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Classroom Research

In some courses students collect data on human subjects, even though the student's research may not contribute to generalized knowledge, i.e., publication or public presentation of data. In some instances, the subjects could be placed at risk. For this reason, proposed human subjects activity should be reviewed and approved prior to initiation of the course work to help ensure that the rights and welfare of human subjects are protected. Please refer to the guidelines below to determine which types of activities will require IRB review and approval.

Course instructors have primary responsibility for ensuring that the rights and welfare of human subjects are safeguarded. This responsibility includes communicating to students the ethical principles for the protection of human subjects (Section A). It also includes reviewing student research protocols and monitoring these activities to ensure that human subjects are protected. Both quantitative and qualitative research methods fall under the scrutiny of human subjects review. All student investigators have the obligation to clearly state what is expected of subjects if they choose to participate in a research project. Protection of subjects, rather than research methodology per se, should be the foremost concern of any human subjects review.

Please note that student projects that are not submitted to the Institutional Review Board for review must fall within the parameters described in Section F below.

A. Ethical Principles for the Protection of Human Subjects

1. In a research study, every person has the right to determine what shall be done to him or her, what activities (s)he shall engage in, and what risks (s)he will take. Consequently, research on human subjects cannot be carried out without the subjects' or the subjects' legal guardians' competent, voluntary, and informed consent. The only exception to this requirement is in the case of anonymous data collection.

2. No person should be placed at risk as a subject unless the risks are reasonable in relation to the anticipated benefits of that activity. THE ONLY ACCEPTABLE LEVEL OR RISK FOR STUDENT PROJECTS IS MINIMAL RISK. (See B-4) Any project involving greater than minimal risk must be submitted to the IRB for review and approval.

3. The benefits and burdens to subjects should not be unjustly distributed. The recruitment and selection of subjects should be reasonably related to the research. Subject selection should not impose inequitable risks and burdens on any segment of society, nor should it unfairly benefit one group over others. Selection of subjects must be equitable. Justification is required if the subject population is restricted to one gender or ethnic group.

4. Special consideration and protection should be given in human subjects activities to persons who may lack full capacity to secure their own rights and interests due to age, mental capacity, involuntary custody, language barriers, or other special circumstances. Adequate provision must be made for the rights and welfare of participants who are mentally, physically, economically or educationally disadvantaged. Projects that involve these subject populations must be submitted to the IRB for review and approval.

B. Definitions

1. "Course Directed Human Subjects Activity" means any observation of or intervention with human subjects by a student as part of a course that is designed to develop or contribute to learning research and data gathering skills, where the intent is to collect data; i.e., learning how to interview, how to administer an IQ test, or conducting a journalistic interview does not qualify as research.

2. "Human Subject" means an individual about whom an investigator conducting research obtains data through intervention, interaction, or observation of a person or their identifiable personal information. Human subjects are involved in a project if it utilizes data derived from human responses, observations of human beings or human materials, whether such data is obtained directly from the human source or utilizes secondary data.

3. "Student Researcher" means any student enrolled in a course at DU who conducts Human Subjects Activity as an assignment or project in a course. This excludes master's or doctoral thesis research, which must be reviewed under established IRB procedures.

4. "Minimal Risk" is the probability and magnitude of harm that is normally encountered in the daily lives of healthy individuals. An individual is considered to be at risk if he/she may be exposed to the possibility of harm - physical, psychological, sociological or other - as a consequence of any activity that goes beyond the application of those established and accepted methods necessary to meet his/her needs.

The most obvious examples of placing subjects at risk include the experimental use of the following procedures: surgical and biopsy procedures; the administration of drugs or radiation; the use of indwelling catheters or electrodes; the requirement of unusual physical exertion; subjection to deceit, public embarrassment and humiliation. There is, however, a wide range of medical, social, and behavioral projects in which, although there may be no immediate physical risk, procedures are introduced which involve discomfort, anxiety, harassment, invasion of privacy, or constitute a threat to the subject's dignity through the imposition of demeaning of dehumanizing procedures. Finally, the risk element must be examined for those studies dependent upon stored data, or information, which might have been obtained for quite different purposes.

C. Responsibility of Instructors

1. Instructors of courses in which students conduct activities involving human subjects are responsible for informing students of the ethical principles for the protection of the human subjects and applicable policies and procedures. See The Belmont Report, the University of Denver's Multiple Project Assurance, and the Code of Federal Regulations 45 CFR 46 - attached.

