Institutional Review Board Guideline

Approved by: President's Cabinet

Original Date Effective: 2023-08-23

Last Modified: 2023-08-23

Introduction

The primary purpose of the Jackson State Community College Institutional Review Board is to protect the rights and welfare of human subjects used in research.

All research involving human subjects conducted at or sponsored by JSCC will adhere to Federal, Tennessee Board of Regents (TBR), and JSCC policy and guidelines (See TBR Policy 2:08:00:00).

Anyone conducting or responsible for human subject’s research must adhere to JSCC Institutional Review Board (IRB) policy. The JSCC IRB will recommend approval or disapproval to the College’s President. The President will make the final decision regarding research.

The IRB requires all researchers to provide proof of training in conducting human subjects research. This training may be done at another educational institution. Researchers may also use the National Institute of Health training on the IRB’s website. All researchers' training must be renewed annually.

Anyone conducting or responsible for research involving human subjects must adhere to the three (3) principles outlined in the Belmont Report: Respect for Persons, Beneficence, and Justice.

The decision of human subjects to participate in research at or sponsored by JSCC must meet informed consent standards. An individual’s decision to participate must be:

Voluntary, occurring due to free choice and without compulsion or obligation.
Based on full disclosure of the information needed to make an informed decision about whether or not to participate.
Based on the subject’s comprehension of the information provided.

The Jackson State Community College Institutional Review Board reserves the right to change the review determination or to discontinue the study at any point during the research review and procedures. The IRB also reserves the right to request additional information from the Principal Investigator (PI) during the research process.

This policy is adapted from and aligned with the Tennessee Board of Regents Policy A-110 entitled “Procedures for the Tennessee Board of Regents Institutional Review Board” (https://policies.tbr.edu/guidelines/institutional-review-research).

Need

A. The need for a Jackson State Community College (JSCC) Institutional Review Board (IRB), hereinafter referred to as “JSCC IRB,” is recognized as essential for Jackson State Community, if applicable, for research involving human subjects conducted, supported, or otherwise subject to regulation by any federal department or agency making these procedures applicable to such research. Researchers must be professional and adhere to their disciplinary ethical codes and those codes that govern research in general, i.e., the principles outlined in the Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research, 1979) and the U.S. Department of Health and Human Services (HHS) regulations (45 CFR Part 46 Subpart A, also known as “the Common Rule”).

B. The JSCC IRB may be used for research involving human subjects in educational and social science-based research when conducted:

1. By employees or associates of Jackson State Community College, including research conducted under a federal or state grant

2. By researchers affiliated with institutions or agencies without an IRB

3. Where otherwise required to comply with federal or state law.

All researchers and applicants will follow all procedures outlined below unless there is a conflict with the applicable federal regulations, in which case the federal regulations will govern. These procedures are designed to provide the JSCC IRB with a single source to review in most situations, but an occasional review of the federal regulations may be required.

Human Subjects Research to be Reviewed by the JSCC IRB

A. Anyone proposing research involving human subjects for the purposes specified in section II.B. must apply to the JSCC IRB before recruiting subjects or collecting data. If research is undertaken without the intention of involving human subjects, but it is later proposed to involve human subjects, the research shall first be reviewed and approved by the JSCC IRB.

B. In keeping with the HHS definitions in Title 45, Code of Federal Regulations (CFR) Part 46, 45 CFR 46.102, for these procedures:

1. Research is a systematic investigation designed to develop or contribute to generalizable knowledge, including research development, testing, and evaluation. Activities that meet this definition constitute research for purposes of these procedures, whether or not they are conducted or supported under a program that is considered research for other purposes. For example, some demonstration and service programs may include research activities.
2. A human subject is a living individual about whom an investigator conducting research (a) obtains information or biospecimens through intervention or interaction with the individual and uses studies, or analyzes the information or biospecimens; or (b) obtains, uses, studies, analyzes, or generates identifiable private information or identifiable biospecimens.
3. Intervention includes physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject's environment performed for research purposes.
4. Interaction includes communication or interpersonal contact between investigator and subject.
5. Private information includes information about behavior that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place and information that has been provided for specific purposes by an individual and that the individual can reasonably expect will not be made public (for example, a medical record).

