An Expedited Review Procedure Consists of a Review of Research Involving Human Subjects
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INDIANA UNIVERSITY HEALTH BLOOMINGTON IRB – INSTITUTIONAL REVIEW BOARD TITLE: Expedited Review POLICY NUMBER: RR 401 APPROVED: Wanda Katinszky PAGE 1 OF 12 ORIGINATION: 09/26/2003 REVIEW WITH REVISION: 09/10/2013
REVIEW ONLY:
1. POLICY An expedited review procedure consists of a review of research involving human subjects by the Chair/Vice-Chair or by one or more experienced IRB members designated by the Chair/Vice-Chair from among members of the IRB. The initial review of the submission is conducted by the IRB Administrator or designee to determine if the project qualifies for expedited review. The Chair/Vice Chair or designated member of the IRB will be consulted if necessary to determine qualification status.
The categories of research that may be reviewed by the IRB through an expedited review procedure include research activities that (1) present no more than minimal risk to human subjects, and (2) involve only procedures listed in one or more of the specific categories listed in the regulations at 45 CFR 46.110.
Minimal risk is defined as “...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….”.
Specific Policies 1.1 Expedited Research Categories Category 1: Clinical studies of drugs and medical devices only when either condition below is met: 1.Research on drugs for which an investigational new drug application (21 CFR 312) is not required. Note: Research on marketed drugs that significantly increases the risk or decreases the acceptability of the risks associated with the use of the product is not eligible for expedited review;
2.Research on medical devices for which 1) an investigational device exemption application (21 CFR 812) is not required; or 2) the medical device is cleared/approved for marketing and the medical device is being used in accordance with its cleared/approved labeling.
Category 2: Collection of blood samples by finger stick, heel stick, ear stick or venipuncture as follows: 1. From healthy, nonpregnant adults who weigh at least 110 pounds. For those subjects, the amounts drawn may not exceed 550 ml in an 8 week period and collection may not occur more frequently than 2 times per week; or TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 2 OF 12 2.From other adults and children, considering the age, weight, and health of the subjects, the collection procedure, the amount of blood to be collected, and the frequency with which it will be collected. For these subjects, the amount drawn may not exceed the lesser of 50 ml or 3 ml per kg in an 8 week period and collection may not occur more frequently than 2 times per week.
Category 3: Prospective collection of biological specimens for research purposes by noninvasive means. Examples include: 1. Hair and nail clippings in a nondisfiguring manner;
2. Deciduous teeth at time of exfoliation or if routine patient care indicates a need for extraction;
3.Permanent teeth if routine patient care indicates a need for extraction;
4.Excreta and external secretions (including sweat);
5.Uncannulated saliva collected either in an unstimulated fashion or stimulated by chewing gumbase or wax or by applying a dilute citric solution to the tongue;
6.Placenta removed at delivery;
7.Amniotic fluid obtained at the time of rupture of the membrane prior to or during labor;
8.Supra and subgingival dental plaque and calculus, provided the collection procedure is not more invasive than routine prophylactic scaling of the teeth and the process is accomplished in accordance with accepted prophylactic techniques;
9.Mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; or
10. Sputum collected after saline mist nebulization.
Category 4: Collection of data through noninvasive procedures (not involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves. Where medical devices are employed, they must be cleared/approved for marketing. (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications). Examples: 1. Physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subject’s privacy;
2. Weighing or testing sensory acuity; TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 3 OF 12
a. Magnetic resonance imaging;
b. Electrocardiography; electroencephalography, thermo-graphy detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, Doppler blood flow, and echocardiography; c. Moderate exercise, muscular strength testing, body composition assessment and flexibility testing where appropriate given the age, weight and health of the individual.
Category 5: Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for nonresearch purposes (such as medical treatment or diagnosis). Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects [(45 CFR 46.110(b)(4)]. This listing refers only to research that is not exempt.
Category 6: Collection of data from voice, video, digital, or image recordings made for research purposes. If the data collected is considered individually identifiable health information, the data must be protected from inappropriate use and disclosure.