2. Instructors of courses in which students conduct activities involving human subjects are responsible for prior review of those activities to ensure that they are within the specified parameters allowed for student research (see Section F) and that these activities are in accordance with these policies and procedures.

3. Students must complete, either individually or in small groups, the "Class Project Approval Form." Instructors are responsible for reviewing and approving these student applications and are responsible for retaining the completed applications for a period of one academic year.

4. Course instructors must complete an IRB application and forward it to the Office of Sponsored Programs for approval by the IRB prior to the beginning of the proposed class human subject activity.

D. Instructor Review of Student Research

1. The instructor is responsible for ensuring activity is minimal risk and clearly falls within categories described below (See Section F). Having students complete "Classroom Project Approval Forms" should help instructors ensure that these criteria are met.

2. If the student application involves intervention with human subjects but poses no more than minimal risk, the course instructor may review and approve the application. Informed consent of subjects is required, except in the case of anonymous data collection. If the subjects are under the age of 18, parental consent and child assent is required. If the research involves more than minimal risk, the IRB must review the application. Please note that very few of the allowable exemptions cover research with minors.

3. The instructor is responsible for assessing whether risk is more than minimal as defined in B-4. If there is any question or doubt about the degree of risk posed by the activity and if there is any possibility of more than minimal risk, the protocol must be reviewed by the IRB.

4. The instructor must review and approve the procedures for obtaining informed consent from adult participants, and parental consent and child assent when the participants are minors, and assure that they meet the necessary requirements prior to their use by student researchers. A consent form check list is available in the IRB application and is recommended to help instructors and faculty advisors ensure that consent forms meet IRB requirements.

5. The instructor must review and approve the instruments, methods, and procedures of the student protocol in their final form prior to their use by student researchers.

6. The instructor must keep a record for at least one academic year of each human subject activity. These records must include the project titles, the student names, and the dates of the review and approval by the instructor. Special application forms are available for these course-directed activities.

E. Recommended Format to Obtain Consent from Participants in Class Projects.

1. For use in anonymous data collection: See Attachment A.
2. For use in confidential data collection: See Attachment B.

F. Categories of research that may be approved by this procedure are per Code of Federal Regulation 45 CFR 46 (Exemption Categories):

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as research on regular and special education instructional strategies, or research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.

2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; AND any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk or criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.

PLEASE NOTE: THE EXCEPTIONS IN F-2, FOR RESEARCH INVOLVING SURVEY OR INTERVIEW PROCEDURES OR OBSERVATION OF PUBLIC BEHAVIOR, DOES NOT APPLY TO RESEARCH WITH CHILDREN, EXCEPT FOR RESEARCH INVOLVING OBSERVATIONS OF PUBLIC BEHAVIOR WHEN THE INVESTIGATOR DOES NOT PARTICIPATE IN THE ACTIVITIES BEING OBSERVED.

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 F-2 of this section, if the human subjects are elected or appointed public officials or candidates for public office; OR 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 designed to study, evaluate, or otherwise examine public benefit or service programs; procedures for obtaining benefits or services under those programs; possible changes in or alternatives to those programs or procedures; or possible changes in methods or levels of payment for benefits or services under those programs.

If student Human Subject Activity involves more than minimal risk or falls outside of the categories specified in Section F, the student must submit an individual application to and have approved by the IRB prior to any data collection activity.

If the protocol is generic, i.e., all students will use the same instruments, methods, and consent procedures, the course instructor will submit a regular IRB application form.
Once approved by the IRB, the generic protocol may continue to be used by students without further review by the IRB unless:

1. The protocol is changed.
2. There is a complaint from a subject.
3. There is an adverse reaction to a subject.
4. There is a change in governmental regulations, or new information that would indicate greater risk to human subjects than that assumed when the protocol was initially reviewed and approved.

ATTACHMENT A

PROJECT INFORMATION SHEET

You are invited to participate in a study that will (purpose statement). In addition, this study is being conducted to fulfill the requirements of a class entitled __________________________. The study is conducted by (student name). Results will be used to (purpose) and to receive a grade in the course. (Student) can be reached at (phone/e-mail). This project is supervised by the course instructor, Dr. __________________, (Department), University of Denver, Denver, CO 80208, (phone number), (e-mail address).

