Institutional Review Board
Guide for Research on Human Subjects
Faculty/Student Handbook
2007-08
1
Guidelines for Research on Human Subjects
FACULTY/STUDENT RESEARCH HANDBOOK 2007-08
Table of Contents
Page
I.IRB Quick Reference Sheet 1
- Guidelines for Research on Human Subjects
Introduction(See also appendices for instructions and forms)2
Adherence to the Common Rule2
Definitions2
III.Full IRB Review3
Vulnerable Populations3
Sensitive Topic3
Minimal Risk3
Examples of Sensitive Topics that May Require Full Board Review3
Process for Requesting a Full Board Review4
IV. Expedited Review 5
Criteria for an Expedited Review5
Research Categories for an Expedited Review6
Process for Requesting an Expedited Review7
V. Exempt Review8
Excluded vs. Exempt Research8
Process for Requesting an Exempt Review10
VI.Classroom Research11
Excluded Classroom Research11
Department of Education’s Guidelines for Sensitive Subjects for Students12
Exempt Classroom Research12
Other Excluded Research 13
Oral History Research13
Public Databases13
VII.Informed Consent14
Table of Contents Con’t.
Page
VIII.Researcher’s Continuing Responsibilities16
Continuing Responsibilities16
Request for Change or Modification16
Maintaining Confidentiality16
Recording Data16
Retention and Storage of Data17
Renewals for Continuing Research17
Reporting Incidents18
Closure Report of Research Study18
IX.The Institutional Review Board (IRB)19
Membership 19
Functions and Operations of the IRB19
Responsibilities of the IRB19
X.Research Misconduct20
Research Misconduct Defined20
Allegations of Research Misconduct20
General Policies and Principles for Reporting Misconduct21
Annual Report on Possible Research Misconduct22
XI.References23
XII. Glossary24
XIII.Appendices26
Forms Requesting Approval for Research on Human Subjects (select one)
Student Research Project(s) (Form B)27
APU Faculty/Staff Research Project (Form C)31
Research Project by Person not associated with APU (Form D)35
Informed Consent Template (Form E-1) 39
Informed Consent for Electronic Survey Questionnaires (Form E-2)41
Student Assent Form (Form E-3)42
California Experimental Subject’s Bill of Rights (Form F)43
Authorization for Use of Private Health Information (Form G)44
Request for Renewal of Continuing Research (Form H)46
Closure Report of Research Study (Form J)48
Research Course Faculty Form (Form K)49
Research Course Student Form (Form L)50
Ethics Requirements for Faculty Teaching Research Courses51
Decision Tree for Students Conduction Research with Children 53
Table of Content - Appendices Con’t. Page
Human Subject Research Decision Tree Charts 1-11
(see
1. Is an Activity Research Involving Human Subjects Covered54
2. Is the Research Involving Human Subjects Eligible for Exemption55
3. Does the Exemption for Educational Settings Apply56
4. Does the Exemption for Tests, Surveys, Interviews or Public 57
Behavior Observation Apply58
5. Does the Exemption for Existing Data Documents and Specimens Apply
6. Does the Exemption for Public Benefit or Service Programs Apply59
7. Does the Exemption for Food Taste and Acceptance Studies Apply60
8. May the IRB Review Be Done by Expedited Procedures61
9. Can Continuing Review be Done by Expedited Procedures62
10. Can Informed Consent be Waived or Consent Elements be Altered63
11. Can Documentation of Informed Consent be Waived64
1
IRB Quick Reference Sheet and Frequently Asked Questions
1. What type of review should I suggest from the IRB? If any of the following apply, you must apply for full IRB review:
a. Vulnerable population
b. Sensitive topics
c. Exceeds minimal risk
d. Involves invasive procedure
If you answered yes to any of the above or are not sure, turn to page 3.
If you answered no to all of the above, turn to page 5 and determine if it is expedited or exempt.
