12/22/2014 11:27:51 AM::This is a test of the Viterbo alert system. this is only a test.

Viterbo University’s website and many of our communication systems such as email and telephone services will be unavailable for parts of Saturday, July 26. In case of emergencies please email viterbohelpdesk@gmail.com

Institutional Research Board

Header Image

II: Fundamental Guidelines


A. Ethical Principles

The use of human subjects in research is extremely important to the development of new knowledge in many areas. However, careful attention must be given to questions of ethics and human dignity whenever humans are subjects in research.

In 1978, the National Commission for the Protection of Human Subjects in Biomedical and Behavioral Research developed broad ethical principles to provide a basis on which specific rules could be developed. These principles are discussed in The Belmont Report, from which the following sections are excerpted:

Three basic principles are particularly relevant to the ethics of research involving human subjects: respect for persons, beneficence, and justice.

Respect for Persons

Respect for persons incorporates at least two basic ethical tenets: first, that individuals should be treated as autonomous agents, and second, that persons with diminished autonomy are entitled to protection. The principle of respect for persons thus divides into two separate moral requirements: the requirement to acknowledge autonomy and the requirement to protect those with diminished autonomy.

To respect autonomy is to give weight to autonomous persons' considered opinions and choices while refraining from obstructing their actions unless they are clearly detrimental to others. Respect for the immature and the incapacitated may require protecting them as they mature or while they are incapacitated.

Except in rare cases, respect for persons demands that subjects enter the research voluntarily and on the basis of adequate information about the research situation and possible consequences.

Beneficence

Persons are treated in an ethical manner not only through respecting their decisions and protection them from harm, but also by making efforts to secure their well-being. Such treatment falls under the principle of beneficence. Two general rules have been formulated as complementary expressions of beneficent actions in this sense: first, do no harm and second, maximize possible benefits and minimize possible harms. Learning what will, in fact, benefit may require exposing persons to risk. The problem posed by these imperatives is how to decide when it is justifiable to seek certain benefits, despite the risks involved, and when the possible benefits should be foregone because of the risks.

The obligations of beneficence affect both individual investigators and society at large, because they extend both to particular research projects and to the entire enterprise of research. In the case of particular projects, investigators and members of their institutions are obliged to give forethought to the maximization of benefits and the reduction of risks that might occur from a research investigation. In the case of scientific research in general, members of the larger society are obliged to recognize the longer term benefits and risks that may result from the improvement of knowledge and from the development of novel medical, psychotherapeutic, and social procedures.

Justice

Who ought to receive the benefits of research and bear its burdens? This is a question of justice, in the sense of "fairness in distribution" or "what is deserved." An injustice occurs when some benefit to which a person is entitled is denied without good reason or when some burden is imposed unduly. The selection of research subjects needs to be scrutinized in order to determine whether some groups (e.g., welfare patients, racial or ethnic minorities, persons confined to institutions, students, children, pregnant women, fetuses) are being systematically selected simply because of their easy availability, their compromised position, or their manipulability, rather than for reasons directly related to the problem being studied. Especially when research supported by public funds leads to the development of therapeutic devices and procedures, justice demands that these not provide advantages only to those who can afford them and that such research should not unduly involve persons from groups unlikely to be among the beneficiaries of subsequent applications of the research. 

B. Definitions and Policies

The policies regarding research with human subjects use terms that may need further definition or explanation. For example, it may not be clear under applicable regulations whether a project constitutes research or a person is a subject. The following sections provide regulatory guidance:

Human Subject

The term human subject means a living individual about whom an investigator conducting research obtains data through intervention or interaction with the individual, or obtains individually 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 a subject that occurs in a context in which an individual can reasonably expect that no observation or recording is taking place. It also refers to information that has been provided for specific purposes by an individual with the reasonable expectation that it will not be made public (for example, a medical record).

Information is individually identifiable if the identity of the subject is or may be readily ascertained by the investigator or associated with the information.

