TTU HUMAN SUBJECT POLICIES & PROCEDURES

September 2008

Annotated Outline of Policies & Procedures

I.          Background

All human subjects research, regardless of the source of funding, is subject to Federal regulation.

II.        The Institutional Review Board

The Protection of Human Subjects Committee serves as the Institutional Review Board (IRB) at Texas Tech University and reviews all proposals for human research. The IRB meets monthly on the last Tuesday of each month.

III.       Vice President for Research and The Office of Research Services

The Office of Research Services implements policies and procedures for human subject research.

IV.       Is it Human Subjects Research - The Scope of IRB Authority

All activities involving either Texas Tech personnel, resources, or facilities fall under the authority of the IRB if they meet specific regulatory definitions of research and human subjects described in this section.

V.        Levels of Review

There are three levels of review of human subject research as described and summarized in the three sections that follow. Minimal risk is defined and special protections for children and other protected populations are described.

VI.              Exempt Review Procedures

Claim for Exemption can be filed for human subjects research that falls into one of four specific categories. A project involving human subjects may not begin until the claim is approved by the IRB.

VII.     Expedited Review Procedure

Some minimal risk research may be eligible for expedited review.  The project must be of minimal risk and included in one of nine specific categories to be eligible.

VIII.    Full IRB Review Procedure

All other human subject research is subject to full IRB review. The committee may approve, approve contingent on minor revisions, defer pending resubmission, or disapprove proposals.

IX.       Review Criteria

The IRB employs the criteria set forth in federal regulations (45 CFR 46) and the more general ethical principles of respect for persons, beneficence, and justice described in the Belmont Report.

X.        Appeals of IRB Decisions

In virtually all instances, investigators work with the IRB to reach agreement. Federal regulations specifically prohibit the University from approving a project which the IRB has disapproved.

XI.       Proposal Preparation

This section describes the format requirement for proposals categorized as exempt, expedited and full review, along with proposals involving the TTUHSC IRB. Only full-time or tenured Texas Tech University faculty or any full-time employee with the terminal degree in their discipline (Ph.D., Ed.D., J.D., or M.D.) may submit proposals. Associated grant proposals must be submitted along with IRB proposals for comparison of proposals.

XII.     Submitting Proposals

Proposals and claims for exemption should be sent to the IRB Coordinator who screens applications and sends them to expediting reviewers or the full board as appropriate.

XIII.    Informed Consent Processes and Forms

The consent process can be either oral or written. It is essential that all consent scripts or forms are written at a level that is understandable to the subjects. This section describes the 18 elements of informed consent that are necessary for a valid consent process and gives the criteria for waiver of some or all of the elements of consent.

XIV.    Continuing Review, Annual Progress Reports, and Termination of Projects

Except for exempt projects, all projects are reviewed automatically at least once a year.  If progress report forms sent to investigators are not returned on time, approval of the project is terminated and a new proposal must be submitted before the project can resume.

XV.     Reporting Adverse Events or Noncompliance

Any harm to subjects resulting from research, deviations from an approved protocol, or failure to comply with federal regulations or these policies and procedures must be reported to the IRB immediately. 

XVI.    Amendments to Approved Protocols

Changes to approved projects must not be implemented until approval has been granted by the IRB.  Depending how extensive the changes are, either an amendment or a new proposal should be filed.  Changes in exempt research also require reporting. 

XVII.              Protected Populations

The IRB has a special obligation to protect the rights and welfare of subjects who are particularly vulnerable. Three classes of subjects, (a) fetuses, pregnant women, and human in vitro fertilization; (b) prisoners, and (c) minors are singled out in federal regulations for additional protective measures.  This section summarizes some of the additional issues that must be considered for proposals for research on these populations.  Investigators should note that some university students may be minors. 

XVIII.  Education/Training

All investigators and members of their research teams are required to be familiar with the Belmont Report and the federal regulations. Principal investigators on NIH projects are specifically required to document the completion of training on human subjects protection. .

XIX.    Amendments to Policies and Procedures

These policies and procedures can be changed by a vote of the majority members present of the Protection of Human Subjects Committee. 

The Policies & Procedures

I.  Background

Federal regulation of human subjects research began in 1971.  In 1974 the National Research Act of 1974 created the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research. This law required every institution applying for Federal funds for the conduct of human research to establish an Institutional Review Board (IRB) to protect the rights of the human subjects involved in biomedical and behavioral research. 

After meetings at the Smithsonian Institution’s Belmont Conference Center in 1976 and extensive deliberations over the next three years, the National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research issued a 1979 statement, “Ethical Principles and Guidelines for the Protection of Human Subjects of Research,” (the Belmont Report), laying out basic ethical principles to assist individuals in resolving ethical issues in the conduct of research with human subjects.  In 1981, the Food and Drug Administration (FDA) and the National Institutes of Health (NIH) set forth the regulatory standards for the protection of human subjects and for the operation of Institutional Review Boards.  In 1983, the U.S. Department of Health and Human Services (DHHS) issued new regulations and mandated special protection for vulnerable populations such as prisoners and children.  In 1989, the National Institutes of Health became the coordinator for all the human subjects protection activity of the Federal Government through what is now known as the Office for Human Research Protections (OHRP).  OHRP issued regulations to protect human subjects in research (Title 45 of the Code of Federal Regulations, Part 46) in 1991.  It is these regulations, also known as 45 CFR 46 or the Common Rule, that govern human research activity at Texas Tech University.

To certify that Texas Tech complies with these federal regulations, the university has filed a Federalwide Assurance (FWA 00001568; expires 01-22-2011). The assurance commits the university, the Institutional Review Board, and research investigators to the ethical principles of The Belmont Report and an institutional policy of compliance with the regulations. Importantly, as part of its assurance, Texas Tech is committed to reviewing all research involving human subjects regardless of sponsorship.

II.  The Institutional Review Board

The Protection of Human Subjects Committee (O.P. 74.09) serves as the IRB for Texas Tech University. It operates under the DHHS regulations for the Protection of Human Research Subjects (45 CFR 46), the University’s Federalwide Assurance (FWA), and is guided by the ethical principles regarding human subjects research as set forth in.  Within the scope of these documents, the IRB is charged to ensure full compliance with both the letter and the spirit of regulations designed to protect the rights and welfare of human subjects.

