Michigan Tech–IRB Tutorial

Institutional Review Board (IRB) for the Protection of Human Subjects

 

 

Final DHHS Regulations

On January 13, 1981, Secretary Patricia Harris signed the new regulations. They were published in the Federal Register on January 16, 1981.

On research not funded by PHS, DHHS reached the following conclusion:

The DHHS General Counsel has advised that there is no clear statuary mandate in the National Research Act to support a requirement for IRB review of other than PHS funded research.

Since the purpose of the regulation is that protection of the rights and welfare of human subjects, it is of crucial importance that institutions seeking DHHS funds for research demonstrate their willingness to afford human research subjects protections regardless of the source of funding. The Department feels strongly that the public funds for research involving human subjects should not be awarded to institutions which are unwilling to demonstrate their dedication to this principal.

 

Committee for the Protection of Human Subjects 

July 21, 1980

The Committee was established early in 1974, having the following charge:

"The Committee for the Protection of Human Subjects will be responsible for establishing and maintaining suitable criteria and procedures for reviewing and approving projects at Michigan Tech involving humans subjects. It will be responsible for reviewing and approving, both at the proposal stage and during execution, intra-University and sponsored and un-sponsored projects where humans may be involved. The Michigan Tech Committee's criteria and procedures shall in no event be less stringent that the requirements of the US Department of Health and Human Services whose policies on this matter we are attempting to carry out."

A copy of "Code of Federal Regulations, 45 CFR 46, Protection of Human Subjects," dated November 6, 1975 can be found at: http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm

 

Sec. 46.107 IRB Membership

Each IRB shall have at least five members, with varying backgrounds

No IRB may consist entirely of men or entirely of women, or entirely of members with one profession

Each IRB shall include at least one member whose primary concerns are nonscientific areas

Each IRB shall include at least one member who is not otherwise affiliated with the institution and who is not part of the immediate family of a person who is affiliated with the institution

No IRB may have a member participating in the IRB 's initial or continuing review of any project in which the member has a conflicting interest

An IRB may invite individuals with competence in special areas to assist in the review of complex issues

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Michigan Tech-IRB 

For more information, contact:

  • Cheryl Gherna, Coordinator, Research Integrity and Compliance Office, Michigan Tech
  • Joanne Polzien, Director, Research Integrity and Compliance Office, Michigan Tech

Application forms necessary to use human subjects in either research or classroom situations:

For questions, please contact Joanne Polzien at 906/487-2902 or jpolzien@mtu.edu.

 

Responsibilities of the IRB 

The Institutional Review Board at Michigan Tech is responsible for the protection of subjects participating in research. In reviewing research proposals, the IRB gives extensive consideration to each of the following components:

  • Potential risks (physical, psychological, social, or economic) to research participants.
  • Anticipated benefits to the subjects and others.
  • The importance of the knowledge that may be reasonably expected to result from the research.
  • The consent process to be employed.

 

Definitions 

Research—A systematic investigation designed to develop or contribute to generalized knowledge. Activities which meet this definition constitute "research" for purposes of these regulations, whether or not they are supported or funded under a program which is considered research for other purposes. For example, some 'demonstration' and 'service' programs may include research activities.

Research is the former plus "any dissemination of findings to a scientific audience including, but not limited to, honor's, master's, and doctoral theses; presentation at a scientific meeting or conference; submission to or publication, paper or electronic, in a scientific journal; and Internet postings." This is applicable to all research, whether sponsored or un-sponsored, conducted under the auspices of the University.

Human Subject—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.

Minimal Risk—The risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests.

 

Activities Requiring Review and Approval by the IRB 

All research protocols involving human subjects or human materials must be approved the Michigan Tech Institutional Review Board (IRB) prior to the research being conducted. The type of IRB review required depends on the level of risk to subjects as defined in 45 CFR 46. The IRB must review and approve all research involving human subjects if one or more of the following apply:

  • The research is sponsored by Michigan Tech, regardless of the location of the project.
  • The research is conducted by, or under the direction of, any staff, faculty, student, or other agent of Michigan Tech.
  • The research is conducted using any Michigan Tech property or facility.
  • The research involves the use of Michigan Tech's non-public information to identify or contact human research subjects or prospective subjects.

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Categories of IRB Reviews 

All research activities involving human subjects must be evaluated to determine the type of IRB review needed. There are three categories of review: exempt, expedited, or full committee review.

If the project presents no more than minimal risk to the participants involved and, in addition, it does not compromise the privacy or confidentiality of the participants involved, it may be exempt from formal review.