Research

For IRB purposes, research is defined as a systematic investigation, inquiry, or analysis—such as scholarly or critical study or inquiry or scientific investigation, development, testing, or evaluation—designed to develop or contribute to generalizable knowledge. Research includes activities that aim to test a hypothesis, discover or collate facts, principles or effects, reach new conclusions, or reexamine information by the critical study of a subject or by a course of scientific inquiry. Examples of human subjects research include:

  1. studies in which a substance or stimulus is administered to a subject, and responses or states are measured;
  2. studies that involve changes in the subject's physical or psychological state or environment, or changes in diet;
  3. interviews, surveys, tests, inquiries, and observations designed to elicit or obtain nonpublic information; and
  4. studies of existing records where the identity of the subjects is known or could be readily ascertained by the investigator(s) (through an existing code or identity key).

Activities which meet this definition constitute research for purposes of human subjects policies, whether or not they are considered research for other purposes. For example, some demonstration and service programs may include research activities.

If results are not disseminated (e.g., published, presented, or shared) externally (i.e., outside the Viterbo University campus), the term research is not intended to apply to data acquisition resulting from:

  1. routine course, workshop, or curriculum development activities using accepted educational practices sponsored by Viterbo University (VU), including evaluations to determine student or participant satisfaction, attitude change, or knowledge gained during the educational experience; or
  2. aid or services provided by professionals to their clients that are consistent with accepted and established practice, and intended only to meet the clients' own personal needs.

If results from these activities are disseminated externally, the activities constitute human subjects research and must receive IRB approval. Plan accordingly, there is no retroactive approval.


Responsible Principal Investigator

Under VU policy, the responsible principal investigator (RPI) is a qualified, nonvisiting member of VU faculty or staff who will serve as the project supervisor or representative at VU. The RPI is directly responsible for submitting the IRB application, amendments to the approved research, and all continuing renewal reports. The RPI is also responsible for supervising and monitoring the activities outlined in the approved research protocol and for ensuring that all co-investigators follow the VU human subject training policy. Visiting personnel, including postdoctoral researchers, interns, and faculty on leave from other campuses, may not serve as the RPI on a human subject research protocol.

Voluntariness and Recruitment

Ethical, professional, federal, and campus guidelines for human subjects research all require the voluntary participation of the subject. The subject must give her or his agreement to participate in the research based upon adequate knowledge and an understanding of relevant information, under circumstances that minimize the possibilities of coercion or undue influence. 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 questions about the research.

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 autonomy 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 (e.g., 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.

If access to research subjects is gained through cooperating institutions not under the control of the Viterbo University, the institution(s) must be identified on the IRB application and evidence provided that the authorized official of that institution is or will be informed of the study. Documentation of the institutional approval may be required.

VU Subject Pools

No VU department may establish a student subject pool without prior written authorization from the IRB Office. When VU students are enrolled in a course in which participation as human subjects forms an integral part of the course, the official University course catalogue and timetable shall state that fact in the course description. 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.

Informed Consent

No investigator may involve a human being as a subject in research unless legally effective informed consent is first obtained from the subject or from their legally authorized representative. Investigators must seek consent only under circumstances that provide sufficient opportunity for the subject or their representative to consider whether or not to participate.

The IRB may consider a waiver or alteration of the informed consent requirement only if all four of the following are true:

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


Documentation of Informed Consent

Under federal regulations, informed consent must be documented by the use of a written form approved by the IRB and signed by the subject or their legally authorized representative. The consent form may be a comprehensive written document that embodies the federally required elements of informed consent, or a short form stating that the required elements of informed consent have been presented orally to the subject or their representative. In either case, a copy of the form must be given to the subject or their representative.

The IRB may consider a waiver or alteration of these requirements only 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; or
  2. that the research presents no more than minimal risk of harm and involves no procedures for which written consent is normally required outside the research context.

Within federal guidelines, the methods used to obtain consent may vary. They should be designed to fit the nature of the research, the nature and magnitude of the risks involved, the research setting, the nature of the subjects who will participate, and the requirements of applicable policies, laws, and regulations. If appropriate justification is given, an oral process may be approved by the IRB.