The IRB is composed of 15 members with an additional four non-voting ex-officio members. The members represent diverse backgrounds in order to provide the professional competency necessary to review research, and to provide an understanding of the ethical, legal, and community contexts in which research takes place. The Vice President for Research is responsible for the appointment of members for the IRB. Members are selected on the basis of their experience and expertise and their sensitivity to issues such as community attitudes. One member is appointed specifically to represent the interests of prisoners. Faculty members willing to serve on the IRB are urged to contact the IRB chair or the Office of the Vice President for Research. Three members who are not affiliated with the university represent the larger community. Two additional members are from the faculty of the Texas Tech University School of Medicine. Another member is from the faculty of the Texas Tech University School of Law and The rest of the IRB consists of Texas Tech University faculty members who represent expertise in a wide variety of areas of human research. The ex-officio members are the Senior Associate Vice President for Research, the Director of Environmental Health and Safety, a representative from the Institutional Technology Division and a representative from the Provost Office. There are also alternate members for individuals of the IRB who may replace a regular voting member unable to attend a meeting. Members and alternates are appointed for staggered three-year terms and may be reappointed so that the Board maintains a large number of experienced members. The IRB can and does enlist the help of outside experts whenever review of a proposal requires specialized knowledge concerning research procedures or populations. These outside experts do not have voting privileges.

The Institutional Review Board for the Protection of Human Subjects Committee meets monthly on the last Tuesday of each month at 3:00 p.m. and at other times as necessary.  Proposals must be received two weeks in advance of the meeting.

III.  Vice President for Research and The Office of Research Services

The Vice President for Research is responsible for the implementation of policies and procedures governing the use of human subjects in research. Donna Peters (742-3884), IRB Coordinator is responsible for implementing IRB activities within that office. The IRB Coordinator maintains all IRB records including agendas and minutes, policies, regulations, forms, reference materials, and individual proposal applications. All IRB records are maintained for three years. Active IRB-approved individual protocol files are maintained for the life of the project. When notification is received that a project has been completed, the files are archived for three years and then destroyed. In consultation with the IRB, the Office of Research Services provides information and other educational assistance to departments and to investigators regarding regulations, policies and procedures applicable to research involving human subjects.

IV.  Is it Human Subjects Research? The Scope of IRB Authority

The IRB regulates all activity that constitutes research with human subjects, as defined below (see 45 CFR 46.102, Definitions) that (a) is conducted by Texas Tech University personnel in the course of their employment by the university or (b) uses Texas Tech University facilities or resources. Generally, this means that Texas Tech University personnel conducting research elsewhere need approval by the Texas Tech University IRB even if the work is approved by another IRB. Likewise, work that is conducted on the Texas Tech University campus needs approval by the Texas Tech University IRB even if it has approval by another institution.  Individuals who are in doubt about whether an activity constitutes research with human subjects or who have questions about the applicability of this policy to a research project should confer with the IRB Chair, IRB Coordinator or a member of the IRB.

In most cases, multi-site collaborative research requires IRB review and approval. If the research activities at Texas Tech involve ANY interaction or intervention with subjects, then the protocol must be reviewed. In some instances investigators may obtain, receive, or possess private information that is individually identifiable (either directly or indirectly through coding systems) for the purpose of maintaining “statistical centers” for multi-site collaborative research. If the research activities involve no interaction or intervention with subjects, and the principal risk associated is limited to the potential harm resulting from breach of confidentiality, the IRB need not review each collaborative protocol. However, this is still considered research and the IRB must determine and document that the statistical center has sufficient mechanisms in place to ensure that (i) the privacy of the subjects and the confidentiality of data are adequately maintained, given the sensitivity of the data involved; (ii) each collaborating institution holds an applicable Office for Human Research Protections (OHRP) approved Assurance; (iii) each protocol is reviewed and approved by the IRB at the collaborating institution prior to the enrollment of subjects; and (iv) informed consent is obtained from each subject in compliance with Department of Health and Human Services (DHHS) regulations.

Under no circumstances may an investigator undertake research involving human subjects without approval by the full IRB, approval by expedited review, or approval of a claim for exemption. Retrospective approvals and exemptions cannot be granted.

The following definitions from federal regulations apply: 

Research means a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge. Activities which meet this definition constitute research for purposes of this policy, whether or not they are conducted or supported under a program which is considered research for other purposes. For example, some demonstration and service programs may include research activities.

Human subject means a living individual about whom an investigator (whether professional or student) conducting research obtains (1) data through intervention or interaction with the individual, or (2) identifiable private information

Intervention includes both physical procedures by which data are gathered (for example, venipuncture) and manipulations of the subject or the subject’s environment that are performed for research purposes.

Interaction includes communication or interpersonal contact between investigator and subject.

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 which has been provided for specific purposes by an individual and which the individual can reasonably expect will not be made public (for example, a medical record). Private information must be individually identifiable (i.e., the identity of the subject is or may readily be ascertained by the investigator or associated with the information) in order for obtaining the information to constitute research involving human subjects” (45 CFR 46.102).

Non-research activities. Non-research activities are not subject to review by the IRB and do not have to be certified as exempt from IRB review. Examples of activities that fall outside the jurisdiction of the IRB because they do not have the purpose of contributing to generalized knowledge or are not systematic investigations include, but are not limited to:

·         Teacher and student evaluations;

·         Program evaluations for internal purposes;

·         Texas Tech employee performance evaluations;

·         Marketing research designed to market the institution as a product;

·         Classroom projects that are conducted for didactic purposes and do not extend beyond the classroom (i.e., do not contribute to generalizable knowledge).

o   The student and instructor still have the responsibility to respect the rights of the study participants and to treat them in a fair and ethical manner.

·         Instructors should insure that the projects carried out by their students are being conducted in a manner that is consistent with the ethical principles of their discipline and the federal guidelines for the protection of human subjects.

·         If a student or instructor decides to submit a class project to a conference, journal, etc. it must first be reviewed by the IRB.

·         Journalism

·         Art

·         Oral History

Oral history is defined by the Oral History Association as “a method of gathering and preserving historical information through recorded interviews with participants in past events and ways of life.” In general, oral history interviews are conducted with specific individuals with expertise in certain areas, rather than anonymous individuals selected at random. These individuals most often respond to open-ended questions, rather than a standard survey. In general, oral history interviews are not designed to contribute to “generalizable knowledge” and are therefore outside the jurisdiction of the IRB.

Examples of activities that fall outside the jurisdiction of the IRB because they do not involve interaction or intervention with human subjects and the data do not constitute identifiable private information include, but are not limited to:

·         Studies using aggregated archival data that is de-identified

·         Studies using people to obtain information that does not involve human subjects (e.g., “how many widgets did you produce last quarter?” or “how many sick days were taken last year by people work in your school district?”)

“Identifiable Private Information” includes information that can either directly or indirectly link to specific individuals. An example of information that could be directly linked to a specific individual would be that person’s social security number. An example of information that could be indirectly linked to a specific individual would be coded information, if a key to decipher the code exists.