Participation in this study should take about ____ minutes of your time. Participation will involve responding to (#) questions about (question content). Participation in this project is strictly voluntary. The risks associated with this project are minimal. If, however, you experience discomfort you may discontinue your participation at any time. We respect your right to choose not to answer any questions that may make you feel uncomfortable. Refusal to participate or withdrawal from participation will involve no penalty or loss of benefits to which you are otherwise entitled.

Your responses will be anonymous. That means that no one will be able to connect your identity with the information you give Please do not write your name anywhere on the questionnaire. Your return of the questionnaire will signify your consent to participate in this project.

If you have any concerns or complaints about how you were treated during the interview, please contact Dennis Wittmer, Chair, Institutional Review Board for the Protection of Human Subjects, at 303-871-2431, or Sylk Sotto-Santiago, Office of Research and Sponsored Programs at 303-871-4052 or write to either at the University of Denver, Office of Research and Sponsored Programs, 2199 S. University Blvd., Denver, CO 80208-2121.

You may keep this page for your records.

ATTACHMENT B

INFORMED CONSENT FORM
(Title of Research Project)

You are invited to participate in a study that will (purpose statement). In addition, this study is being conducted to fulfill the requirements of a class in (name of class). The study is conducted by (student name). Results will be used to (purpose) and to receive a grade in the course. (Student) can be reached at (phone/e-mail). This project is supervised by the course instructor, Dr. __________________, Department, University of Denver, Denver, CO 80208, (phone number, e-mail address).

Participation in this study should take about ____ minutes of your time. Participation will involve responding to (#) questions about (question content). Participation in this project is strictly voluntary. The risks associated with this project are minimal. If, however, you experience discomfort you may discontinue the interview at any time. We respect your right to choose not to answer any questions that may make you feel uncomfortable. Refusal to participate or withdrawal from participation will involve no penalty or loss of benefits to which you are otherwise entitled.

Your responses will be identified by code number only and will be kept separate from information that could identify you. This is done to protect the confidentiality of your responses. Only the researcher will have access to your individual data and any reports generated as a result of this study will use only group averages and paraphrased wording. However, should any information contained in this study be the subject of a court order or lawful subpoena, the University of Denver might not be able to avoid compliance with the order or subpoena. Although no questions in this interview address it, we are required by law to tell you that if information is revealed concerning suicide, homicide, or child abuse and neglect, it is required by law that this be reported to the proper authorities.

You may keep this page for your records. Please sign the next page if you understand and agree to the above. If you do not understand any part of the above statement, please ask the researcher any questions you have.

I have read and understood the foregoing descriptions of the study called (name). I have asked for and received a satisfactory explanation of any language that I did not fully understand. I agree to participate in this study, and I understand that I may withdraw my consent at any time. I have received a copy of this consent form.

Signature _____________________ Date _________________

(If appropriate, the following must be added.)

___ I agree to be audiotaped.

___ I do not agree to be audiotaped.

___ I agree to be videotaped.

___ I do not agree to videotaped.

Signature _____________________ Date _________________

___________ I would like a summary of the results of this study to be mailed to me at the
following postal or e-mail address:

Class Project Approval Form

This form must be submitted to the instructor by each student/group after the instructor's application has been approved by the IRB. The project cannot begin until the instructor gives an individual approval. ________________________________________________________________

Printed name of student: _________________________________________________________

Student Email: ______________________________

Printed name of instructor: ________________________________________________________

Instructor Phone: ____________________________

Fax: ______________________________

Email: _____________________________

Class in which the project will take place: ____________________________________________

Instructor's IRB Approval Date: _______________________

IRB Number: __________________

Please circle Y for Yes or N for No.

1. Does the research involve subjects from any of the following categories? If the response to any of the following is "yes," attach an explanation.

Y N Under 18 years of age
Y N Over 65 years of age
Y N Physically or mentally disabled
Y N Economically of educationally disadvantaged
Y N Unable to provide their own legal informed consent
Y N Pregnant females as target population
Y N Victims
Y N Subjects in institutions (e.g., prisons, nursing homes, halfway house)

2. Does the research involve any of the following? If the response to any of the following is "yes," attach an explanation.