Category 7: Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus group, program evaluation, human factors evaluation, or quality assurance methodologies. Note: Some research in this category may be exempt from the HHS regulations for the protection of human subjects [45 CFR 46.110(b)(2) and (b)(3)]. This listing refers only to research that is not exempt.
1.2 Considerations 1.2.1 Expedited categories 1-7 apply regardless of the age of subject, except as noted.
1.2.2 The activities listed should not be deemed to be of minimal risk simply because they are included on the list of eligible research. Inclusion on this list merely means that the activity is eligible for review through the expedited review procedure when the specific circumstances of the proposed research involve no more than minimal risk to human subjects.
1.2.3 The expedited review procedure may not be used where identification of the subjects and/or their responses would reasonably place them at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, insurability, reputation, or be stigmatizing, unless reasonable and appropriate protections will be implemented so that risks related to invasion of privacy and breach of confidentiality are no greater than minimal. Furthermore, the expedited review procedure may not be used for classified research involving human subjects. TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 4 OF 12 1.2.4 The expedited review procedure may not be used for research involving prisoners or classified research involving human subjects.
1.2.5 The standard requirements for informed consent, or its waiver, alteration, or exception, apply to research reviewed under the expedited review procedure.
1.3 Expedited Determination Although investigators make a preliminary determination about whether a research study meets the criteria for expedited review procedures, the IRB makes the final determination. If the IRB does not concur with the investigator’s determination, it may request modification to the research study or require that the research be submitted for full IRB review in accordance with the requirements and deadlines for full review studies.
1.4 Authority of the IRB Chairperson Under expedited review procedures, the IRB Chair, or an experienced IRB member designated by the Chair/Vice Chair, shall review the research protocol, which includes the same materials that the full board receives for protocols reviewed by the full board.
The IRB Chair/Vice-Chair or designee may exercise all of the authorities of the IRB, except that he/she may not disapprove the research. A research proposal may be disapproved only after review by the full IRB.
1.5 Consultants Consultants with specific expertise may be used to assist in the review of expedited research, when appropriate. Their comments will be documented and forwarded to the IRB reviewer for review and approval.
1.6 Reporting of Expedited Research The IRB Administrator will report to the IRB research proposals that have been approved under the expedited review procedure to ensure all IRB members are kept advised of such approvals.
1.7 Submission Requirements Research submitted for expedited review is not subject to meeting cycle deadline dates, however, it is recommended that the study be submitted a few weeks prior to meeting deadlines in the event that full board review is needed. Protocols are received and reviewed in an expeditious manner.
For the review of any submission that qualifies for expedited review, once the review has been completed, the IRB Office will send written correspondence with their decision, along with additional comments where appropriate. TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 5 OF 12
1.8 Documentation If the study qualifies for expedited review, the IRB Chair/Vice-Chair or designee will document his/her determination of risk and a letter of approval will be forwarded to the investigator.
1.9 Additional Items That May be Reviewed by the Chair/Vice-Chair or Designee 1.9.1 Conditional approval pending minor revisions, clarification: Revisions to consent documents and other documentation or clarifications submitted as a result of full IRB review and as a condition to final approval may be reviewed by the IRB Chair/Vice-Chair or designee. Final approval will be issued providing the revisions, documentation or clarifications do not indicate or result in a change to the study or change the risk/benefit ratio.
1.9.2 An expedited review procedure can be used for the continuing review of: 1.9.2.1 Research originally approved as meeting the requirements for expedited review pursuant to 46.110 if the research continues to meet one or more of the acceptable 7 expedited categories; or
1.9.2.2 Research previously approved by the convened IRB as follows: 1.9.2.2.1 Where (i) the research is permanently closed to the enrollment of new subjects; (ii) all subjects have completed all research-related interventions (i.e. there are no active subjects); and (iii) the research remains active only for long- term follow-up of subjects.