2. Does exempt mean that I do not need to submit to the IRB?
This is perhaps the most frequently asked question. Unfortunately the federal government used exempt review to mean that it is exempt from full review. Even if your project is exempt, you still must fill out the same IRB application and submit it to the office of the Vice Provost for registration.
3. What is the typical turn around time to receive IRB approval?
If an application is complete and well done, the typical project can be reviewed and approved within a month.
4. When does the IRB meet to approve projects?
The IRB meets on the third Wednesday of every month in the Darling Library Conference Room.
5. I am an instructor of a research course… do I need to have every student project approved?
Please turn to page 11.
6. What needs to be submitted for an IRB application?
This depends on the type of review that you are requesting. For a full board review, see page 4 for a list of what to submit; For expedited review, see page 7 for a list of what to submit; For exempt review, see page 10 for a list of what to submit.
For any questions you may call Joanie Stude in the Office of the Vice Provost for Graduate Studies at 626.815.2036 or on campus at extension 2036, or the Chair of the IRB.
Guidelines for Research on Human Subjects
Introduction
Azusa Pacific University (APU) encourages the conduct of research in and among its schools, and in collaboration with other educational institutions, agencies, and organizations. The University, while respecting the right of faculty and students to academic freedom in research, is firmly committed to adhering to the basic Christian ethical principles underlying the acceptable conduct of research involving human subjects.
Adherence to the Common Rule: On June 18, 1991, seventeen Federal Departments and Agencies adopted a common set of regulations known as the Federal Policy for the Protection of Human Subjects or “Common Rule.” See 45 CFR 46). These federal regulations require that any institution requesting and receiving funds from a federal department or agency for research involving human subjects must assure that research is reviewed and approved by the University’s Institutional Review Board (IRB). The design of these regulations is based on established, internationally recognized ethical principles discussed in the Belmont Report (1979) as follows:
Respect for persons incorporates at least two ethical convictions: “first, that individuals should be treated as autonomous agents; and second, that persons with diminished autonomy are entitled to protection” (thus, the need to obtain informed consent).
Beneficence entails treating persons “in an ethical manner not only by respecting their decisions, but also by making efforts to secure their well-being. . . Two general rules: (1) do no harm; and (2) protect from harm by maximizing anticipated results and minimizing possible risks of harm.”
Justice requires that the “benefits and burdens of research be distributed fairly”
(thus, the principle of justice is applied in the selection of research subjects).
Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects:
Definitions
Research is defined as “a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge” (§ 45 CFR. 46.102 [d]). (For the current Code of Federal Regulations, please see: project or study is research if it: a) is conducted with the intention of drawing conclusions that have some general applicability, and b) uses a commonly accepted qualitative or quantitativemethod. (Opportunity samples are subject to IRB review.)
Human Subjects are “living individual(s) about whom an investigator conducting research obtains: (1) data through intervention or interaction with the individual; or (2) identifiable private information” (§ 45 CFR 46.101[f]).
The Institutional Review Board provides an opportunity and place for individuals with different backgrounds to discuss and make judgment about the acceptability of projects, based on the criteria set out in the Common Rule. The purpose of the IRB is to ensure the protection of human research subjects. Members of the IRB at APU are appointed and must have completed the following programmed instruction and receive subsequent certification: see Human Participant Protections Education for Research Teams:
Full IRB Review
Criteria
Research that involves (a) more than minimal risk, or (b) involves vulnerable populations or (c) includes sensitive topics requires full board review. Examples of vulnerable populations and sensitive topics are listed below. (Decision Trees are available in the Appendix)
A. Vulnerable Populations: All research that involves fetuses, pregnant women, prisoners, or groups who may have diminished capacity to provide consent or who may be high risk, must be provided full review.
See § 45 CFR 46.201 - 207, pregnant women;
46.300 - 306, prisoners;
46.401 - 409, children and minors (except as included under exempt and expedited categories)
B. Sensitive Topic: Any research protocol that involves solicitation of information from human subjects that could reasonably cause harm to the participant if the data were not kept confidential. Causing embarrassment is the minimum threshold for determining whether research harm is foreseeable and thus sensitive (See information box below for examples of sensitive topics).
