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 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.
I. RESEARCH INVOLVING PHOTOGRAPHY, VIDEOTAPING OR AUDIOTAPING POLICY: All nonexempt research involving photographs, videotapes or audiotapes of human subjects must contain provisions for written consent from all participating human subjects, unless specifically waived by the ERC. The ERC Application Packet includes sample formats for Assent and Consent Forms for nonexempt research projects involving photographs, videotapes or audiotapes of human subjects.
III. FACULTY, STAFF AND STUDENT RESPONSIBILITIES A. COMPLIANCE WITH PGI POLICIES AND FEDERAL REGULATIONS 1. POLICY: Research projects conducted by PGI faculty, students or staff that do not meet the criteria for exempt research as defined in section I.C. or non-research as defined in section I.B. herein must be reviewed and approved in writing by the PGI ERC prior to the collection of any data from human subjects. 2. POLICY: All PGI faculty, staff and students conducting research with human subjects are responsible for reviewing and complying with PGI policies and federal regulations concerning the protection of human research subjects. 3. POLICY: Faculty, staff and students conducting nonexempt research are responsible for submitting to the ERC all application and documentation materials in support of the ERC review process. 4. POLICY: Faculty, staff and students involved in nonexempt research are responsible for obtaining proper consent from research participants (or their legally authorized representatives) and providing research participants with copies of the fully executed consent forms, unless specifically waived by the ERC. 5. POLICY: Faculty, staff and students involved in nonexempt research are responsible for reporting to the ERC any unanticipated problems involving risks to human subjects or unanticipated noncompliance with PGI policies or federal regulations. 6. POLICY: Faculty and staff involved in nonexempt research are responsible for informing the ERC when the data collection phase of their research project is completed. This information will be used to determine when ERC application files will be purged by the ERC.
7. POLICY: Faculty, students, and staff involved in nonexempt research are responsible for destroying all original forms, surveys, code books, code sheets, consent forms and other documents that disclose the identity of participants (the "Original Data") in their study as follows: a. With Respect to Faculty Research (1) Faculty and staff will destroy all Original Data in a time that is consistent with the consent or assent forms (if used) or after a period not to exceed five (5) years subsequent to the completion of their study. (2) Faculty and staff will submit to the ERC a notarized letter indicating that the destruction of the Original Data have occurred. b. With Respect to Student Class Projects Involving Research (1) Students completing class projects that involve research and require Ethical Research Committee review and approval prior to data collection will submit a letter to the Ethical Research Committee certifying in writing that they will destroy all Original Data that they collected for their class research project in a time that is consistent with the consent or assent form (if used) or no more than five years after completion of their study. (2) Students will identify a specific month and year when such Original Data will be destroyed. (3) Students will submit a notarized letter indicating that the destruction of the Original Data have occurred.
c. With Respect to Student Psy.D. Projects and Professional Papers Involving Research (1) At their graduation (exit) clearance from PGI, all students involved in nonexempt research will certify in writing that they will destroy all Original Data that they collected while at PGI in a time that is consistent with the consent or assent form (if used) or no more than five years after completion of their study. (2) Students will identify a specific month and year when such Original Data will be destroyed. (3) Students will submit a notarized letter indicating that the destruction of the Original Data have occurred.
The PGI ERC shall maintain a database that tracks the scheduled destruction of Original Data collected by faculty, staff and students conducting research at PGI.
The PGI ERC shall inform in writing faculty, staff and students who have not submitted their written notice certifying the destruction of Original Data. This policy does not apply to databases, aggregate data or data compiled in such a manner that does not in anyway disclose the identity of participants in a study. Such data does not have to be destroyed.
B. EXPEDITED AND 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. Full committee reviews require approximately four weeks to complete, not including holidays, weekends or semester breaks. Projects requiring revisions may take longer. 2. 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. Federal regulations require that these projects be reviewed by all members of the ERC. 3. POLICY: Nonexempt research projects qualifying for expedited review will be reviewed by one (1) designated member of the ERC. The timeline for the initial ERC review of expedited projects is three to four (4) weeks, not including holidays, weekends or semester breaks. Projects requiring revisions may take longer. 4. POLICY: Nonexempt research projects qualifying for expedited review will be reviewed year around including during the summer months (June, July and August) since these reviews may be completed by single designated members of the ERC.
