Revision(s) to an Approved Study Form

Save this PDF as:
 WORD  PNG  TXT  JPG

Size: px
Start display at page:

Download "Revision(s) to an Approved Study Form"

Transcription

1 Revision(s) to an Approved Study Form Revisions may range from a request to change a typographical error in the consent form to a significant change in the study design. Federal regulations and University policy require that each change must be reviewed and approved by the IRB prior to initiation. Revisions include amendments, modifications, addenda, updates, and administrative changes, additions, and other labels identified with study changes. Minor revisions involve procedures that are no more than minimal risk, or risks to subjects are not increased, and/or the revision is not a significant alteration of the study design. Minimal risk means that the probability and magnitude of harm or discomfort anticipated in the research are not greater than those ordinarily encountered in daily life or during the performance of routine physical or psychological examinations or tests. At FSU, the Chair is designated to review and approve minor revisions to approved studies. Examples may include changes in telephone numbers, addition or deletion of associates or staff, reduction in the number or research participants, or the deletion of questions in a survey. Substantive (major) revisions: Any revision to a study that involves increased risk to subjects or significantly affects the nature of the study must be reviewed by the full IRB. Examples may include revisions to the recruitment plan, adding, revising, eligibility criteria, adding or changing a research site, changing the Principal Investigator, or changing the consent form to include a newly identified side effect. Project Title Protocol Number Principal Investigator Approval Date Expiration Date Changes are requested to the (check all that apply) Protocol Consent form Questionnaires Other *Describe the proposed revision(s) to the study and justification (rationale) for the revision. If changes are requested in the protocol state each section in which changes are requested and fill out those sections in the application provided:

2 *State whether the proposed revision(s) increases or decreases the risk to participants (thereby changing the risk/benefit ratio) and if so, describe. If the level of risk remains the same, please descirbe this as well. Increase Decrease Same *Please describe: Upload two (2) copies of the revised questionnaires and/or consent form inclusive of all revision(s) proposed. In one copy, the revisions should be identified in bold or highlightedto facilitated IRB review. The second copy should be a "clean" copy. Translations: The consent forms and other applicable subject materials must be in a language easily understood by the subject and all translations must be approved by the IRB prior to use. Translated consent form or other subject material must be uploaded for review. Human Subjects Application For Full IRB and Expedited Exempt Review Logout te: If you logout or close the browser during the submission process, the information you have already input is saved. When you re-login next time, you are directed to the breaking point to continue your application. You can click the navigation bar on the top to review and edit previous steps. In each step, click Save and Go to Next button to save your changes. Only after you pressed Save and Go to Next button is the information on that screen saved. DO NOT open/or have open more than one HSC application (HSC applications in other tabs/windows). This may cause errors in the system and a delay in the review process. If you need to reference other applications you may view and print any application from the Investigator Homepage.

3 1. Project Title and Identification As Principal Investigator of this study, I assure the IRB that the following statements are true: The information provided in this form is correct. I will seek and obtain prior written approval from the IRB for any substantive modifications in the proposal, including changes in procedures, co-investigators, funding agencies, etc. I will promptly report any unexpected or otherwise significant adverse events or unanticipated problems or incidents that may occur in the course of this study. I will report in writing any significant new findings which develop during the course of this study which may affect the risks and benefits to participation. I will not begin my research until I have received written notification of final IRB approval. I will comply with all IRB requests to report on the status of the study. I will maintain records of this research according to IRB guidelines. The grant that I have submitted to my funding agency which is submitted with this IRB submission accurately and completely reflects what is contained in this application. If these conditions are not met, I understand that approval of this research could be suspended or terminated. *I Agree 1.1 *Project Title (Project title must match grant title. If different, also provide grant title) *Project is: Dissertation Thesis Teaching Other: * Required Field 1. Project Title and Identification 1.2 Principal Investigator (PI) Name: *First: Middle: *Last: *Mailing Address or Four Digit Campus Mail Code: *Phone: Fax: * *University Department:

4 *Highest Education Level: *Occupational Position: Faculty Staff Student Other *Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: FSU Training Module NIH HIPAA Other ne CITI Project Title and Identification 1.3 Co-Investigators/Research Staff Include any individual who will have responsibility for the consent process, direct data collection from subjects, or follow-up. Check following checkbox button to add Co-Investigators (or Research Staff). te: If you are a student do not place major professor(s) as Co-PI. Add Co-Investigator/Research Staff #1: Co-Investigator Research Staff Name: *First: Middle: *Last: *Mailing Address or Four Digit Campus Mail Code: *Phone: * *University Department: Fax: *Highest Education Level: *Occupational Position: Faculty Staff Student Other Indicate the training and education, if any, completed in the protection of human subjects or human subjects records: FSU Training Module NIH HIPAA Other ne CITI

