The following forms are to be completed and included with each IRB submittal.
1. IRB Application Cover Page
2. IRB Application Questionnaire
3. Informed Consent Form Template
4. Human Subjects Bill of Rights
In March of 1983 the Department of Health and Human Services issued the most recent human subject regulation, i.e., "Additional Protection for Children Involved as Subjects in Research" (45 cfr 46-Subpart D).
These regulations governing children in research situations decree that investigators need to take into consideration age, maturity, and psychological state of the participating children and include them in the consent process; having the older and more mature sign
the informed consent form, and soliciting the assent of younger children. The regulation defines "assent" as the child's affirmative agreement to participate. "Mere failure to object should not, absent affirmative agreement, be construed as assent."
The following items should be addressed in an assent procedure utilizing language appropriate to the child's age and/or developmental level:
• Why the child is asked to participate;
• What is going to take place in the child's point of view;
• The risk to the child;
• The benefit to the child; and
• Identification of the researcher by name and telephone number in case questions should arise.
In non-therapeutic research, a statement that the child has a choice to participate or withdraw at any time without negative consequences:
• A statement that the child may retain a copy of the assent form; and date and signature lines for the researcher and, if appropriate, for the child.
Loyola Marymount University
Human Subjects Protections
IRB APPLICATION COVER SHEET (SIGNATURE PAGE)
Principal Investigator (P.I.):
Title of Project:
(check one) 0 Faculty
Faculty Sponsor (if applicable):
Previous IRB Number:
For evaluation of your project, indicate involvement of any of the following:
0 Charges Incurred by Subjects
0 Non-patient volunteers
0 Patients as Subjects
0 Elderly Subjects (over 65)
0 Establishment of a cell line
0 Psychology Subject Pool
0 Experimental Devices
0 Experimental Drugs
0 Sensitive Topics
0 Fetal Tissue
0 Subjects Studied Off Campus
0 Mentally Disabled Subjects
0 Subjects to be Paid
0 Minor Subjects (younger than 18)
0 Surgical Pathology Tissue
0 Non-English Speaking Subjects
0 Approved Drugs for “Non-FDA” Approved Conditions
0 Charges Incurred by Third Party Carriers
0 Data Banks, Data Archives, and/or Medical Records
0 Filming, Photographing, Video- or Voice Recording of Subjects
0 Pregnant Women, Human Fetuses, and Neonates
0 Prisoners, Parolees, or Incarcerated SubjectS
0 Subjects inArmed Services (Active Duty)
The principal investigator assures the Committee that all procedures performed under the project will be conducted by individuals legally and responsibly entitled to do so and that any deviation from the project (e.i., change in principal investigatorship, subject recruitment procedures, drug dosage, research methodology, etc.) will be submitted to the review committee for approval prior to its implementation.
What do you plan to do with the results? Please provide a brief summary statement below:
Are you applying to a federal, state, foundation, or any non-LMU organization for funding? If so, please list: _________________________________________________________________________________________
NOTE: Applications and any additional material requested by the IRB will not be processed unless signed personally by the principal investigator.
Date Signature of Principal Investigator (Required) Name (printed)
Date Signature of Faculty Sponsor (Required) Name (printed)
Date Signature of Department Chair (Required) Name (printed)
Date IRB Approval (Signature) Name (printed)
IRB Approval Number
Please deliver to:
Julie Paterson, Sr. IRB Coordinator, Institutional Review Board Office, University Hall, Suite 1718 or firstname.lastname@example.org.
Loyola Marymount University, Human Subjects Research Protections
IRB APPLICATION QUESTIONNAIRE
1. RESEARCH BACKGROUND
Please describe the purpose of your research. Provide relevant background information and briefly state your research question(s). You may provide relevant citations as necessary. (300 word max.)
2. SUBJECT RECRUITMENT
How will subjects be selected? What is the sex and age range of the subjects? Approximately how many subjects will be studied?
How will subjects be contacted? Who will make initial contact with subjects? Specifically, what will subjects be told in initial contact?
If subjects will be screened, describe criteria and procedures.
Summarize fully all procedures to be conducted with human subjects.
4. RISKS / BENEFITS
What are the potential benefits to subjects and/or to others?
What are the reasonably foreseeable risks to the subjects? (Risks may include discomfort, embarrassment, nervousness, invasion of privacy, etc.) If there are potential risks to subjects, how will they be minimized in advance? How will problems be handled if they occur?
Will subjects be identifiable by name or other means? If subjects will be identifiable, explain the procedures that will be used for collecting, processing, and storing data. Who will have access to data? What will be done with the data when the study is completed?
6. INFORMED CONSENT
Attach an informed consent form or a written request for waiver of an informed consent form. Include waiver of written consent if appropriate. If your research is being conducted in another language, please include copies of the translated “Informed Consent” or “Waiver of Written Consent” forms.
7. STUDENT RESEARCH
When a student acts as principal investigator, a faculty sponsor signature is required on the application form.
8. RENEWAL APPLICATIONS
When the submission is a Renewal Application, include a summary of the research activities during the previous granting period specifically addressing: number of subjects studied and any adverse reactions encountered, benefits which have been derived, any difficulty in obtaining subjects or in obtaining informed consent, and approximate number of subjects required to complete the study.