OR
1.9.2.3 Where no subjects have ever been enrolled at the local site and no additional risks have been identified at any research site (e.g. for multi- center protocols);
OR
1.9.2.4 Where the remaining research activities are limited to data analysis that may require access to records and/or specimens;
OR
1.9.2.5 Where the research is not conducted under an investigational new drug application (IND) or investigational device exemption (IDE) and the IRB has determined and documented at a convened meeting that (i) the research involves no greater than minimal risk; and (ii) no additional risks have been identified.
1.9.3 For multi-center protocols, an expedited review procedure may be used by the TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 6 OF 12 IRB at the local site whenever the above conditions are satisfied for that site.
1.9.4 Amendments to Expedited Research 1.9.4.1 The IRB Chair/Vice-Chair or designee may use the expedited review procedure to review minor changes in previously approved research during the period for which approval is authorized. Any protocol revision that entails more than a minimal risk to the subjects must be reviewed by the full IRB at a convened meeting.
IU Health Bloomington IRB has established guidelines for determining whether an amendment is considered “minor” or “major”. These are only guidelines and pertain to any amendment to a study that previously qualified for full board review. Minor amendments can be reviewed via our expedited review process. Major amendments must be reviewed at a full board meeting of the IRB. If an amendment is submitted to an expedited study and the changes are such that it still qualifies as an expedited study, the amendment can be reviewed via our expedited process.
1.9.4.2.1 Examples of Minor Amendment Changes: Any decrease in the amount of risk to the subject; Decrease in the amount of blood drawn; Title change; Investigator change; Addition or subtraction of Co-Investigator’s; Clarification issues; Additional risks due to adverse reactions; Dose reduction; Advertisements; Extending accrual of subjects period; Addition of urine pregnancy test; Audiotaping of subjects, etc.
1.9.4.2.2 Example of Major Amendment Changes: Any extra risk to the subject; Increase in the amount of blood drawn; Safety issues; Extension of the duration of the study; Multiple changes in the study design; New software in devices; Additional arm added to the study; Additional population; Increase in the amount of dose; Increase in infusion rate; Addition of subjects; Additional radiation exposure; Videotaping of subjects, etc.
1.9.4.3 Revisions to informed consent documents: Minor changes to informed consent documents that do not affect the rights and welfare of study subjects, or do not involve increased risk or significant changes in study procedures may be reviewed and approved by the Chair/Vice-Chair or designee.
1.9.4.4 Serious adverse event, safety reports data monitoring reports, interim analysis, etc. TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 7 OF 12 1.9.4.5 Advertisements: The IRB Chair/Vice-Chair or designee may approve new or revised recruitment advertisements or scripts by expedited review. The IRB will review all printed media advertisements, Internet advertisements (which include more information than simply a listing of available trials), scripts of radio and television commercials, fliers, postcards, letters, pamphlets, and any other advertising material proposed for use in recruiting study subjects. No material may be used prior to approval by the IRB.
No "open-reads" for radio or television will be permitted. Open reads are live discussions by a person on radio or television that are intended advertisements.
The following guidance is provided (and approved by IU Health Bloomington IRB) by the FDA for Media Advertising: [http://www.fda.gov/oc/ohrt/irbs/toc4.html#recruiting]:
Direct advertising for research subjects (i.e., advertising that is intended to be seen or heard by prospective subjects to solicit their participation in a study), is not in and of itself, an objectionable practice. Direct advertising includes, but is not necessarily limited to: newspaper, radio, TV, bulletin boards, posters, and flyers that are intended for prospective subjects. Not included are: 1) communications intended to be seen or heard by health professionals, such as Dear Doctor letters or doctor-to- doctor letters (even when soliciting for study subjects), 2) news stories and 3) publicity intended for other audiences, such as financial page advertisements, directed toward prospective investors.
IRB review and approval of listings of clinical trials on the Internet is not required as long as the information provided is basic trial information, such as the title of the study, the purpose of the study, protocol summary, basic eligibility criteria, study site location(s) and how to contact the site for further information. Examples of Internet listings that do not require IRB approval include the National Cancer Institute's cancer clinical trial listing (PDQ) and the government-sponsored AIDS Clinical Trial Information Service (ACTIS).