5 1. Project Title and Identification 1.4 Faculty Advisor/Chair/Dean Information If the PI is a student, the advisor's information is required. If PI is faculty or staff, the Department Head's information is required. If PI is also the Department Head, the Dean or Division Head's information is required. Name: Faculty Advisor Department Chair/Director Dean Other *First: Middle: *Last: *Mailing Address or Four Digit Campus Mail Code: *Phone: * *University Department/Unit: 2.1 Is this research funded by an internal (FSU) or external agency? Sponsored or Funded Projects If you are applying for funding, please answer all of the following questions. If you are receiving funding from multiple sources, please check Add More Funding Source checkbox button and fill out the form for each of your sources. Funding Source #1: This project has been / will be submitted to the following funding agency: *Name of Sponsor: OMNI Number: *SRS/Research Foundation Contact Person: The funding decision: is pending has been awarded *Type of funding source:

6 2.1 Is this research funded by an internal (FSU) or external agency? n-funded Projects *If no, please explain how costs of research will be covered: 3. Institutional Oversight 3.1 *Is this research proposal being reviewed by any other institution or peer review committee? *Please select which other committee approvals are required for this research and provide documentation of their approval if it has been granted, or the application submitted if approval has not been granted (please upload the documentation at the end of the application): CRC Other IRB, please specify: Other, please specify: 4. Conflict of Interest Federal guidelines encourage Institutions to assure there are no conflicts of interest in research projects that could adversely affect the rights and welfare of human subjects. If this proposed research study involves a potential conflict of interest, additional information will need to be provided to the IRB. Examples of potential conflicts of interest may include: any sort of compensation, in cash or other form, for services to an individual and his or her immediate family, the value of which exceeds $10,000 in a one-year period or an equity interest which exceeds $10,000 or which exceeds a five percent ownership interest. 4.1 *Do any of the Investigators or personnel listed on this research have a potential conflict of interest associated with this study?

7 *Identify the individual(s): *Has this potential conflict of interest been disclosed and managed? If you are a Florida State University researcher, please disclose your potential conflict of interest in writing for review by your Department Head and Dean. Final IRB approval cannot be granted until all potential conflict matters are settled. The full IRB committee determines what disclosure language should be in the consent form. 5. Payment or Other Compensation for Research Subjects 5.1 *Will you give subjects gifts, payments, compensation, reimbursement, services without charge or extra credit/class credit? *Please explain: 6. Protocol Description and Other Detail Use lay language, do not refer to grant or abstract. All questions are required! 6.1 *Describe the objective(s) of the proposed research including purpose, research question, hypothesis, method, data analysis, research design and relevant background information etc.

8 6.2 *For Evaluation of your project, please check the following which apply: Mentally or Physically Challenged Subjects Children or Minor Subjects (under 18 years old) Prisoners, Parolees, or Incarcerated Subjects Filming, Video or Audio recording of Subjects Questionnaires or Surveys to be administered Review of Existing Data, Archives, or Medical Records Subjects primary language is not English Involves Deception Exclusion of Women or Children Subjects (must explain why they are being excluded) Subjects studied at FSU Subjects studied at non_fsu location(s) Students as Subjects Employees as Subjects Pregnant Subjects Fetal, placental, or surgical pathology tissues Involves blood Samples (fingerpricks, venipuncture, etc.) 6.3 Survey Techniques: check applicable category if the only involvement of human subjects will be in one or more of the following categories: Research on normal educational practices in commonly accepted educational settings Research involving educational tests (cognitive, diagnostic, aptitude, achievement) Research involving survey or interview procedures Research involving the collection or study of existing data, documents, records, archives, specimens 6.4 *Which methods will this study include? (check all that apply or specify other)

