Institutional Review Board (IRB)

Advice & Guidance

• Who do I contact for advice and guidance regarding IRB policies?
  Office for Protection of Research Subjects (OPRS)
     10945 Le Conte Avenue
     2107 Peter V. Ueberroth Building
     Box 951694
     Los Angeles, California 90095-1694
     Campus Mail Code: 169407
  The Committees:
     The Chancellor's Animal Research Committee (ARC)
     Telephone: (310) 206-6308
     Email: ARC@OPRS.UCLA.EDU
     The General Institutional Review Board (GC-IRB)
     Telephone: (310) 825-7122
     Email: GCIRB@OPRS.UCLA.EDU
     The Medical Institutional Review Board (M-IRB)
     Telephone: (310) 825-5344
     Email: MIRB@OPRS.UCLA.EDU
• Where can I find information on UCLA policy and procedures regarding human subjects?
  Policy and procedure information can be found in the UCLA Multiple Project Assurance (MPA) and the Investigator's Manual. The UCLA's Office for the Protection of Research Subjects website (http://www.oprs.ucla.edu/) has links to the UCLA MPA, the Investigator's Manual, forms, and more or these items can be requested in hard copy from the Office for the Protection of Research Subjects.
• Are there any training/information/Q&A sessions regarding IRB policies and procedures?
  Yes. You can check the UCLA's Office for the Protection of Research Subjects website (http://www.oprs.ucla.edu/) for scheduled classes on the human research calendar or call the OPRS for more information.

IRB Certification

• Who needs to get IRB certification and when?
  Anyone dealing with human subjects or the personal data collected about them should be IRB certified before any contact is made with the human subject or his/her personal data.
• How do I get IRB certification?
  Go to http://training.arc.ucla.edu/ online, read through the material, take one short quiz, and print out your certificate. There is separate certification for biomedical researchers and social/behavioral researchers. The entire certification process should take no more than 2 hours. You can also complete IRB certification in person at the Office for Protection of Research Subjects. Please contact the office to find out the schedule for in person certification.
• If IRB certification is obtained from a body other than UCLA, do I still need to obtain UCLA IRB certification?
  Yes, unless the UCLA IRB approves the certification as equivalent to that of UCLA's.

Human Subjects

• Who is considered a human subject?
  A human subject is a living individual about whom an investigator obtains either
  1. Data through intervention (e.g. taking blood sample) or interaction (e.g. interview) with the individual; or
  2. Identifiable private information
• What constitutes research in human subjects?
  Human subject research includes any activity with a human subject that is designed to produce generalizable knowledge and involves the systematic gathering of information. This research may include direct interaction or intervention with subjects or it may involve indirect activities like the analysis of human subject specimen or data.
• What are the rights of human subjects involved in research?
  
  1. The subjects' autonomy should be respected by satisfying standards for informed consent.
  2. Every subject in research should be assured of the best-proven diagnostic and treatment methods.
  3. Private information collected about potential or actual subjects should not be released without subject's consent except under certain special conditions (see Confidentiality section of FAQ).
  4. Research studies should be designed to minimize as much risk (economic, social, psychological, etc.) as possible to the subject.

Ethical Requirements

• What are the basic ethical requirements for research with human subjects?
  The fundamental ethical principles are:
    1) Respect for Persons - This concept incorporates: first that individuals should be treated as autonomous beings (being capable of freely determining whether to participate in research through the process of informed consent), and second, that individuals with diminished autonomy (e.g. children, the mentally and physically sick, the aged, the destitute and prisoners) are entitled to special protections.
    2) Beneficence - Do no harm; maximize possible benefits and minimize possible harms.
    3) Justice - Determine fairly who should bear the burdens of research and receive its benefits. Please see http://www.oprs.ucla.edu/human/manual/hspcmanual/1B#Ch1B0 for more information.

IRB Review and Approval

• Who reviews my protocol and consent forms?
  In accordance with federal regulations, the UCLA IRB review committee is made up of individuals with expertise, experience, and diversity in academic, research, and professional background, racial and cultural heritage, and sensitivity to community attitudes.
• What is the process for IRB review and approval of a research application?
  