Essential Elements of Informed Consent

The required elements of a consent document follow (printable version available in Word, pdf), though not all items will be applicable to every project. It cannot be overly stressed that the language used in every consent form or script must be understandable to the subject or their representative. Commonly, IRB approval of research is delayed over inadequate consent forms that have either too much or too little information, that are confusing, or that are written above the average subject's reading level. Consent forms should be written for the average participant's level of understanding, by keeping in mind the 8th grade reading level of the average American adult, and by being careful to avoid technical language or terminology. Every form should contain the following essential elements:

  • a statement that the study involves research, an explanation of the purposes of the research and the expected duration of the subject's participation, a description of the procedures to be followed, and identification of any procedures which are experimental; a description of any reasonably foreseeable risks or discomforts to the subject;
  • a description of any benefits to the subject or to others which may reasonably be expected from the research;
  • a disclosure of appropriate alternative procedures or courses of treatment, if any, that might be advantageous to the subject;
  • a statement describing the extent, if any, to which confidentiality of records identifying the subject must be maintained;
  • for research involving more than minimal risk, an explanation as to the availability of medical treatment in the case of research-related injury, including who will pay for the treatment and whether other financial compensation is available;
  • an explanation of whom to contact for answers to pertinent questions about the research and research subjects' rights, and whom to contact in the event of a research-related injury to the subject;
  • a statement that participation is voluntary, refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled;
  • an explanation of whom to contact to voice concerns or complaints about the research.
  • contact information for the IRB to obtain answers to questions about the research; to voice concerns or complaints about the research; to obtain answers to questions about their rights as a research participant; in the event the research staff could not be reached; and in the event the subject wishes to talk to someone other than the research staff.

Additional elements of informed consent to be applied, as appropriate:

  • Anticipated circumstances under which the subject’s participation may be terminated by the investigator without regards to the subjects' consent. Example: when there is an established research procedure such as a dietary study where the participants have to follow a strict dietary regimen. There is a reasonable likelihood for such protocols that some participants may not adhere to the regimen.
  • Any additional costs to the participant that might result from participation in the research. Example: this statement would be required to appear on the consent document whenever participants could potentially be traveling from outside of the immediate La Crosse (or other research area for studies conducted by VU researchers) and might incur gas expenses that would not be compensated.
  • The consequences of a participant’s decision to withdraw from the research. It is especially required on any protocol involving VU students, staff, and faculty as participants to indicate that their decision to withdraw will have no effect on the participants' current status or future relations with the Viterbo University. Any protocol that involves any form of compensation (monetary, gift card, course credit) must have a statement regarding whether or not the participant would still earn the compensation if they withdrew from the study, would lose the compensation, or whether it would be prorated.
  • Procedures for orderly termination of participation by the participant. Example: this statement could be required on consent documents for protocols that involve more than one session. In those cases, an explanation of what will happen to the data if the participant withdraws should be included.
  • A statement that if the participant was to become pregnant, the particular treatment or procedure might involve risks to the embryo or fetus, which were currently unforeseeable.
  • A statement that significant new findings developed during the course of the research which might relate to the participant’s willingness to continue participation would be provided to the participant.
  • The approximate number of participants involved in the study. Example: When the number of participants is relatively small in number and the information being collected from the participants is potentially sensitive in nature, then the number of subjects should be included on the consent document.

Policy for Date-Stamping Approved Consent Forms

Consent forms must bear a stamp showing the expiration date of the project's approval. The expiration date is determined by the IRB and applied to an original copy of each approved consent form. The stamped form(s) are sent to the responsible project investigator and copies of these date-stamped forms must be used in obtaining informed consent, then retained for a period of at least three years after the research is finished. It's possible that consent forms might contain information (e.g., names, phone numbers, locations) that will vary with time or with the circumstances of the project. The IRB Office must be informed in writing of any such variables in consent forms and must approve revisions before new forms are used.


