Policies and Definitions
This document describes the Phillips Graduate Institute (PGI) Policies for Protecting Human Research Subjects. The policies of PGI are derived from the Code of Federal Regulations adopted by the Office of Human Subjects Research ( Title 45 CFR Part 46 Protection of Human Subjects [link http://ohsr.od.nih.gov/guidelines/45cfr46.html). For background reading, you can read the principles upon which these regulations are based. These principles are found in The Belmont Report: Ethical Principles and Guidelines for the Protection of Human Subjects of Research (link: Http://ohsr.od.nih.gov/guidelines/belmont.html ).
Four sections are covered in these policies: Definitions and Procedures; Ethical Research Committee (ERC) Responsibilities; Faculty, Staff and Student Responsibilities; and Administration Responsibilities. Administration, faculty, staff and students at PGI are responsible for reviewing and complying with these policies.
I. DEFINITIONS OF KEY TERMS & RELATED POLICIES A. RESEARCH - Section 46.102 of the federal regulations define research as "a systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge." The notion of research may also extend to those data which will be published in a public forum.
B. NON-RESEARCH STUDIES POLICY: Faculty (faculty members of any program who supervise research courses or activities) are responsible for determining whether theirs or their students' studies qualify as non-research. If a study qualifies as non-research, it does not have to be reviewed by the Ethical Research Committee and an application to the ERC for review and approval is not required. However, the Non Research Form ( link to this form which will be a separate page also linked to the homepage) must be completed and submitted to the ERC.
To qualify as non-research, a proposed study or project must meet at least one of the following two conditions identified below. If a proposed study or project meets at least one of the two conditions, the study or project does not require review by the Ethical Research Committee (ERC) or submittal of an ERC application. 1. The proposed study or project will comprise, exclusively, a review of the literature and not involve data collection from or about human subjects. 2. The proposed study or project will involve the collection of data directly related to the administration of clinical services, and any data collected will not be published in any publicly available forum such as a professional journal, textbook, periodical or Psy.D. doctoral project or MFT/OC/SP professional paper.
C. EXEMPT RESEARCH - Section 46.101(b) of the federal regulations state "Unless otherwise required by department or agency heads, research activities, in which the only involvement of human subjects will be in one or more of the following categories, are exempt from this policy:
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.
a. Note: Another example is research assessing the effectiveness of a workshop presentation. The assessment instruments must focus on the perceived benefits derived from participation in workshop or other feedback directly related to the workshop itself, and must not focus on the individual characteristics, such as personal attitudes, behaviors or beliefs.
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.
a. Note: This exemption applies to a very restricted set of studies because most research requires signed informed consent which links an individual to their data, thus, precluding the basis of this exemption. The exception would be large scale studies which do not exceed minimal risk which could not realistically be done if signed consent was required, e.g., phone interviews of thousands of people on a topic of minimal risk.
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 (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.
a. Note: This claim refers to research with public databases, such as public health databases that has been de-identified and is housed by a government agency available to any researcher.
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.
a. Note: This exemption typically refers to research mandated by government agencies, and is most likely not applicable to data used by PGI students or faculty.
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."
Faculty, students and staff may request that their project be reviewed and considered exempt research by submitting a completed Phillips Graduate Institute Ethical Research Committee Application Packet (ERC Application) to the PGI ERC. Copies of the ERC Application are available through this website by clicking on Application Packet.
D. NONEXEMPT RESEARCH - Research projects conducted by PGI faculty, students or staff that do not meet the criteria for exempt research as defined in section I.C. above must be reviewed and approved in writing by the PGI ERC prior to the collection of any data from human subjects. Faculty, students and staff may request that their project be reviewed and considered exempt research by submitting a completed Phillips Graduate Institute, Los Angeles Human Subjects Application Packet. Copies of the ERC Application are available through this website by clicking on Application Packet.
E. EXPEDITED REVIEW - Section 46.110 of the federal regulations allow the ERC to conduct an expedited review of nonexempt research projects if the research involves no more than minimal risk, and provided that the only involvement of human subjects will be in one or more of the categories identified below. The following is a listing of the categories (identified in the federal regulations) that may be most appropriate to PGI research. Faculty, students and staff should refer to Section 46.110 of the federal regulations and Addendum: 46 FR 8392 for a complete listing of all federal categories.
