Part VI - Review Procedures | KCTCS

Part VI

Review Procedures

All research involving human subjects that is conducted at or sponsored by KCTCS, whether funded or unfunded and whether conducted by KCTCS faculty or others, must comply with the federal policy for the protection of human subjects. This includes pilot projects, student dissertation projects, independent study projects, and course projects if they involve human subjects. The Human Subjects Review Board is responsible for ensuring that all KCTCS research activities meet these requirements and campus policy (See p. 3). KCTCS is required to file an Assurance of Compliance with the Department of Health and Human Services Regulations for the Protection of Human Subjects to receive federal funds.

How to Obtain Approval for Human Subject Research

Example A:

  • If the research involves more than minimal risk,
  • Or if it is externally funded,
  • Then it must be submitted to the Human Subjects Review Board for review.

Example B:

  • If it is no more than minimal risk,
  • And it is not externally funded,
  • Then it may be submitted to that body for review.

Your research may be exempted from full review if the only involvement of human subjects will be in one or more of the six categories listed in Section B below. You must consult with the Administrative Assistant of the HSRB (859-256-3187) to determine if the project satisfies the exemption criteria. The HSRB maintains a database of all exempt human subjects’ projects conducted by KCTCS researchers. All human subjects’ research that is exempt must be conducted in accordance with the ethical principles as set forth in the "Belmont Report" and KCTCS policy.

If your project is not exempt, review must occur and approval must be granted by the HSRB prior to any involvement of human subjects in your research. For HSRB review, you must complete an HSRB-1 form and submit it to the HSRB office, 300 North Main Street. The form asks for information about the nature of the research, the funding source, how subjects will be recruited, how informed consent will be obtained, and the risks and benefits to the subjects of the proposed research. Answers should be brief and concise, but complete, and should avoid the use of jargon that might not be familiar to reviewers. In Section C below, there is further discussion of the criteria by which human subject’s research is reviewed.

Upon completion of the review, a letter will be sent to you authorizing initiation of your project or containing stipulations that must be met before approval is granted. Once approval is granted, the use of human subjects may begin.

HSRB-1 forms and this handbook can be accessed via the KCTCSC website or from the HSRB office, 300 North Main Street, 859-256-3187.

Categories of Exempt Human Subject Research

If your project meets any of the following six exemption categories and is not excluded by the limitations for the specific categories, it may be exempt from full review. Consult with either the Executive Secretary of the HSRB (859-256-3187) to determine if the project satisfies the exemption criteria. The following categories are defined in the Federal Policy for the Protection of Human Subjects.

Federal Regulation 46.101(b)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, or
  2. research on the effectiveness of or the comparison among instructional techniques, curricula or classroom management methods.

Limitations

Such work can be exempted only if the investigator believes that the research protocol will place the subjects at no more than minimal risk.

The consent of authorized school official(s) can serve in lieu of consent of the individual subjects, but consent must be obtained in an appropriate way. If subjects are children with the capacity to give assent, normally their assent must also be solicited. 

Confidentiality of identifiable information must be maintained without the express permission of the subjects to do otherwise. 

If the work is governed by HHS regulations, this exemption does not apply to research involving prisoners or research directed toward pregnant women as subjects.

Federal Regulation 46.101(b)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 than human subjects can be identified, directly or through identifiers linked to the subjects; and
  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.

Limitations

Exemption Category:

Such work can be exempted only if the investigator believes that the research protocol will place the subjects at no more than minimal risk.

If the research is undertaken in a commonly accepted educational setting, the consent of authorized school official(s) can serve in lieu of consent of the individual subjects. Otherwise, consent of the subjects or their authorized representatives must be obtained. If subjects are children with the capacity to give assent, normally their assent must also be solicited.

Confidentiality of identifiable information must be maintained without the express permission of the subjects to do otherwise.

If governed by HHS regulations, this exemption does not apply to research involving prisoners or research directed toward pregnant women, and the following types of research involving children are not exempt:

  1. Survey
  2. Interview
  3. Observation of public behavior when the investigator is a participant.

Federal Regulation 46.101(b)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:

  1. Human subjects are elected or appointed public officials or candidates for public office; or
  2. Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.

Limitations

Such work can be exempted only if the investigator believes that the research protocol will place the subjects at no more than minimal risk.

If the work is governed by HHS regulations, this exemption does not apply to research involving prisoners or children, or research directed toward pregnant women as subjects.

