Human Subjects Research

University of Notre Dame IRB

On behalf of the University of Notre Dame, the Institutional Review Board’s (IRB) major role is to safeguard the rights and welfare of all human subjects who participate in research. In compliance with Federal law and institutional policy, all research projects involving human subjects or human material must be reviewed and approved by the IRB. All social and behavioral research or biomedical projects conducted by the faculty, staff and students of the University are subject to the Policies and Procedures of the Institutional Review Board. All faculty and students engaged in such research should submit requests for IRB approval prior to beginning their work. This requirement applies to all such research, regardless of the source of support.

The University of Notre Dame IRB adheres to the principles established by in the Belmont Report and federal policies, such as the United States Department of Health and Human Services (DHHS) announcement in the Federal Register (Financial Relationships and Interests in Research Involving Human Subjects: Guidance for Human Subject Protection (May 12, 2004) and Office for the Research Protections’ (OHRP) (Title 45 part 46 of the Code of Federal Regulations).

Additional guidelines regarding the ethical conduct of research may be exist within academic disciplines, such as The American Psychological Association’s Ethical Principles of Psychologists and Code of Conduct and the Code of Ethics of the American Anthropological Association.

The IRB is composed of faculty volunteers affiliated with the variety of disciplines at ND. It also includes a representative from the community.

The University of Notre Dame’s IRB has the authority to disapprove, modify, or approve protocols based upon consideration of human subject protection. IRB approval of research must occur before research begins and approval cannot be given retroactively.

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Definition of Human Subject and Research

Federal regulations (45 CFR 46.102(d)) define research as “a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.”

For the purposes of this policy, a systematic investigation is an activity that involves a prospective research plan, which incorporates data collection, either quantitative or qualitative, and data analysis to answer a research question. Investigations designed to develop or contribute to generalizable knowledge are those designed to draw general conclusions (i.e., knowledge gained from a study may be applied to populations outside of the specific study sample), inform policy, or generalize findings.

Federal regulations (45 CFR 46.102(f)) define human subject as “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.” Private information includes information that an individual can reasonably expect will not be made public, and information about behavior that an individual can reasonably expect will not be observed or recorded. Identifiable means that the identity of the individual is or may readily be ascertained by the investigator or associated with the information.

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Criteria for IRB Approval

The overall criteria for IRB approval are:

  1. The risks to subjects are minimized as much as possible.
  2. The risks to subjects are reasonable in relation to anticipated benefits.
  3. The informed consent is adequate.
  4. Where appropriate, the research plan makes provisions for the safety of the subjects during the data collection process.
  5. Where appropriate, there are adequate provisions to protect the privacy of subjects and maintain confidentiality of data.
  6. Appropriate safeguards are included within the study to protect the rights and welfare of the vulnerable subjects.

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The IRB Submission Process

All researchers (faculty, staff, students) must complete the following procedures for IRB review:

  1. All researchers, including persons who are responsible for design, conduct, data analysis or reporting of research, must complete Human Subjects Protection Certification prior to protocol submission. The University of Notre Dame utilizes the Collaborative IRB Training Initiative (CITI), a web-based instructional approach, to certify researchers in the training of human subjects protections. Notification of certification is automatically sent to the Director of Compliance. Note that such certification must be completed every five years.
  2. All IRB protocols should be submitted through the eProtocol system, the web-based submission system.
  3. Proposals must be submitted at least 10 working days before the IRB meets. The IRB is made up of faculty and community volunteers who require sufficient time to review numerous protocols. Given that the IRB meets only once a month, substantial delays may occur if materials are missing or if there are substantive questions about the protocol.

The IRB approval is valid only for one year. After one year, approvals must be either renewed or terminated. Renewal notices will be emailed at 60 and 30 days before the expiration date. If a protocol is not renewed, all analysis and data collection must stop.

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The IRB Process

The IRB reviews a proposal by first assessing the risks and benefits of research participation. After determining that the research benefit outweighs the risks involved, the IRB turns to the consent process to ensure that subjects are fully aware of the risks and the benefits and that they participate in the project voluntarily. The consent form is a key element in this review.

After reviewing the application and its supporting materials, the IRB may require revisions in the protocol. When the investigator revises a project, the IRB reviews the project again to see whether its concerns have been adequately addressed. A project may undergo several reviews.

To fully protect subjects, the IRB must approve a project before investigators start to work on it–even before they begin to recruit subjects, since recruitment strategies are part of the review. Although there are different types of review, many projects require “full” committee review. All IRB actions are communicated in writing to the investigator by the IRB staff.

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Primary Types of Review

Research projects are reviewed at one of three levels, according to the IRB’s determination of the project’s potential risk to the human subjects and the federal guidelines that define the categories of review, which are:

  1. Screening for exemption from full IRB review,
  2. Expedited IRB review, and
  3. Full convened IRB review.

Director of Compliance and the IRB Chairperson (not the principal investigator) determine the level of review.

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Screening for Exempt Status

Investigators do not have the authority to determine whether research involving human subjects is exempt from full review 45 CFR 46.101(b) and (c) & 21 CFR 56.104(c) and (d). Hence, while research that involves only minimal risk to human subjects is sometimes exempt from full IRB committee review, it is still subject to IRB review. Researchers must file an application requesting that the IRB determine exempt status for a project.

