IRB Approval Guidelines

Overview

The Institutional Review Board for the Protection of Human Subjects at Tennessee Technological University (TTU) serves as the Institutional Review Board (IRB) for the institution. The IRB has developed the following Guidelines to assure the protection of the rights and welfare of human subjects in research. These Guidelines use Department of Health and Human Services (DHHS) criteria (45 CFR 46) and closely follow recommendations of the Belmont Report.

Research projects vary in the risks they pose to subjects' rights and welfare. The IRB follows three different procedures depending on the risks involved in the research project. Studies that involve minimal risk require less stringent safe guards and can sometimes be reviewed by the department or unit. Minimal risk means that 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.

Good research design dictates careful consideration of risks, protections, and benefits, even if detailed review by the IRB does not occur. Moreover, the research design should meet applicable research ethics standards of the investigator's professional association or society. In all cases, the standards of respect for persons, beneficence, and justice enumerated by the Ethical Principles and Guidelines for the Protection of Human Subjects of Research (Belmont Report) apply to research involving human subjects, whether reviewed or certified as exempt from review. All research involving human subjects conducted at or sponsored by this University will be obligated to these ethical principles or their equivalent.

Please read the criteria below to determine the procedures to be followed for your research project. When a project is approved through the IRB, that approval is for a maximum period of 12 months. If the project has also been or will be submitted for consideration of external funding, the effective start date for the 12-month approval is the date indicated on the approved IRB application or on the grant/contract award notification, whichever date is later. For projects that continue for more than 12 months, the PI/project director must submit a statement of compliance to the Office of Research for review and approval of project continuation. The compliance statement must be submitted not later than one week prior to the expiration of the previous 12 month approval. It should provide reference to the earlier approved project along with the project title and PI and indicate continued compliance by the investigators with procedures outlined in their approved IRB application.  Additional details are provided in Item 2 in the General IRB Procedures

There are several classifications of research which may involve human subjects but their classification falls outside of the IRB's policies and jurisdiction. Examples include, but are not limited to:

Steps for Obtaining Approval to Use Human Subjects

These steps are also described in this flowchart pdf_icon_sm

  1. Complete Form A and identify category of exempt research, if applicable, and whether minimal risk is involved.
  2. If research meets exempt criteria and minimal risk is involved, submit Form A and Form C to Department or Unit Review Board/designee for approval. If approved by department, a copy should be sent to the Office of Research.  A description of the project is required.  Please reference the Attachment for Form A  for details.
  3. If research is not exempt (and with minimal risk), then also complete Form B and submit along with Form A,  Form C and any other required information to the Office of Research for either Expedited Review or Full Board Review.

Research Classified as "Exempt"

Procedure

Complete Form A , Attachment to Form A, and Form C and obtain approval from departmental review committee or Departmental designee. If an external sponsor funds research, approval must also be obtained from the TTU IRB Executive Officer. Consult with your departmental review committee for turn around time on reviews. For externally funded projects, expect a turn around time of one week on exempt research.

Criteria

Research projects in this category must involve minimal risk to the subject and must satisfy one or more of the following criteria:

    1. Research conducted in established or commonly accepted educational settings (including K-12), involving normal educational practices, such as (a) research on regular and special education instructional strategies, or (b) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods. [45 CFR 46.101(b)(1)]

    2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (a) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (b) 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. PLEASE NOTE: An exemption cannot be used when children are involved for research involving survey or interview procedures or observations of public behavior, except for research involving observation of public behavior when the investigator(s) do not participate in the activities being observed. [45 CFR 46.101(b)(2)]

    3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph B. 2. of this section, if: (a) the human subjects are elected or appointed public officials or candidates for public office; or (b) federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter. [45 CFR 46.101(b)(3)]

    4. 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. [45 CFR 46.101(b)(4)]

    5. 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: (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. [45 CFR 46.101(b)(5)]

    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, or the Food Safety and Inspection Service of the U.S. Department of Agriculture. [45 CFR 46.101(b)(6)]

Research Requiring an "Expedited Review"

Procedure

Complete Form A, Form B, and Form C together with supporting material and submit one (1) copy to the Office of Research for review and approval by the expedited review subBoard of the IRB. Expect a turn around time of two weeks on expedited reviews.

Applicability

    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 IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.

    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 greater than minimal.