Some clinical trial web sites ask viewers to answer questions regarding eligibility for a specific clinical trial. If identifiable private information is collected via the clinical trial web site, the IRB should review plans for protecting the confidentiality of that information. The IRB should ensure that the web site clearly explains how identifiable private information might be used. Informed consent must be obtained for the collection of any information about the respondent unless the IRB has determined that the informed consent requirement can be waived. The two circumstances for consent waiver: 1) applicable only to research activities designed to study certain aspects of state of local public TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 8 OF 12 benefit or service programs; the conditions under which this waiver may be authorized by an IRB are detailed at 45CFR46.116(c); 2) Per 45CFR46.116(d), an IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent set forth in this section, or waive the requirements to obtain informed consent provided the IRB finds and documents that 1) the research involves no more than minimal risk to the subjects; 2) the waiver or alteration will not adversely affect the rights and welfare of the subjects; 3) the research could not practicably be carried out without the waiver or alteration; and 4) whenever appropriate, the subjects will be provided with additional pertinent information after participating.
Advertisements should be reviewed and approved by the IRB as part of the initial review. However, if submitted at a later date, it should be submitted as an Amendment to the study. When such advertisements are easily compared to the approved consent document, the IRB Chair/Vice-Chair, or other designee, may review and approve by expedited means, as provided by 21 CFR 56.110(b)(2). When the IRB reviewer has doubts or other complicating issues are involved, the advertising should be reviewed at a convened full board IRB meeting.
The FDA expects IRB's to review the advertising to assure that it is not unduly coercive and does not promise a certainty of cure beyond what is outlined in the consent and the protocol.
When direct advertising is to be used, the IRB should review the information contained in the advertisement and the mode of its communication, to determine that the procedure for recruiting subjects is not coercive and does not state or imply a certainty of favorable outcome or to offer benefits beyond what is outlined in the consent document and the protocol. The IRB should review the final copy of printed advertisements to evaluate the relative size of type used and other visual effects. When advertisements are to be taped for broadcast, the IRB should review the final audio/video tape. The IRB may review and approve the wording of the advertisement prior to taping to preclude re-taping. The review of the final taped message prepared from IRB-approved text may be accomplished through expedited procedures.
No claims should be made, either explicitly or implicitly, that the drug, biologic or device is safe or effective for the purposes under investigation, or that the test article is known to be equivalent or superior to any other drug, biologic or device. Such representation would not only be misleading to subjects, but would also be a violation of the Agency's regulations concerning the promotion of investigational TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 9 OF 12 drugs [21 CFR 312.7(1)] and of investigational devices [21 CFR 812.7 (d)].
Advertising for recruitment into investigational drug, biologic, or device studies should not use terms such as "new treatment", "new medication" or "new drug" without explaining that the test article is investigational.
Advertisements should not promise "free medical treatment", when the intent is only to say subjects will not be charged for taking part in the investigation. Advertisements may state that subjects will be paid, but should not emphasize the payment or the amount to be paid, by such means as larger or bold type.
Generally, the FDA believes that any advertisement to recruit subjects should be limited to the information the prospective subjects need to determine their eligibility and interest. When appropriately worded, the following items may be included in your advertisement: The name and address of the clinical investigator and/or research facility The condition under study and/or the purpose of the research A summary of the eligibility criteria A brief list of participation benefits, if any The time or other commitment required of the subject The location of the research and the person to contact for further information
The Investigator must submit two copies of the advertisement or one copy if the advertisement is an audio/video tape. Once the advertisement is approved, either a letter of approval, a stamp of approval, or both will be forwarded to the investigator.
1.9.4.6 Receptionist Scripts The first contact prospective study subjects make is often with a receptionist who follows a script to determine eligibility to the study. The IRB should assure the procedures followed adequately protect the rights and welfare of the prospective subjects. A simple statement such as "confidentiality will be maintained" does not adequately inform the IRB of the procedures that will be used. For example, what happens to personal information gathered during the screening? Are the data gathered by a marketing company? If so, are names, etc., sold to others? Are names of non-eligible maintained in case they would qualify for another study? Are paper copies of records shredded or are readable copies put out as trash?