  1. Investigator submits a protocol, HS-1 Principal Investigator Assurance Form, the informed consent from, and any proposed advertisements or recruiting material to the UCLA IRB.
  2. The appropriate IRB committee meets and reviews all materials.
  3. The IRB then approves, asks for modifications, or disapproves the protocol and additional materials.
  4. Research begins only after approval from the IRB.
• What forms and materials does the IRB require for review?
  The most common form of HSPC application for non-medical research consists of three core documents: 1) the Form HS-1, Application to Involve Human Subjects in Research; 2) the informed consent form; and 3) a grant proposal. The most common form of HSPC application for medical research consists of five core documents: 1) the Form HS-1, Application to Involve Human Subjects in Research; 2) the lay language summary; 3) the informed consent form; 4) a complete detailed scientific protocol; and 5) a grant proposal. Other documents may be required as part of the submission depending on the type of research. See sample forms and check-Off List for New, Renewal and Addendum Submissions (http://www.oprs.ucla.edu/human/forms/).
• Do research activities previously approved by the IRB require continued review?
  Yes. Research activities will be continued to be reviewed at least once a year and possibly more often, if the degree of risk to human subjects warrants it.

IRB Review and Approval Exemption

• What type of research may be exempt from IRB review and approval?
  Some examples of possibly exempt research are research involving only data from deceased individuals, research that exposes subject to no more than everyday risk, or research involving only existing records and samples. Please check appendix IIIG of the UCLA MPA for detailed descriptions of exemptions and follow the steps below if you think your research may be exempt.
• What do I do if my research involves human subjects, but I believe it is exempt from IRB review and approval?
  Even if you believe your research is exempt, you may not start research until OPRS has determined that your research is indeed exempt from IRB review. To do this the Investigator must complete a HS-7 form and submit it to OPRS. If OPRS determines the research is exempt, they will send a written confirmation and research may begin. However, please note that exemption from IRB review and approval does not also exempt an investigator from the responsibility of obtaining informed written consent from human subjects. If OPRS decides the research is not exempt, then IRB review must be initiated.

Expedited Review

• What is expedited review?
  Expedited review is a procedure through which certain kinds of research may be reviewed and approved without convening a meeting of the IRB. Instead, just the chairperson or an experienced IRB member designated by the chairperson may carry out the review. The reviewer may only approve the research or pass it on for full review by the IRB committee.
• What types of research studies are eligible for expedited review?
  Certain research activities may qualify for expedited review if they present no more than minimal risk to human subjects and involve only procedures listed under exemptions in the Investigator's manual (http://www.oprs.ucla.edu/human/manual/hspcmanual/3B#Ch3Bc). An addendum to a currently approved protocol may qualify for expedited review if the modification is a minor change and does not increase the risk to the human subjects involved.
• Do I still have to obtain informed consent if I have been granted expedited review?
  Yes. Informed consent (or its waiver, alternative, or exception) is always required, regardless of the type of review.
• What happens if my application is not approved during expedited review?
  If approval is not granted during expedited review, then the application will be sent to the entire IRB committee for review.

Collaborative Research

• What is considered collaboration by the IRB? Collaborative activities may include collection of specimen
  s, exchange of information containing personal identifiers, or intellectual contribution to research technique. Collaboration exists anytime an investigator expects something in return for participation in a research activity. "Something in return" could include data, authorship on a publication, samples, or patent rights.
• What steps must I take before I collaborate in research involving human subjects with investigators at another institute?
  
  1. In order to collaborate in research where subjects are enrolled at a non-UCLA site, you should first find out if your collaborating institution has an MPA. A list of MPA-holding institutions is available at http://ohsr.od.nih.gov/.
  2. If the collaborating institution has an MPA, research may begin after IRB approval is obtained from both UCLA & the collaborating institution. You and the UCLA IRB must have documentation of IRB approval from the collaborating institution and the UCLA IRB must acknowledge this approval.
  3. If the collaborating institution does not have an MPA &/or is foreign a Letter of Compliance or a Single Project Assurance (SPA) may need to be completed (http://www.oprs.ucla.edu/human/manual/hspcmanual/7H#Ch7Hb).
• When is dual review not required?
  The UCLA HSPC will not perform a dual review provided that all of the following conditions are met:
  1. the research is conducted at an institution with an OPRR approved MPA
  2. the primary appointment of the principal investigator is with the other institution
  3. UCLA is not the primary recipient of funding, and
  4. the research is conducted entirely at the other site. If any of these conditions are not met, the research proposal has to be submitted to the UCLA HSPC for review and approval.
• Should I obtain IRB approval simultaneously from both collaborating institutions or obtain one before the other?
  It is usually best to try to get IRB approval from both institutions simultaneously, so that time is not wasted.