C. In accordance with 45 CFR 46.108(a)(3) and (4), the JSCC IRB establishes these written procedures for:

1. Conducting its initial and continuing review of research and reporting its findings and actions to the investigator and the JSCC President
2. Determining which projects require review more often than annually and which projects need verification from sources other than the investigators that no material changes have occurred since the previous JSCC IRB review
3. Ensuring prompt reporting to the JSCC IRB of proposed changes in research activity and ensuring that investigators will conduct the research activity in accordance with the terms of the JSCC IRB approval until any proposed changes have been reviewed and approved by the JSCC IRB, except when necessary to eliminate apparent immediate hazards to the subjects
4. Ensuring prompt reporting to the JSCC IRB of:
  1. Any unanticipated problems involving risks to the subjects or others or any serious or continuing noncompliance with these procedures or the requirements or determinations of the JSCC IRB
  2. Any suspension or termination of JSCC IRB approval

D. Additional guidelines concerning human subjects:

- If persons involved cannot legally give consent but are capable of assent, their assent to participate must be solicited in addition to the permission of a parent or legal guardian. (Example: A student under 18 must give assent to participate in a study and obtain a parent’s signature on the Informed Consent form.)
- The selection of research subjects must be fair. Subjects should not be selected for potentially beneficial research based on favoritism, nor should risky research be targeted to vulnerable subjects.
- The procedures for recruiting participants must protect their privacy and be reasonable in terms of their condition or circumstances. No coercion should be used to obtain or maintain cooperation.
- Any payment made to subjects should not be so large as to constitute excessive inducement for participation.
- When access to subjects is gained through cooperating institutions or individuals, prior commitments made to the subjects about the confidentiality or other terms of the primary relationship should not be bridged.
- Risks to subjects must be minimized and justified by the anticipated benefits to the subject or society.
- Adequate provision must be made to protect subjects’ privacy and maintain the confidentiality of identifiable information. (See TBR Policy 5:01:00:10, Policy 3:02:03:00, and TBR Guideline S-020 concerning privacy and protection of records for personnel and students.)
- Approval for conducting research concerning human subjects must be obtained before collecting any data.
- Any research requests that involve animal testing of any kind will be immediately disapproved of.
- Any research requests that involve participants to release confidential information as defined by TBR will be immediately disapproved. (TBR keeps confidential the following information about students, personnel, and immediate family members or household members of personnel: home telephone and personal cell phone numbers, bank account information, social security number, driver’s license number, and residential information. TBR Policy 5:01:00:10)
- Any research requests in which the subjects do not give full consent or volunteer without coercion will be immediately disapproved.

Institutional Authority

All complaints, unexpected problems, risks, or adverse events must be reported to the IRB Chair immediately. This information must also be documented in writing and turned in to the IRB.
Any changes or additions to the original research methods, procedures, or purpose must be submitted in writing to the IRB for approval before implementation.
Any change of researchers (primary or secondary) should be reported to the IRB immediately. Any new researcher must submit information (found on the IRB application) to the IRB before he/she begins to collect information.
The JSCC IRB reserves the right to change the review determination or to suspend or discontinue the study at any point during the research review and procedures. The IRB also reserves the right to request additional information from the Principal Investigator during the research process.

IRB Membership

The JSCC IRB is a board tasked by the JSCC President with rendering decisions, rather than recommendations, about permission to conduct research within JSCC as specified in section I.b. and to review and conduct the periodic monitoring of such research involving human subjects. The JSCC IRB assumes the responsibility for protecting the rights of human subjects.

The membership should consist of at least five diverse members, with one being from a scientific background, one nonscientific, and one member that is not associated with the college. This person cannot be a student or a member of any school board or be of immediate relation to any person associated with the college. The other members must be from various areas of the institution and have the professional capacity to review IRB requests and make decisions based on internal, state, federal, and agency policies. The Standing Chair will be the person who holds the position of Director of Institutional Research and Accountability.

Status Category

The Institutional Review Board (IRB), not the investigator, shall determine as to whether a project is or is not exempt. Internal research conducted by JSCC staff, faculty, or students may be given an internal exemption. Final permissions regarding research will be given by the College’s President.

The IRB Chair or Designee does the initial screening. The IRB Chair or Designee may deem the request exempt (and it is sent directly to the President for final determination), conduct an expedited review, send the application and materials for full review by the Board, or may deem the application incomplete and request further information from the applicant.

The IRB Chair or Designee cannot “disapprove” of a project protocol but may table action pending further information/clarifications. The IRB Chair or Designee will inform the PI of its actions. The IRB must resolve any disagreement between the PI and the IRB Chair or Designee. The PI will be notified officially of the IRB decision by the JSCC IRB Chair.

