1. What is the definition of research?

2. What is the definition of human subject?

3. Can students serve as principal investigators?

4. Do service-learning projects require IRB approval before students begin their service-learning?

5. What about journalism, oral histories, or biographies, are these approaches reviewable by the IRB?

6. Do I need to go through the IRB process if my project is exempt?

7. What sort of review is needed for class-related projects?

8. What are some common things that may disqualify research as “exempt” research?

9. Can the IRB give approval once data collection has begun?

10. What types of student research activities do no require direct review by the IRB?

11. Can I start collecting data before I receive approval?

12. What is the role of a faculty advisor?

13. Are there special considerations required in cross-cultural research?

14. Are IRB applications required for students participating in the study abroad programs?

15. What happens if I conduct human research without IRB approval?

16. What is the turn around time for review?

17. What is required for off-campus research?

18. What training do I need?

19. Do I need to have a course in research or research ethics to receive IRB approval?

20. What happens when there are multiple IRBs?

21. What should I know about data security?

22. What are the responsibilities after IRB approval?

23. What information must be included in a consent form?

24. Can advertisements or snowball recruitment be used to find potential participants?

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1. What is the definition of research?

The Code of Federal Regulations (45 CFR 46.102 (d)) defines research as a systematic investigation, including research development, testing, and evaluation, designed to develop or contribute to generalizable knowledge.

A Systematic investigation means an activity that may include:

• Collection of observational or qualitative data
• Collection of data using surveys, testing or evaluation procedures, interviews, or focus groups
• Collection of data using experimental designs such as clinical trials; or
• Some demonstration and service activities.

Contributions to generalizable knowledge means public presentation of the study data through any of the following:

• Meetings, conferences, seminars, poster presentations, and similar venues;
• Publications distributed beyond Notre Dame including evaluation reports, journal articles, papers, dissertations; and,
• Senior Theses, Master’s Theses, Dissertations, and Projects

2. What is the definition of human subject?

Federal Regulations (45 CFR 46.102), define a human subject as any living individual about whom an investigator obtains data:

• Through observation of the individual, or
• Through intervention or interaction with the individual, or
• Through the collection of private information

Observation includes:

• Counting the frequency or otherwise recording specific behaviors of humans
• Audio or video tape recording of the subject’s behavior or interactions

Intervention includes:

• Manipulations of the subject’s environment; or
• Applications of procedures or treatments, such as drugs, devices, or biologics; or
• Administration of psychological therapies or counseling to change behavior or promote well-being

Interaction includes:

• Communication with the subject; or
• Interpersonal contact with the subject; or
• Physical procedures to collect data, such as taking blood samples

Private information must be individually identifiable and includes:

• Information about behavior that the subject expects will not be observed or recorded
• Specific information about the individual that the individual can reasonably expect will not be made public

3. Can students serve as principal investigators?

Students may serve as principal investigators for their own research projects and are responsible for submitting the IRB application. The IRB reviews and holds student research projects to the same standards as human subjects research conducted by faculty or staff. IRB approval or exemption must be obtained prior to initiating any research activity under IRB oversight. Research for undergraduate honors’ theses, master’s theses, and doctoral dissertations involving human subjects requires IRB review. “Retroactive” IRB approval or exemption is not permitted under federal regulations. Failure to obtain IRB approval for research with human subjects may preclude the use of the previously collected data and could result in other institutional sanctions.

4. Do service-learning projects require IRB approval before students begin their service-learning?

Informal collection of information by students from respondents does not require IRB review, but IRB review is required only where there is the intent to undertake systematic investigation, produce a design or protocol for the research, a sampling of a population, or reportable findings.

If data collection and analysis are for instructional purposes only within the context of the course, without the intent of communicating it beyond the instructor and students of the course, IRB review is not required.

If a student research project intended only for class purposes develops into disseminated research, IRB approval must be obtained immediately.  IRB cannot grant retroactive approval.

While IRB approval is not required for service-learning and community-based learning course projects except in the cases described above, such activity must still be planned and carried out in consideration of the ethical and legal responsibilities to protect the individuals participating in these activities. Projects involving special populations as subjects (e.g., youth under age 18; prisoners, individuals with physical or mental disabilities; economically or educationally disadvantaged; institutionalized individuals; pregnant women) require additional safeguards.  In these cases, researchers should contact the Director of Compliance to determine whether IRB approval is required.