C. Minimal Risk: The probability and magnitude of harm or discomfort anticipated in the research are not greater in and of themselves than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests (45 CFR 46).
Examples of Sensitive Topics that May Require Full Board Review1. Sexual orientation, attitudes, preferences, or practices
2. Illegal or punishable conduct, including use of alcohol, drugs, or other addictive products
3. Information that could damage an individual’s financial standing, employability, or reputation
4. Information (usually in medical records) that could lead to social stigmatization or
discrimination
5. Psychological well-being or mental health, including physical or mental abuse
6. Incest, rape, date rape, or sexual molestation
7. Genetic information
8. Religious orientation or views – Religion is just one example of a sensitive topic. As with all sensitive topics, the broader principle is whether or not there is a potential for harm if the data were revealed. Identifying religious orientation on a research project would not typically be considered a sensitive topic at AzusaPacificUniversity. However, it should be noted that there are many possible scenarios where religious research could be potentially harmful to the participant if confidential data were revealed.
9. Veteran or wartime experiences
See also the Department of Education’s Guidelines for Sensitive Subjects Related to the Protection of Students’ Privacy in Examination, Testing, or Treatment on page 12.
Please note: The sensitive subjects listed above are examples and not an exclusive list.
Process for Requesting a Full Board Review
For an IRB application to be considered by the Board, the primary researcher needs to complete the following:
a.) One of the following APU forms for requesting a full board review (see appendix or IRB forms in APU
public folders)
1. Student Research Project (Form B) or;
2. Faculty/Staff Research Project(Form C)or;
3. Research Project by Person not Associated with APU (Form D).[1]
b.) Include an Informed Consent or the Informed Consent for Survey Questionnaires for studies that exclusively use self report questionnaires or opinion surveys. Informed Consents forms must be on APU letterhead (see templates on page 39-42).(In some cases the Informed Consent requirement may be waived by request. See page 15).
c.) Provide copies of all research instruments used (Survey, Questionnaire etc.)
d.) Provide a letter of agency approval if data collection involves working with an agency/institution other
than AzusaPacificUniversity (example: UCLAMedicalCenter; CrisisCounselingCenter; IBM)
e.) Include California Experimental Subject’s Bill of Rights (Form F)if research involving clinical
treatment
f) Provide authorization for Use of Private Health Information (Form G) if medical records are
used.
Submit: For a full board review, submit twelve (12) hard copies and an electronic copy of the complete application as detailed above to the Office of the Vice Provost for Graduate Programs ten working days before the scheduled meeting. Please note that the electronic copy needs to be in one Microsoft Word document. This document will be forwarded to the members of the IRB before the meeting. The request will be reviewed at the regular monthly full IRB meetings.
Note: It is recommended that the primary researcher be as thorough as possible in completing the application. The most frequent reason that an IRB application is delayed is because there is not enough detail included for the IRB members to understand the exact nature, benefit and procedure of the study.
Expedited Review
Criteria for an Expedited Review
Expedited review procedures refer to research that does not involve vulnerable populations, sensitive topics and involves no more than minimal risk to human subjects. Expedited review may be used for minor changes in already approved research. (See charts 8-9 in the appendix.)[2]
Criteria for IRB approval of expedited review include:
(1) Risks to subjects are minimized:
(i)by using procedures which are consistent with sound research design and which do not unnecessarily expose subjects to risk, and
(ii)whenever appropriate, by using procedures already being performed on the subjects for diagnostic or treatment purposes.
(2)Risks to subjects are reasonable, in relation to the anticipated benefits if any to subjects and the importance of the knowledge that may be reasonably expected to result.
(3)Selection of the subjects is equitable.
(4)Informed consent is sought from each prospective subject.
(5)Informed consent is appropriately documented.
