Institutional Review Board
Handbook
Guide for Research on Human Subjects
2008-09
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Guidelines for Research on Human Subjects
INSTITUTIONAL REVIEW BOARD RESEARCH HANDBOOK 2008-09
Table of Contents
Page
I. IRB Quick Reference Sheet 1
II. Guidelines for Research on Human Subjects 2
Introduction (See also appendices for instructions and forms) 2
Adherence to the Common Rule 2
Definitions 2
III. Full IRB Review 3
Criteria for Full Board Review 3
Vulnerable Populations 3
Sensitive Topic s 3
Minimal Risk 3
Examples of Sensitive Topics that May Require Full Board Review 3
Process for Requesting a Full Board Review 4
IV. Expedited Review 5
Criteria for an Expedited Review 5
Research Categories for an Expedited Review 6
Process for Requesting an Expedited Review 7
V. Exempt Review 10
Process for Requesting an Exempt Review 10
VI. Classroom Research 11
Excluded Classroom Research 11
Department of Education’s Guidelines for Sensitive Subjects for Students 12
Exempt Classroom Research 12
Other Excluded Research 13
Oral History Research 13
Public Databases 13
Table of Contents (Cont’d)
Page
VII. Informed Consent 14
VII. Conflict of Interest Policy 16
IX. Researcher’s Continuing Responsibilities 17
Continuing Responsibilities 17
Request for Change or Modification 17
Maintaining Confidentiality 17
Recording Data 17
Retention and Storage of Data 18
Renewals for Continuing Research 18
Reporting Incidents 18
Closure Report of Research Study 18
X. The Institutional Review Board (IRB) 19
Membership 19
Functions and Operations of the IRB 19
Responsibilities of the IRB 19
XI. Research Misconduct 20
Research Misconduct Defined 20
Allegations of Research Misconduct 20
General Policies and Principles for Reporting Misconduct 21
Annual Report on Possible Research Misconduct 22
XII. References 23
XIII. Glossary 24
Table of Contents (Cont’d)
Page
XIV. Appendices 26
Forms Requesting Approval for Research on Human Subjects (select one)
Student Research Project(s) (Form B) 27
APU Faculty/Staff Research Project (Form C) 32
Research Project by Person not associated with APU (Form D) 36
Informed Consent Template (Form E-1) 40
Informed Consent for Electronic Survey Questionnaires (Form E-2) 42
Student Assent Form (Form E-3) 43
California Experimental Subject’s Bill of Rights (Form F) 44
Authorization for Use of Private Health Information (Form G) 45
Request for Renewal of Continuing Research (Form H) 47
Request for Revisions or Additions (Form I) 49
Closure Report of Research Study (Form J) 51
Research Course Faculty Form (Form K) 52
Research Course Student Form (Form L) 53
Conflict of Interest Form (Form M) 54
Ethics Requirements for Faculty Teaching Research Courses 56
Decision Tree for Students Conduction Research with Children 58
Human Subject Research Decision Tree Charts 1-11
(See http://www.hhs.gov/ohrp/humansubjects/guidance/certconf.htm)
1. Is an Activity Research Involving Human Subjects Covered 59
2. Is the Research Involving Human Subjects Eligible for Exemption 60
3. Does the Exemption for Educational Settings Apply 61
4. Does the Exemption for Tests, Surveys, Interviews or Public 62
Behavior Observation Apply
5. Does the Exemption for Existing Data Documents and Specimens Apply 63
6. Does the Exemption for Public Benefit or Service Programs Apply 64
7. Does the Exemption for Food Taste and Acceptance Studies Apply 65
8. May the IRB Review Be Done by Expedited Procedures 66
9. Can Continuing Review be Done by Expedited Procedures 67
10. Can Informed Consent be Waived or Consent Elements be Altered 68
11. Can Documentation of Informed Consent be Waived 69
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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 Programs and Research 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 http://www.hhs.gov/ohrp/ (Regulations 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: http://ohsr.od.nih.gov/guidelines/belmont.html
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: http://www.hhs.gov/ohrp/ A 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 quantitative method. (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 Protecting Human Research Participants (PHRP) (http://phrp.nihtraining.com)
Full IRB Review
Criteria for a Full Board Review
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 Topics: 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 Azusa Pacific University. 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; [1]
3. Research Project by Person not associated with APU (Form D).
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 40-43). (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.) Complete Conflict of Interest Form (Form M)
e.) Provide a letter of agency approval if data collection involves working with an agency/institution other
than Azusa Pacific University (example: UCLA Medical Center; Crisis Counseling Center; IBM)
f.) Include California Experimental Subject’s Bill of Rights (Form F) if research involving clinical
treatment
g.) Provide authorization for Use of Private Health Information (Form G) if medical records are
used.
Submit: For a full board review, submit fourteen (14) signed, paginated hard copies and an electronic copy of the complete application as detailed above to the Office of the Vice Provost for Graduate Programs and Research ten working days before the scheduled meeting. Please note that the electronic copy needs to be in one Microsoft Word document. 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 received from each prospective subject.
(5) Informed consent is appropriately documented.
(6) The research plan makes adequate provision for monitoring the data collected to ensure the safety of subjects.
(7) Adequate provisions are made to protect the privacy of subjects and to maintain the confidentiality of data.
2 This section discusses research that is excluded from the purview of an IRB. Please note that the term “exclusion” is also used in connection with IRB review to indicate that, although vulnerable populations require special consideration, it is unethical to exclude groups likely to benefit from research. The federal regulations speak in terms of equitable selection of subjects (45CFR, 111,1,3). The Belmont Report discusses fair distribution of the “burdens and benefits” of research.