However, when the investigator(s) cannot readily ascertain the identity of the individual(s) to whom the coded private information pertains, this constitutes non-identifiable information. Examples of non-identifiable information include:

·         Identifiable information that is coded (name or social security number could be replaced with a number, letter, symbol, or combination thereof), AND the key to decipher the code is destroyed before the research begins.

·         Coded information in a situation in which the investigator(s) and the holder of the key enter into an agreement prohibiting the release of the key to the investigator(s) under any circumstance.

It is possible that some activities such as those above may evolve into research at which time they  begin to fall under IRB jurisdiction, and a proposal for IRB approval or a claim for exemption should be submitted. For example, a program evaluation intended solely to aid in improving the performance of a government agency might incidentally yield data that would be of interest to a wider audience through publication. When the intent in analyzing or presenting the data becomes one that involves a contribution to generalized knowledge, an exemption or IRB approval becomes necessary.

It is important to bear in  mind that activities that fall outside the purview of the IRB may still involve some of the same ethical issues that confront researchers (e.g., confidentiality). Such issues ought to be considered from the perspective of ethics for teachers, practitioners, clinicians, or other professions or groups whose ethical guidelines or legal authority are relevant to the activity.

Non-research activities should not be confused with research that may be exempt from review. If an activity meets the definition of research with human subjects, it is exempt only if (a) it meets one or more criteria for exemption, and (b) a proper claim for exemption is filed and approved.

Subject pools. Departments that have written procedures for organizing pools of subjects that can be used for research within the department are urged to submit the procedures for IRB approval. The procedures should describe the procedures for recruiting and compensating subjects. If credit toward meeting a course requirement is offered to students in the pool, the nature of that credit should be specified. Non-research alternatives for earning the same credit with similar time and effort must be available and should be described. If the subject pool procedures are approved by the IRB, the details of subject recruitment and compensation need not be reported in detail in projects proposing to use the subject pool. It is sufficient to refer to the procedures on file with the IRB. The IRB reviews existing procedures once each year and considers new procedures and modifications as they are submitted.

V.  Levels of Review

If a project constitutes human subjects research according to the definitions above, there are three levels of IRB review. Each successive level usually requires more details to be submitted to the IRB. The levels include

A.   “Exempt” review for human subjects research that involves minimal risk and fits certain precisely defined categories such as survey research in which responses are anonymous. The principles of The Belmont Report must still be observed in exempt research. A Claim for Exemption may be approved without it being presented at a monthly meeting of the full IRB;

B.   “Expedited” review for human subjects research that involves minimal risk and fits within one of nine precisely defined categories such as research in classrooms or educational practices. A project in this category may be approved without being presented at a monthly meeting of the full IRB;

C.   “Full Board” review applies to all other projects over which the IRB has jurisdiction. Investigators should use the descriptions that follow to determine which level of review is appropriate and check with the IRB Coordinator, the IRB Chair, or a member of the IRB if questions remain. Note that both exemptions and expedited review apply only to research that poses no more than minimal risk to subjects. The regulatory definition of minimal risk is:

“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” (45 CFR 46.102). 

The definition of “risk” is determined by assessing the probability of harm and the magnitude of harm. Consideration is given to both aspects of potential harm. In some cases, (perhaps research in physical exercise) one of the possible risks could be death. However, this would be an extremely rare occurrence which is likely to never occur. Thus, the probability of harm would be exceptionally low. Therefore, although the potential magnitude of harm could be high, the probability of that occurring is so low that research does not necessarily need to be considered high risk.

All research with children receives special scrutiny (see “Protected Populations” below). Children are defined (45 CFR 46.402) 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.” In Texas, the legal age for consent is 18. All research for which consent is required must also, where possible, obtain the assent of the child subject. Most often, assent is obtained with the use of a child “assent form” which is a version of the consent form in language appropriate for the child’s ability to understand the elements of consent. Proposals categorized as exempt or expedited where the subjects are children (except those enrolled as regular students at Texas Tech University) will be reviewed by two expediting reviewers which may result in a somewhat longer time to process the proposal.

VI.  Exempt Review Procedure 

Certain research may be exempt from the requirements of federal regulations although the investigator still must meet the requirements for ethical research practices outlined in The Belmont Report.  Out of respect for persons, even without a consent form or formal consent process, subjects should usually be sufficiently informed about the research so that a reasonable decision to participate can be made. Risks should be minimized and subject selection should be equitable. The principal investigator will make preliminary determination as to whether a project is exempt from review although the final determination rests with the IRB. The investigators will prepare a Claim for Exemption form furnished by the Office of Research Services (also see Section XI. Proposal Preparation below). Note that questionnaires, interview schedules, etc. and copies of recruitment materials must be submitted with the form. For surveys or standard instruments that cover mundane issues, a description of the instrument or how it will be developed may be sufficient. Research qualifying for exemption most often consists of anonymous surveys or interviews, or research conducted in traditional educational settings for evaluation of instructional programs, etc. Proposals categorized as exempt claiming an exemption per federal regulations will be reviewed by one of the designated expediting reviewers on the IRB (see IRB membership list), or two expediting reviewers in the case of projects involving children. Some exemptions do not apply to research with children when the research involves interviews or survey procedures or research where public behavior is observed and the investigator participates or interacts with the children. The IRB reserves the right to give full committee review to any such claim, but such reviews are rare. If a claim is rejected, the investigator must file a proposal for expedited or full review.

Categories of research exempt from review: Only research activity in which the only involvement of human subjects is in one or more of the following categories and that poses no more than minimal risk is exempt. Like all research at Texas Tech, exempt projects must be conducted in accordance with the principles of The Belmont Report. On the Claim for Exemption form, the investigator should check the appropriate basis of the claim for exemption.

(1) Research conducted only in established or commonly accepted educational settings (like classrooms) AND involving normal educational practices such as research on regular and special educational instructional strategies, or 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), or survey or interview procedures, or observing the public behavior of subjects if (a) the information obtained will be recorded in such a manner that subjects cannot be identified directly or through identifiers linked to the subjects, or (b) any disclosure of the subjects’ responses outside the research could not reasonably place the subject at risk of criminal or civil liability, or be damaging to the subjects’ financial standing, employability, or reputation (e.g., information regarding illegal or immoral conduct, drug or alcohol use, sexual behavior, mental illness, or other possibly personally embarrassing subjects) or (c) the subjects are elected officials or candidates for public office.

(3) Research is limited to the collection or study of existing data, documents, records, pathological or diagnostic specimens under one of the following conditions if (a) these sources are publicly available or (b) 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) Other, rarely used, provision of 45 CFR 46.101(2), e.g., taste and food quality evaluations. See regulations for details.