Y N Deception of subjects
Y N Shock or other forms of punishment
Y N Sexually explicit materials or questions
Y N Handling of money or other valuable commodities
Y N Extraction of blood or other bodily fluids
Y N Questions about drug use
Y N Questions about sexual orientation, sexual experience, or sexual abuse
Y N Purposeful creation of anxiety
Y N Any procedure that might be viewed as invasion of privacy
Y N Physical exercise or stress
Y N Administration of substances (food, drugs, etc.) to subjects
Y N Any procedure that might place subjects at risk
Y N Examination of subjects' personal behavior
Y N Questions about illegal behavior
Y N Compensation to subjects in any form; for example, money or course
credit
Y N Questions about suicidal thoughts or ideas

3. Answer the following questions about the researchers.

Y N Are you aware of the University guidelines regarding rights of human
subjects code of Federal Regulations - 45 CFR 46, the University of Denver's Federalwide Assurance, and the Belmont Report)?
Y N Is the research part of a thesis or dissertation?
Y N Do you plan to publish or report information based on your research
outside of the classroom?

4. Answer the following questions about the research.

Y N In your opinion, does the research involve more than minimal risk to
Subjects: ("Minimal Risk" means that "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.") If the answer is yes, attach an explanation including the benefits of the research to the subjects and to the discipline or profession.
Y N Are any emergencies or adverse reactions (physical, psychological,
social, legal, or emotional) probable as a result of the research? If yes,
then explain how they will be handled.
Y N Do subjects leave the study or experiment in approximately the same
emotional state as they began? If "no," explain how distress will be
handled. In most cases, this means informing subjects that if they
become upset, want to talk about the study or related experiences, etc.,
you or someone else is available. You should provide subjects with your telephone number and your instructor's telephone number.

5. Answer the following questions about the informed consent procedures.
Y N Are you using a written informed consent form? If so, include a copy. If
not, explain why and describe how consent will be obtained.
Y N Do you plan to identify the subject(s) by name or any other identifiers?

6. Identify the subject pool being utilized: (example: random customers at a grocery store.)

7. Describe your sample population, the procedures, measures, and explain the objective of your project. Please limit your description to one typewritten page.

8. Attach your consent form and/or information sheet to be given to subjects.

9. Attach a copy of any survey or measure used in the research.

Assurance by Principal Investigator:
I agree to conduct this research project in accordance with Federal Policy for the Protection of Human Subjects, and with the University of Denver "Assurance of Compliance with HHS Regulations for Protection of Human Research Subjects." No changes in my research protocol will be implemented without the prior review and approval of my instructor.

Student Signature:

_____________________________________________________________

Instructor Signature:

____________________________________________________________

ADDENDUM: Protected Health Information (PHI)

The Health Insurance Portability and Accountability Act of 1996 (HIPAA), was written to allow for insurance portability but also as a Privacy Rule to protect the privacy and security of a person's identifiable health information (Protected Health Information or PHI.)

PHI is identified as all individually identifiable health information that is created or received by or from a health care entity that includes information about the past, present or future physical or mental health of a person, the provision of health care to a person, or payment for care is considered Protected Health Information (PHI) and falls under HIPAA regulations. This includes identifiable demographic and genetic information.

DU's Institutional Review Board reviews the presence of PHI authorizations as part of the IRB application and review process.

Signed permission (authorization) is almost always required for the use and disclosure of PHI.

Participants consented into approved protocols before April 14, 2003, or into a protocol which has a waiver of consent, do not need to provide authorization. These subjects are grandfathered under HIPAA. However, if subjects are re-consented for any reason after April 14, 2003, or additional subjects are enrolled after April 14, 2003, authorization is required from those subjects.

If the protocol was approved to have waiver of consent, then authorization from subjects is not needed. The waiver of consent is considered to be a grandfathered legal permission to conduct the research without obtaining authorization.

Authorization must be obtained in each of these two circumstances:
1. When requesting permission from a patient to have their name, address and phone number or other health information released to an investigator for recruitment into a research study.

a. Are you requesting permission from a clinical location to contact a patient for recruitment Into your study?
___Yes ___No

If your answer to question a. is yes, the site's completed (minus subject signature and name) request for Recruitment Authorization must be Included with this application.

2. When enrolling a subject into a specific research study to request permission to collect their PHI as related to the research study.

a. Does this research involve the creation and/or use of PHI?
___Yes ___No

If yes, either i. or ii. listed below must be included with this application:

i. A completed (minus subject signature and name) Authorization To Use or Release Health Information For Research Purposes or an Authorization for Enrollment into Research from the health care site OR

ii. A completed Request for Waiver of Authorization.

Please include information about the recruitment site as well as the recruitment and HIPAA authorization process. Explain steps taken at the recruitment site to assure HIPAA compliance. Provide documentation such as Authorization Forms, policies, etc., that verify that the processes in place at the health care site are HIPAA compliant.