Assent of Children and the Consent of their Parents

Children must provide assent to participation when, in the judgment of the IRB, the children are capable of providing assent. Assent is defined as the voluntary agreement of a person not legally able to give consent. In determining whether children are capable of assenting, the IRB shall take into account the age, maturity, and psychological state(s) of the children, either individually or as a group. Children under age 8 may give assent orally or by the act of participating in cases involving infants or very young children. Children who can read, generally thought to be those 8-18 years old, should provide assent by signing a written form unless the VU IRB committee approves a different process.

In addition to the assent of the children, regulations require legally effective informed consent from the parents or the legally appointed guardian of all children who are subjects in research. The consent of just one parent is allowed if the research presents no greater than minimal risks or if it holds out the prospect of providing direct benefits to the child. If the research presents greater than minimal risks and no prospect of direct benefit to individual subjects, the consent of both parents is required, unless one parent is deceased, unknown, incompetent, not a legal custodian, or not reasonably available.

Informed Consent in Ethnographic Research

Fieldwork and ethnographic research typically involves observation of and interaction with groups of subjects in their own environment, often over long periods of time. It may not be possible to specify in an informed consent statement the detailed contents of the experimental protocol, as the research itself may involve continuing interactions between the researcher and hosts that are difficult to describe prior to initiation of the research. Differences in language or culture may preclude the use of a written or formal consent agreement. If appropriate justification is given, the IRB committee may waive the requirement for formal, written consent in these cases. The American Sociological Association (www.asanet.org) and the American Anthropological Association (www.aaanet.org) have developed guidelines that address ethical issues in research, including informed consent. Investigators conducting research in these disciplines should consider those guidelines when designing their protocol.

Confidentiality and Anonymity

Confidentiality and anonymity are not the same. If anyone, including the investigator, can readily ascertain the identity of the subjects from the data, then the research is not anonymous and the IRB committee must determine if appropriate protections are in place to minimize the likelihood that the information will be inappropriately divulged. The level of confidentiality protections should be commensurate with the potential of harm from inappropriate disclosure.

  • Questionnaires, inventories, interview schedules, and other data-gathering instruments and procedures should be carefully designed to limit the personal information to be acquired to that which is essential, and should be administered using procedures that will protect the subject's privacy.
  • Information that could reveal a subject's identity should be securely stored in files accessible only to the project investigator and authorized staff.
  • As early as feasible, data should be coded to remove identifying information and identifiers destroyed.
  • The identity of subjects must not be released except with their express permission. This includes audio tapes, videos, photos, or other images (e.g.,MRI, CT scan) that either show the subject's face or would divulge unique or identifying features. Subjects should always be told during the informed consent process if their likeness or other unique or identifying features will be imaged and how the images will be used. Explicit consent must be obtained for any public use of such images (including uses in the classroom, on the World Wide Web, or as part of a presentation of the research results), since publication would otherwise constitute a breach of the basic confidentiality requirement.
  • Use of existing data that were originally obtained for different purposes and that involve identifiable subject information requires examination of the risks 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.
  • The identity of research subjects or research data can be sought under a subpoena. Any investigator served with a subpoena should immediately contact the Office of University Legal Counsel and the IRB Chair for assistance. For studies involving the collection of data on sensitive matters or involving criminal activities, the investigator should consider obtaining a federally granted Certificate of Confidentiality, which will provide some protection even against a subpoena for research data.
  • If research data is sought under the Freedom of Information Act, investigators should contact the Viterbo University Vice President for Communications and Marketing, Vice President for Academic Affairs, and the IRB Chair.
  • Mandated reporters are required by law to report instances of suspected child or elder abuse or neglect or instances where a research subject is in danger of harming himself/herself or others. The circumstances where confidentiality will be broken should be conveyed in the consent form. Any investigator may feel ethically bound to break confidentiality in case of suspected abuse or neglect, and this should be made clear to research participants.