Informed Consent

• When is an informed consent form required?
  The consent form gives potential research subjects sufficient written information to decide whether to participate in a research study. Legal informed consent requires that potential human subjects be given a full and fair explanation of the proposed research in order to understand the nature of their participation. The consent form documents and protects all parties: the subject, the investigator, and the institution.
• What information should be included in an informed consent form?
  Some topics to cover in an informed consent form are:
  - Purpose of study
  - Procedures
  - Potential risks and discomforts
  - Anticipated benefits to subject and society
  - Alternatives to participation
  - Payment for participation
  - Possible commercial products
  - Financial obligation
  - Emergency care
  - Privacy and confidentiality
  - Participation and withdrawal
  - New findings
  - Identification of investigators
  - Rights of research subjects
  Please see http://www.oprs.ucla.edu/human/manual/hspcmanual/4C#Ch4C0 for more details on these topics.
• What guidelines should be followed when writing an informed consent form?
  - Use simple language.
  - Be concise/Use short paragraphs.
  - Describe process chronologically.
  - Define & explain technical jargon.
  - Make use of flowcharts & illustrations.
  - Specify assignments to study groups, duration of participation, etc.
  - List the reasonably foreseeable risks or discomforts in order of decreasing magnitude.
  - Do not overstate benefits (Remember that payment is not considered a benefit).
  - Describe alternative treatments, if applicable.
  - State that information obtained during the course of research will remain private & confidential.
  - Federal regulations require a clear statement that participation is voluntary, refusal to participate will result in no penalty or loss of benefits, and subject may discontinue participation at any time.
  - Federal regulations also require a separate statement that any new information that may affect a subjects willingness to continue participation, will be brought to the subjects attention promptly.
  See http://www.oprs.ucla.edu/human/forms/ for sample consent and assent forms.
• At what point during the research should informed consent be obtained?
  Informed consent should be obtained from every research participant before research processes have begun with the participant.
• When may the requirement for an informed consent form be waived?
  The HSPC may waive the requirement to obtain a consent form for some or all of the subjects enrolled in the study if one of the following conditions exist:
  1. The consent document is the only record linking the subject and the research, where the principle risk would be potential harm resulting from a breach of confidentiality. The HSPC will request that the investigator ask subjects whether or not they want documentation linking them to the research and subject's wishes will prevail.
  2. 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.
  3. For projects of minimal risk involving the use of questionnaires, the required elements of informed consent may be included in an introductory letter attached to the instrument, which includes a statement that completion and return of the questionnaire will constitute consent to participate in the project.
  Please check http://www.oprs.ucla.edu/human/manual/hspcmanual/4D#Ch4Da for more information regarding informed consent waivers.
• If the signed consent form requirement is waived, do I still have to obtain informed consent?
  Yes. A waiver of documentation of signed informed consent, does not constitute a waiver of informed consent. In cases where documentation is waived, the HSPC may require the investigator to provide subjects with a written statement regarding the research. The HSPC is required to review and approve the written statement prior to its distribution to subjects. The HSPC may also approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirement to document informed consent, under certain documented conditions. For more information, please see http://www.oprs.ucla.edu/human/manual/hspcmanual/4D#Ch4D0.
• Is getting the subject to sign a consent document all that is required by the IRB?
  No. The consent process does not end with the signing of a consent form. Investigators are ethically obligated to keep subjects apprised of all issues related to their participation in the study. The new information should be presented to research subjects in a written form and the subjects should be asked to sign a copy of the form or to sign a revised consent form. Adverse events may also occur during a research activity that would directly affect whether prospective or enrolled subjects would wish to continue in a particular research activity. Subjects must also receive the new information as a part of the continuing consent process. Investigators should note that the HSPC requires Committee review and approval prior to an investigator providing subjects with new research information.

