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I have copied the Brown University IRB Protocol below.

I have already received IRB approval to study "Role of Learning Reflections in Teaching the Neurobiology of Learning and Memory"

 

                                                                                                                                                                              

<place w:st="on"><placename w:st="on">BROWN</placename> <placetype w:st="on">UNIVERSITY</placetype></place> 

INSTITUTIONAL REVIEW BOARD 

HUMAN RESEARCH PROTOCOL 

 

 

Protocol Title:        

 

Principal Investigator:        

 

Funding Source (if no external funding for the project, enter "University"):        

 

(1)           Attach to this form the information required for a complete protocol, as outlined on the IRB Form #1 Instructions and Information pages.  In addition, please review the document “What Makes a Complete Protocol” (an appendix to the ‘Brown University Policies and Procedures for the Protection of Human Participants in Research’) at http://www.brown.edu/research/policies-procedures-regulations-guidance.  

 

(2)           Select the appropriate type (and category number) of review.  (See the following pages for a description of the exempt and expedited categories.  If no exempt or expedited categories completely describe the proposed research, select ‘Full Board’. )            Exempt #               Expedited #           Full Board 

  

(3)           Principal Investigator Conflict of Interest Statement:   

                (1) Have you filed the annual Assurance of Compliance form and, if necessary, a disclosure as required by the University’s Conflict of Interest Policy for Officers of Instruction and Research (http://www.brown.edu/research/compliance-education-training/research-compliance/conflict-interest/conflict-interest)?                                                                                                              YES      NO   

                (2) Do you have a significant financial interest that is related to this research protocol?                                                                                                                                                                                                                           YES      NO 

 

Principal Investigator certifies to the following:  (1) The rights and welfare of the participants are adequately protected.  (2)  The risks to an individual are outweighed by the potential benefits to him/her or by the importance of the knowledge to be gained.  (3)  This protocol is accurate and complete; and if the project scope or design is later changed, the PI will resubmit for review.  (4)  All research personnel, including the PI, has been, or will be, adequately educated in human research protections prior to beginning work on the project.  (5)  Where a financial conflict exists, the PI has disclosed all relevant information regarding Conflict of Interest according to University policy. 

  

Principal Investigator signature:  _____________________________________________      Date:  _____________  

===================================================================================== 

(Advisor’s signature is required for all graduate/medical student projects.) 

Advisor certifies to the following:  Advisor has read the protocol and approves of the project. 

Advisor's signature: ________________________________________________        Date:  _____________ 

Print name:         

===================================================================================== 

Undergraduate student investigator signature: _____________________________________         Date:  ___________ 

Print name:                                                                             (optional signature) 

 

For IRB Use Only 

FULL BOARD PROTOCOLS - Institutional Review Board Members:  If approving the proposed project, please certify to the best of your knowledge to the following:  (1)  IRB Member is familiar with the above described proposed research.  (2)  The rights and welfare of the research participants will be adequately safeguarded by the procedures described.  (3)  The potential benefits justify the risks involved.  (4)  IRB Member has no vested interest in the project. 

IRB Member Signature:  ________________________________________________ Date:  ___________  

 

Signature of the Authorized Official of the IRB: __________________________________________ Date: ________ 

IRB Form #1 (Rev. 10/10) 

 


THIS PAGE MUST BE INCLUDED WITH YOUR ORIGINAL SUBMISSION 

 

Protocol Checklist and Submission Procedures 

 

Protocol Checklist 

 

All protocols for IRB review (full board, expedited, or exempt) must be submitted in the following format.  Protocols that do not follow this required format will be returned to the investigator without IRB review. 

 

#1 ______            IRB Form # 1 (fully signed) 

 

#2 ______            Required protocol components (pages must be numbered) (see “What Makes a Complete Protocol” for a more detailed description) 

 

#3 ______            Consent forms, including assent forms (if applicable) (pages must be numbered) 

 

#4 ______            Interview instruments/questionnaires (if applicable) (pages must be numbered) 

 

#5 ______            Recruitment documents (such as advertisements, flyers, cards) (if applicable) 

 

#6 ______            Letters of commitment/approval from collaborating organizations (see “What Makes a Complete Protocol” for a more detailed description) (if applicable) 

 

#7 ______            Copies of other IRB approvals (if applicable) 

 

#8 ______            Checklist Form for Research Involving the Use of Prisoners as Study Participants (if applicable) 

 

#9 ______            Complete application for outside funding/support (pages must be numbered) 

 

09 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 201409 June 2014~ 

 

Protocol Submission Procedures 

 

Full Board Protocols:  Submit the original and 11 copies of the complete protocol (as identified above) to the Research Protections Office, <street w:st="on">Box</street> 1986 in sufficient time to meet the agenda deadline (see http://www.brown.edu/research/deadline-receipt-protocols for upcoming IRB meeting dates and protocol deadlines). 