Research Risks and Benefits

There are different risks inherent in different research procedures. All risks must be thoroughly described and assessed in the investigator's application for IRB approval and minimized during the research. For purposes of safeguarding human subjects and according to federal guidelines, 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 and the specific risks that are possible may be most obvious in procedures requiring physical intervention or involving strenuous exertion. The researcher must specifically describe such risks to both the IRB committee (on the IRB application form) and to the subject (during the consent process and at appropriate points throughout the research) who is considering participation in the research. If, during the course of the research, the researcher becomes aware of new information about risks, he or she must notify both the IRB committee and the subjects who are enrolled in the research so that they can reassess the risk-benefit ratio applicable to research participation.

There is a wide range of medical, social, and behavioral research protocols that may pose no immediate physical risk to the subject but that may involve varying degrees of emotional stress, deceit, or invasion of privacy. If a subject's dignity, self-respect, psyche, emotions, reputation, employment, financial standing, or criminal or legal status would be adversely affected through either participation in the research or as a result of a breach of confidentiality with regard to the research results, then the subject is at risk from the research.

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, course credits 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 during the IRB review of research protocols.

Adverse Events and Unanticipated Problems Involving Risks to Subjects or Others

Federal regulations require organizations to have written policies and procedures to ensure the prompt reporting of unanticipated problems involving risks to subjects or others to the IRB committee, appropriate institutional officials, and regulatory agencies.

Definitions:

Unanticipated Problem Involving Risks to Participants or Others (for simplicity, unanticipated problems involving risks to subjects or others will be referred to as unanticipated problems in this policy): Any event or information that (1) was unforeseen and (2) indicates that the research procedures (i.e. related to the research) caused harm to participants or others or indicates that participants or others are at increased risk of harm.

Adverse event: Any physical, psychological or social harm to subjects during the course of research.

Unexpected: An event is unexpected when its specificity and severity are not accurately reflected in the IRB application documents or in the informed consent document.

Related to the research: An event is related to the research procedures if it was more likely than not to be caused by the research procedures or if it is more likely than not that the event affects the rights and welfare of current participants.

Reporting Adverse Events and Unanticipated Problems

Principal investigators must report the following types of events to the IRB as soon as possible:

  • Adverse events which in the opinion of the principal investigator are both unexpected and related to the research.
  • An unanticipated event related to the research that exposes individuals other than the research participants (e.g., investigators, research assistants, students, the public, etc.) to potential risk.
  • Information that indicates a change to the risks or potential benefits of the research. For example: a) An interim analysis or safety monitoring report indicates that frequency or magnitude of harms or benefits may be different than initially presented to the IRB; b) A paper is published from another study that shows that the risks or potential benefits of your research may be different than initially presented to the IRB.
  • A breach of confidentiality.
  • Incarceration of a participant in a protocol not approved to enroll prisoners.
  • Change to the protocol taken without prior IRB review to eliminate an apparent immediate hazard to a research participant.
  • Complaint of a participant when the complaint indicates unexpected risks or cannot be resolved by the research team.
  • Protocol violation (meaning an accidental or unintentional change to the IRB approved protocol) that harmed participants or others or that indicates participants or others may be at increased risk of harm.
  • Event that requires prompt reporting to the sponsor.
  • Sponsor imposed suspension for risk.

The IRB committee will accept other reports when the investigator is unsure whether the event should be reported.

Events that result in death, life-threatening experiences, hospitalization, or disability must be reported to the IRB committee within 24 hours after discovery. All other unanticipated problems should be reported to the IRB committee within 5 working days. Principal investigators should report the above events using the Unanticipated Problems Event form. Reports may be accepted by other means such as e-mail or phone.

Unanticipated problems are reported at the regular IRB meeting and note whether or not they caused risk to the participants or to others. If the event has caused unexpected risk as a result of the research, the IRB committee will determine if procedures need to be changed and whether or not other participants should be contacted. This will be reported in the minutes.