Confidentiality of identifiable information must be maintained without the express permission of the subjects to do otherwise.

Federal Regulation 46.101(b)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.

Limitations

Such work can be exempted only if the investigator believes that the research protocol will place the subjects at no more than minimal risk.

The requirement for consent of the subjects is waived if the data, documents, records, or specimens, etc., are publicly available. The authorization of the custodian of the data, etc., can serve in lieu of specific subject consent for access to data, etc., which are not publicly available. In such cases, the investigator must be satisfied that the custodian is authorized to release the data, etc., for research purposes.

If work is governed by HHS regulations, this exemption does not apply to research involving prisoners or for research directed at pregnant women.

Federal Regulation 46.101(b)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:

  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; or
  4. possible changes in methods or levels of payment for benefits or services under those programs.

Limitations

Such work cannot be exempted if prior review is specifically required by statue, or if the Secretary of HHS determines that a research or demonstration project presents a danger to the physical, mental, or emotional well-being of a participant or subject of the research or demonstration project.

If the work is governed by HHS regulations, this exemption does not apply to research involving prisoners or to research directed toward pregnant women. The KCTCS requirements for informed consent can be waived if:

  1. the research could not be carried out practicably without the waiver, and
  2. the Secretary of HHS has not determined that the project presents a danger to a participant or subject.

Federal Regulation 46.101(b)6

Taste and food quality evaluation and consumer acceptance studies,

  1. if wholesome foods without additives are consumed or
  2. if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Limitations

If the work is governed by HHS regulations, this exemption does not apply to research involving prisoners or to research directed toward pregnant women.

Review of Non-exempt Research

The issues of informed consent, classification of risk, method of selection of research subjects and assurance of confidentiality of identifiable subject information are key to the review process of all human subject research. Each of these is discussed in greater detail below. This information should be consulted when filling out the HSRB-1 form and when preparing the consent form for your project.

Informed Consent

The participation of human subjects in research must be voluntary. The subjects must give their informed consent, or, if a subject lacks the capacity to consent, an authorized representative must consent. The principle of voluntary participation of subjects applies whether or not the research is governed by federal regulations and whether or not the research is exempt from full HSRB review. Federal regulations provide the following requirements for documentation of informed consent:

Federal Regulation 46.117 Documentation of Informed Consent
  1. Except as provided in paragraph (c) of this section, informed consent shall be documented by the use of a written consent form approved by the HSRB and signed by the subject or the subject's legally authorized representative. A copy shall be given to the person signing the form.
  2. Except as provided in paragraph (c) of this section, the consent form may be either of the following: 
    1. A written consent document that embodies the elements of informed consent required by [currency] 46.116. [See Basic Elements of Informed Consent below] This form may be read to the subject or the subject's legally authorized representative, but in any event, the investigator shall give either the subject or the representative adequate opportunity to read it before it is signed;
    2. Or a "short form" written consent document stating that the elements of informed consent required by [currency] 46.116 [See Basic Elements of Informed Consent below] 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 HSRB shall approve a written summary of what is to be said to the subject or the representative.
    Only the short form itself is to 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 actually obtaining consent shall sign a copy of the summary.
    A copy of the summary shall be given to the subject or the representative, in addition to a copy of the "short form."
  3. An HSRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds either:
    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 will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern; or
    2. That the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside the research context.
    3. In cases where the documentation requirement is waived, the HSRB may require the investigator to provide subjects with a written statement regarding the research.

When children (in Kentucky, those under the age of 18) are included as subjects, see Part VII for discussion of parental consent and requirements for assent of children.

The basic elements of informed consent are presented below. Not all items will be applicable to every project, but the language used in every consent form should be understandable to the subject or representative. An incomplete or poorly written consent form is the most common problem with material submitted to the HSRB for review.