Subject Recruitment

• Do I need approval from the IRB before I can advertise for research subjects?
  Yes. Direct advertising for research subjects (e.g. newpaper, radio, flyer, TV) is considered by the FDA to be the start of the informed consent and subject selection process. Advertisements should be given to the IRB as part of the initial package for review and approval. If advertisement is proposed for an ongoing project, the advertising may be considered as an amendment to the project and may be eligible for expedited IRB review.
• What are the guidelines for subject recruitment advertising?
  - The mode and procedure for recruiting subjects should not be coercive or imply a favorable outcome or other benefits not outlined in the consent document and protocol.
  - No claim of safety, effectiveness, equivalency or superiority should be made about a drug, biologic or device used in the study.
  - Terms such as "new treatment," "new medication" or "new drug" should not be used without explaining that the treatment, medication, etc. is investigational.
  - Free medical treatment should not be promised in lieu of saying that subjects will not be charged for taking part in the study.
  - Although advertisements may state that subjects will be paid, no emphasis (e.g. larger or bolder type) should be put on the payment or the amount of the payment.
  - In general the FDA recommends that advertisements for recruitment only provide the information necessary for subjects to determine their eligibility and interest. This info may include 1) the name and address of the clinical investigator and/or research facility; 2) the study purpose; 3) summarized criteria for eligibility; 4) brief list of participation benefits, if any; 5) commitment required of subjects; 5) research location and contact person/office for further information.
• Does the IRB allow monetary incentives for subject participation?
  Yes. Please note that payment for study participation is considered a recruitment incentive, not a benefit. Payment amount and schedule should be provided to the IRB during the initial review, so that the IRB may make sure that is not coercive.
• What is the policy on inclusion of women and minorities in research projects?
  The guidelines indicate that researchers should include minorities and women in study populations, "so that the research findings can be of benefit to all persons at risk of the disease, disorder, or condition under study." The HSPC will ask for a clear and compelling justification if women and/or minorities are not appropriately represented or are excluded from the research.

Vulnerable Subjects

• Who is considered a member of a vulnerable population?
  Children, prisoners, pregnant women, fetuses, mentally disabled persons, economically disadvantaged persons, educationally disadvantaged persons, terminally ill persons, students and employees are all considered members of vulnerable populations.
• What special procedures must take place when proposed subjects are members of a vulnerable population?
  See Chapter 8 (http://www.oprs.ucla.edu/human/manual/hspcmanual/8A) of the UCLA's Investigator Manual and 45 CFR 46, Subpart B, C, and D for strictly regulated guidelines on the participation of special or vulnerable populations (e.g. children, prisoners, pregnant women, fetuses, mentally disabled persons, economically disadvantaged persons, educationally disadvantaged persons, terminally ill persons, students, and employees).

Confidentiality

• What confidentiality issues might be appropriate for IRB review?
  The IRB may be concerned about confidentiality when breaches of confidentiality or invasion of privacy may result in:
  1. Social risks through disclosure of personal or group attributes, attitudes, or preferences that may lead to stigmatization, discrimination, prejudice.
  2. Psychological harms. Psychological harms may constitute undesired transitory, recurrent, or permanent changes in thought processes or emotions.
  3. Economic risks from disclosure of an individual's direct or indirectly identifiable information. This may negatively impact employability, insurability, or academic status.
  4. Physical harms. Information about others may arise and individuals may become suspicious and retaliate against subjects, for example, research on domestic violence, illegal activities such as drugs or gangs, or political activity.
  In order to approve research that impacts a subject's privacy or confidentiality, the IRB must determine that:
  1. The invasion of privacy is acceptable in light of the subject's reasonable expectations of privacy in the situation under study
  2. The protocol includes sufficient safeguards to ensure against potential harms resulting from a breach of confidentiality
  3. The research question is of sufficient importance to justify the intrusion.
• What steps can I take to assure confidential information obtained during research is properly handled?
  - Limit recording of personal information to that which is absolutely essential to the research
  - Store personally identifiable data securely and limit access to the principal investigator and authorized staff
  - Code data as early in the research as possible, and plan for the ultimate disposition of the code linking the data to individual subjects
  - Apply for federal Certificates of Confidentiality (see below) in all situations for which certificates are reasonable and available
  - Do not disclose personally identifiable data to anyone other than the research team without the written consent of the subjects or their legal representative.
• What are the exceptions to privacy of medical records?
  The exceptions are limited and reasonably well defined, including such situations as: (a) legal reporting obligation; (b) emergency release; or (c) request for consultation (inferred consent).
• What information on confidentiality of subject records should be provided to the subject?
  During the informed consent process all human subjects should be informed of the extent to which confidentiality of records will be maintained and of the possibility that the FDA may inspect records. All other entities that may have access to records identifying the subject should also be listed on the consent document.