If subjects are to be paid in cash, services, or benefits, include the specific amount, degree, and basis of remuneration.
10. PSYCHOLOGY SUBJECT POOL
When students from the Psychology Subject Pool (PSP) are to be involved as subjects, permission must be obtained from the PSP prior to running subjects. Forms are available from the Psychology Office in 4700 University Hall. It is not necessary to inform the IRB of approval from the PSP, however the PSP requires IRB approval prior to permission for using the pool being granted.
11. QUALIFICATIONS AND TRAINING
Describe the qualifications of, or method of training and supervision afforded student experimenters. This includes past experience, type and frequency of student/sponsor interactions during the experiment, and Human Subjects Protections Training.
Describe criteria for assigning subjects to sub-groups such as “control” and “experimental.”
13. USE OF DECEPTION
If the project involves deception, describe the debriefing procedures that will be used. Include, verbatim, the following statement in the consent form: "Some of the information with which I will be provided may be ambiguous or inaccurate. The investigator will, however, inform me of any inaccuracies following my participation in this study."
14. QUESTIONNAIRES AND SURVEYS
Include copies of questionnaires or survey instruments with the application (draft form is acceptable). If not yet developed, please so indicate and provide the Committee with an outline of the general topics that will be covered. Also, when the questionnaire or interview schedule has been compiled, it must be submitted to the Committee for separate review and approval. These instruments must be submitted for approval prior to their use. Consider your population. If they are foreign speakers, please include copies in the foreign language.
15. PHYSICIAN INTERACTIONS
To ensure that all patients receive coordinated care, the principal investigator is obligated to inform the primary physician (when not the principal investigator) of all studies on his/her patients.
16. SUBJECT SAFETY
Describe provisions, if appropriate, to monitor the research data collected, to ensure continued safety to subjects.
To minimize risks to subjects, whenever appropriate, use procedures already being performed on the subjects for diagnostic or treatment purposes. Describe provisions.
In projects dealing with sensitive topics (i.e., depression, abortion, intimate relationships, etc.) appropriate follow-up counseling services must be made available to which subjects might be referred. The IRB should be notified of these services and how they will be made available to subjects.
19. SAFEGUARDING IDENTITY
When a research project involves the study of behaviors that are considered criminal or socially deviant (i.e., alcohol or drug use) special care should be taken to protect the identities of participating subjects. In certain instances, principal investigators may apply for "Confidentiality Certificates" from the Department of Health and Human Services or for "Grants of Confidentiality" from the Department of Justice.
If advertisements for subjects are to be used, attach a copy and identify the medium of display.
21. FOREIGN RESEARCH
When research takes place in a foreign culture, the investigator must consider the ethical principles of that culture in addition to the principles listed above.
22. EXEMPTION CATEGORIES (45 CFR 46.101(b) 1-6)
If you believe your study falls into any of the Exemption Categories listed below, please explain which category(ies) you believe it falls into and why.
1) Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2) Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), if information taken from these sources is recorded in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
3) Research involving survey or interview procedures, except where all of the following conditions exist: (i) responses are recorded in such a manner that the human subjects can be identified, directly or through identifiers linked to the subjects, (ii) the subject's responses, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability, or be damaging to the subject's financial standing, employability, or reputation, and (iii) the research deals with sensitive aspects of the subject's own behavior, such as illegal conduct, drug use, sexual behavior, or use of alcohol.
All research involving survey or interview procedures is exempt, without exception, when the respondents are elected or appointed public officials, or candidates for public office.
4) Research involving the observation (including observation by participants) of public behavior, except where all of the following conditions exist: (i) observations are recorded in such a manner that the human subjects can be identified, directly or through the identifiers linked to the subjects, (ii) the observations recorded about the individual, if they became known outside the research, could reasonably place the subject at risk of criminal or civil liability, or be damaging to the subject's financial standing, employability, or reputation, and (iii) the research deals with sensitive aspects of the subject's own behavior such as illegal conduct, drug use, sexual behavior, or use of alcohol.
5) 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.
6) Unless specifically required by statute (and except to the extent specified in paragraph (1), research and demonstration projects which are conducted by or subject to the approval of the Department of Health and Human Services, and which are designed to study, evaluate, or otherwise examine: (i) programs under the Social Security Act or other 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.
Please deliver to: Julie Paterson, IRB Coordinator, Institutional Review Board Office, University Hall, Suite 1718 or email@example.com.
Loyola Marymount University, Human Subjects Research Projections
IRB INFORMED CONSENT FORM (TEMPLATE)
Note: This form is only a template and is invalid without information particular to a proposed research study. It is the responsibility of the Principle Investigator (PI) to complete all blanks prior to submission.
Date of Preparation _____________________________________
Loyola Marymount University
(Title in Lay Language)
1) I hereby authorize (Name & Degree) to include me (my child/ward) in the following research study: ___________________________________________________.
2) I have been asked to participate on a research project which is designed to _________ _____________________________________________________________________
and which will last for approximately ______________________.