If the IRB Chair or Designee receives guidance from the Tennessee Board of Regents concerning research requests that are system-wide in nature, the request will be forwarded to the President for review. The President may ask the Chair/Designee to decline the request or send it back for IRB review/approval/rejection.

A. Exempt

EXEMPT from Review: To be classified as Exempt from Review, the research project must involve no more than minimal risk to the subject and must satisfy one or more of the following criteria:

Research conducted in established or commonly accepted educational settings that specifically involves everyday educational practices that are not likely to adversely impact students' opportunity to learn required educational content or the assessment of educators who provide instruction. This includes most research on regular and special education instructional strategies and research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods [45 CFR 46.104(d)(1)]
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. 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.
  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 the JSCC IRB conducts a limited IRB review to make the determination required by 45 CFR 46.111(a)(7), which is that there must be adequate provisions for protecting privacy and maintaining confidentiality. [45 CFR 46.104(d)(2)

C. 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. 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
  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 required by 45 CFR 46.111(a)(7)
  4. For these procedures, benign behavioral interventions are defined as being brief, 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
  5. 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. [45 CFR 46.104(d)(3)]

D. Secondary research for which consent is not required: Secondary research uses identifiable private information or identifiable biospecimens if at least one of the following criteria is met:

1. 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 regulated under 45 CFR parts 160 and 164, subparts A and E, for “health care operations” or “research” as those terms are defined at 45 CFR 164.501 or for “public health activities and purposes” as described under 45 CFR 164.512(b)
  4. The research is conducted by, or on behalf of, a Federal department or agency using government-generated or government-collected information obtained for nonresearching 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. [45 CFR 46.104(d)(4)]

B. Expedited

EXPEDITED Review: A project that does not qualify for Exemption from Review may be classified for Expedited Review by the JSCC IRB if it meets one or more of the following criteria for Expedited Review established by federal guidelines:

1. 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 JSCC IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed 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.
2. The categories in this list apply regardless of the age of subjects, except as noted.
3. 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 more significant than minimal.
4. The expedited review procedure may not be used for classified human subjects research.
5. Relevant research categories that pertain to both initial and continuing JSCC IRB review, unless the reviewer determines there is more than minimal risk:
  1. 1. 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: Some research in this category may be exempt from the HHS regulations for protecting human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
    2. Data collection from voice, video, digital, or image recordings made for research purposes. (NOTE: Some research in this category may be exempt from the HHS regulations for protecting human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)
    3. 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 protecting human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)
    4. Continuing review of research previously approved by the convened IRB as follows:

where (i) the research is permanently closed to the enrollment of new subjects;

(ii) all subjects have completed all research-related interventions; and

(iii) the research remains active only for long-term follow-up of subjects; or

1. 1. 1. 1. where no subjects have been enrolled and no additional risks have been identified; or
        
        where the remaining research activities are limited to data analysis.

iv. Continuing review of research where categories one (1) through four (4) does not apply, but the JSCC IRB has determined and documented at a convened meeting that research involves no more significant than minimal risk and no additional risks have been identified.

C. Full Board Review

FULL BOARD REVIEW: Any research project which does not satisfy the criteria for Exemption or Expedited Review must undergo Full Board Review.

Informed Consent

General requirements for informed consent. All participants in the research must be provided with the information listed below, and the Principal Investigators and Co-Principal Investigators must obtain legally effective informed consent from each participant or consent from a legally authorized representative for the participant before involving a human subject in research covered by these procedures.

- Consent can only be received after the potential subject or subject representative has had sufficient time to consider whether or not to participate in the study.
- The information about the study must be provided in language understandable to the participant or legally authorized representative.
- Informed consent must begin with a concise and focused presentation of the key information that is likely to assist a prospective subject or legally authorized representative in understanding why one might or might not want to participate in the research. This part of the informed consent must be organized and presented in a way that facilitates comprehension.
- Informed consent as a whole must present information in sufficient detail relating to the research and must be organized and presented in a way that does not merely provide lists of isolated facts but rather facilitates the prospective subject’s or legally authorized representative’s understanding of the reasons why one might or might not want to participate.
- An informed consent form or information sheet will not state that the participant waives her/his legal rights or releases the Principal Investigators, Co-Principal Investigators, or any sponsors, institutions, or organizations from liability for negligence.