 

Exempt or Expedited Protocols: There is no specified deadline for submissions of Exempt or Expedited Protocols. Review time varies depending upon the project. The average review time is approximately 4 weeks. Please submit the complete (as identified above) original protocol to the Research Protections Office (RPO), <street w:st="on">Box</street> 1986, with sufficient time to allow for review and revisions, if necessary. 

 

{Note that the IRB (not the investigator) makes the final determination of whether a protocol is full board, expedited, or exempt. Thus, full board review may be necessary even if you suggest expedited or exempt review in your protocol.} 


IRB Form #1 Instructions and Information 

 

 (DO NOT INCLUDE THIS PAGE WITH YOUR PROTOCOL SUBMISSION.) 

 

 

The following information must be provided by the person responsible for the project and attached to the completed IRB Form #1: 

 

 

                A.    A brief (1-3 page) lay-person summary of the proposed project, including page references (when necessary) for the location of where more information can be found in the protocol.  (Note:  This summary will also be required for future related submissions such as progress reports and modification requests.) 

 

                B.    Application/proposal for funding/support (if an application/proposal of any kind was/will                                   be submitted, either internally to <place w:st="on"><placename w:st="on">Brown</placename> <placetype w:st="on">University</placetype></place> or externally, in order to obtain                                                 funding/support of the project, attach a copy of the full application/proposal.) 

 

                C.    Describe the specific aims of this project and the methodology including a description of the                                       project, purpose, procedures, participant population (criteria for inclusion/exclusion                                                            including the attempts made to include women and members of minority groups),                                                                 recruitment procedures, and how confidentiality of data will be maintained. 

 

                D.    Describe the possible risks to participants (including how the project is designed to minimize                                    those risks) and describe anticipated benefits (if any) to participants or to the body of science. 

 

                E.    Describe the methods to be used in securing the informed consent (or, when involving minors, assent) of the participants.  If an informed consent (or assent) form is to be used, attach it.  If consent (assent) is conducted verbally, attach a written copy of the script.  (See the next page for the basic elements of informed consent.) 

                 

                F.     Complete and attach the ‘Protocol Checklist and Submission Procedures’ page. 

 

                G.    Attach the following, if applicable to your research project:  all interview/survey questions, focus group topics, survey instruments, anticipated letters/emails to participants, recruitment materials, letters of support from groups/organizations, copies of other IRB approvals, a completed ‘Checklist Form for Research Involving the Use of Prisoners as Study Participants’, and a completed ‘Checklist Form for Research Involving Children as Study Participants’. 

 


IRB Form #1 Instructions and Information 

 

 (DO NOT INCLUDE THIS PAGE WITH YOUR PROTOCOL SUBMISSION.) 

 

 

The following are the basic elements of informed consent: 

 

 

                        1.     A statement that the study involves research, an explanation of the purposes of the                                                         research and the expected duration of the subject's participation, a description of the                                                      procedures to be followed, and identification of any procedures which are experimental; 

 

                        2.     A description of any reasonably foreseeable risks or discomforts to the subject; 

 

                        3.     A description of any benefits to the subject or to others which may reasonably be                                                             expected from the research; 

 

                        4.     A statement of appropriate alternative procedures (or courses of treatment), if any, that                                                 might be advantageous to the subject; 

 

                        5.     A statement describing the extent, if any, to which confidentiality of records identifying                                                the subject will be maintained; 

 

                        6.     For research involving more than minimal risk, an explanation as to whether any compensation or any medical treatments are available if injury occurs during the conduct of the study; and, if so, what they consist of, or where further information may be obtained; 

 

                        7.     An explanation of whom to contact for answers to pertinent questions about the research                                             and research participants' rights, and whom to contact in the event of a research-related                                                       injury to the subject; and 

 

                        8.     A statement that participation is voluntary, refusal to participate will involve no penalty                                              or loss of benefits to which the individual is otherwise entitled; and s/he may discontinue                                  participation at any time without penalty or loss of benefits to which the s/he is                                                                      otherwise entitled. 

 

 

(See OHRP regulations at 45CFR46, section 46.116 for additional elements of information that may be provided to participants in the consent procedure, when appropriate.) 

 


IRB Form #1 Instructions and Information 

 

 (DO NOT INCLUDE THIS PAGE WITH YOUR PROTOCOL SUBMISSION.) 

 

 

Categories of EXEMPT REVIEW: 

 

(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. 

 

(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 research participants can be identified, directly or through identifiers linked to the participants; and (ii) any disclosure of the human subject's responses outside the research could reasonably place the participants at risk of criminal or civil liability or be damaging to the subject's financial standing, employability, or reputation. 