5. What about journalism, oral histories, or biographies, are these approaches reviewable by the IRB?

Because biographers, journalists and historians are often working on research that is particular to the individual or individuals they are studying, their activities are outside of the purview of IRB and do not require review.  In other words, because the research is not meant to be generalized outside of a specific person or situation, it does not meet the definition of research as set forth in the federal guidelines.  Oral histories have recently been excluded from oversight by the IRB and no longer require review as they have in the past.

6. Do I need to go through the IRB process if my project is exempt?

Yes. If the proposed research activity involves human participants and may contribute to “generalizable knowledge,” it still must be submitted and reviewed by the IRB before any recruitment or involvement of human participants. Exempt research is a classification determined by the chair of the IRB.

7. What sort of review is needed for class-related projects?

IRB review of classroom-related activities is not required when the collection of information from participants is exclusively for the purpose of class discussion or for the purpose of training in research or research methods.

Even when IRB review is not required, activities designed to collect information from human participants should protect the rights of these participants.  In such cases, the instructor remains responsible for educating students about the protection of human subjects and providing ethical guidance for all student projects.

Data collected for a class project may not be used for publication or presentation, unless the project was reviewed and approved by the IRB prior to recruitment and data collection.  Should there be any possibility of or intent to publish, present, or otherwise disseminate research data or findings outside the course in the future (e.g., for a Senior Paper, a Master’s Thesis, by the instructor), an application must be submitted for review and approval by the IRB prior to the start of recruitment and data collection.

8. What are some common things that may disqualify research as “exempt” research?

• Use of minors in some categories
• Use of prisoners
• The subject of research relates to sensitive information where the names of the subjects may be capable of being identified
• Research requires subjects to do a task, for example, write responses to certain objects shown on a computer screen, or give responses to vignettes shown on a videotape
• Research that is more than minimal risk

9. Can the IRB give approval once data collection has begun?

No. The IRB is unable to provide approval of a research project after data collection has begun. As a result, it is essential that researchers receive IRB approval in advance if it is possible that their work may contribute to generalizable knowledge or they may at some point desire to present their findings outside of the institutional setting (e.g., at a conference, via publication, on the World Wide Web, etc.).

Students are encouraged to seek IRB approval first to ensure they are able to use their data in future research.

10. What types of student research activities DO NOT require direct review by the IRB?

IRB approval is typically not required for a student research project involving human subjects when the primary objective is for the student researcher to learn research methods and procedures. Specifically, it is not necessary for the IRB to review these projects when all of following conditions are met:

• Research involves minimal or no risk to participants; and
• Participants do not include members of vulnerable populations such as children and/or impaired adults; and
• Research findings are only to be distributed within the classroom and/or institutional setting (not outside of Notre Dame).

11. Can I start collecting data before I receive approval?

Absolutely not.  You must have approval before any data are collected.

12. What is the role of a faculty advisor?

All students conducting research projects are required to have a faculty advisor. By signing the protocol form the faculty advisor both attests to the veracity, accuracy, and completeness of the application and identifies him/herself as the one held responsible for insuring that the research is conducted in compliance with research standards.

13. Are there special considerations required in cross-cultural research?

Yes. Researchers engaged in cross-cultural research should give particular attention to the use of culturally appropriate assessment instruments and procedures, the language(s) used in the conduct of the research and consent process, and the language preference and language variability of the research participants. Researchers developing studies involving members of an unfamiliar racial, ethnic, cultural, linguistic, gender or sexuality group should develop a reasonable level of familiarity with, but would not be limited to, the language, behavior, social mores, customs and traditions of that group. A researcher should consider consulting social and behavioral scientists and others who are more knowledgeable of, and experienced with, the intended study group before constructing a protocol.

Students should be aware that the economic conditions of developing countries may create vulnerable populations in which participation in research, especially the offering of incentives, may appear coercive.

14. Are IRB applications required for students participating in the Study Abroad programs?

Yes, if human subjects are involved and the primary objective is the development of new knowledge (i.e., thesis research).