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

    5. IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB.

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

Criteria

    1. Clinical studies of drugs and medical devices only when condition (a) or (b) is met.
      1. (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not required. (Note: Research on marketed drugs that significantly increases the risks or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review.)
      2. Research on medical devices for which (i) an investigational device exemption application (21 CFR Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.

    2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows:
      1. (a) 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 children2, 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 gumbase or wax or by applying a dilute citric solution to the tongue; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) supra- and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization.

    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=s privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

    5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.)

    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. (NOTE: Some research in this category may be exempt from the HHS regulations for the protection of human subjects. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.)

    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 two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified.

_______________________

1 An expedited review procedure consists of a review of research involving human subjects by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110.

2 Children are defined in the HHS regulations as "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." 45 CFR 46.402(a).

Source: 63 FR 60364-60367, November 9, 1998.

 

 

Research Requiring "Full Board Review"

Procedure

Complete Form A, Form B and Form C together with supporting material and submit fourteen (14) copies to the Office of Research for review and approval by the full IRB. The full IRB Board meets two times per semester to review proposals. Proposals must be received two weeks before the meeting to be considered. Check with the Office of Research for meeting dates.

Criteria

Any research or training project involving the use of human subjects which does not fall in the "Exempt Review" or the "Expedited Review" categories must be submitted to the IRB for a full board evaluation.

Appendices

The Review Process

  1. The Principal Investigator: The researcher, as principal investigator, is responsible for preparing the necessary forms and other required materials as applicable, and for ensuring that these make their way to the Office of Research for review and disposition. The staff in the Office of Research are always available to provide assistance.

  2. Student Research
    1. For Research Other Than Thesis, Graduate Problems, or Dissertation: All students conducting research involving human subjects for course or classroom requirements must have their projects approved by a person or Board designated by the departmental chairperson to review human subjects research.
      Caution: If the student's instructor is one of the department's designated reviewers, the instructor should request someone else to review the project if the instructor feels uncertain about whether the project is exempt or if the instructor cannot objectively evaluate the risks to human subjects. Any research that may be coauthored or copresented by a faculty member must be reviewed by another departmental representative designated to review human subjects research.
      In situations where the research does not fall into the exempt category, two copies of completed Form A and Form B and supporting materials should be submitted to the Office of Research for approval. Students should be informed about the turn around times on applications for Expedited and Full Reviews. Under no circumstances can a faculty member be the departmental reviewer of a research project that is part of their own research program.
    2. Thesis, Graduate Problems, and Dissertation Research: Graduate students conducting research involving human subjects for theses or dissertations must have their projects approved by their advisor and/or thesis/dissertation Board before preparing Form A and Form B. The thesis/dissertation advisor/chair must sign the form certifying that the Board has approved the research and application. Under no circumstances can a faculty member be the departmental reviewer of a research project that is part of their own research program.

  3. Departmental review committee and Department/Unit Head: The department or unit head is responsible for reviewing and approving research at the department/unit level. Units that regularly engage in research involving human subjects may establish departmental review committees (DRC) to discharge this responsibility. The department head must also review student research projects, or delegate the responsibility to a departmental review committee, or to instructors familiar with research methods and ethical guidelines for conducting research on humans. The departmental review can only be used to approve research that falls into the exempt category. Under no circumstances can a faculty member be the departmental reviewer of a research project that is part of their own research program. Copies of departmentally-approved research projects (Form A) must be sent to the Office of Research to satisfy federal record keeping guidelines. When developing a research plan, the investigator must carefully plan for the time required by departmental review. The investigator should consult with the DRC about ways to minimize risk to the subjects.

Requirements for Nonexempt Research on Children

  1. Requirements for Assent by Children: Adequate provisions must be made for soliciting the assent of children, when in the judgment of the IRB, the children are capable of providing assent. Assent means a child's affirmative agreement to participate in research. Mere failure to object should not absent affirmative agreement, or be construed as assent. In determining whether children are capable of assenting, the IRB shall take into account the ages, maturity, and psychological state of the children involved. This judgment may be made for all children to be involved in research under a particular protocol, or for each child, as the IRB deems appropriate. If the IRB determines that the capability of some or all of the children is so limited that they cannot reasonably be consulted, or that the intervention or procedure involved in the research holds out a prospect of direct benefit that is important to the health or well-being of the children, and is available only in the context of the research, the assent of the children is not a necessary condition for proceeding with the research. Even where the IRB determines that the subjects are capable of assenting, the IRB may still waive the assent requirement under circumstances, in which consent may be waived.