Basic Elements of Informed Consent
  • Statement that the study involves research
  • Explanation of the purposes of the research
  • Expected duration of the subject's participation
  • Description of the procedures to be followed
  • Identification of any experimental medical treatments or procedures
  • Statement that participation is voluntary
  • Statement that refusal to participate will involve no penalty or loss of benefits to which subject is otherwise entitled
  • Statement that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled
  • Explanation of any compensation and, if appropriate, procedures to pro- rate compensation for subjects who withdraw prior to completion of the study
  • Description of any reasonably foreseeable risks or discomforts
  • Description of any benefits to the subject or to others which may reasonably be expected from the research
  • Disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject
  • Statement describing the extent, if any, to which confidentiality of records identifying the subject will be maintained
  • Name and telephone number of person to contact for questions about the research, and name and telephone number of responsible project investigator, if different
  • Name and telephone number of person to contact for questions about research subjects' rights. (NOTE: The HSRB Office is willing to serve as a contact for such questions)
  • Name of person to contact in the event of research-related injury
  • Statement that subjects may have a copy of the consent form
  • Language used is understandable to the subject or representative
  • No language is included through which the subject is made to waive any of her or his legal rights, including any release of the college, KCTCS or its agents from liability or negligence

For research involving more than minimal risk:

  • An explanation of whether any compensation is available if injury occurs
  • An explanation of whether any medical treatments are available if injury occurs, what they consist of (if any), and where further information may be obtained

Additional elements of informed consent may be appropriate for research involving children, pregnant women and fetuses, and prisoners. See Section IV for further discussion of research involving special subject groups.

Occasionally, fully informed consent may itself have an injurious effect on the subject, or it may invalidate the research. Incomplete disclosure (or deceit) can be justified if it is clear that incomplete disclosure is truly necessary to accomplish the goals of the research or to protect the subjects; and there are no undisclosed risks to subjects that are more than minimal; and, where appropriate, there is an adequate plan for debriefing subjects and for communicating research results to them.

Information shall not be withheld if withholding it would influence a reasonable person's decision to participate or would damage his or her subsequent self-esteem. Information about risks shall never be withheld for the purpose of eliciting the cooperation of subjects, and truthful answers should always be given to direct questions about the research.

Risk Classification

There are different risks inherent in different research procedures. For purposes of safeguarding human subjects, risks are classified as either minimal risk or more than minimal risk. Under minimal risk, the risks of harm in the proposed research are no greater, considering probability and magnitude, than those ordinarily encountered in the subject's daily life or during the performance of routine physical or psychological examinations or tests.

The potential for physical risk is most obvious in procedures requiring medical intervention or involving strenuous exertion. There is a wide range of medical, social and behavioral research that may pose no immediate physical risk to the subject, but may involve varying degrees of emotional stress, deceit, invasion of privacy, etc. It is the investigator's responsibility to minimize the risks associated with any research and to make clear to the research subjects any benefits that may result to them directly or more generally to society. Direct payments or other forms of remuneration to the research subject are not considered to be benefits of participation. Evaluation of the risk/benefit ratio is a primary consideration in the HSRB review of research protocols.

Recruitment of Research Subject

The selection of subjects must be carefully considered. Subjects should not be selected for potentially beneficial research on the basis of favoritism, nor should risky research be directed to subjects who have limited power. Certain groups, such as the economically disadvantaged, the very sick, and the institutionalized, may have compromised capacity for free consent, and should be protected against the danger of being involved in research solely for administrative convenience or because they can be relatively easily manipulated.

No coercion, explicit or implicit, should be used to obtain or maintain cooperation. When the investigator has a specific relationship--faculty-student, professional-client, employer-employee--with a potential subject, special care must be taken to ensure that the subject feels completely free to decline to participate. Where access to subjects is gained through cooperating institutions or individuals, care should be taken not to abridge prior commitments made to the subjects about the confidentiality or other terms of the primary relationship

When KCTCS students are enrolled in a course in which participation as human subjects forms an integral part of the course, the official KCTCS course catalogue and timetable shall state that fact in the description of the course. A statement such as the following shall be included in the course description: "Includes limited voluntary participation as a subject in research activities." This statement will serve to alert registrants, but it does not suffice as the only means of ensuring that the subjects' participation in a specific research activity is voluntary.

If access to research subjects is gained through cooperating institutions not under the control of KCTCS, the institution(s) must be identified on the HSRB-1 form and evidence provided that the authorized official of that institution is or will be informed of the study. (If such subjects are placed at more than minimal risk, documentation of the institutional approval will be required.)