3) It has been explained to me that the reason for my inclusion in this project is that ____________________________________ (i.e., I am a student, female, etc.)
4) I understand that if I am a subject, I will _______________________________________.
The investigator(s) will _____________________________________________________.
These procedures have been explained to me by (Name & Qualifications) _ ___.
5) I understand that I will be videotaped, audiotaped and/or photographed in the process of these research procedures. It has been explained to me that these tapes will be used for teaching and/or research purposes only and that my identity will not be disclosed. I have been assured that the tapes will be destroyed after their use in this research project is completed. I understand that I have the right to review the tapes made as part of the study to determine whether they should be edited or erased in whole or in part.
6) I understand that the study described above may involve the following risks and/or discomforts: _____________________________________________________________.
7) I also understand that the possible benefits of the study are ________________________ _______________________________________________________________________.
8) I understand that the following alternative procedures (and/or drugs) are available. The reason these are not being used is: ___________________________________________ _______________________________________________________________________.
9) I understand that ___________________________________________ who can be reached at ________________________________ will answer any questions I may have at any time concerning details of the procedures performed as part of this study.
10) If the study design or the use of the information is to be changed, I will be so informed and my consent reobtained.
11) I understand that I have the right to refuse to participate in, or to withdraw from this research at any time without prejudice to (i.e., my future medical care at LMU.)
12) I understand that circumstances may arise which might cause the investigator to terminate my participation before the completion of the study.
13) I understand that no information that identifies me will be released without my separate consent except as specifically required by law.
14) I understand that I have the right to refuse to answer any question that I may not wish to answer.
PLEASE INCLUDE THIS ITEM ONLY IF DECEPTION IS INVOLVED
15) Some of the information with which I will be provided may be ambiguous, or inaccurate. However, I will be informed of any inaccuracies following my participation in this study.
16) I understand that I will receive $______for my participation in this study; I further understand that if I withdraw before the study is completed I will receive only $_____. I understand that in the event my participation is terminated through no fault of mine, I will be compensated in the amount of $ _____.
17) I have been informed that my insurance carrier and I are financially responsible for ______________________________________________________________________.
FOR MEDICAL STUDIES ONLY
18) If any of the cells obtained from my blood are used to establish a cell line which may be shared in the future with other researchers and which may be of commercial value, I (do____, do not____) (circle one and initial) voluntarily grant to the Loyola Marymount University any and all rights I, or my heirs, may have in any cell line or any other potential product which might be developed from the blood, bone marrow, and/or other materials obtained from me. A cell line is one that will grow indefinitely in the laboratory. Cell lines may be useful because of the characteristics of the cell and/or the products that they may produce.
FOR FOOD OR DRUG STUDIES ONLY
19) I understand that the Food and Drug Administration and (identify sponsoring drug company) may inspect the records relating to my participation in this study, therefore, my identity will be known to those agencies /companies.
FOR MEDICAL, FOOD, OR DRUG STUDIES ONLY
20) If I am a woman of childbearing potential, due to the possible risks to the fetus, I will not participate in this research study unless, with the investigator's knowledge and approval, I am using a medically acceptable form of birth control (contraception).
21) I understand that in the event of research related injury, compensation and medical treatment are not provided by Loyola Marymount University.
22) I understand that if I have any further questions, comments, or concerns about the study or the informed consent process, I may contact Julie Paterson, Institutional Review Board (IRB) Coordinator, Loyola Marymount University, Institutional Review Board Office, 1 LMU Drive, University Hall, Suite 1718, Los Angeles CA 90045-2659 (310) 258-5465 or David Hardy, Ph.D, Chair, Institutional Review Board, (310) 338-5294, firstname.lastname@example.org.
23) In signing this consent form, I acknowledge receipt of a copy of the form, and a copy of the "Subject's Bill of Rights."
Subject's Signature _________________________________________ Date ____________
Witness ________________________________________________ Date ____________
OR Subject is a minor (age_____), or is unable to sign because _____________________________
Mother/Father/Guardian ___________________________________ Date ____________
Loyola Marymount University, Human Subjects Research Protections
IRB EXPERIMENTAL SUBJECTS BILL OF RIGHTS
Pursuant to California Health and Safety Code §24172, I understand that I have the following rights as a participant in a research study:
1. I will be informed of the nature and purpose of the experiment.
2. I will be given an explanation of the procedures to be followed in the medical experiment, and any drug or device to be utilized.
3. I will be given a description of any attendant discomforts and risks to be reasonably expected from the study.
4. I will be given an explanation of any benefits to be expected from the study, if applicable.
5. I will be given a disclosure of any appropriate alternative procedures, drugs or devices that might be advantageous and their relative risks and benefits.
6. I will be informed of the avenues of medical treatment, if any, available after the study is completed if complications should arise.
7. I will be given an opportunity to ask any questions concerning the study or the procedures involved.
8. I will be instructed that consent to participate in the research study may be withdrawn at any time and that I may discontinue participation in the study without prejudice to me.
9. I will be given a copy of the signed and dated written consent form.
10. I will be given the opportunity to decide to consent or not to consent to the study without the intervention of any element of force, fraud, deceit, duress, coercion, or undue influence on my decision.