9 Descriptive Formative Phenomenological Ethnographic Longitudinal Qualitative Experimental/Control Design Oral history Quantitative Field work Other, specify: 6.5 *Describe the tasks subjects will be asked to perform. Upload (at the end of the application) surveys, instruments, interview questions, focus group questions etc. Describe the frequency and duration of procedures, psychological tests, educational tests, and experiments; including screening, intervention, follow-up etc. (If you intend to pilot a process before recruiting for the main study please explain.) 6.6 *How many months do you anticipate this research study will last from the time final approval is granted? 7. Participant (Subject) Population 7.1 *Expected number of participants. of male:. of female: 7.2 Expected Age Range (Check all that apply) 0-7 (Upload parental permission form) 8-17 (Upload child's assent form and parental permission form) and older 7.3 *Inclusion/Exclusion of Children in this Research 7.3 *Inclusion/Exclusion of Children in this Research

10 Inclusion Exclusion If this study proposes to include children, this inclusion must meet one of the following criterion for risk/benefit assessment according to the federal regulations (45CFR56, subpart D). Please check: (404) Minimal Risk (405) Greater than minimal risk, but holds prospect of direct benefit to subjects (406) Greater than minimal risk, no prospect of direct benefit to subjects, but likely to yield generalizable knowledge about the subject's disorder or condition Inclusion Exclusion If this study would exclude children, NIH guidelines advise that the exclusion be justified, so that potential for benefit is not unduly denied. Indicate whether there is potential for direct benefit to subjects in this study and if so, provide justification for excluding children. te that if inclusion of children is justified, but children are not seen in the PI's practice, the sponsor must address plans to include children in the future or at other institutions. Please check: direct benefit established (exclusion of children permissible) Potential for direct benefit exists Provide justification for exclusion of children: 7.4 Other Protected Populations to be Included in this Research (Check all that apply) Protected by Federal Regulations Pregnant Woman/Fetuses/Neonates Prisoners (Refer to 45 CFR 46 subpart B and 45 CFR 46 subpart C on the populations protected by Federal Regulations)

11 Protected by Federal Guidelines Mentally/Emotionally/Developmentally/Decisionally Impaired Persons Minority Group(s) and n-english Speakers Elderly Subjects Gender Imbalance - all or more of one gender 7.5 *Inclusion and Exclusion of Subjects in this Research Study Describe criteria for inclusion and exclusion of subjects in this study Inclusion Criteria: Exclusion Criteria: 7.6 *Location of subjects during research activity or location of records to be accessed for research Check all that apply and specify: Florida State University TBA1 TBA2 Other, specify: Hospitals, specify: Community Clinic, specify: Elementary/Secondary Schools, specify: Community Center, specify: University Campus (non-clinical), specify: Prisons/Halfway Houses, detention centers, specify: Nursing Home(s), specify:

12 Subject's Home, specify: International Location, specify: Other Special Institutions, specify: 7.7 *Describe the rationale for using each location checked above Upload copies of IRB approvals or letters of cooperation from other agencies or sites, if it has been granted or the application submitted if approval has not been granted ( at the end of the application): 8. Recruitment of Participants (Subjects) 8.1 *Describe the recruitment process to be used for each group of subjects Upload a copy of any and all recruitment materials to be used e.g. advertisements, bulletin board notices, s, letters, phone scripts, or URLs. 8.2 *Explain who will approach potential subjects to take part in the research study and what will be done to protect individuals' privacy if required in this process 8.3 *Are subjects chosen from records? Are records "private" medical or student records? *Who or what entity is the custodian of the records?

13 *Who gave approval for use of the records: 8.4 *FSU policy prohibits researchers from accepting gifts for research activities. Is the study sponsor offering any incentive connected with subject enrollment or completion of the research study (i.e. finders fees, recruitment bonus, etc.) that would be paid directly to the research staff? 8.5 *Is the study going to be posted on the Research Studies at Florida State University recruiting website? 9. Risks and Benefits 9.1 Does the research involve any of these possible risks or harms to subjects? Check all that apply Use of a deceptive technique. Use of private records (educational or medical records) Manipulation of psychological or social variables such as sensory deprivation, social isolation, psychological stresses Any probing for personal or sensitive information in surveys, interviews or questionnaires Presentation of materials which subjects might consider sensitive, offensive, threatening, degrading or dangerous Possible invasion of privacy of subject or family Financial standing, employability, or reputation Criminal, civil, or legal liability Other risks, specify: 9.2 *Does the Research Involve Greater Than Minimal Risk to Human Subjects? "Minimal Risk" means that the risks of harm anticipated in the proposed research are not greater, considering probability and magnitude, than those ordinarily encountered in daily

14 life or during the performance of routine physical or psychological examinations or tests. *Describe the nature and degree of the risk or harm checked above (The described risks/harms must be disclosed in the consent form.) 9.3 *Explain what steps will be taken to minimize risks or harms and to protect subjects' welfare. If the research will include protected populations (see question 7.4) please identify each group and answer this question for each group 9.4 *Describe the anticipated benefits of this research for individual subjects in each subject group. If none, state "ne" 9.5 *Describe the anticipated benefits of this research for society, and explain how the benefits outweigh the risks. 10. Confidentiality of Data 10.1 *Will you record any direct identifiers, names, social security numbers, addresses, telephone numbers, addresses, cookies etc.?