1.9.4.7 Translations: Translations of consent documents will also be TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 10 OF 12 submitted for IRB approval and may be reviewed in an expedited manner. The IRB-approved consent form is translated by the Sponsor or site and submitted to the IRB along with its certificate of authenticity.
2. SCOPE These policies and procedures apply to all research submitted to the IRB(s) that qualifies for expedited review.
3. RESPONSIBILITY IRB Chair/Vice-Chair or IRB Administrator or designee is responsible for identifying submissions that qualify for expedited review.
IRB Administrator or designee is responsible for providing a summary of expedited reviews performed to IRB members at convened meetings.
IRB Chair/Vice-Chair or designee is responsible for conducting expedited review.
4. APPLICABLE REGULATIONS AND GUIDELINES Minimal Risk: 45 CFR 46.102 21 CFR 56.102 Expedited Review: 45 CFR 46.110 21 CFR 56.110 FDA Information Sheets, 1998 OHRP IRB Guidebook
5. REFERENCES TO OTHER APPLICABLE SOPs This SOP affects all other SOPs.
6. ATTACHMENTS RR 401-A Determination of Qualification for Expedited Review RR 401-B Guidance – Expedited Review RR 401-C Expedited Review - Reviewer Materials Checklist RR 401-D Study Information Sheet Template
7. PROCESS OVERVIEW Describe the research that can be reviewed by the IRB Chairperson or designee by an expedited review procedure and outline the process to determine if the research meets criteria for expedited review.
8. PROCEDURES EMPLOYED TO IMPLEMENT THIS POLICY A. Expedited Review - New Study Who Task Tool TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 11 OF 12 IRB Administrator Make initial determination regarding Determination of qualification for expedited review. Refer to Qualification for Guidance as needed. If the submission is still in Expedited Review question, refer to the IRB Chair, or designee, for Guidance – Expedited final determination. Review IRB If the study qualifies for expedited review, Expedited Review - Administrator assemble reviewer's material and place on Reviewer Materials schedule for review by the designated IRB Checklist member. Notify the IRB member by e-mail or phone that a new study is ready to be reviewed, as applicable. This information may be delivered to the member who will be performing the review. IRB Perform review. Chair or designee IRB Administrator Add the study to the next IRB meeting agenda and indicate the outcome following the review.
B. Expedited Review - Renewal Who Task Tool IRB Administrator Make initial determination regarding Determination of qualification for expedited review. If the Qualification for submission is still in question, refer to the IRB Expedited Review Chair, or designee, for final determination. Refer Guidance – Expedited to Guidance as needed. Review IRB Administrator If the study renewal qualifies for expedited Expedited Review - review, assemble reviewer's material and place Reviewer Materials on schedule for review by the designated IRB Checklist member. Notify IRB member by e-mail or phone that a previously reviewed study is ready to be reviewed for renewal. The material to be reviewed may be delivered to the member who is reviewing. IRB Chair or Perform review. designee IRB Administrator Add the renewal to the next IRB Agenda and indicate the outcome following the review. .
C. Expedited Review - Amendments Who Task Tool TITLE: Expedited Review POLICY NUMBER: RR 401 REVIEW WITH REVISION: 09/10/2013 PAGE 12 OF 12 IRB Administrator Review Checklist and make initial determination Determination of regarding qualification for expedited review. If Qualification for the submission is still in question, refer to the Expedited Review IRB Chair for final determination. Refer to Guidance – Expedited Guidance as needed. Review IRB Administrator If the amendment qualifies for expedited review, Expedited Review - assemble reviewer's material and place on Reviewer Materials schedule for review by the designated IRB Checklist Member. Notify IRB Member by e-mail that a new amendment is ready to be reviewed. The material that is going to be reviewed may be delivered to the reviewing member. IRB Member Perform review. IRB Administrator Add the amendment to the next IRB Agenda and indicate the outcome following the review.