

Children and minors who are able to understand the meaning of participation in research and who have parental/guardian permission are required to sign an "Assent" Form. The Assent Document for children or minors must be prepared with the same thoroughness as the Permission Document for adults.

The following are two samples of an Assent Form. Language must be simplified as appropriate for the age group used as participants.

(Note: This format is suggested by the IRB. This form is intended only as a guide. You must edit this to fit your particular situation.)

Minor Assent Template

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Section 23: Guidance for Researchers

23.1 鈥� Inclusive Demographic Data Collection: Best Practices and Suggested Language

In the interest of upholding the highest possible ethical standards for research activities involving human subjects at our institution, the 糖心logo入口 State IRB encourages all researchers to utilize the following Harvard ORARC guidance when deciding when and how to collect demographic data from participants:

These recommended practices, along with suggested language for demographic questions and additional links to training and resources are included on the

  1. In order to uphold the Belmont Report ethical principles of respect for persons (treating humans with respect), beneficence (do no harm), and justice (representative sample), researchers should give careful thought to the options provided to participants when collecting demographic data.

  2. Researchers must balance the protection of human subjects when including underrepresented populations - namely, minimizing risks to subjects vs. exploitation of vulnerable populations.

  1. Researchers should assess whether or not this information about participants is needed to accomplish the goals/aims of the study. If not, the researcher should consider not collecting it at all. If this data is needed, gender identity, sexual orientation, race, and ethnicity are four categories where inclusive options should be provided. See below for suggestions.

  2. Regardless of the specific options, consider the following when designing a survey/study:

    • Give the participant the option to skip, omit, and/or not respond to any question they do not wish to answer.

    • Do not force a response/choice on any demographic question.

    • Provide the option to select multiple responses, rather than one single choice, on demographic questions (e.g. 鈥渟elect all that apply鈥� vs. 鈥渟elect one鈥�). 

    • All human subjects research is required to include a consent process where participants are reminded participation is voluntary.

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