(6)The research plan makes adequate provision for monitoring the datacollected to ensure the safety of subjects.
(7)Adequate provisions are made to protect the privacy of subjects and tomaintain the confidentiality of data.
Research Categories for an Expedited Review
The follow categories generally require an expedited review. For further explanation, see (see expedited review).
(1)Clinical studies of drugs and medical devices when either an investigational new drug application or an investigational device exemption application is not required.
(2)Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as per guidelines.
(3)Prospective collection of biological specimens for research purposes by noninvasive means, e.g., hair and nail clippings, excreta, skin swab, etc.
(4)Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.
(5)Research involving materials (data, documents, records, or specimens) that have been collected, or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis).
(6)Collection of data from voice, video, digital, or image recordings made for research purposes.
(7)Research employing survey, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies.
(8)Continuing review of research previously approved by the convened IRB:
(a)where
(i)the research is permanently closed to the enrollment of new subjects;
(ii)all subjects have completed all research-related interventions; and
(iii)the research remains active only for long term follow-up of subjects; or
(b)where no subjects have been enrolled and no additional risks have been identified; or
(c)where the remaining research activities are limited to data analysis (see expedited review).
Process for Requesting an Expedited Review
For an IRB application to be considered by the Board, the primary researcher needs to complete the following:
a.) One of the following APU forms for requesting an expedited review (see appendix or IRB forms in
APU public folders)
1. Student Research Project (Form B) or;
2. Faculty/Staff Research Project(Form C)or;
3. Research Project by Person not associated with APU (Form D).[3]
b.) Include an Informed Consent or the Informed Consent for Survey Questionnaires for studies that exclusively use self report questionnaires or opinion surveys. Informed Consents forms must be on APU letterhead (see templates on page 39-42). (In some cases the Informed Consent requirement may be waived by request. See page 15).
c.) Provide copies of all research instruments used (Survey, Questionnaire etc.)
d.) Provide a letter of agency approval if data collection involves working with an agency/institution other
than AzusaPacificUniversity (example: UCLAMedicalCenter; CrisisCounselingCenter; IBM)
e.) Include California Experimental Subject’s Bill of Rights (Form F)if research involving clinical
treatment
f) Provide authorization for Use of Private Health Information (Form G) if medical records are
used.
Submit: For an Expedited Review submit two signed hard copies and an electronic copy of the complete application as detailed above to the Office of the Vice Provost for Graduate Programs. Please note that the electronic copy needs to be contained in one Microsoft Word document. Theapplication will be forwarded to the IRB Chair for approval. The project will be reviewed at the regular monthly full IRB meetings.
Note: It is recommended that the primary researcher be as thorough as possible in completing the application. The most frequent reason that an IRB application is delayed is because there is not enough detail included for the IRB Chair to understand the exact nature, benefit and procedure of the study.
Exempt Review
Some studies on human subjects may be exempt from the need for full or expedited review by the Institutional Review Board. This does not mean that the project is beyond the purview of the IRB. (See the box below for further clarification of the meaning of exempt versus excluded.) As indicated below, descriptions of such research must nevertheless be filed with the university for periodic review by the Institutional Review Board.
Research on human subjects that is Exempt requires an application for institutional approval through either:
(a)approval by a faculty member who is certified, i.e. having completed the Human Participant Protections Education Programmed Instruction within the last two years and who is not an investigator or involved with the research, or
(b)application to the IRB. (See subsequent exempt categories and process for requesting approval for projects that are Exempt.)
EXEMPT vs. EXCLUDED Research:
Excludedresearch does not require an application to the IRB. Examples include:
(a)research using public, pre-existing, or simulated databases in which the individuals cannot be identified;
(b)except for research on vulnerable populations*, sensitive issues, or invasive procedures, classroom research projects designed to provide hands on experience or research training for students are excluded if the results of the research will not be presented or published outside of Azusa Pacific University (e.g. local professional conferences). (See also Classroom Research, pp. 11-12)