Institutional Review Board Documentation

Status Category

The Institutional Review Board (IRB), not the investigator, shall make the determination 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.

  1. Exempt
    1. Research conducted in established or commonly accepted educational settings, involving normal educational practices such as
      1. Research on regular and special education instructional strategies
      2. Research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless:
      1. Information obtained is recorded in such a manner that Human Subjects can be identified, directly or through identifiers linked to the subjects
      2. Any disclosure of the Human Subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
      3. Human Subjects meet criteria described in section II. A. ii.
    3. Research 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 subjects cannot be identified, directly or through identifiers linked to the subjects.
    4. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
      1. Public benefit or service programs
      2. Procedures for obtaining benefits or services under those programs
      3. Possible changes in or alternatives to those programs or procedures
      4. Possible changes in methods or levels of payment for benefits or services under those programs.
    5. Taste and food quality evaluation and consumer acceptance studies
      1. If wholesome foods without additives are consumed
      2. If a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.
  2. Expedited

    Under federal regulations certain types of research qualify for an 'expedited' review

    [http://www.hhs.gov/ohrp/policy/expedited98.html].

    These are activities that (1) present no more than minimal risk to Human Subjects, (2)

    involve only procedures specified in federal regulations, (3) minor changes in previously approved research during the period (of one year or less) for which approval is authorized. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on the list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research

    1. Research involving the use of education tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior if:
      1. The human subjects are elected or appointed public officials or candidates for public office
      2. Federal statue(s) require(s) without exception that the confidentiality of personally identifiable information will be maintained throughout the research and thereafter.
    2. 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 federal regulations for the protection of Human Subjects. This listing refers only to research that is not exempt).
    3. Collection of data from voice, video, digital, or image recordings made for  research purposes.
    4. Research on individual or group characteristics or behavior including, but not limited to:
      1. research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior)
      2. research  employing survey, interview, oral history, focus group, program evaluation, human  factors evaluation, or quality assurance methodologies.
      3. (NOTE: Some research in this category may be exempt from federal regulations for the protection of Human Subjects. This listing refers only to research that is not exempt.)
    5. Continuing review of research previously approved by the convened IRB as follows:
      1. the research is permanently closed to the enrollment of new subjects;
      2. all subjects have completed all research-related interventions
      3. the research remains active only for long-term follow-up of subjects
      4. where no subjects have been enrolled and no additional risks have been identified
      5. where the remaining research activities are limited to data analysis.
    6. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where the previous categories 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.
    7. The IRB Chair or Designee does the initial screening. The IRB Chair or Designee may recommend a project to the IRB for expedited review, for expedited review pending recommended changes/clarifications, or for review by the full board.  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. Any disagreement between the PI and, the IRB Chair or Designee must be resolved by the IRB. The PI will be notified officially of the IRB decision by the JSCC IRB Office.
  3. Full Board Review
    1. Protocols that involve more than minimal risk must go to Full Board Review
    2. The PI should allow at least six weeks for projects for full-board (IRB) review. The prospective PI will submit to the IRB Office one (1) original and one (1) electronic copy of the Application for Human Subjects Research form. Copies of the form are available on the JSCC website: __________________________
    3. In the application form, the Investigator or Project Director assures the IRB that he/she will follow the principles, procedures and guidelines established in the present document and agrees to allow the IRB access to pertinent records or research.   In addition, the Investigator or Project Director: 1) should present any information that will aid in evaluating the proposal for compliance with this policy, and 2) must be available to discuss the project and/or consent forms at the discretion of the IRB.

Purpose

The main purpose of the JSCC IRB is to protect the rights and welfare of human subjects used in research. 

Institutional Authority

Any and all complaints, unexpected problems or risks, or adverse events must be reported to the IRB Chair immediately.  This information must also be documented in writing and turned into the IRB. 

Any changes or additions made to the original research methods, procedures, or purpose must be submitted in writing to the IRB for approval prior to being implemented.

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 rights 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 at any time during the research process. 

IRB Membership

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 request and make decision based on internal, state, federal and agency policies.

The Jackson State Community College IRB members are:

The IRB will meet on an Ad Hoc basis.  The IRB will not have regularly scheduled meeting times.  At least five (5) members must be present for each vote.  After the IRB comes to a decision, a recommendation will be made to the College’s President who will make the final decision regarding research done at JSCC.  Once the IRB has received an application for research, a decision will be made, and the Principal Investigator will be notified within ten (10) business days.

Informed Consent

The National Institute of Health defines informed consent as” a legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study.” 

All participants must sign an informed consent waiver (to be designed by the investigator) before any information has been collected

All participants must be given full disclosure of possible risks and rewards of the study.  This information can be given orally or in writing.  Informed Consent must be given in a “language that is understandable to the subject …” (45 CFR 46.116).   Participants must have the mental capacity to understand the information presented to them in order to make a sound decision about participation in the study.