15 *Explain why it is necessary to record findings using these identifiers and describe the coding system you will use to protect against disclosure of these identifiers: 10.2 *Will you retain a link between study code numbers and direct identifiers after the data collection is complete? *Explain why this is necessary and state how long you will keep this link: 10.3 *Will you provide the link or identifier to anyone outside the co-investigators/research staff? *Explain why and to whom: 10.4 *Where, how long, and in what format (such as paper, digital or electronic media, video, audio, or photographic) will data be kept? In addition, describe what security provisions will be taken to protect this data (password protection, encryption, etc.) 10.5 *Will you place a copy of the consent form or other research study information in the subjects' record such as medical, personal or educational record? *Explain why this is necessary: 10.6 If the data collected contains information about illegal behavior, please refer to the NIH Certificates of Confidentiality Kiosk for information about obtaining a Federal Certificate of Confidentiality *Will you be given or have access to personal information regarding employee, customer, student, parent and/or patient accounts with Florida State University?

16 *Please upload a signed copy of the Employee Confidentiality Statement. For more information, read the OP-F-7 Policy on Safeguarding of Confidential Financial and Personal Information. PDF: 11. Use of Protected Health Information (PHI): HIPAA Requirements In the course of conducting research, researchers may desire to obtain, create, use, and/or disclose individually identifiable health information. Under the HIPAA Privacy Rule, covered entities (healthcare providers, health plans, employer or healthcare clearinghouses) are permitted to use and disclose protected health information for research with individual authorization, or without individual authorization under limited circumstances set forth in the Privacy Rule *As part of this study, will you be accessing PHI from a covered entity for research purposes? *Please explain which of the following you will be utilizing to comply with the HIPAA regulations for use of PHI: Research Use/Disclosure Without Authorization Documented Institutional Review Board or Privacy Board Approval (alteration or waiver of research participants' authorization) Preparatory to Research Research on Protected health Information of Decedents Limited Data Sets with a Data Use Agreement Research Use/Disclosure With Individual Authorization 12. Informed Consent Process 12.1 *Recognizing that consent itself is a process of communication, please expand on your responses to questions 8.1 and 8.2 and describe what will be said to the subjects to introduce the research. Do not say see consent form. Write the explanation in lay language. If you are using telephone surveys, telephone scripts are required.

17 12.2 *In relation to the actual data gathering, when will consent be discussed and documentation obtained? (e.g., mailing out materials, delivery of consent form, meetings) Be specific *Please name the specific individuals who will obtain informed consent and include their job title/credentials and a brief description of your plans to train these individuals to obtain informed consent and answer subject's questions: 12.4 *What questions will you ask to assess the subjects' understanding of the risks and benefits of participation? (Questions should be open-ended and go beyond requiring only a yes/no response.) 12.5 Informed Consent Waivers Request waiver of documentation of consent In some instances, the written consent of subjects increases risk of exposure or embarrassment. The IRB may in some specific instances waive documentation. See 45 CFR An IRB may waive the requirement for written documentation of consent but still require that consent be obtained if either of the following conditions exist: (select the conditions that apply)

18 The only record linking the subject and the research would be the consent form and the principle risk of the research would be the potential harm from a breach of confidentiality: (the IRB may allow an option to sign or decline) The research involves minimal risk and includes no procedures for which written consent is normally required outside the research context. te: The IRB may, in either case, require the researcher to provide the participant with a written statement about the research. Upload copy of written statement about research. Request waiver of consent The IRB may, in some specific instances, waive the requirement for informed consent in accordance with 45 CFR (d). Select the following that apply to this research: (All answers must be checked to qualify for a waiver) The research involves no more than minimal risk to the subjects. A waiver will not adversely affect the rights and welfare of the subjects. The research could not practicably be carried out without waiver or alteration. Where appropriate, the subjects will be provided with additional pertinent information after participation. Appendices Click on each link below to finish all the required appendices. Prisoners as Subjects in Research Inclusion of Vulnerable Populations Use of Deception Pregnant Women, Human Fetuses and neonates involved in Research Children Involved as Subjects in Research Research Studies at Florida State University Seeking Volunteers Documents Upload all supporting documents to the application such as consent forms, assent forms, cover letters, parental permission forms, guardianship permission form, reminder postcards, recruiting flyers, questionnaires, support letters for research sites, and other IRB approval letters.