Adverse Events from Exercise Testing

The following protocol should be used by all VU researchers for categorizing and reporting adverse outcomes resulting from exercise testing:

  1. Qualified, attending medical personnel will categorize the test outcomes (including posttest events) as one of the following, using the criteria that follow:
    1. Benign events that fall within the "normal" set of outcomes for the tests;
    2. "Abnormal" outcomes that do not, by themselves, warrant termination of the test and that do not cause the subject to stop the test or complain; or
    3. Adverse Events or Serious Adverse Events that are not "normal" outcomes, that warrant termination of the test, or that cause the subject to complain or terminate the test of their own volition.
  2. In Type III events, the test will be immediately terminated and the subject attended. As needed, this could include on-site medical treatment, referral to hospital for immediate follow-up care, or call for Emergency Medical Services (EMS), transport to hospital, and emergency treatment. Except where EMS are involved, the subject will be asked to stay at the testing lab for observation for at least half an hour after his or her condition is stable.
  3. In all Type III cases, the research staff will attempt to contact the subjects' personal physician (or the person covering his or her practice, as available) by phone, to apprise him or her of the test outcome and the treatment given. Except where EMS are involved, this first phone call will be made after the subject is stable and before the subject leaves the testing lab. If no person-to-person contact can be made with the subject's physician (or their substitute) within this time frame, this fact will be documented and repeated attempts will be made and documented until contact is made.
  4. Within 48 hours of the test, for both Type II and III events, the outcomes, treatments, and documentation of phone calls and other correspondence (e.g., with EMS) will be described in a written report to the subject's personal physician in a recorded delivery letter, copied to the subject.
  5. All Type III events must be reported to the IRB by e-mail (irb@viterbo.edu) within 24 hours of the event and described on an Adverse Events form (with physician reports attached) that is submitted within 5 days of the event.
  6. The number of Type II and III events should be reported by the Responsible Principal Investigator (RPI) in every project's renewal report for continuing review.


Criteria for Categorizing Exercise Test Outcomes

Type II Indications—"Abnormal" outcomes that do not, by themselves, warrant terminating the exercise test

  • Occasional premature beats at rest and which are more frequent with exercise, or the appearance of a new but nonsustained arrhythmia.

Type III Indications—Adverse Events or Serious Adverse Events that should result in terminating the exercise test*

Absolute Indications

  • Drop in systolic blood pressure of 10 mm Hg or more from baseline blood pressure despite an increase in workload, when accompanied by other evidence of ischemia
  • Moderate to severe angina
  • Increasing nervous system symptoms (e.g., ataxia, dizziness, or near syncope)
  • Signs of poor perfusion (cyanosis or pallor)
  • Technical difficulties monitoring the ECG or systolic blood pressure
  • Subject's desire to stop
  • Sustained ventricular tachycardia
  • ST elevation (1.0 mm Hg or more) in lead without diagnostic Q-waves (other than V1 or a VR)

Relative Indications

  • Drop in systolic blood pressure of 10 mm Hg or more from baseline blood pressure despite an increase in workload, in the absence of other evidence of ischemia
  • ST or QRS changes such as excessive ST depression (>2 mm horizontal or downsloping ST-segment depression) or marked axis shift
  • Arrhythmia other than sustained ventricular tachycardia, including multifocal PVCs, triplets of PVCs, supraventricular tachycardia, hear block or bradyarrhythmia
  • Fatigue, shortness of breath, wheezing, leg cramps, or claudication
  • Development of bundle-branch block or intraventricular conduction delay that cannot be distinguished from ventricular tachycardia
  • Increasing chest pain
  • Hypertensive response (systolic bp of more than 250 mm Hg and/or a diastolic BP of more than 115 mm Hg)

* From ACSM's Guidelines for Exercise Testing and Prescription, 6th edition

 

Summary of Exercise Test Reporting Protocol

Event Type Description Research Team Action Report to Subject's MD Report to IRB
I Benign events that fall within the "normal" set of outcomes for the tests Continue tests as planned Send First Class letter within 48 hours of test In aggregate in renewal report
II "Abnormal" outcomes that do not, by themselves, warrant termination of the test and that do not cause the subject to stop the test or complain Continue tests as planned, observe subject for 30 more minutes Send Recorded Delivery letter within 48 hours of test In aggregate once per month and in renewal report
III Adverse Events or Serious Adverse Events that are not "normal" outcomes, that warrant termination of the test, or that cause the subject to complain or terminate the test of their own volition Stop tests, observe subject for 30 more minutes after stable, attend or call EMS as needed Call patient's personal MD after patient is stable and before subject leaves testing lab (except in EMS cases), or make repeated attempts until person-to-person contact is made; and send Recorded Delivery letter within 48 hours of test By phone within 24 hours, on Adverse Event form within 5 days of event, and in aggregate in renewal report