If the project can be completely described by one or more of the exempt review categories, it may qualify for an exemption from committee review. If all of the procedures carried out are described within the list of exempt activities, the IRB may exempt the proposal from formal review. However, if any of the activities to be carried out are not to be found on this list, the project will require either an expedited or full committee review.

If the activity does not qualify for exempt status, but it presents no greater than minimal risks to subjects, it may qualify for expedited review. In an expedited review, the application is sent for designated member review. If the designated reviewers feel that the activities present no more than minimal risks to subjects and the procedures follow federal guidelines, approval may be granted without a formal review before the whole committee. However, if a reviewer has concerns about potential risks to subjects or proposed procedures, the proposal will be referred for full committee review.

If the project does not qualify for exempt or expedited review, it will be referred to the whole committee for formal review. If the committee requests it, investigators should be prepared to explain and provide a rationale for all procedures and to discuss the risks and benefits of the proposed research.

 

Categories of Research That May Be Exempt from Coverage 

Research conducted in established or commonly accepted education settings, involving normal education practices.

  • Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information from these sources cannot be identified directly or indirectly through identifiers linked to the subjects
  • Research involving survey or interview procedures, except where any one of the following conditions exist:
    • Responses are recorded in such a manner that the human subjects can be identified directly or indirectly.
    • The subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability.
    • The research deals with sensitive aspects of the subject's own behavior (i.e. illegal conduct, drug use, sexual behavior, or use of alcohol). Except for elected or appointed officials or candidates.
  • Research involving the observation of public behavior, except where any one of the following conditions exist:
    • Observations are recorded in such a manner that the human subjects can be identified.
    • The observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability or be damaging to the subject's financial standing or employability.
    • The research deals with sensitive aspects of the subject's own behavior (i.e. illegal conduct, drug use, sexual behavior, or use of alcohol).
  • Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that the subjects cannot be identified.
  • Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed, or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

 

Minimizing Risks to Subjects 

Psychological Harm—includes undesirable changes in cognition and emotion, such as feelings of stress, depression, guilt, embarrassment, or loss of self-esteem. These changes, usually transitory, can arise simply from thinking or talking about one's own behavior or attitudes on sensitive topics or from filling out a questionnaire. Stress may be induced when researchers manipulate the subjects' environment (such as staging fake emergencies or fake assaults; by providing false feedback about subjects' performances, abilities, or personality; by deceiving subjects in other ways). The use of deception is justifiable only when using deception is the only way to answer the research question. In most instances when deception is used, subjects later need to be debriefed as to the nature of the deception, but this determination is made on a case-by-case basis.

Social and Economic Harm—includes invasions of privacy and breaches of confidentiality, which may result in embarrassment within one's business or social group, loss of employment, or criminal prosecution. Areas of particular sensitivity include information related to alcohol or drug consumption, mental illness, illegal activities, and sexual behavior. Some information about individuals could label or stigmatize subjects' standing in the community and could adversely affect present or future employment or eligibility for insurance.

Physical Harm—includes the potential of pain, discomfort, or injury from physical or medical procedures. Researchers must be aware of the potential for negative consequences from changes in any underlying conditions from which the subject may suffer.

 

Elements of Informed Consent

Voluntariness—an investigator must provide the prospective subject or the subject's representative sufficient opportunity to consider whether or not to participate without coercion or undue influence.

Comprehension—the information that is given to the subject or the subject's representative shall be in language understandable to the subject or the representative.

Information—includes specific items for disclosure intended to assure that subjects will be given sufficient information (procedures, purposes, risks, anticipated benefits, alternative procedures (if applicable), person(s) conducting the research, and a statement offering the opportunity to ask questions and to withdraw at any time from the research.

No informed consent, whether oral or written, may include any language through which the subject or the representative is made to waive or appear to waive any of the subject's legal rights, or releases or appears to release the investigator, the sponsor, the institution or its agents from liability for negligence.

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Information Required on Consent Forms 

Federal regulations require that the following information must be provided to each subject as part of the informed consent process:

  • 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 others, including scientific benefits which may reasonably be expected from the research.
  • A disclosure of appropriate alternative procedures or treatments, if any, that might be advantageous to the subject.
  • A statement describing the extent to which confidentiality of records identifying the subject will be maintained.
  • For research involving more than minimal risk, an explanation as to whether any compensation, or medical treatments are available if injury occurs, and, if so, what they consist of, and whether subjects are expected to pay for treatment of research-related injuries or illness.
  • A statement of whom to contact for (a) answers to pertinent questions about the research, (b) research-related illness or injury, and (c) the rights of research subjects.
  • A statement that participation is voluntary, that refusal to participate will involve no penalty or loss of benefits to which the subject is otherwise entitled, and that the subject may discontinue participation at any time without penalty or loss of benefits to which the subject is otherwise entitled.