No, if the primary objective is for the student researcher to learn research methods and procedures. Additionally, such student research must meet all of the following conditions:

• Minimal or no risk to participants; and
• Participants do not include members of vulnerable populations such as children and/or impaired adults; and
• Research findings are only to be distributed within the classroom and/or institutional setting (not outside of Notre Dame).

15. What happens if I conduct human research without IRB approval?

You will place the university out of compliance with Federal requirements that regulate human subjects research. This can result in Federal or IRB actions that will prevent you, your Department/Division, or the university from conducting human subjects research. It will also jeopardize the Institution’s human research certification with the Office for Human Research Protections (the FWA).

Data collected without IRB approval cannot be used in class research, theses and dissertations, which may ultimately prevent students from fulfilling graduation requirements.

16. What is the turn around time for review?

Provided the submission is complete with faculty advisor support, a new exempt study is generally reviewed in 3 business days and a new expedited study is generally reviewed in 10 business days. For full IRB review, a protocol may take a month. The Full Committee of the IRB meets once a month.

It is important to note that full IRB review may take longer than a month. Protocols submitted to the full IRB that are deferred, require revisions, or more information must be returned to the full IRB committee. Since the IRB meets once a month, approval of students’ research may result in long delays.

Students are encouraged to submit their research protocols well in advance of the IRB meeting dates and grant deadlines.

17. What is required for off-campus research?

Research that is physically conducted on private property (schools, hospitals, community agencies, NGOs, businesses) requires documented approval from that site (site letter).

18. What training do I need?

Notre Dame provides access to the required training through an interactive online tutorial – CITI (Collaborative Institutional Training Initiative) Course in The Protection of Human Research Subjects. CITI offers a basic (initial) course and then a refresher course which must be taken every three years.

Completion of CITI online certification is required for IRB approval.

19. Do I need to have a course in research or research ethics to receive IRB approval?

No. But, students are expected to have a strong foundation in research methods, design, and ethics before they begin research.

20. What happens when there are multiple IRBs?

Many institutions and agencies have their own IRBs. Students interested in human subject research within those institutions and agencies are required to have approval from the agencies’ IRB and the University of Notre Dame’s IRB.

The University of Notre Dame IRB is responsible for the review of all human subjects research conducted by its students, whether the research is conducted at Notre Dame, a Notre Dame affiliate institution or another site outside Notre Dame.

21. What should I know about data security?

Breach of confidentiality is a serious risk posed to participants. Rigorous data security is a key element of protecting subject data from an accidental or malicious breach. Data security includes a plan to manage the physical documentation associated with the project, such as paper surveys, signed consent forms or documents that contain contact information for subjects, to insure that those materials are not lost or accessed inadvertently by an unauthorized person. Increasingly important is the management of electronic data on desktops or servers as well as on mobile devices such as laptops and flash drives.

22. What are the responsibilities after IRB approval?

Approval of a research project by the IRB does not end an investigator’s responsibilities with respect to reporting to the IRB. IRB review and approval must be obtained before any change to a research protocol or associated materials (consent, survey instruments, and recruitment materials) can be implemented, unless the project is exempt. All non‐exempt human subjects research projects continuing to interact with subjects or analyzing data must be re‐reviewed by the IRB prior to the expiration of the approval period, as determined by the IRB. For projects that involve more than minimal risk or for some other special consideration, the IRB may require a more frequent review. Finally, investigators have an obligation to report adverse events, unanticipated problems, or protocol deviations to the IRB as soon as they are aware of the problem.

Amendments

An amendment is a modification to an approved research project. IRB review and approval is required before investigators implement a modification to a research protocol, except when necessary to eliminate immediate hazards to the subjects, which rarely applies to social and behavioral research. Any proposed change to a previously approved project must be submitted to the IRB as an amendment. For exempt projects, an amendment is required ONLY if the study is modified in such a way that the exemption criteria no longer applies.

Scheduled Continuing Review

The IRB conducts continuing review of research studies continuing to involve human subjects according the approval period issued. IRB approval must be renewed as long as the investigator is actively analyzing the data collected as part of the project, unless the data set has been completely de‐identified (including destruction of the key to coded identifiers).

Expiration of Approval Period ‐ If the approval period for an active study has expired (or lapsed), all research‐ related procedures must stop, except where doing so would jeopardize the welfare of the human subjects.