Issues of Confidentiality

In all research involving human subjects, confidentiality of identifiable information is presumed and must be maintained unless the investigator obtains the express permission of the subject to do otherwise. The more sensitive the material, the greater the care that must be exercised. Ordinarily, the following requirements must be met:

  • Questionnaires, inventories, interview schedules, and other data-gathering instruments and procedures should be carefully designed to limit the personal information to be acquired to only that information which is essential.
  • Data that could reveal a subject's identity should be stored in files accessible only to the project investigator and authorized staff.
  • As early as feasible, the data should be coded to remove identifying information.
  • The identity of subjects must not be released except with their express permission.
  • Use of existing data that were originally obtained for different purposes and that involve identifiable subject information, requires examination of the risk involved. There should be a determination of whether the new use is within the scope of the original consent or whether it is necessary or feasible to obtain additional consent. Anonymity of the subjects must be preserved.

Some research protocols use audio and video taping of research subjects. Subjects should always be told in the informed consent that taping will occur. Explicit consent must be obtained for any public use of the tapes such as use in the classroom or as part of a public presentation of the research results, since this constitutes a waiver of the normal confidentiality of research data.

Some studies involve collection of data on sensitive matters such as sexual behavior or criminal activities. There have been instances in which the identities of subjects or research data have been sought by law enforcement agencies. Under federal law, researchers can obtain an advance grant of confidentiality that will provide some protection even against a subpoena for research data (Public Health Service Act 301(d)). Protection is available whether or not the project has federal funding. Consult with the Executive Secretary of the HSRB (859-256-3187) for more information concerning the Certification of Confidentiality.

Continuation Reviews

The HSRB conducts continuing reviews of nonexempt research at intervals appropriate to the degree of risk, but at least once per year.

Record Retention

Federal regulations require that all records relating to the HSRB and to human subjects activities be retained for at least three years after completion of the research. Records, including signed consent forms and collected data, must be accessible for inspection at any time and for copying by authorized representatives of KCTCS and/or the agencies sponsoring the research.

Grant Submissions that Involve Human Subjects

No human subject’s research can be conducted without prior approval. In addition, most funding agencies require certification of HSRB review and approval prior to the award or expenditure of funds. Some agencies permit a grace period of up to 60 days from receipt of the grant application for certification of HSRB approval of the project; however, requirements for the timing of HSRB approval vary across agencies. When submitting the HSRB-1 form, it is the responsibility of the responsible project investigator to provide the HSRB with the address to which certification of approval should be sent and with adequate time to meet agency deadlines.

Training Grants

When training grants are submitted and some projects are expected to involve human subjects, the training grant will be reviewed administratively by the Executive Secretary of the HSRB, and a certification of HSRB review and approval will be sent to the funding agency. The Principal Investigator is responsible for ensuring that all subprojects supported by the training grant also be submitted for full HSRB review prior to initiation. The annual continuing review of the training grant requires submission of a list of subprojects that involve human subjects and documentation that they have been reviewed by the HSRB.

Institutional Oversights

The central HSRB has the authority to suspend or terminate approval of any research conducted at or sponsored by KCTCS that is not being conducted in accordance with the HSRB's requirements or that has been associated with unexpected serious harm to subjects. Any suspension or termination of approval will include a statement of the reasons for the HSRB's action and shall be reported promptly to the investigator and to the appropriate institutional officials. For any HHS-supported work so terminated or suspended, HHS regulations require that the Secretary of HHS be notified as well.

Research that has been approved by the HSRB may be subject to further appropriate review and approval by officials of KCTCS. KCTCS officials may not approve the research if it has been disapproved by the HSRB.

Emergencies and Reporting of Adverse Events

The responsible project investigator must promptly notify the HSRB of any problems involving human subjects that arise during the course of the research project (333-2670). Problems include unanticipated side effects or adverse reactions from participation in the project and, of course, any injuries. If any emergency occurs during a research project, you should call 911 and be prepared to provide the following information to the dispatcher: 1) type of injury and what assistance is needed, 2) number of victims, 3) the location and instructions on how to get there, and 4) name and phone number.

For research projects at more than minimal risk, the consent form should include information on available medical treatment if injury should occur and whether any compensation is available for treatment of injuries.

Human Subjects Research Regulated by FDA

Investigators conducting human subject research involving products regulated by the Food and Drug Administration (FDA) are subject to FDA regulations CFR parts 50 and 56. There are some differences in FDA and PHS regulations and investigators should become familiar with those that may apply to their research. A summary of the differences in the two sets of regulations is available on the FDA website. The most significant difference involves the FDA exception from informed consent requirements for emergency research (CFR 50.24).