Note: For PGI students and faculty, the most likely reason for requesting an expedited review is #6.
1. "Recording of data from subjects 18 years of age or older, using noninvasive procedures routinely employed in clinical practice. This includes the use of physical sensors that are applied either to the surface of the body or at a distance, and do not involve input of matter or significant amounts of energy into the subject, or an invasion of the subject’s privacy. It also includes such procedures as weighing, testing sensory acuity, electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, diagnostic echography, and electroretinography. It does not include exposure to electromagnetic radiation outside the visible range (for example, x-rays, microwaves).
2. Collection of blood samples by venipuncture, in amounts not exceeding 450 milliliters in an eight week period, and no more often than two times per week, from subjects 18 years of age or older, and who are in good health and not pregnant.
3. Voice recordings made for research purposes, such as investigations of speech defects.
4. Moderate exercise of healthy volunteers.
5. The study of existing data, documents, records, pathological specimens, or diagnostic specimens.
6. Research on individual or group behavior or characteristics of individuals, such as studies of perception, cognition, game theory, or test development, where the investigator does not manipulate subjects’ behavior, and the research will not involve stress to subjects.
a. Note: For PGI students and faculty, most claims of expedited review will fit this category because this point is that the assessment (by survey, interview, focus group, etc) does not exceed minimal risk and that the study does not involve an intervention, i.e., a manipulation of a participant’s behavior (or attitude).
7. Research on drugs or devices, for which an investigational new drug exemption or an investigational device exemption is not required."
Federal regulations state that expedited reviews may be completed by the Chair of the ERC or by one or more reviewers designated by the Chair of the ERC. ERC review of projects qualifying for expedited review is three to four weeks, not including holidays, weekends or semester breaks. Projects requiring revisions may take longer.
ERC review of projects not qualifying for expedited review will be completed by the full ERC. Full committee reviews require approximately four weeks to complete, not including holidays, weekends or semester breaks. Projects requiring revisions may take longer. The extended time required for projects not qualifying for expedited review is because federal regulations require that these projects be reviewed by all members of the ERC. Full committee reviews take place during the entire calendar year with the exception of the month of August when most faculty and staff are not on campus.
F. MINIMAL RISK - Pursuant to section 46.102 of the federal regulations "minimal risk means that 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."
II. ETHICAL RESEARCH COMMITTEE RESPONSIBILITIES A. COMMITTEE COMPOSITION AND MEETINGS 1. POLICY:The Ethical Research Committee (ERC) is responsible for selecting a Chair to preside over the functions of the ERC. 2. POLICY: The ERC Chair is responsible for scheduling meetings and ensuring that minutes of the meetings are maintained.
B. EXEMPT AND NONEXEMPT RESEARCH PROJECTS 1.POLICY: The ERC Chair or her/his designee(s) is/are responsible for reviewing and determining (pursuant to Federal Regulations as described section in I.C. herein) which research projects conducted by PGI faculty, staff or students are exempt from ERC review. 2.POLICY: The ERC is responsible for reviewing all non exempt research projects conducted by PGI faculty, staff or students. This includes course related research projects having data collection components involving intervention or interaction with individuals or analyses of existing data about individuals. Appendix 1 includes criteria for ERC approval of nonexempt research.
C. NON-RESEARCH STUDIES POLICY: Faculty (Research advisors and instructors of all course involving research) are responsible for determining whether theirs or their students' studies qualify as non-research. If a study qualifies as non-research, it does not have to be reviewed by the Ethical Research Committee and an application to the ERC for review and approval is not required. However, the Non Research Form included in the ERC Application Packet must be completed and submitted to the ERC.
To qualify as non-research, a proposed study or project must meet at least one of the following two conditions identified below. If a proposed study or project meets at least one of the two conditions, the study or project does not require review by the Ethical Research Committee (ERC) or submittal of an ERC application. 1. The proposed study or project will comprise, exclusively, a review of the literature or a proposed research design neither of which will involve data collection from or about human subjects. 2. The proposed study or project will involve the collection of data directly related to the administration of clinical services, and any data collected will not be published in any publicly available forum such as a professional journal, textbook, Psy.D. doctoral project or MFT/OC/SP professional paper.