VII.  Expedited Review Procedure

Certain research projects involving no more than minimal risk are suited for expedited review in which a single designated member of the IRB may approve, but not disapprove, a proposal. Research with children or other vulnerable populations must be approved by two expediting reviewers. Projects that are not suitable for expedited review or those that raise other than routine ethical issues will, at the discretion of the reviewer, be referred to the full board for review. If the expediting reviewer approves a proposal it will be returned to the IRB office. Proposals that require very minor modifications can be approved contingent on the execution of the required changes. If reviewers have questions about a proposal and cannot approve it in its current form, they will generally contact the principal investigator by e-mail or telephone. Only when that procedure is infeasible will the proposal be sent back to the IRB office for rerouting. In any event, investigators will be notified of the final outcome of each review by letter, a copy of which will be maintained in the IRB office for review by institutional officials.

The following regulations (63 FR 60364, November 9, 1998) apply to expedited review:

(a) 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.

(b) The categories in this list apply regardless of the age of subjects, except as noted.

(c) 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.

(d) The expedited review procedure may not be used for classified research involving human subjects.

(e) 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.

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

(1) Clinical studies of drugs and medical devices only when condition (a) or (b) is met.

(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.)  (b) 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:

(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

(b) from other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.

(3) Prospective collection of biological specimens for research purposes by noninvasive means.

Examples: (a) hair and nail clippings in a non-disfiguring 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 non-research 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.)

VIII.  Full IRB Review Procedure

All research projects involving human subjects that do not qualify for either exempt or expedited levels of review must be reviewed and approved by the full IRB at a convened meeting. The IRB usually meets on the last Tuesday of each month with a submission deadline of two weeks prior to the scheduled meeting, but investigators are urged to submit earlier in order to allow for the possibility of negotiating changes in the proposal before the meeting of the board.

The review process.  When a proposal is received, the Coordinator appoints a primary reviewer for each proposal from among the IRB members, sends the proposal to the primary reviewer within three working days of receipt, and notifies the investigators of the identity of the primary reviewer.  The proposal and all attachments are sent to all members of the IRB at least 10 days before the meeting.  If primary reviewers have questions about proposal, they should contact the principal investigator and attempt to resolve the issues well before the meeting of the board.  Other board members should express their concerns to the primary reviewer.  

The agenda for each meeting is sent out at least 10 days before each meeting. The primary reviewer or committee chair may request the attendance of the principal investigator at the meeting to answer specific questions or investigators may check with the primary reviewer to determine whether attendance at the meeting would be helpful in avoiding delays. Principal investigators or others representing a project who wish to attend the meeting should contact the Coordinator of the Committee, Donna Peters (Office of Research Services, MS 1035, 742-3884), to arrange a time.

Meetings. A quorum, required for a valid meeting, is defined as a convened meeting at which the majority of members of the Institutional Review Board Protection of Human Subjects Committee are present, including at least one member whose primary concerns are in non-scientific areas. At meetings of the IRB, members are provided with an agenda and a list of projects granted exemptions and projects approved by expedited review. The board approves the minutes of the previous meeting, considers projects undergoing continuing review and proposed protocol changes one at a time, and receives reports of unanticipated problems involving risk to subjects or serious non-compliance.

Resubmissions are considered in the order received and then new projects are taken up in the order received where possible. The primary reviewer for each proposal summarizes the proposal and the ethical issues it entails and then leads the discussion of the project, but all members participate fully and freely. Investigators may attend the part of a meeting during which their projects are reviewed in order to answer questions from the IRB membership but cannot be present during the ensuing discussion or the final vote. IRB members with conflicts of interest may be present to answer questions posed by the IRB, but must leave the room for the discussion and voting on the proposal. The minutes note the absence of members due to conflicts of interest.

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

Approve: IRB may approve the project as submitted without any changes for a maximum period of 12 months. Projects that involve risks that require closer on-going monitoring can be approved for any period of less than 12 months at the discretion of the IRB. The decision to require a period of approval of less than 12 months is determined in the course of discussion of the proposal and is part of the motion to approve the project. Any specific findings required by 45 CFR 46 such as those needed for approval of research with prisoners (45 CFR 46.305-306), or for waivers of signed consent (45 CFR 46.117) should be documented in the minutes. Motions to approve a proposal may include a finding that the research involves no more than minimal risk, thus making the project potentially eligible for expedited continuing review. 

Minor Revisions Required: The IRB may approve a project contingent upon specific, minor modifications that require simple concurrence by the principal investigator. When the revised proposal with the changes incorporated is received by the IRB Coordinator, it will be routed to the chair or a member designated in the minutes (usually the primary reviewer) who will compare the modifications received with the actions requested by the IRB. A memo detailing and locating the changes in the proposal should accompany the submission. If the modifications are in compliance with the IRB directives, the chair or the primary reviewer will approve the project for the period of time specified by the IRB. Note: although the approval is not effective and the project may not go forward until the modifications are approved, the period of approval is a maximum of 12 months from the date of the convened meeting.          

Defer Pending Resubmission: If the IRB deems that the proposal and/or informed consent as submitted require substantive revisions, or if unanswered questions remain, it will require the investigator to resubmit the application and attachments with all of the changes required and all of the questions resolved, as detailed in an action letter sent to the investigator. In some cases, the IRB Chair may request one or more IRB members (usually the primary reviewer) to assist the investigator in resubmitting the application. If no IRB member has been designated, the investigator is urged to consult with the Chair to receive assistance in the preparation of the revision. A revised version of the proposal with the revisions incorporated will be reconsidered at the next board meeting following resubmission.

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. This action is taken only after all negotiations with the investigator have failed to result in a resolution of the pertinent ethical issues. The IRB will notify the principal investigator, the chair of the investigator’s department (or equivalent), and the Vice President for Research. Notification will include a complete rationale for the disapproval. Upon disapproval, the principal investigator has the option to revise and resubmit the project to reduce the risks to the subjects. Please note that Federal regulations specify that the administration of the University cannot approve a project which the IRB has disapproved.

Principal investigators will be notified by letter of the action of the IRB. Letters for projects approved contingently or deferred will include list of any changes required or suggested by the committee. In addition, after final approval, a letter of approval will be sent to the principal investigator. Copies of these letters will be maintained in the IRB office for review by institutional officials.

After 90 days, pending full board, expedited and exempt proposals with no response or communication will be closed.