Record Retention

All records relating to the IRB and to human subjects activities should 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 VU, HHS, or the specific agencies sponsoring the research.


C. VU Policy Statement

Consult the VU Investigator Handbook, the IRB Web site (www.irb.viterbo.edu), and other formal VU policy documents for details. This is a summary statement.

Applicability of the Policy

This policy applies to any human subjects research activity that is conducted by any VU employee or agent, or otherwise conducted at or sponsored by the Viterbo University, irrespective of the risks, scope, funding, or location of the research. The policy is applicable to research involving living human beings whose physical, emotional, or behavioral conditions, responses, speech, tissues, or fluids are investigated for research purposes. It is applicable to the use of interviews, tests, observations, and inquiries designed to elicit or obtain nonpublic information about individuals or groups. It also applies to the study of existing records where the identity of individuals is known or could be readily ascertained, if the information was provided by the individual(s) under the reasonable expectation that it would not be made public (e.g., a medical record).

The policy is applicable to research undertaken on either a large or small scale, whether it is externally funded, internally funded, or not funded, and regardless of where it occurs. Pilot projects, student dissertation and thesis projects, and independent study projects must follow this policy if they involve human subjects.

Summary Statement of the Policy

Viterbo University recognizes its basic responsibility to ensure the protection of human subjects. To this end, it has adopted the following statement of policy applicable to all research involving human subjects that is conducted at or sponsored by VU or conducted by any VU employee or agent:

  1. Anyone responsible for such research must
    • adhere to the principles of respect for persons, beneficence, and justice embodied in the Belmont Report;
    • adhere to all VU policies and procedures set forth in the VU Handbook for Investigators and elsewhere;
    • adhere to the policies, principles, and procedures set forth in the VU’s Federalwide Assurance, on file with the Office for Human Research Protections; and
    • adhere to all applicable federal, state, and local requirements for the conduct of human subjects research.
  2. The decision of human subjects to participate in research governed by this policy must meet the standards of informed consent. If children are involved as subjects and are capable of assent, their assent to participate must be solicited in addition to the consent of their parents. The decision to participate must be
    • voluntary—it must occur as the result of free choice, without compulsion or obligation;
    • based on full disclosure of the information needed to make an informed decision about whether or not to participate; and.
    • based on the subject's comprehension of the information provided.
  3. The selection of research subjects must be fair. Subjects should not be selected for potentially beneficial research on the basis of favoritism, nor should risky research be targeted to subjects who are less powerful.
  4. The procedures for recruiting subjects must protect their privacy and be reasonable in terms of their conditions or circumstances. No coercion, explicit or implicit, should be used to obtain or maintain cooperation.
    • Any payment made to subjects should not be so large as to constitute excessive inducement for participation.
    • When access to subjects is gained through cooperating institutions or individuals, prior commitments made to the subjects about the confidentiality or other terms of the primary relationship should not be abridged.
  5. Risks to subjects must be minimized and should be justified by the anticipated benefits to the subject or society.
  6. Adequate provision must be made to protect the privacy of subjects and to maintain the confidentiality of identifiable information.
  7. Approval for conducting research with human subjects must be obtained prior to any involvement of subjects. All such research must be reviewed by the VU Institutional Review Board (IRB) or an approved entity appropriately delegated by the IRB committee. All approved projects must be periodically reevaluated.
  8. This policy does not generally apply to routine course, workshop, or curriculum development using accepted educational practices sponsored by the Viterbo University or to aid or services provided by professionals to their clients.

Site Name