  2. Requirements for Parental Permission
    1. Adequate provisions should be made for soliciting the permission of each child's parents or guardian. Where parental permission is to be obtained, the IRB may find that the permission of one parent is sufficient for research to be conducted involving minimal risk or greater than minimal risk, but with direct benefit to the subjects. Research with greater than minimal risk that does not provide a direct benefit to the subject requires permission to be obtained from both parents, unless one parent is deceased, unknown, incompetent, or not reasonably available, or when only one parent has legal responsibility for the care and custody of the child.
    2. If the IRB determines that a research protocol is designed for conditions, or for a subject population, for which parental or guardian permission is not a reasonable requirement to protect the subjects (for example, neglected or abused children), it may waive the consent requirements provided an appropriate mechanism for protecting the children who will participate as subjects in the research is substituted, and provided further that the waiver is not inconsistent with Federal, state or local law. The choice of an appropriate mechanism would depend upon the nature and purpose of the activities described in the protocol, the risk and anticipated benefit to the research subjects, and their age, maturity, status, and condition.

Activities Directed Toward Pregnant Women as Subjects

  1. No pregnant woman may be involved as a subject in an activity, unless (a) the purpose of the activity is to meet the health needs of the mother, and the fetus will be placed at risk only to the minimum extent necessary to meet such needs, or (b) the risk to the fetus is minimal.

  2. An activity permitted under paragraph (A.) of this section may be conducted only if the mother and father are legally competent and have given their informed consent, after having been fully informed regarding possible impact on the fetus, except that the father's informed consent need not be secured if: (1) the purpose of the activity is to meet the health needs of the mother, (2) his identity or whereabouts cannot reasonably be ascertained, (3) he is not reasonably available, or (4) the pregnancy resulted from rape. (45 CFR 46.207)

Activities Directed Toward Prisoners as Subjects

  1. Contact the IRB ( This e-mail address is being protected from spambots, you need JavaScript enabled to view it ) prior to proposing, considering, or in any way becoming involved in research involving prisoners as human subjects.

  2. Any activities directed toward prisoners as subjects will follow 45 CFR 46 Subpart C

Review Criteria

The substance of our concern for research involving human subjects lies in the criteria by which the IRB evaluates proposals. In order to review and approve a project, the IRB must determine that it satisfies the following requirements:

  1. Risks to Subject: Risks to the subject are minimized by using procedures that are consistent with sound research and that do not unnecessarily expose the subject to risks (e.g., physical, psychological, social or economic) and by using, whenever appropriate, procedures already being performed on subjects for diagnostic and treatment purposes.

  2. Risks vs. Benefits: Risks to the subject are reasonable in relation to anticipated benefits, if any, to subject, and to the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB considers only those risks and benefits that may result from the research (as distinguished from the risks and benefits of therapies or services that subjects would receive even if they do not participate in the research). The IRB does not consider the long-range effects of applying the knowledge gained in the research as among those research risks or benefits that fall within its responsibility.

  3. Subject Selection: The selection of subjects must be equitable. In making this assessment, the IRB takes into account the purposes of the research, the setting in which the research will be conducted, and the population from which the subjects will be recruited.

  4. Informed Consent: Informed consent must be sought from each prospective subject or the subject's legally authorized representative and will be legally documented.

  5. Confidentiality and Privacy: The research plan must provide for monitoring the data collected to ensure the subjects' privacy and the confidentiality of the data.

  6. Other Considerations: The IRB also considers the acceptability of the research project in terms of institutional commitments and regulations, applicable law, standards of professional conduct and practice, and special vulnerabilities of the subjects.

Informed Consent

  1. General Requirements for Informed Consent All investigators must obtain the legally effective informed consent of the subject or the subject's legally authorized representative. An investigator must seek such consent only under circumstances that provide the prospective subject or the representative sufficient opportunity to consider whether or not to participate, and that minimize the possibility of coercion or undue influence. The information that is given to the subject or the representative must be in language understandable to the subject or the representative. No informed consent, whether oral or written, may include any exculpatory language, through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution, or its agents from liability for negligence.

  2. Basic Elements of Informed Consent
    1. A statement that the study involves research, an explanation of the purposes of the research, and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental.
    2. A description of any reasonably foreseeable risks or discomforts to the subject.
    3. A description of any benefits to the subject or to others which may reasonably be expected from the research.
    4. A disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject.
    5. A statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained.
    6. 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.
    7. 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.
    8. 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.