Additional elements as required:

  • A statement that the particular treatment or procedure may involve risks to the subject which are currently unforeseeable.
  • Anticipated circumstances under which the subject's participation may be terminated by the researcher without regard to the subject's consent.
  • Any additional costs to the subject that may result from participation in the research.The consequences of a subject's decision to withdraw from the research as well as the procedures for orderly termination of participation by the subject.
  • A statement that significant new findings developed during the course of the research which may relate to the subject's willingness to continue participation will be provided to the subject.
  • The approximate number of subjects involved in the study.

 

Written Documentation of Informed Consent 

In most cases, federal regulations require that informed consent is to be documented in writing. Documentation usually involves the use of a written consent form containing all of the information to be disclosed and signed and dated by the subject (or the subject's legal representative) and by the person obtaining the consent. One copy should be given to the subject (or representative), and one copy should be retained by the investigator for at least three years.

Federal regulations require that IRBs give special consideration to protecting human subjects who are particularly vulnerable. These subjects include children, prisoners, pregnant women, cognitively impaired individuals, traumatized or comatose individuals, persons who are terminally ill and those who are economically or educationally disadvantaged. With the exception of research involving children, investigations using special populations are approved only when the research objectives cannot be met using populations outside this special category and when there is only minimal risk involved or when the research will directly benefit the subjects.

In rare instances, the IRB may waive written documentation of the consent process (but not the process itself) for research presenting no more than minimal risk. In certain instances of research involving no more than minimal risk where the research could not be practically carried out if written documentation were required ( such as telephone surveys), the IRB also may waive the requirement for written documentation of the consent process.

In some cases (if the subject is unable to read or if written consent is found to be culturally disrespectful or inappropriate), the information about consent may be presented verbally. In these cases, the researcher reads the consent form to the subject, and a short written consent document is substituted. This document should state that the elements of informed consent have been presented orally to the subject. When a short form is used, there should also be a witness to the oral presentation. All parties should sign the short written consent document.

 

Constructing the Consent Document 

The consent document should have three parts: beginning, middle, and end.

Beginning

    • Who is doing the experiment.
    • The nature, purpose, and duration of the research.
    • The uses to be made of the data

Middle

    • The methods to be employed.
    • The hazards, inconveniences, discomforts, and any potential risks to which the subjects will be subjected.
    • The availability of compensation and treatment, if injured.
    • The benefits that might be expected.
    • Disclosure of alternate procedures the subject may choose, if applicable.
    • The conditions of participation if any.

End

    • A statement that the data are confidential and a description of the procedures to be employed in maintaining confidentiality.
    • The facts that subjects are at liberty to withdraw their consent prior to the experiment or to discontinue participation in the experiment at any time without prejudice or penalty.
    • An offer to answer any questions.
    • Instructions for who to contact should questions arise later, as well as who to contact in case of a research related injury or illness.
    • A place for the date of signing and the signatures of the subject and investigator.

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Responsibilities of the Faculty Investigator or Responsible Faculty Member 

The faculty investigator or responsible faculty member is responsible for:

  • The compliance of all co-investigators, student investigators, and research associates with the IRB decisions, conditions, and requirements.
  • Reporting to the IRB any changes to the research protocol.
  • Requesting re-approval when contact with subjects will extend beyond the approval expiration date.
  • Reporting to the IRB any unanticipated adverse reactions or unanticipated events associated with the conduct of the research.
  • Seeking clarification and advice from the IRB regarding ethical aspects of the research.

 

Special Responsibilities for Student Research

Before submitting proposals for research planned by students, faculty have the responsibility of ensuring that students have received appropriate faculty input. Student researchers, like faculty, need to be able to explain all procedures employed in their study, risks and benefits of the project, and a rationale for their methods. For students who may be just learning the research process, this could involve multiple proposal revisions and meetings with their advisor. Proposals for student research should not be submitted until faculty advisors are confident that their students understand and can justify their study based on input from their faculty advisor and any other faculty or staff that are involved in the study, and that all suggested changes have been incorporated into the proposal.

Faculty investigators and responsible faculty members have the additional responsibility of ensuring that student researchers understand the federal guidelines for conducting research with human participants.

Student researchers also have the responsibility of ensuring that they understand the research they are proposing to undertake: all procedures employed in their study, risks and benefits of the project, and a rationale for their methods.