C. COOPERATIVE RESEARCH 1. POLICY: Faculty, staff and students involved in cooperative research with investigators from other institutions are responsible for obtaining approval from the PGI ERC and the Institutional Review Board (IRB) of the other (collaborative) institution if that institution has an IRB. Faculty, staff and students involved in cooperative research are responsible for providing the ERC with proper documentation demonstrating IRB approval from the collaborating institution when that review is completed.
D. RESEARCH INVOLVING PRISONERS 1. POLICY: The PGI ERC will not approve any research involving prisoners, because 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. Faculty, staff and students conducting research with prisoners are responsible for applying for and obtaining approval from the IRB of the prisoner retention institution. If approval is granted by the IRB of the prisoner retention institution, the IRB application and approval notice should be submitted to the PGI ERC to ensure that the proposed study concurs with PGI policy.
E. RESEARCH INVOLVING CHILDREN 1. POLICY:Faculty, staff and students conducting research with children are responsible for complying with the Ethical Standards for Research with Children, published by the Society For Research in Child Development Membership Directory. These standards are included herein as Appendix 3.
IV. ADMINISTRATION RESPONSIBILITIES A. COMPOSITION OF ERC 1. POLICY: The President of PGI is responsible for coordinating the appointment of faculty within their programs to serve as members of the ERC. 2. POLICY: The President of PGI is responsible for recruiting and appointing (pursuant to Federal Regulations) an individual not affiliated with the PGI community to serve as a member of the PGI ERC. 3. POLICY: The President of PGI is responsible for coordinating the appointment of at least one (1) PGI staff member to serve on the ERC. 4. POLICY: The President of PGI is responsible for ensuring that the composition of the ERC (in number, qualifications, experience, expertise and diversity) is sufficient to promote the safeguarding of the rights and welfare of human subjects involved in research conducted by PGI faculty, staff and students.
B. ADMINISTRATION OF ERC APPLICATIONS 1. POLICY: The PGI ERC is responsible for (1) collecting completed ERC Applications from faculty, staff and students conducting research; (2) distributing completed ERC Application packets to the ERC for review; (3) informing faculty, staff and student applicants of the status of their ERC review; and (4) ensuring that nonexempt projects involving data collection methods that extend beyond one year are reviewed annually by the ERC.
C. RECORD KEEPING 1. POLICY: The PGI ERC is responsible for maintaining copies of the minutes of all ERC meetings. 2. POLICY: PGI ERC is responsible for maintaining and disposing of ERC applications and related documentation as follows: a. ERC applications supporting faculty and staff research - will be maintained for a period of five (5) years after data collection is completed. The PGI ERC is responsible for purging ERC applications after the five year period. Faculty/staff involved in nonexempt research are responsible for informing the PGI Ph.D. Program Office when the data collection phase of their research project is completed. b. ERC applications supporting student research - will be maintained until the student graduates from PGI. The PGI ERC is responsible for purging ERC applications after students graduate from PGI. The Registrar’s Office is responsible for providing the ERC annually with a list of students who graduate from PGI. 3. POLICY: The PGI Registrar’s Office is responsible for providing annually a memo to the ERC identifying all students who have graduated from PGI and must have their ERC application packets purged.
D. TRACKING THE DESTRUCTION OF ORIGINAL DATA POLICY: The PGI ERC shall maintain a database that tracks the scheduled destruction of original data collected by faculty, staff and students conducting research at PGI.
E. PUBLICATION OF PGI ERC POLICIES: 1. POLICY: The President of PGI is responsible for ensuring that the Phillips Graduate Institute, Los Angeles Policies for Protecting Human Research Subjects are incorporated as needed in the student, staff and faculty handbooks, and posted on the PGI website.