 

(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 number (2) above, if :  (i) the human participants 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 participants cannot be identified, directly or through identifiers linked to the participants. 

 

(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. 

                             

(6)   Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if the 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. 

 

 


IRB Form #1 Instructions and Information 

 

 (DO NOT INCLUDE THIS PAGE WITH YOUR PROTOCOL SUBMISSION.) 

 

 

EXPEDITED REVIEW1 – applicability and categories of review 

 

Applicability 

(A)          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 following categories, may be reviewed by the IRB through the expedited review procedure authorized by 45 CFR 46.110 and 21 CFR 56.110. The activities listed should not be deemed to be of minimal risk simply because they are included on this list. 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. 

(B)           The categories in this list apply regardless of the age of subjects, except as noted. 

(C)          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.  

(D)          The expedited review procedure may not be used for classified research involving human   subjects. 

(E)           IRBs are reminded that the standard requirements for informed consent (or its waiver, alteration, or exception) apply regardless of the type of review--expedited or convened--utilized by the IRB. 

(F)           Categories one (1) through seven (7) pertain to both initial and continuing IRB review. 

 

Categories of Review 

 

(1)   Clinical studies of drugs and medical devices only when condition (a) or (b) is met. 

 

         (a) Research on drugs for which an investigational new drug application (21 CFR Part 312) is not            required. (Note: Research on marketed drugs that significantly increases the risks or decreases the      acceptability of the risks associated with the use of the product is not eligible for expedited review.);                 (b) Research on medical devices for which (i) an investigational device exemption application (21 CFR                Part 812) is not required; or (ii) the medical device is cleared/approved for marketing and the                medical device is being used in accordance with its cleared/approved labeling. 


IRB Form #1 Instructions and Information 

 

 (DO NOT INCLUDE THIS PAGE WITH YOUR PROTOCOL SUBMISSION.) 

 

Expedited Review (con’t.) 

 

 (2)  Collection of blood samples by finger stick, heel stick, ear stick, or venipuncture as follows: 

 

         (a) from healthy, nonpregnant adults who weigh at least 110 pounds.  For these participants, 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 (b) from other adults and children2, considering the age, weight,    and health of the participants, the collection procedure, the amount of blood to be collected, and the            frequency with which it will be collected. For these participants, 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. 

 

(3)   Prospective collection of biological specimens for research purposes by noninvasive means. 

 

Examples: (a) hair and nail clippings in a nondisfiguring manner; (b) deciduous teeth at time of exfoliation or if routine patient care  indicates a need for extraction; (c) permanent teeth if routine patient care indicates a need for extraction; (d) excreta and external secretions (including sweat); (e) 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; (f) placenta removed at delivery; (g) amniotic fluid obtained at the time of rupture of the membrane prior to or during labor; (h) 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; (i) mucosal and skin cells collected by buccal scraping or swab, skin swab, or mouth washings; (j) sputum collected after saline mist nebulization. 

 

 (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: (a) 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; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection of naturally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual. 

 

 (5) Research involving materials (data, documents, records, or specimens) that have been collected, or          will be collected solely for non-research 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        research participants. 45 CFR 46.101(b)(4). This listing refers only to research that is not exempt.) 

 

(6)   Collection of data from voice, video, digital, or image recordings made for research purposes. 


IRB Form #1 Instructions and Information 

 

 (DO NOT INCLUDE THIS PAGE WITH YOUR PROTOCOL SUBMISSION.)  

 

 

Expedited Review (con’t.) 

 

(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 research          participants. 45 CFR 46.101(b)(2) and (b)(3). This listing refers only to research that is not exempt.) 

 

(8)   Continuing review of research previously approved by the convened IRB as follows: 

 

        (a) where (i) the research is permanently closed to the enrollment of new participants; (ii) all       participants have completed all research-related interventions; and (iii) the research remains active    only for long-term follow-up of participants; or (b) where no participants have been enrolled and no             additional risks have been identified; or (c) where the remaining research activities are limited to data                analysis. 

 

(9)   Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories two (2) through eight (8) do not apply but the IRB has determined and documented at a convened meeting that the research involves no greater than minimal risk and no additional risks have been identified. 

 

_______________________ 

 

 

1 An expedited review procedure consists of a review of research involving human research participants by the IRB chairperson or by one or more experienced reviewers designated by the chairperson from among members of the IRB in accordance with the requirements set forth in 45 CFR 46.110. 

 

 

2 Children are defined in the HHS regulations as "persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted." 45 CFR 46.402(a). 

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The fact that you already have approval is great. Just keep in mind if you decide to change anything as a result of participating in the residency, you might have to file an amendment.
Posted 18:16, 23 Jul 2014
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