Basic elements of informed consent. An Informed Consent Form should include the following elements.

- - A statement that the study involves research
  - An explanation of the purposes of the research
  - The expected duration of the subject’s participation
  - A description of the procedures to be followed
  - Identification of any experimental procedures
  - A description of any reasonably foreseeable risks or discomforts to the subject
  - A description of any benefits to the subject or to others that may reasonably be expected from the research
  - A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  - A statement addressing anonymity in the reporting of the findings;
  - For research involving more than minimal risk, an explanation as to whether any compensation, and an explanation as to whether any medical treatments are available, if injury occurs and, if so, what they consist of, or where further information may be obtained;
  - 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;
  - 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 the subject is otherwise entitled
  - The approximate number of subjects involved in the study
  - A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject, if applicable
  - Identification of any experimental procedures, if applicable
  - Any additional costs to the subject that may result from participation in the research, if applicable
  - Anticipated circumstances under which the subject's participation may be terminated by the investigator without regard to the subject's consent, if applicable
  - 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, if applicable
  - The consequences of a subject's decision to withdraw from the research and procedures for orderly termination of participation by the subject, if applicable
  - 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, if applicable
  - Any additional information the JSCC IRB believes will be helpful to the participants

Types of informed consent. Unless the JSCC IRB waives the requirement for an investigator to obtain a signed informed consent form for the reasons as set out in these procedures, informed consent shall be documented by the use of a written informed consent form approved by the IRB and signed (including in an electronic format) by the subject or the subject’s legally authorized representative. A written copy (including in an electronic format) shall be given to the person signing the informed consent form. The consent form may be either of the following:

1. 1. Written Consent: A written consent document that embodies the elements of informed consent required by §46.116. This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigators should give either the subject or the representative adequate opportunity to read it before it is signed.
  2. Oral Consent: A short-form written consent document stating that the elements of informed consent required by §46.116 have been presented orally to the subject or the subject's legally authorized representative. When this method is used, there shall be a witness to the oral presentation. Also, the JSCC IRB shall approve a written summary of what is to be said to the subject or the representative. Only the short form must be signed by the subject or the representative. However, the witness shall sign both the short form and a copy of the summary, and the person obtaining consent shall sign a copy. A copy of the summary shall be given to the subject or the representative, in addition to a copy of the short form.

Waiver of requirement for signed informed consent form. The JSCC IRB can waive the requirement for the investigators to obtain a signed consent form for some or all subjects if it finds either:

1. 1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject (or legally authorized representative) will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
  2. The research presents minimal risk of harm to subjects and involves no procedures for which written consent is usually required outside the research context. In cases where the documentation requirement is waived, the JSCC IRB may require the investigators to provide subjects with a written statement regarding the research.