IX.  Review Criteria

Letter and spirit both matter. The IRB cannot approve a proposal that is not consistent with the criteria set forth in 45 CFR 46 or the interpretations of 45 CFR 46 issued by OHRP (see Guidance Documents at http://www.hhs.gov/ohrp/policy/). At the same time, every project is reviewed in consideration of the more general ethical principles of respect for persons, beneficence, and justice described in The Belmont Report. The integrity and good will of investigators is assumed, but the IRB is required not only to ensure the protection of human subjects but also to document that their rights and welfare have been protected. In reviewing proposals, the IRB must determine that each one satisfies the following standards:

Risks to subjects. Risks to subjects are minimized by the use of procedures that are consistent with sound research and that do not unnecessarily expose the subjects to physical, psychological, social, economic, or other risks. In the case of research involving diagnosis or treatment, risk is minimized by the use of, whenever appropriate, procedures already in use for diagnostic and treatment purposes.

Risks vs. benefits. Risks to the subject are reasonable in relation to anticipated benefits, if any, to subjects, and to the importance of the knowledge that may reasonably be expected to result. In order to assess the importance of the knowledge resulting from the research, the IRB must be satisfied with the soundness of the rationale and the research design. The board’s concern about the scientific validity of research is in direct proportion to the risk involved. 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 did 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. When students are offered course credit for participation, there must be non-research alternatives for earning the same credit for the similar time and effort.

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.

Informed consent. Informed consent is obtained from each prospective subject or the subject’s legally authorized representative and the consent is properly documented. Informed consent is a process by which investigators assures themselves that the subjects fully understand that they are agreeing to participate in research, understand the procedures to be employed and the conditions of participation, and freely agree to participate. A signed consent form or the signature of a witness to the consent process is used to document the consent process, but does not in itself constitute a valid consent process. The IRB must be assured that explanations of the research and consent forms are readable by individuals in the proposed subject population.

Confidentiality and privacy. The research plan must provide for monitoring the data collected to ensure the subjects’ privacy and the confidentiality of the data. The board’s concerns about confidentiality are in direct proportion to the potential harm to subjects that might occur as a result of disclosure.

Other considerations. The IRB may also consider the acceptability of the research project in terms of other applicable standards of professional conduct and special vulnerabilities of the subjects.

X.  Appeals of IRB Decisions

In virtually all instances, investigators work with the IRB to reach agreement on the best ways to meet human subjects requirements while conducting research. In cases where the investigator and committee reach an impasse, a decision by the IRB to disapprove a project is final. Federal regulations specifically prohibit the University from approving a project which the IRB has disapproved.

XI.  Proposal Preparation

Only full-time or tenured Texas Tech University faculty, or any full-time employee with the terminal degree in their discipline (Ph.D., Ed.D., J.D., or M.D.) may submit proposals. Proposals for research by students, other personnel, or individuals from outside Texas Tech University must be submitted with a Texas Tech University eligible Principal Investigator (PI). faculty sponsor. All other investigators (students, other personnel, or individuals from outside TTU) must be listed as a Co-PI. Each proposal must include a completed Cover Sheet for Human Subjects Proposal and, as appropriate, a completed Claim for Exemption form, or Expedited Review Form. For full board reviews, a brief non-technical summary of the research is required. Researchers should be aware that IRB proposals may be considered to be public information in accord with the Texas open records statute. Proposals and Claims for Exemption should be submitted to Donna Peters, Office of Research Services, Mail Stop 1035.

Cover Sheets for all proposals must include a signature from the Principal Investigator’s supervisor.  The supervisory signature certifies to the IRB that the investigator is knowledgeable in the area of the proposed research and that the investigator will employ sound scientific methods in the conduct of the research. A refusal by a supervisor to sign a proposal can be appealed through the usual academic channels but not to the IRB.

Some proposals for external funding may require human subjects research approval. The decision of the IRB to approve a project rests solely on its evaluation of the IRB protocol. However, federal regulations require that proposals to the IRB for projects that are being submitted for funding from external sources must include a copy of the full text of the research grant proposal as submitted. The full research proposal is reviewed only by the primary reviewer and only to certify that it matches the protocol submitted for IRB approval. Therefore, the IRB protocol must stand on its own merits and cannot be approved on the basis of information that is available only in the full grant proposal.

Occasionally, a project already approved by the IRB is submitted for external funding. In such a case, the Office of Research Services will require verification from the IRB that the proposed research protocol is the same as the one previously approved by the IRB. The investigator should submit the grant proposal to the IRB in the form of an amendment to the original IRB proposal.  The grant proposal and the approved IRB proposal will be forwarded to an expediting reviewer who will verify that the two protocols match.

Deadlines. The Institutional Review Board/Protection of Human Subjects Committee meets monthly on the last Tuesday of each month at 3:00 pm. Proposals must be received at least two weeks in advance of the meeting. Claims for Exemption or proposals for expedited review may be submitted at any time. Normally ten working days should be allowed for processing, longer if the proposal involves children or other vulnerable populations.

IRB approval from TTUHSC and other institutions. 

(1)   Projects that involve human subjects research at both Texas Tech University and another institution need to be reviewed and approved by the other institution’s IRB as well as the Texas Tech University IRB. For projects where another institution is the primary institution, that institution’s approval letter should be submitted along with the proposal in the format required by TTU.

(2)   Research being conducted jointly by faculty at Texas Tech University Health Sciences Center (TTUHSC) and Texas Tech University (TTU) campuses may be reviewed by a single IRB. The TTU IRB designates the TTUHSC IRB as its IRB of record for projects originating at TTUHSC that use the faculty, facilities, staff, and/or students of TTU. TTU studies containing medical interventions will normally be referred to the TTUHSC IRB. TTU studies containing only psychological interventions will normally be reviewed by the TTU IRB unless TTUHSC is involved in the research. If the most appropriate assignment of an application is in doubt, the administrators and chairs of the two IRBs should reach a consensus on which IRB is most appropriate.

Proposals for Exempt Review. For a proposal to be eligible for the Exempt category, the investigator must be able to certify that the research fulfills the criteria for one of the four permissible bases defined on the Claim for Exemption form. More than one basis for requesting an exemption from continued review may be checked if the investigator believes the research qualifies under more than one category. A five-point proposal formatted document with a brief description of the research (see Appendix D) should be included. While a consent form is not generally required for exempt research by the IRB, information about the research project should be provided to the participants in order to make a reasonable judgment to participate. Investigators should be aware that consent may be required on legal, ethical, or practical grounds that do not involve the protection of research subjects. No activities involving human subjects may take place until the proposal is approved by the IRB. A completed IRB Cover Sheet for Human Subjects Proposal must be submitted with the Claim for Exemption.