Health and Human Services regulations (45 CFR 46.116(a)) require that researchers disclose:

  1. The purpose of the study
  2. Any reasonably foreseeable risks to the individual
  3. Potential benefits to the individual or others
  4. Alternatives to the research protocol
  5. The extent of confidentiality protections for the individual
  6. Compensation in case of injury due to the protocol (May include money, other material compensation, such as a coupon or gift certificate, or other non-monetary rewards.)
  7. Contact information for questions regarding the study, participants’ rights, and in case of injury
  8. The conditions of participation, including right to refuse or withdraw without penalty

Potential participants must understand that enrolling in the research is voluntary and that they may withdraw from the study at any time without penalty or loss of benefits (45 CFR 46.116(a)).

In order for participation in research to be voluntary, the potential for coercion and undue influence must be minimized.

All informed consent components listed above must be addressed in the informed consent form.

Institutional Review Board Policy

All research involving human subjects conducted at or sponsored by Jackson State Community College (JSCC) must be approved by the Office of Institutional Research and Accountability.  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 research or responsible for research involving human subjects must adhere to JSCC Institutional Review Board (IRB) policy.  The JSCC IRB will make a recommendation for 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 on conducting research involving human subjects.  This training may be done at another educational institution.  Researchers may also use the National Institute of Health training which is found on the IRB’s website.  All researchers training must be renewed annually.

Anyone conducting research or responsible for research involving human subjects must adhere to the three (3) principles set forth 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 the standards of informed consent. An individual’s decision to participate must be:

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 the age of 18 must give assent to participate in a study as well as 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 on the basis of favoritism, nor should risky research be targeted to subjects with vulnerabilities. 

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. 

Risks to subjects must be minimized and should be justified by the anticipated benefits to the subject or society.

Adequate provision must be made to protect the privacy of subjects and to 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 record for personnel and students.) 

Approval for conducting research concerning human subjects must be obtained prior to collecting any data.

Any research requests that involve animal testing of any kind will be immediately disapproved.

Any research requests that involve participants to release confidential information as define by TBR will be immediately disapproved.  (TBR keeps confidential the following information pertaining to 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 license number, 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.

The Jackson State Community College Institutional Review Board reserves the rights 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 at any time during the research process.   

Responsibility of the Principal Investigator:

Complaints:

To file a complaint pertaining to 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 is located in the Administration Building, Room 111. 

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

Glossary of Terms:

Assent

“...affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent.”
Source: 45 CFR 46.402(b)

Children

“Persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted.”

Source: 45 CFR 46.402(a)

Coercion

Influencing an individual’s decision about whether or not to do something by using explicit or implied threats (loss of good standing in a job, poor grades, etc.)

Source: Faden, RR, and Beauchamp, TL. 1986. A History and Theory of Informed Consent. New York: Oxford University Press, p. 339.

Human Subject

“a living individual about whom an investigator...conducting research obtains:

  1. Data through intervention or interaction with the individual, or
  2. Identifiable private information.”

“OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research.

Source: National Institute of Health. Protecting Human Subject Research Participants-Glossary. (http://phrp.nihtraining.com)

Informed consent

A legally-effective, voluntary agreement that is given by a prospective research participant following comprehension and consideration of all relevant information pertinent to the decision to participate in a study

Source: National Institute of Health. Protecting Human Subject Research Participants-Glossary. (Http://phrp.nihtraining.com)

Investigator

“OHRP considers the term investigator to include anyone involved in conducting the research. OHRP does not consider the act of solely providing coded private information or specimens (for example, by a tissue repository) to constitute involvement in the conduct of the research. Note that if the individuals who provide coded information or specimens collaborate on other activities related to the conduct of this research with the investigators who receive such information or specimens, then OHRP would consider such additional activities to constitute involvement in the conduct of the research. Examples of such additional activities include, but are not limited to: (1) the study, interpretation, or analysis of the data resulting from the coded information or specimens; and (2) authorship of presentations or manuscripts related to the research.”

Source: OHRP, HHS. 2004. Guidance on Research Involving Coded Private Information or Biological Specimens. (http://www.hhs.gov/ohrp/policy/cdebiol.html)

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.”

Source: 45 CFR 46.102(i)

Pregnancy

“Encompasses the period from the implantation until delivery.  A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery.”

Source: 45 CFR 46.202(f)

Research

a systematic investigation...designed to develop or contribute to generalizable knowledge.

This definition includes:

Source: National Institute of Health. Protecting Human Subject Research Participants-Glossary. (http://phrp.nihtraining.com)