In general, the federal guidelines for research on human subjects allow a project to be exempt from full review only if the research involves no risk to the subject and the procedures are limited to the following criteria:

  1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) 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), survey procedures, interview procedures or observation of public behavior, unless:
(i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and 
(ii) any disclosure of the human subjects’ responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects’ financial standing, employability, or reputation.
  3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if:
(i) the human subjects are elected or appointed public officials or candidates for public office; or 
(ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
  4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
  5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine:
(i) Public benefit or service programs; 
(ii) procedures for obtaining benefits or services under those programs; 
(iii) possible changes in or alternatives to those programs or procedures; or 
(iv) possible changes in methods or levels of payment for benefits or services under those programs.
  6. 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.

Projects that involve contact with subjects may still qualify as exempt. Copies of the written consent form should be filed with the application or justification for a waiver of written documentation should be provided. See 45 CFR 46.117.

The IRB administrator decides whether the project qualifies as exempt, and the decision is confirmed in writing, most often within one week. If the project does not qualify as exempt, it is referred back to the investigator with the appropriate application forms.

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Expedited Review

To qualify for expedited review, a research procedure must be limited to the activities that are federally approved (from 63 FR 60364-60367, November 9, 1998.) for expedited review and incur no more than minimal risk for participants, or be a minor change in previously approved research that involves no additional risk to the research subject.

The activities approved in the federal regulations for expedited review are:

  1. Clinical studies of drugs and medical devices
  2. Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture
  3. Prospective collection of biological specimens for research purposes by noninvasive means
  4. Collection of data through noninvasive procedures
  5. Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes
  6. Collection of data from voice, video, digital, or image recordings made for research purposes
  7. Research on individual or group characteristics or behavior
  8. Continuing review of research previously approved by the convened IRB
  9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified

The researcher must demonstrate in the application how the proposed project activities fall into one or more of these categories.

To apply for expedited review, investigators complete the Submission Form and indicate that they are requesting expedited review in the appropriate section.

The IRB administrative staff assures that all of the elements essential for review, including consent forms and supporting information, have been submitted. The application is then forwarded to a designated committee member for review and decision. Either the research is approved (perhaps with stipulations) by the committee member or it is forwarded for full review.

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Full Review

A project that involves greater than minimal risk requires approval by an IRB panel composed of members qualified to review research in that field. Research that requires full committee review includes:

  • research that involves greater than minimal risk
  • non-exempt research that involves children or other vulnerable populations;
  • research that involves experimental drugs or devices;
  • research that involves invasive procedures; and
  • research that involves deception.

Survey research that involves sensitive questions or information about sexual practice or illegal behavior is subject to full review, in keeping with federal guidelines. Any survey or interview that is likely to be stressful for the subject requires full committee review. IRB staff will make this determination.

All applications are screened by the administrative staff before they are assigned to an IRB panel; if the application is incomplete, it is returned to the investigator. After review by the IRB panel, the application will be:

  • approved as submitted;
  • approved with minor suggestions for changes;
  • approved with stipulations (conditions that must be met before final approval is granted) – most common;
  • deferred, pending receipt of additional information or major revisions; or
  • not approved.

All non-exempt research is subject to continuing review at least annually. If research involves significant risk to subjects, the IRB may require more frequent review and may ask to be kept apprised of all research activity. For example, researchers in acute care settings or whose research involves novel therapies are asked to submit their protocols for frequent review.

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Class Research and Assignments

Research, as defined in Federal Regulations 45 CFR 46 and conducted by undergraduate and graduate students, is subject to federal regulations that require that all research protocols involving human subjects be reviewed by the IRB.

However, a number of departments offer courses that require students to undertake projects in which other people are interviewed, observed, or otherwise serve as participants. The purposes of these course projects are to train students and to provide them with an opportunity to practice various research methods. These projects do not generally result in generalizable knowledge or publications and are not undertaken with these goals in mind. Therefore, the IRB does not consider them to be research and IRB review is not required. Such projects are considered “classroom exercises” and are typically quite limited in scope.

It is the responsibility of the faculty to determine, prior to assigning a project, whether the project is a classroom project or research. Faculty members are encouraged to consult with the Director of Research Compliance in making such a determination. Should a class project be conducted that meets the definition of research but does not receive IRB review and approval, the faculty member will be considered to have engaged in IRB noncompliance and may be personally liable. Research must be reviewed by the IRB. No data collected as a course assignment can be used for research purposes.

IRB approval cannot be granted retroactively. Any data collected without IRB approval cannot be used for future theses, publications, or outside of classroom presentations. It will need to be recollected if it is subsequently determined that the work is appropriate for a research project. Recollection of the data may delay a student’s completion of course assignments or theses and dissertations.

It is the responsibility of the faculty to monitor student projects from beginning to end for impact on human participants. Special attention should be paid to maintaining confidentiality and minimal levels of risks for participants, assuring freedom to withdraw without penalty, and providing informed consent to participants. All participants should be made aware of this activity as a class project.

 

As stated in the “Institutional Statement Supporting the Choice for Life” and consistent with the teaching of the Catholic Church, the University of Notre Dame recognizes and upholds the sanctity of human life from conception to natural death. Thus, the University of Notre Dame prohibits research upon primary human tissue obtained through elective abortion and derived cell lines obtained through elective abortion.

 

The University of Notre Dame has never, does not now, nor will it ever conduct or support human embryonic stem cell research.