Procedures for JSCC IRB

To approve research covered by these procedures, the JSCC IRB shall determine that all of the following requirements are satisfied:
1. Risks to subjects are minimized:
  1. By using procedures that are consistent with sound research design and that do not unnecessarily expose subjects to risk, and
  2. Whenever appropriate and if applicable, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
2. Risks to subjects are reasonable in relation to anticipated benefits, if any, to subjects and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the JSCC IRB should consider only those risks and benefits that may result from the research (as distinguished from the risks and benefits of therapies subjects would receive even if not participating). The JSCC IRB should not consider possible long-range effects of applying knowledge gained in the research (e.g., the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility.
3. Selection of subjects is equitable. In making this assessment, the JSCC IRB should consider the purposes of the research and the setting in which the research will be conducted. The JSCC IRB should be particularly cognizant of the special research problems involving subjects vulnerable to coercion or undue influence, such as children, prisoners, individuals with impaired decision-making capacity, or economically or educationally disadvantaged persons.
4. Informed consent will be sought from each prospective subject or the subject's legally authorized representative in accordance with, and to the extent required by, these procedures.
5. Informed consent will be appropriately documented or waived per these procedures.
6. When appropriate, the research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
7. When appropriate, there are adequate provisions to protect subjects' privacy and maintain data confidentiality.
The JSCC IRB, or JSCC IRB members designated by the JSCC IRB Chair, will determine the level of IRB review required for submitted research proposals (e.g., “exempt,” “expedited,” or “full” IRB review).
No research covered by these procedures can begin until it has been formally approved by the JSCC IRB. Except when an expedited review procedure is used, the JSCC IRB must review proposed research at convened meetings at which a majority of the members of the JSCC IRB are present, including at least one member whose primary concerns are in nonscientific areas. A majority of those present at the meeting must approve the research.
Upon approval, only Principal Investigators and Co-Principal Investigators will be authorized to participate in the research process, access the participants and data collected, and disseminate any of the study’s findings.
Review Documentation Procedures:
1. An “exempt” review requires the completion of Form A, Attachment to Form A, Form C, a copy of the interview protocol or survey, a copy of the Informed Consent Form, and any letter(s) of permission to research as needed. The complete application will be submitted to the JSCC IRB Chair for review. If the JSCC IRB Chair, or designated JSCC IRB member, determines that the complete application meets the criteria for exemption, will forward it to the JSCC President, and upon President’s review and approval, the applicant will be notified of the approval as well as provided with a copy of the approved application.
2. An “expedited” review requires the completion of Form A, Form B, and Form C, a copy of the interview protocol or survey, a copy of the Informed Consent Form, and evidence of a valid certificate of completion of Human Subjects Training. The complete application will be submitted to the JSCC IRB Chair for review. Upon receiving the application, the JSCC IRB Chair will confirm the completeness of the application and make a recommendation for expedited review. For applications recommended for expedited review, the JSCC IRB Chair will identify a subcommittee of three (3) members of the JSCC IRB to review and provide a recommendation to approve or not approve the application. The reviewers will have two weeks (14 business days) from receiving the application to provide a recommendation to the JSCC IRB Chair. The JSCC IRB Chair will forward the recommendation to the JSCC President based on the reviewers' recommendations. The JSCC President will have five (5) business days to review the recommendation and make the final determination. The JSCC IRB Chair will notify the applicant of the decision. If approved, the applicant will also receive a copy of the approved application with the signatures of the JSCC IRB Chair and the three IRB members who reviewed the application. If not approved, the JSCC IRB Chair will provide instructions and recommendations for revising the application.
3. A “full board” review requires the same application and submission process as an “expedited” review. Upon receiving the application, the JSCC IRB Chair will confirm the completeness of the application and make a recommendation for a full board review. A full board review requires all JSCC IRB members to review the application and provide a recommendation. The decision to approve the application requires a majority vote by the JSCC IRB members. Full board reviews can take a substantial amount of time to establish a decision; therefore, a specific timeline for a decision cannot be provided. If the application is approved, the applicant will also receive a copy of the approved application with the signatures of the JSCC IRB Chair and the IRB members who reviewed the application. If not approved, the JSCC IRB Chair will provide a rationale regarding the decision. If all JSCC IRB members are unavailable for the full board review, a quorum of IRB members, with at least one member with non-scientific interests, will review and vote on the application. A quorum is defined here as at least 51 percent of JSCC IRB members, including the JSCC IRB.
Decision Categories

1. Approval. The application meets all of the ethical standards for research involving human subjects. Upon written notification of approval, the research can begin.
2. Not Approve/Modify; Revise and Resubmit. The JSCC IRB Chair or a designated subcommittee has identified aspects of the application that require additional information, clarity, or revision. The applicants will be notified of the decision in writing, along with a list of requested modifications, revisions, and recommendations necessary to obtain approval.
3. Rejection. If, after review and discussion, the majority vote of the board decides to reject the application, the JSCC IRB Chair will provide the applicant with a detailed written explanation of the issues identified and a justification for the decision and will provide the investigator an opportunity to respond either in person or in writing, at the JSCC IRB’s discretion. Rejection reconsideration will be denied when the JSCC IRB determines that the issues identified could not be resolved through modifications or revisions.

7. The JSCC IRB Chair may solicit additional assistance in the case of complexity of problems or potential risk to participants for which the JSCC IRB Chair or members of the JSCC IRB itself desire additional expertise to decide. Individuals providing additional assistance may not vote with the JSCC IRB.

8. The JSCC IRB Meetings. The JSCC IRB will meet on an ad hoc basis. Meetings will be held virtually through email correspondence and/or video conferencing.

9. Approved applications are valid for a period of time to be at most twelve (12) months. The JSCC IRB shall conduct continuing review of research requiring JSCC IRB approval at intervals appropriate to the degree of risk, but not less than once per year. For an application requiring continuing review, the Principal Investigator must submit a written request to the JSCC IRB Chair for the renewal of the application, along with a copy of the approved JSCC IRB application. In the request, the Principal Investigator must outline any intended changes or modifications to the research project. If no changes are made to the original application, the Principal Investigator must state so in the request. A continuing review is subject to expedited review procedures, including only requiring approval of the JSCC IRB Chair if the criteria in Section VI.2.e.4 are met or unless the JSCC IRB Chair determines that additional review is warranted.