APPENDIX 1 - ERC CRITERIA FOR APPROVAL OF PGI RESEARCH PROJECTS
CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES
Section 46.111: "a. In order to approve research covered by this policy, the IRB shall determine that all of the following requirements are satisfied:
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. Risk to subjects are reasonable in relation to anticipated benefits, if any, to subjects, and the importance of the knowledge that may reasonably be expected to result. In evaluating risks and benefits, the IRB should consider only those risks and benefits that may result from the research (as distinguished from risks and benefits of therapies subjects would receive, even if not participating in the research). The IRB should not consider possible long-range effects of applying knowledge gained in the research (for example, the possible effects of the research on public policy) as among those research risks that fall within the purview of its responsibility. 3. Selection of subjects is equitable. In making this assessment, the IRB should take into account the purposes of the research, and the setting in which the research will be conducted, and should be particularly cognizant of the special problems of research involving vulnerable populations, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons. 4. Informed consent will be sought from each prospective subject or the subject’s legally authorized representative, in accordance with, and to the extent required by section 46.116. 5. Informed consent will be appropriately documented, in accordance with, and to the extent required by section 46.117. 6. When appropriate, the research plan makes adequate provision for monitoring the data collected, to ensure the safety of subjects. 7. When appropriate, there are adequate provisions to protect the privacy of subjects, and to maintain the confidentiality of data.
b. When some or all of the subjects are likely to be vulnerable to coercion or undue influence, such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, additional safeguards have been included in the study to protect the rights and welfare of these subjects."
APPENDIX 2 - ERC CRITERIA FOR WAIVING CONSENT
Section 46.117(c): "c. An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects, if it finds either: 1. That the only record linking the subject and the research would be the consent document, and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject’s wishes will govern; or 2. That the research presents no more than minimal risk of harm to subjects, and involves no procedures, for which written consent is normally required outside of the research context."
APPENDIX 3 ETHICAL STANDARDS FOR RESEARCH WITH CHILDREN
Society for Research in Child Development (1996). Ethical standards for research with children. In Society for Research in Child Development Membership Directory. Ann Arbor, MI: Pages 337-339.
PRINCIPLE 1 - NON-HARMFUL PROCEDURES: - The investigator should use no research operation that may harm the child either physically or psychologically. The investigator is also obligated at all times to use the least stressful research operation whenever possible. Psychological harm in particular instances may be difficult to define; nevertheless its’ definition and means for reducing or eliminating it remain the responsibility of the investigator. When the investigator is in doubt about the possible harmful effects of the research operation, consultation should be sought from the Ethical Research Committee. When harm seems inevitable, the investigator is obligated to find other means of obtaining the information or to abandon the research. Instances may, nevertheless, rise in which exposing the child to stressful conditions may be necessary, if diagnostic or therapeutic benefits to the child are associated with the research. In such instances careful deliberation by the Ethical Research Committee should be sought before instituting such procedures.
PRINCIPLE 2 - INFORMED CONSENT: - Before seeking consent or assent (i.e. agreement) from the child, the investigator should inform the child of all features of the study that may affect his or her willingness to participate and should answer the child’s questions in terms appropriate to the child’s level of comprehension. The investigator should respect the child’s freedom to choose to participate in the research or not by giving the child the opportunity to give or not give assent to participation as well as to choose to discontinue participation at any time. Assent means that the child shows some form of agreement to participate without necessarily comprehending the full significance of the research necessary to give informed consent. Investigators working with infants should take special effort to explain the research procedures to parents and be especially sensitive to any indicators of discomfort in the infant. In spite of the paramount importance of obtaining consent, instances can arise in which consent or any kind of contact with the participant would make the research impossible to carry out. Non-intrusive filed research is a common example. Conceivably, such research can be carried out ethically if it is conducted in public places, participants’ anonymity is totally protected, and there are no foreseeable negative consequences to the participant. However, judgments on whether such research is ethical in particular circumstances should be made in consultation with the Ethical Research Committee.
PRINCIPLE 3 - PARENTAL CONSENT: - The informed consent of parents, legal guardians or those who act in loco parentis (e.g. teachers, superintendents of institutions) similarly should be obtained, preferably in writing. Informed consent requires that parents or other responsible adults should be informed of all the features of the research that may affect their willingness to allow the children to participate. This information should include the profession and institution affiliation of the investigator. Not only should the right for the responsible adult to refuse consent be respected, but they should be informed that they may refuse to participate without incurring any penalty to them or to the child.