Proposals for Expedited or Full Review. All proposals not categorized as Exempt research should be submitted as Expedited or Full Board. The format outlined in XII Submitting Proposals is required. Particular attention is called to the requirement to submit copies of all letters, notices, advertisements, etc., and outlines of all oral presentations to be used in recruiting subjects. A completed Cover Sheet for Human Subjects Proposals must be submitted with each proposal. Proposals for Expedited review should include the Expedited Review Form; proposals for Full Board review must include a brief non-technical summary of the research that emphasizes the procedures to be used and the risks and benefits of the research.

The rationale and the description of the procedures must be sufficient for the IRB to make a decision on the basis of the review criteria outlined above. Thus, particular attention should be directed toward the rationale for, and the details of, research procedures that involve more than minimal risk, including the risk of the disclosure of private information that might be harmful to the subject. If these sections of the proposal do not allow the IRB to judge whether risks have been minimized and are reasonable in proportion to benefits, the investigator will be asked for additional information. On the other hand, where risks are negligible or minimal (see definition above), particularly when the project falls into one of the categories suitable for expedited review, a very brief description of the rationale and procedures may be all that is necessary if it is sufficient to allow the IRB to make an informed decision about the research. Submission of unnecessary, lengthy material, such as a literature review or method sections of a dissertation proposal, may serve only to slow down the processing of a proposal. As detailed in the next section, all expedited or full review proposals must include a copy of a consent form or a request to waive the requirement for a consent form.

XII.  Submitting Proposals

Investigators should send their human subjects research proposals to the IRB Coordinator, Donna Peters (Office of Research Services, MS 1035, 742-3884) who screens all applications. As part of the initial screening process, the Coordinator may ask the principal investigator to revise the format of an application to make it suitable for review. A complete application includes the following in the order indicated:

The Coordinator will route exempt and expedited review proposals to one of the expediting reviewers. Normally, ten working days should be allowed for processing, longer if the proposal involves children or other vulnerable populations. Proposals must be received at least two weeks before each monthly meeting which takes place on the last Tuesday of each month at 3:00 pm.

Data collection may begin as soon as the human subjects research proposal has received IRB approval from the IRB Reviewer or the full board. Exemptions and proposals are approved only for the specific project as described. Any proposed changes or extensions of the project must be approved prior to their implementation by submitting new forms or memo describing minor changes (see section XVI. Amendments, below).

XIII.  Informed Consent Processes and Forms

Note: “Consent process” and “consent form” are two terms that are used frequently in this section. Although these terms are similar, they are not interchangeable. The consent process is the overall process by which the participant is made aware of the purpose, risks, benefits, etc. of the research. It certainly includes the use of a consent form, but is not limited to that alone. The consent process also may include a dialogue between the investigator and the participant, in order to insure that the participant has received sufficient information to give informed consent. The consent form is the written document that the participant signs indicating consent.

Documentation of informed consent is the most problematic issue in the review of proposals for human subjects research. The required modification of consent forms is the most frequent reason that proposals submitted for expedited or full review are deferred. However, because federal regulations (45 CFR 46.117) and applicable ethical principles from The Belmont Report are reasonably clear about the essential elements required in the consent process, delays in processing many proposals can be avoided by carefully following the guidelines in this section.

Human subjects research proposals submitted for exempt reviews do not require a consent form. However, pertinent information materials such as oral scripts, project summary sheets, etc. are required to provide adequate information to the participant to form a decision to participate.

Readability. The content of the consent form is irrelevant if subjects cannot understand it fully. Therefore, the IRB cannot approve a consent form, even if it contains all the required information, if it will not be fully understood by the individuals expected to read it. Technical material and the purpose of the study must be explained in lay terms. Procedures should be explained from the point of view of what will happen to the subject in the course of the study. The consent form should be written in the 2^nd person. A general rule of thumb used by federal regulators is that consent forms aimed at the general public should be written at a 7^th grade reading level. Adjustments up or down from that standard can be made depending on the target population of subjects. Research projects involving children either require an Assent Form or waiver of consent. The Assent Form is written in language understandable to the age level or comprehension level of the child. The Assent Form allows the child a choice to participate or not, even though the parent has given permission. Both the Consent Form (for parents) and the Assent Form (for minors) is required.

Assistance with readability and language level wording can be found at http://www.plainlanguage.gov/

(1)   Written Consent Form.

Information about a study that embodies the elements of informed consent required by 45 CFR 46.116 may be presented in a written consent form that is signed by the subject or a legally authorized representative. The form may be read to the subject or representative, but in any event, the investigator should give either the subject or representative adequate opportunity to read the form before it is signed. When consent is obtained with a full, written consent form that is understood and signed by a competent subject, no witness is required and the consent form should not contain a space for the signature of a witness. A copy of a signed consent form should be given to each participant.

Appendices F and G contains sample consent forms.

(1)   Short Form Written Consent

Information about a study may be presented in a short form written consent document that states that the elements of informed consent required by 45 CFR 46.116 have been presented orally to the subject or a legally authorized representative (e.g., Dr. Smith told me the purpose of the study; Dr. Smith told me what the risks of this study are). The short form is most useful when a study is complex and the investigator can’t be sure that a signed written consent is well enough understood to indicate a valid consent process. The short form allows the individual obtaining the consent to engage in a continuous dialog with the subject to ensure fully informed consent.

In this case, the following consent process should be followed:

(a)    The IRB must approve a written summary of the oral presentation

(b)   For the short form consent, there must be a witness to the oral presentation and the witness must sign both the short form consent form and the written summary.

(c)    The person making the oral presentation must also sign the written summary.

(d)   The subject or a legal representative must sign the short form consent form and be given a copy of both the short form and the summary.

Appendix G contains a sample short form written consent.

(1)   Internet Research

(a)    Exempt Review. Projects submitted for exempt review do not need participant consent. However, all research projects should provide necessary information to potential subjects to assist in the decision-making process to participate. This could be done in internet research by having an informational page or email letter which provides all of the required information before the participant begins the study. The Elements of Consent is a helpful guide in creating this document.

(b)   Expedited and Full Review. In internet research, the consent process must still be followed if the project undergoes expedited or full review. A possibility of conducting the consent process would be to have a check box at the end of the consent page that says, “I have read the information about this research and agree to participate.” Thus, the participants must actively check the box (indicating their consent to participate) before continuing. This fulfills the requirement of informed consent, but not for the documentation of consent. Therefore, the IRB must waive the requirement for documentation of consent before the research can be approved. Include a blank Waiver of Elements of Consent Form when submitting your proposal.

Appendix M. Electronic Data Policy Statement.

Required Elements of Consent.