Student researchers also have the responsibility of ensuring that they understand the federal guidelines for conducting research with human participants. Students must not conduct research until they are confident that they understand the federal rules and regulations pertaining to their research activities.

 

Use of Human Subjects in Research Training

Michigan Technological University is committed to the protection of human subjects in research. To ensure that all investigators and research personnel receive a well-rounded education in human subjects protection, Michigan Tech has posted several important sources of information at this IRB web site.

To meet the standard of excellence set forward by Michigan Technological University, every Michigan Tech investigator is encouraged to give assurance that he/she has read the following required human subject protection documents. It is only a matter of time before the NIH and other federal funding sources will themselves require more extensive human subjects protection education and training. Our commitment compels us to lead the way!

Belmont Report: The Office of Human Research Protections (OHRP) considers it unethical for anyone involved in human subject research not to have read the Belmont Report. It describes and explains the ethical principles that should be followed by such investigators: respect for persons, beneficence and justice. http://www.hhs.gov/ohrp/humansubjects/guidance/belmont.htm.

Code of Federal Regulations: All human subject researchers must read 45 CFR 46. This document is the Federal regulation that describes the authority and responsibility of Institutional Review Boards (IRBs) in protecting human subjects. http://www.hhs.gov/ohrp/humansubjects/guidance/45cfr46.htm.

 

Michigan Tech Training Recommendations for Human Subject Research

DHHS Training Requirement: The Department of Health and Human Services (DHHS) has mandated that researchers receive training in human subject protections and the ethical conduct of research. Beginning October 1, 2000, any DHHS grant application must be accompanied by a cover letter indicating that training in human subject protections has been completed.

The training requirement set forth by DHHS can be met through participation in a computer based training program (CBT) or tutorial. CBT's are available on the Internet and there is no cost. Certificates of Completion should be printed and included with your Application for Human Subject Research.

REGARDLESS of funding agency, we recommend that you undertake one of the on-line training sessions listed below and obtain a certificate of completion. Investigators should maintain a file with copies of all relevant training.

Human Subjects (CITI) Training and obtain a certificate of completion. Investigators should maintain a file with copies of all relevant training.

Previous training will be accepted from the sites listed below. If you completed this training three or more years ago, you will need to complete the CITI Training. Please follow the link above.

Human Participant Protections Education for Research Teams (NIH)

Office for Human Research Protection (DHHS)

 

Noncompliance

Noncompliance means significant failure of the investigator(s) to abide by the University and federal regulations protecting human subjects in research. Examples of noncompliance would include conducting research without prior IRB approval, misuse or nonuse of consent forms, failure to obtain informed consent, failure to obtain approval for revisions, and continuing to gather data after approval expires.

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Modifying Approved Research 

Any proposed change in protocol affecting human subjects must be reviewed and approved by the IRB prior to implementation of these changes. Proposed changes should be submitted in written form. If the revisions involve different risks to the subjects than those assumed when the proposal was initially reviewed and approved, a revised consent form should be attached to the request. Proposal revisions should include the following:

  • The title of the project.
  • The date of the approval.
  • Name and phone number of the faculty investigator or responsible faculty member.
  • A brief description and explanation of the proposed changes.
  • A copy of documents that include any changes (procedures, consent forms, etc).

 

Renewing Approval 

IRB approval is valid for a maximum of one year; although the IRB can request approval more often. Investigators wishing to continue to collect data on human subjects after the expiration date must apply for a "continuing review" from the IRB by completing a renewal application form. Projects needing continuing review will be reviewed in the same manner as the original proposal. For continuing projects, approval will need to be renewed on a yearly basis.

Failure to submit an application for renewed approval prior to the expiration date will automatically result in termination of the approval of the research. If approval has lapsed but the investigator wants to renew approval, s/he should contact the Research Compliance office. If data is collected without IRB approval, investigators are acting in noncompliance with IRB guidelines and are in violation of university and federal regulations for the protection of human subjects.

Projects will be re-approved without submission of a new proposal ONLY if the following criteria are met:

  • The human subjects protocol is the same as previously approved by the IRB.
  • There have been no ill effects suffered by the subjects due to their participation in the study.
  • There has neither been a change in the research environment nor new information which would indicate greater risk to human subjects than that assumed when the proposal was initially reviewed and approved.

 

International Research

All human subjects research in which Michigan Tech investigators are involved must comply with the federal regulations for the protection of human subjects in all material respects. The IRB will approve international research as long as the procedures prescribed by the foreign institution or entity afford protections that are at least equivalent to those provided in the federal guidelines.