Subject Screening

• How can I minimize risk to subjects from screening data?
  - Training and educating staff with direct contact with study subjects and access to their research records about privacy protection and carefully monitoring their performance
  - Electronic storage of patient identifying information from other files
  - Physical separation of pages containing personal identifying information from other pages of the data forms
  - Coding data
  - Prohibition against distribution/ publication of data listings that contain subject name, name code, or any other identifiers associated with a specific patient.
• In what situations do I need to obtain screening informed consent in addition to research informed consent?
  The collection of data from or about a person, through screening, for the purpose of research, constitutes a research interaction or intervention and is subject to informed consent requirements. Please check http://www.oprs.ucla.edu/human/news/item?item_id=126397 for a sample informed consent script and guidelines.
• What do I do when full disclosure of study purposes may bias or unduly negatively effect subject participation and/or selection?
  Contact the IRB to see whether some of the elements of the consent process may be waived or if it is appropriate for the participant to be debriefed after participation. The IRB will assess (1) the scientific validity and value of the research, (2) the efficacy of alternative methodologies, (3) whether the deception influences the subject's willingness to participate, (4) the possibility of experimentally induced harm and the ability of the proposed procedures to remove such harm through debriefing, and (5) the potential of deception to facilitate unwanted and inappropriate invasions of privacy.
  Please check http://www.oprs.ucla.edu/human/news/item?item_id=126397 for a sample informed consent script and guidelines.

Conflicts of Interest

• What is considered a conflict of interest?
  Examples of conflict of interest to be disclosed in the consent form:
  • Investigators who enroll potential research subjects and are also responsible for the healthcare of that subject
  • Investigators who accept compensation from the sponsor of an investigation for something as simple as a one-time honorarium, or for a more complex relationship, such as a paid consultant. Examples of conflict of interest to be disclosed in application:
  • Financial involvement in the sponsor company (e.g. stocks, ownership, or other financial interest) by the principal investigator creates a conflict of interest, since the outcome of the study could have a financial impact on the researcher.
  • Researchers who have received compensation from the study sponsor (e.g. honorarium, consulting fee, etc.) also have a conflict of interest.
• What do I do if there is a conflict of interest?
  Investigators have an ethical and legal responsibility to disclose conflicts of interest to potential research subjects in the consent form. It is also required that investigators disclose within their application all potential financial conflicts of interest and explain how the potential conflict of interest will be minimized or resolved. In these situations, disclosure of conflicts of interest in consent forms may be required.

Website Links

• UCLA IRB Certification/Training
    • UCLA Research Training and Compliance http://www.training.arc.ucla.edu/ - site to complete UCLA Human Subjects certification
• UCLA IRB Policy/Procedures
    • UCLA's Office for the Protection of Research Subjects http://www.oprs.ucla.edu/ - links to the UCLA Investigators Manual, the UCLA MPA, IRB forms, IRB meeting and submission deadlines
• IRB Other (Human Subjects/Informed Consent/Ethics/Etc.)
    • Bioethics: http://www.nih.gov/sigs/bioethics/ - NIH site which contains annotated web links on education, research involving human subjects, medical and healthcare ethics, and more
    • HHS Office for Human Research Protection (OHRP): http://ohrp.osophs.dhhs.gov -information from the Department of Health and Human Services on protecting human subjects in both biomedical and behavioral research
    • Office of Research Integrity: http://www.hhs.gov/ohrp/ - guidelines for the conduct of research within the public health service
    • U.S. Food and Drug Administration: http://www.fda.gov/ - information for health professionals on clinical trials, IRBs, Human Subjects, and more
    • Public Responsibility in Medicine and Research http://www.primr.org/ - addresses a broad range of issues in biomedical and behavioral research, clinical practice, ethics, and the law.