The consent process, whether written or oral, must cover certain basic elements. Additional elements of informed consent may be required depending on circumstances. Appendix E contains a checklist of the required and additional elements of informed consent.  “Written Consent Format” guidelines and examples of consent forms are included in Appendix F. In order to facilitate comprehension and to make review of the form easier, the IRB strongly suggests that each paragraph of the consent form contains no more than one or two elements of consent and/or that the information headings be used (see examples in Appendix F).  The consent form should be written in the 2^nd person. If it is not, the reason should be explicitly justified.

Distribution and Storage. One copy of the consent form must be given to the subject and one copy must be retained by the investigator. The investigator must keep consent forms for a period of three years after the termination of the IRB approval.

The following items must be contained in every consent form:

Additional elements of informed consent that must be included to meet the standard of fully informed consent on the part of research subjects may involve items such as the following:

Refer to “Written Consent Format” in Appendix F for more specific information about creating a written consent form.

Waiver or Alteration of the Elements of Consent. The IRB (or an expediting reviewer operating on behalf of the IRB) may approve a waiver or alteration of the elements of consent only if it makes one of the following specific findings:

(1) The research involves the evaluation of public benefit or service programs as specified in 45 CFR 46.116(c).

(2) The research involves no more than minimal risk to the subjects; the waiver or alteration will not adversely affect the rights and welfare of subjects; the research could not be practicably be carried out without the waiver or alteration; and whenever appropriate, the subjects will be provided with additional pertinent information after participation. 

In Section V. Consent of the proposal narrative, explain the justification of the request for the waiver or alteration. Include a blank copy of the “Waiver or Alteration of the Elements of Consent” form (Appendix H) with your proposal packet. The form is for the IRB or the IRB Reviewer to document that the conditions specified are satisfied.

Waiver of Consent Form. The IRB may waive the requirement to obtain a signed consent form only if it finds one of the following: 

(1) 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. 

(2) The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.  The IRB may require the investigator to provide subjects with a written statement regarding the research in these cases. 

In Section V. Consent of the proposal narrative, explain the justification of the request for a waiver. Include a blank “Waiver of Written Consent” form (Appendix H) with your proposal packet. The form is for the IRB or the IRB Reviewer to document that the conditions specified are satisfied.

XIV.  Continuing Review,  Annual Progress Reports, and Termination of Projects

Texas Tech University’s assurance of compliance with the federal government requires at least annual review by the IRB of all expedited and full review studies involving human subjects research. As part of continuing review, the IRB has regulatory authority to observe, or have observed, the consent process and the research itself and to audit records such as consent forms at any time. When the approval for a project nears expiration, the investigator should respond to the letter sent by the IRB Coordinator. The procedures below apply depending on the level of initial review. Except for exempt projects, the investigator will be informed by letter of the outcome of continuing review.

Exempt research. Exempt research is not subject to continuing review. Any modifications that (a) change the research in a substantial way, (b) might change the basis for exemption, or (c) might introduce any additional risk to subjects should be reported to the IRB for review before they are implemented. A yearly courtesy letter is sent to the principal investigator. A response to this letter informs the IRB Coordinator when the exempt research is completed so that the file can be archived.

Timing of review. When a proposal is approved or extended by either expedited or full review, approval normally extends to the last day of the month preceding the anniversary of the approval. The anniversary is determined by the date of final approval (initial or continuing) by an expediting reviewer or the date of the convened full IRB meeting at which approval (including contingent approval) occurs, not the date of final approval of required changes. When continuing review is required for a period of less than a year, the expiration date is determined in a similar manner. 

Approximately eight weeks prior to the expiration of the approval, the IRB Coordinator will send a form, “Notice of Expiration, Progress Report, and Request for Extension” to the principal investigator. The Progress Report requires a report on the status of the project, descriptions of all adverse events affecting the rights or welfare of human subjects, and any changes contemplated in the research protocol and/or informed assent/consent forms. A complete clean proposal is required every three years if the initial proposal has been amended within the three years.

Expedited continuing review. Projects initially approved by expedited review will normally undergo expedited continuing review unless changes to the research are contemplated that might move it out of the expedited category. Because 10 working days should be allowed for processing a proposal and due to the volume of expedited reviews, prompt return of the Notice of Expiration, Progress Report, and Request for Extension form is important to ensure that the approval of a project does not lapse. Expediting reviewers will be provided with the Progress Report, the original proposal including the current consent form, any subsequent amendments, and access to the complete file on each project. Criteria are the same as for initial review, but continuing expedited review of research involving children requires review by only one expediting reviewer. At the discretion of the reviewer, independent verification that no material changes have occurred since the previous IRB review may be required.

Full board continuing review. Projects initially approved by the full board will normally undergo full board continuing review unless (a) the full board found and documented at a convened meeting that the research involved no more than minimal risk, and (2) the Progress Report identifies no additional risks. Prompt return of the Notice of Expiration, Progress Report, and Request for Extension form is important to ensure that the approval of a project does not lapse. Thus, forms that are returned at least two weeks before the last Tuesday of the month in which they were received can be reviewed one month before expiration.  Should any complications arise, this will allow the projects to be reviewed again at subsequent full board meetings.

For continuing review conducted by the full board, the primary reviewer system used for initial review is used. When deemed appropriate, protocols requesting full board review are distributed to all IRB members which include the Progress Report, current consent forms, prior amendments and the original proposal. The primary reviewer will be provided with the Progress Report, the original proposal, any subsequent amendments, and access to the complete file on each project. Criteria are the same as for initial review. At its discretion, the board may require independent verification that no material changes have occurred since the previous IRB review.

Termination. All principal investigators must maintain an active IRB-approved protocol until the project is complete. Once data have been rendered non-identifiable they no longer constitute identifiable private information and further data analysis does not require continuing approval.

If the IRB Coordinator does not receive the request for an extension by the due date noted on the form, the IRB approval automatically expires and a letter of termination is sent to the principal investigator. By not returning the form or otherwise notifying the IRB that the project has been terminated, the investigator certifies that during the preceding period of approval there were no changes to the protocol or consent form and no adverse events. Projects that continue without IRB approval or projects initiated without IRB approval are out of compliance with federal regulations and with Texas Tech University policy. In such cases a report of non-compliance will be filed with the Vice President for Research for further action. The University is required to inform OHRP of any serious or continuing non-compliance.

XV.  Reporting Adverse Events or Noncompliance

In the event of unexpected serious harm to subjects or if a project is not being conducted in accordance with a protocol approved by the IRB, or there is any other failure to conform to the requirements of 45 CFR 46 and/or these policies and procedures, the principal investigator is required to report the details of these deviations immediately to the IRB Chair. The Chair may ask the IRB to consider the matter. The IRB has the authority in such cases to suspend or terminate the research and/or to report them to the Vice President for Research. Reports to the Vice President for Research will be made as soon as possible. In the case of serious adverse events or deviations from an approved protocol, Texas Tech University is required by its assurance of compliance with the federal government to report such incidents to the federal Office for Human Research Protections. In addition, the university may need to report the events to research sponsors. Thus, the reporting requirement for investigators is an extremely serious one.