PRINCIPLE 4 - ADDITIONAL CONSENT: - The informed consent of any persons, such as school teachers for example, whose interaction with the child is the subject of the study should also be obtained. As with the child and parents or guardians informed consent requires that the persons interacting with the child during the study be informed of all features of the research which may affect their willingness to participate. All questions posed by such persons should be answered and the persons should be free to choose to participate or not, and to discontinue participation at any time.
PRINCIPLE 5 - INCENTIVES: - Incentives to participate in a research project must be fair and must not unduly exceed the range of incentives that the child normally experiences. Whatever incentives are used, the investigator should always keep in mind that the greater the possible effects of the investigation on the child, the greater is the obligation to protect the child’s welfare and freedom.
PRINCIPLE 6 - DECEPTION: - Although full disclosure of information during the procedure of obtaining consent is the ethical ideal, a particular study may necessitate withholding certain information or deception. Whenever withholding information or deception is judged to be essential to the conduct of a study, the investigator should satisfy the Ethical Research Committee that such judgment is correct. If withholding information or deception is practiced, and there is reason to believe that the research participants will be negatively affected by it, adequate measures should be taken after the study to ensure the participant’s understanding of the reasons for the deception. Investigators whose research is dependent upon deception should make an effort to employ deception methods that have no known negative effects on the child or the child’s family.
PRINCIPLE 7 - ANONYMITY: - To gain access to institutional records, the investigator should obtain permission from responsible authorities in charge of records. Anonymity of the information should be preserved and no information used other than that for which permission was obtained. It is the investigator’s responsibility to ensure that responsible authorities do, in fact, have the confidence of the participant and that they bear some degree of responsibility in giving such permission.
PRINCIPLE 8 - MUTUAL RESPONSIBILITY: - From the beginning of each research investigation, there should be some clear agreement between the investigator and the parents, guardians or those who act in loco parentis, and the child, when appropriate, that defines the responsibilities of each. The investigator has an obligation to honor all promises and commitments of the agreement.
PRINCIPLE 9 - JEOPARDY: - When, in the course of research, information comes to the investigator’s attention that may jeopardize the child’s well-being, the investigator has a responsibility to discuss the information with the parents or guardians and with those expert in the field in order that they may arrange the necessary assistance for the child.
PRINCIPLE 10 - UNFORESEEN CONSEQUENCES: - When research procedures result in undesirable consequences for the participant that were previously unforeseen, the investigator should immediately employ appropriate measures to correct these consequences, and should redesign the procedures if they are to be included in subsequent studies.
PRINCIPLE 11 - CONFIDENTIALITY: - The investigator should keep in confidence all information obtained about research participants. The participants’ identity should be concealed in written and verbal reports of the results, as well as in nformal discussion with students and colleagues. When a possibility exists that others may gain access to such information, this possibility, together with the plans for protecting confidentiality, should be explained to the participant as part of the procedure of obtaining informed consent.
PRINCIPLE 12 - INFORMING PARTICIPANTS: - Immediately after the data are collected, the investigator should clarify for the research participant any misconceptions that may have arisen. The investigator also recognizes a duty to report general findings to participants in terms appropriate to their understanding. Where scientific or humane values justify withholding information, every effort should be made so that withholding the information has no damaging consequences for the participant.
PRINCIPLE 13 - REPORTING RESULTS: - Because the investigator’s words may carry unintended weight with parents and children, caution should be exercised in reporting results, making evaluative statements or giving advice.
PRINCIPLE 14 - IMPLICATIONS OF FINDINGS: - Investigators should be mindful of the social, political, and human implications of their research and should be especially careful in the presentation of findings from their research. This principle, however, in no way denies investigators the right to pursue any area of research or the right to observe proper standards of scientific reporting.
PRINCIPLE 15 - SCIENTIFIC MISCONDUCT: - Misconduct is defined as the fabrication or falsification of data, plagiarism, misrepresentation, or other practices that seriously deviate from those that are commonly accepted within the scientific community for proposing, conducting, analyzing, or reporting research. It does not include unintentional errors or honest differences in the interpretation of data.