  3. Exceptions to Normal Informed Consent Procedures: The IRB may approve a consent procedure, which does not include, or which alters, some or all of the elements of informed consent set forth above, or waive the requirements to obtain informed consent, provided the IRB finds and documents that:
    1. The research involves no more than minimal risk to the subjects.
    2. The waiver or alteration will not adversely affect the rights and welfare of the subjects.
    3. The research could not practicably be carried out without the waiver or alteration.
    4. Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

  4. Checklist for Informed Consent

 

Research Involving Use of Translators

  1. Consent Form Procedure
    1. The translator must translate the entire IRB-approved English version of the consent form to the subject in a language understandable to him/her, and the subject must be given a copy of the written translation of the consent document to read;
    2. The entire consent process must be witnessed by an individual who is fluent in both English and the language understandable to the subject. The translator may serve as the witness;
    3. The IRB-approved English version of the consent form must be signed by the investigator who’s authorized by the IRB to obtain consent, and signed by the witness to the consent process (may be the translator). The form must also be signed by the subject and the witness to the consent process (again, this may be the translator);
    4. The subject must be given copies of both the IRB-approved English version of the consent form and the translated version of the consent form. The originals of both forms should be placed in the subject’s research record.
  2. Verification of Translation Accuracy
    1. The translated documents (any translated documents that relate to this study) should be verified for accuracy
    2. This may be accomplished by completing a form that includes:
      1. Name of the Investigator
      2. Title of the Project
      3. Name of Verifying Individual
      4. The language being verified (Spanish, French, etc.)
      5. Contact information for the verifying individual
      6. A signatory line (signature and date) for the verifying individual that states: "I, the undersigned, verify that all translated materials related to the above named study reflect the intent and spirit of the English text."
  3. The verifying individual may be someone from the Department of Foreign Languages or someone who has a bachelor’s degree in the language being verified. It does not have to be a certified translator.

 

IRB Review Procedures and Results

After a full discussion, the IRB may take one of the following actions:

  1. Approve Without Reservation: The IRB may approve the project as submitted without any changes noted for a maximum period of 12 months.

  2. Approve With Minor Modifications: The IRB may approve a project contingent upon modifications to be completed by the Principal Investigator. When the changes are received by the Office of Research, the Executive Officer, acting on behalf of the IRB, will compare the modifications received with the actions requested by the IRB. If the modifications are in compliance with the IRB directives, the Office of Research will approve the project for a maximum period of 12 months.

  3. Table Approval Pending Resubmission: If the IRB deems that the proposal and/or informed consent as submitted require major revisions, they will require the Principal Investigator to resubmit the application and attachments with all of the changes required. In some cases, the IRB Chair may request one or more IRB members to assist the Principal Investigator in resubmitting the application. If no IRB member has been designated, the Principal Investigator is strongly urged to consult with the Office of Research to receive assistance in the preparation of a new application.

  4. Disapprove: The IRB may disapprove a research project if it has determined that the human subjects are at a greater risk than the benefits to be accrued. The IRB will notify the Principal Investigator, the advisor (if the Principal Investigator is a student), and the department head of the investigator. Notification will include all of the reasons and rationale behind the disapproval. Upon disapproval, the Principal Investigator has the option of one or the following two actions:
    1. Revise and resubmit the project, reducing the risks to the subjects; or
    2. Appeal the IRB's decision to the Vice President for Academic Affairs.

Adverse Events (from University of Memphis)

New findings are unexpected problems whose nature, severity, and frequency are not described in the information provided to the IRB or to participants. Examples include unexpected complications in a subject, missteps in the consent documentation, or breaches of confidentiality. Adverse events should be reported to the IRB within 10 working days.. Sometimes a study must be suspended to ensure subjects' safety.

The report of the event should discuss:

These reports usually receive expedited review, but in some cases the full IRB is involved.

The University's policies on adverse events are based on Food and Drug Administration regulations. According to the FDA, a "serious adverse drug experience" with respect to human clinical experience includes "any experience that suggests a significant hazard, contraindication, side effect, or precaution," including "any experience that is fatal or life-threatening, is permanently disabling, requires inpatient hospitalization, or is a congenital anomaly, cancer, or overdose." An "unexpected adverse experience" is any adverse experience whose nature, severity, and frequency of risk are not described in the information provided for IRB review or in the consent form. (From University of Memphis)

(See 21 CFR 312.32 [4-1-92])

 


Updated 9/20/2012