XVI.  Amendments to Approved Protocols

Changes to currently approved projects require approval by the IRB. Such modifications may include, but are not limited to changes which affect the participation of human subjects, changes to informed consent forms and/or assent forms, additional sites for conducting the research, changes in project principal investigators or key personnel, and the discovery of unanticipated risks to subjects. Substantive changes to projects must not be implemented until approval has been granted. If a project is not being conducted in accordance with the protocol approved by the IRB, the IRB has the authority to suspend or terminate its approval of the research.

In the case of minor changes to a protocol or consent form, a memo referencing the original proposal and describing the proposed changes should be filed with the IRB Coordinator who will route it for expedited review. In the case of major changes, the investigator should determine whether a memo or a new proposal should be filed. In either case, approval of the changes will be made either by expedited or full review as appropriate. The process and distribution of documents for reviewing major changes is the same as for initial review.  For proposals that have been amended, submission of a complete, clean copy that incorporates the amendments is required at least every three years.  The revised copy should be submitted with the request for extension.

XVII.  Protected Populations

The IRB has a special obligation to protect the rights and welfare of subjects who are particularly vulnerable including all those who cannot themselves give informed and legal consent. Three classes of subjects, (a) fetuses, pregnant women, and human in vitro fertilization; (b) prisoners, and (c) children are singled out in federal regulations for additional protective measures.

Fetuses, pregnant women, and human in vitro fertilization. Any research activity that may involve more than minimal risk to a fetus is covered by 45 CFR 46 Subpart B. This includes research that may pose minimal or low risk for subjects themselves, but would fall into this category should subjects be pregnant or become pregnant during the course of the study. In such cases, screening for pregnancy and exclusion of pregnant subjects is appropriate. Researchers who are doing research that is directed toward fetuses, pregnant women, or in vitro fertilization should be familiar with the requirements of 45 CFR 46 Subpart B.

Prisoners. Any research activity that involves prisoners as subjects must undergo full board review subject to 45 CFR 46 Subpart C.

The regulations require the IRB to provide additional safeguards because incarceration per se could affect the ability of prisoners to make truly voluntary and un-coerced decisions about whether to participate in research. It is required that at least one member of the IRB be a prisoner or prisoner representative in order to approve prisoner research. The Texas Tech University IRB has one member who serves on the board at meetings to represent interest in prisoner research. In order to approve research on prisoners, the board must make specific findings:

(1) The research must represent one of the four specific categories listed in 45 CFR 46.306. Except for research [see 45 CFR 46.306(2)(C and D)] on conditions affecting prisoners as a class or research that has a reasonable probability of improving the health or well-being of the subject, research on prisoners can involve no more than minimal risk or inconvenience to the subjects and can involve only research on incarceration, criminal behavior, or prisons as institutional structures [see 45 CFR 46.306(2)(A and B)].

(2) The risks in the study are commensurate with what would be accepted by nonprisoner volunteers.

(3) Any benefits to prisoner-subjects must not impair their ability to weigh risks.

(4) Selection of subjects must be fair to all prisoners.

(5) Information must be presented in language understandable to members of the population.

(6) Assurance exists that parole boards will not consider participation or refusal to participate.

(7) There must be adequate follow-up examination or care that considers the variable length of sentences and informs prisoners of this fact.

Proposals to the IRB for research with prisoners should take into consideration that the board must make these specific findings and address each of these issues specifically as part of the protocol. Researchers contemplating research in jails and prisons should consult the OHRP guidance at http://www.hhs.gov/ohrp/policy/index.html#prisoners.

Minors. Special protection is also required (see 45 CFR 46 Subpart D) for research involving individuals who have not attained the age of legal consent (18 years of age in Texas). Most notably, exemptions granted for research with adults that involves interview or survey procedures or research where public behavior is observed and the investigator participates with the subjects can not be granted to similar research projects where the subjects are minors. Moreover, it is the policy of the Texas Tech University Institutional Review Board for the Protection of Human Subjects Committee that all Claims for Exemption and proposals submitted for expedited review be approved by two expediting reviewers if the subjects are children unless the only minors involved are regularly enrolled students at Texas Tech University.

Research with children involving more than minimal risk must usually provide the prospect of direct benefit to individual subjects. Research involving no more than minimal risk is permitted only if the legal consent of parents or guardians is obtained along with the assent of the minor insofar as possible in the judgment of the IRB. Note that this provision applies even if the minor is a university student because minors are not capable of giving legal consent. Generally assent of a minor involves something analogous to a consent procedure (e.g., an assent form that must be included with a proposal) that is appropriate given the age of the subject and the circumstances of the research. Some special provisions for waiver of consent where parental or guardian permission is not reasonable (e.g., neglected or abused children) are included in the federal regulations 45 CFR 46.408.

Subjects with limited competence. Under some circumstances it is possible to conduct research with subjects who may not be competent to fully consent to research. In such cases, the consent must be signed by a legally authorized representative, if there is one, and an assent must be agreed to by the subject. When no legally authorized representative exists and the competence of the subject might be in doubt, the subject’s signature on a consent form should be validated by someone believed to be able to speak on behalf of the subject. That person (a) should be a close relative or family member or a friend of long standing, if possible, and (b) must also sign a declaration stating that s/he knows the subject well enough to be able to express the subject’s wishes.

XVIII.  Education/Training

In addition to the obligation of the IRB to educate the Texas Tech community generally about issues of human subjects research ethics, principal investigators on NIH projects are specifically required to document the completion of training on human subjects protection for themselves and for key personnel before funds are released. Generally, such documentation is obtained by the completion of a computer-based educational module (http://www.cancer.gov/clinicaltrials/learning/) provided by NIH through the Office of Research Services at the time a proposal is submitted to NIH. Other investigators are encouraged to complete the same training. In any case, all investigators and members of their research teams are required to be familiar with The Belmont Report and the federal regulations at 45 CFR 46.

XIX.  Amendments to Policies and Procedures

The Texas Tech University Protection of Human Subjects Committee adopted these procedures on October 30, 2001. Except for minor alterations or changes needed to comply with Federal regulations and guidance, this document can be changed only by a vote of the majority of members present at a meeting of the Protection of Human Subjects Committee.  Proposed amendments must be presented with the meeting agenda.
 

This page was last updated on 09/09/2008 
Copyright?Office of Research Services
mail your comments to webmaster