D. EXPEDITED ERC REVIEW 1. POLICY: The ERC Chair or her/his designee(s) is/are responsible for reviewing and determining which nonexempt research projects qualify for expedited review. Section I.E. of this document includes criteria for determining which projects qualify for expedited review. 2. POLICY: Nonexempt research projects qualifying for expedited review will be reviewed by one designated member of the ERC. If the designated ERC member recommends disapproval of the project, the entire ERC must review and vote on the project, unless the disapproval is based on methods that can be remediated. Members of the ERC will be designated (on a rotational basis) to review projects qualifying for expedited review. The timeline for the ERC review of expedited projects is three to four (4) weeks, not including holidays, weekends or semester breaks. Projects requiring revisions may take longer. 3. POLICY: If the designated ERC member believes an application submitted for expedited review should be resubmitted for Full Committee review, she/he will consult with a second ERC member. If the second ERC member does not concur with the Full Committee review recommendation, the application will receive an expedited review. If both members agree that the application should be submitted for Full Committee review, the application will be submitted to the ERC Staff Representative for distribution and review by the entire ERC. 4. POLICY: Nonexempt research projects qualifying for expedited review will be reviewed twelve months a year since these reviews may be completed by single designated members of the ERC. 5. POLICY: Nonexempt research projects qualifying for expedited review will be approved in accordance with criteria identified in Appendix 1. 6. POLICY: The ERC Chair or her/his designee is responsible for informing the ERC of all proposals approved by expedited review.
E. NONEXPEDITED ERC REVIEW 1. POLICY: All nonexempt research projects that do not qualify for expedited review will be reviewed by all members of the ERC. Appendix 1 includes criteria for approval of research projects not qualifying for expedited review. 2. POLICY: Nonexempt research projects that do not qualify for expedited review must be approved by a majority of the ERC at an ERC meeting at which the majority of the members are present. 3. POLICY: Nonexempt research projects not qualifying for expedited review will not be reviewed by the ERC during August when the majority of the PGI faculty are not on campus.
F. INFORMED CONSENT 1. POLICY: All nonexempt research projects must contain provisions for oral or written consent from participating human subjects, unless specifically waived by the ERC. Appendix 2 includes criteria for waiving consent from participating human subjects. 2. POLICY: The ERC is responsible for developing sample assent and consent forms containing provisions identified in the Federal Guidelines. 3. POLICY: Nonexempt research requiring written consent forms shall use the following subject identification code procedures: a. If the consent form is attached to the research instruments, subject identification codes shall not be used. b. If the consent form is not attached to the research instruments (e.g., the consent form is mailed separately from the research instruments), subject identification codes shall be used in both the consent form and the research instruments. This will ensure that proper consent is obtained for all completed research instrument packets. 4. POLICY: No studies involving minors or at risk populations shall be conducted on the internet. 5. POLICY: Research projects conducted on the internet shall be designed to include: a. All provisions included in written consent forms for subjects 18 years and older, and b. Provisions that require all subjects to select an option that states "I have read all of the above description regarding this study and understand what it says. I am 18 years or older and voluntarily agree to participate in this research project" before they can proceed with their participation in the study or access any portion of the study, and c. Include provisions that allow all subjects to withdraw at any time from the study without having their responses recorded or submitted to the principal investigator.
G. RESEARCH INVOLVING PRISONERS POLICY: The PGI ERC will not approve any research involving prisoners. Federal regulations require that Institutional Review Boards (IRB’s) where prisoners are involved include a prisoner or prisoner representative as a member of the IRB. The IRB for the protection of human subjects of the prisoner retention institution is responsible for approving all research (conducted by PGI faculty, staff and students) involving prisoners. If approval is granted by the prisoner retention institution IRB, the IRB application and approval notice should be submitted to the PGI ERC to ensure that the proposed study concurs with PGI policy.
H. INTERNET (ON-LINE) RESEARCH 1. POLICY: The PGI ERC recognizes that the internet can be used to: (a) recruit subjects; or (b) collect data on-line. 2. POLICY: The PGI ERC shall not approve any research designed to collect data on-line that involves minors or at risk populations. 3. POLICY: Research projects conducted on the internet shall be designed to include: a. All provisions included in written consent forms for subjects 18 years and older, and b. Provisions that require all sub