Reporting Adverse Events and Other Reportable Information or Occurrences

Adverse events are events that involve physical, social, economic or psychological harm to subjects or others. Such adverse events may also indicate risks of harm to other subjects.

Please contact the IRB for guidance if one of these events occurs during your research.

23. What information must be included in a consent form?

• 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 that 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 that may be reasonably 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 the records identifying the subject will be maintained;
• For research involving more than minimal risk, an explanation as to whether any compensation and/or medical treatments are available if injury occurs and, if so, what they consist of, or where further information may be obtained;
• An explanation of whom to contact for answers to pertinent questions about the research and research subject’s rights, and whom to contact in the event of a research related injury to the subject, if relevant. Typically, questions concerning a research project should be referred to the PI for that project, whereas questions concerning the rights of human subjects should be referred to the IRB.
• 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.
• Other requirements may apply.

24. Can advertisements or snowball recruitment be used to find potential participants?

Advertisements are part of the informed consent and participant selection process. Samples of all advertisements, such as flyers, newspaper ads, radio and television announcements, bulletin board tear-offs, and posters, along with an explanation of other methods of recruiting participants, must be submitted to the IRB.

Advertisements should be submitted with the application or as soon as the principal investigator decides to use them. The content of advertisements should be limited to:

• names of the investigators conducting the research, identification of the university by name as the location of the research or the researchers main affiliation, and contact information for the researchers;
• purpose of the research;
• general eligibility criteria;
• straightforward and truthful descriptions of benefits (e.g. research procedures are free of charge) and risks.

Advertisements should not claim, explicitly or implicitly, that the research is treatment or is superior to any current practice. Extravagant attention-getting devices such as extremely large, bold typefaces and dollar signs for payment information are prohibited.  Advertisements should not pressure readers into participating.

Snowball Recruitment.

Often times researchers have an initial pool of contacts and they hope those people will identify other qualified potential participants. This kind of sampling is commonplace in case study and qualitative psychological, sociological, and anthropological research.

The following excerpt from the Belmont Report regarding voluntariness compels IRBs to pay close attention to snowball recruitment procedures:

“Unjustifiable pressures usually occur when persons in positions of authority or commanding influence – especially where possible sanctions are involved – urge a course of action for a subject. A continuum of such influencing factors exists, however, and it is impossible to state precisely where justifiable persuasion ends and undue influence begins.”

For example, what if a highly respected individual in the community (say a local elected official, teacher, member of the clergy, or tribal elder) provided the name of a potential contact. When the nominee is contacted, the person might be unduly influenced to participate in the project because of the stature of the nominator. Consideration of minimal risk is likely to play an important role in IRB review of snowball recruitment procedures. For example, it would make a big difference whether the research involved extramarital affairs or substance use as opposed to family meal-time routines or leisure activities. To “cold call” someone on sensitive topic issues places him or her in a potentially embarrassing situation, which should be avoided. Moreover, the original subject is being placed in the position of being asked to disclose information about a third party without that party’s consent.

One means of reducing the risks in snowball recruitment is for the researcher to gently ask subjects whether they would be willing to pass some information about the study they just completed to other potential subjects. The researcher may give the original subject an information sheet that they can give to people they think might be interested and qualified. Then these potential participants can contact the researcher if they are interested. The researcher must provide the IRB with a copy of the information sheet (which must include all of the same information that is in the initial recruitment script) he/she will give to the initial contact to distribute. If the potential subject were interested in study participation, they would be free to contact the researcher.

The IRB recommends the following safeguard procedures if snowball recruitment is to be used:

• Let subjects know that they will be asked to provide the names of other potential recruits, but that they have the right to decline to provide this information.

• Obtain the nominating subject’s written permission to reveal their identity to subsequent contacts on the consent form via an initialed check-list item. That is, if the subject agrees to provide names of other possible contacts, they could initial a check box on the consent form that they agree to allow their identity to be revealed to the subsequent contacts. Not initialing the box would be interpreted as meaning the subject was unwilling to permit his/her name to be used when making the additional contacts, even if he/she supplied the names and contact information.

• Provide the IRB with a script detailing how the researcher will be obtaining the information for the snowball recruitment.