10. The JSCC IRB has the authority to suspend or terminate the approval of research that is not being conducted in accordance with the JSCC IRB’s requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval shall include a statement of the reasons for the JSCC IRB’s action and shall be reported promptly to the investigator, appropriate institutional officials, and the Secretary of Health and Human Services (or head of any other appropriate federal department or agency).

Researchers’ Responsibilities

Approved research lasting longer than twelve (12) months from the initial date of approval by the JSCC IRB must be resubmitted for the JSCC IRB approval.
Proposed changes to the research protocol must be forwarded to the JSCC IRB Chair, who will review them to determine if the proposed changes are substantive, thus requiring an additional review.
Unanticipated problems that pose subsequent risks to human subjects must be reported by the Principal Investigator to the JCC IRB Chair and the JSCC President. The Principal Investigator is responsible for retaining all documents about informed consent and adverse events for three (3) years.
Researchers should affirm that they have read The Belmont Report, the federal regulations for protecting research subjects, and the history and ethics of research with human participants. The JSCC IRB Chair or conditions of a grant may require that researchers complete training in the ethical conduct of research and compliance. The completion of sections 1 and 6 of the Online Research Ethics Course offered through the Office of Research Integrity at the Department of Health and Human Services (https://ori.hhs.gov/education/products/montana_round1/research_ethics.html) or Human Subject Research in Education and the Social Sciences training through the Collaborative Institutional Training Initiative (CITI) (https://about.citiprogram.org) or any other JSCC IRB-approved training will be accepted as verification of training in ethical conduct of research and compliance. The JSCC IRB Chair will make the final determination for educational compliance.
Researchers acknowledge that their primary responsibility is to safeguard the rights and welfare of each research subject and that the subject’s rights and welfare must take precedence over the goals and requirements of society and the research.
Researchers will obtain, document, and maintain records of informed consent from each subject or participant as required by the HHS and stipulated in the JSCC IRB procedures.
Researchers will not enroll subjects in research before the review and approval of the JSCC IRB.

Record Keeping

The Office of Institutional Research and Accountability will house electronic (and other, if applicable) documentation of JSCC IRB activities for at least ten (10) years after the research is completed.
The following records must be maintained:
1. copies of all research proposals reviewed; scientific evaluations, if any, that accompany the proposals; approved sample consent forms; progress reports submitted by investigators; and reports of injuries to subjects
2. minutes of the JSCC IRB meetings, which shall be in sufficient detail to show attendance at the meetings; actions taken by the JSCC IRB; the vote on those actions, including the number of members voting for, against, and abstaining; the basis for requiring changes in or disapproving research; and a written summary of the discussion of the controverted issues and their resolution
3. records of continuing review activities, including the rationale for conducting continuing review of research that otherwise would not require continuing review described in § 46.109(f)(1)
4. copies of all correspondence between the JSCC IRB and researchers, including emails
5. list of the JSCC IRB members, including degrees, areas they represent, relevant experience, and association with Jackson State Community College
6. the JSCC IRB procedures and forms and evidence of training completed by the researchers
7. statements of significant new findings provided to subjects, as required by § 46.116(c)(5)
the rationale for an expedited reviewer’s determination that research appearing on the expedited review list in these procedures is more than minimal risk
documentation specifies the responsibilities that an institution and an organization operating an IRB will undertake to ensure compliance with these procedures.

Complaints:

To file a complaint about a research project or an investigator, please contact the Office of Institutional Research and Accountability. The IRB might request a formal, written complaint based on the severity of the complaint.

Office of Institutional Research and Accountability Contact Information:

anelms@jscc.edu, atodd2@jscc.edu or research@jscc.edu

Phone: 731/425-2638 or 731/425-3520 Ext 50222.

TBR Guidelines and Policies pertaining to Privacy and Research:

Policy 3:02:03:00 Confidentiality of Student Records
Policy 5:01:00:10 Personnel Records
Policy 2:08:00:00 General Policies Regarding Research
Guideline S-020 Confidentiality of Student Records
Institutional Review for Research: A-110