19 The following file extensions are acceptable formats:.doc,.pdf,.xls,.ppt, and.vsd. Name each file with the PI's last name and type of document it is. ( e.g. Smithconsentform.doc ) The size of uploaded file can not be larger than 4MB. Total Number of Files Uploaded: 0 Document: After you have submitted all the required appendices and uploaded all the related documents, please click the Submit Application button below to confirm the submission. OR you can simply close the browser and re-login in the future time to edit and submit your application later on. In either case, YOU MUST CLICK THE FOLLOWING BUTTON TO COMPLETE YOUR APPLICATION. Please click here to check your application before submitting. If you have any technical problem, please contact webmaster. Appendix: Prisoners as Subjects in Research Federal Regulations require that investigators comply with the additional protections as summarized below. Please respond to each factor below for consideration: 1. *Will this study examine the possible causes, effects, or processes of incarceration and/or criminal behavior? 2. *Will this study examine prisons as institutional structures or prisoners as incarcerated persons? 3. *Will this study examine a condition(s) particularly affecting prisoners as a class of people? 4. *Will this study examine a procedure, innovative or accepted, that will have the intent or reasonable probability of improving the health or well being of the subjects?

20 *If, how will prisoners be assigned to groups? 5. *Will prisoners receive any incentives or advantages by agreeing to participate? he targeting or inclusion of potentially vulnerable populations (other than children, pregnant women/fetuses and prisoners) in research requires special considerations. Provide information on the following populations, if applicable, in this research. *te: 1-4 not all required but at least one must be filled out. 1. Mentally/Emotionally/Developmentally Disabled Targeted Included Provide justification: Explain how competency to provide consent will be determined and plan for obtaining surrogate consent: 2. Minority Group(s)/n-English Speakers Targeted Included Provide justification:

21 Provide plan for obtaining consent: 3. Elderly (65+) Targeted Included Provide justification: If competency to provide consent may be an issue, describe how competency will be determined and plan for obtaining consent: 4. Gender Imbalance If all or more of one gender are targeted, provide justification for this: Appendix: Use of Deception Subjects must be told the purpose of the study, the reason for the deception and given an opportunity to withdraw their data from the project. (For guidance, see APA Ethical Standard 8.07) 1. *Explain the scientific rationale for deceiving the study subjects. Which aspects of study procedures will be withheld from subjects? Why?

22 2. *Describe when the subjects will be told the true purpose of the study, the reason for the deception and explain how they will be informed and by whom. (Upload a copy of the material or script to be used) 3. *Describe how and when subjects will be given an opportunity to withhold use of the data gathered under deceptive conditions. 4. Upload the full debriefing "protocol" or explanation that will be provided to subjects. Appendix: Pregnant Women, Human Fetuses and Neonates involved in Research 1. *Does your research involve a pregnant woman or her fetus? Federal regulations define pregnancy as encompassing the period of time from implantation until delivery. A woman shall be assumed to be pregnant if she exhibits any of the pertinent presumptive signs of pregnancy, such as missed menses, until the results of a pregnancy test are negative or until delivery. Fetus means the product of conception from implantation until delivery. *If yes, please explain: 2. *Is there any risk involved in this research? *If yes, the risk must be the least possible for achieving the objectives of the research. Please explain how any risk has been minimized for subjects:

23 3. *Is there any direct benefit to the pregnant woman and/or the fetus? *If yes, please explain: 4. *Is the pregnant woman a minor (under age 18)? *If yes, how will you obtain assent and permission of the parent? 5. *Does this research involve a neonate? Neonate is defined in the federal regulations to mean a newborn. *If yes, please explain: *Is the neonate of uncertain viability? *If yes, please explain: 6. *Does the research involve nonviable neonates? A nonviable neonate means a neonate after delivery that, although living, is not viable. *If yes, please explain: Appendix: Children Involved as Subjects in Research

24 Children are 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 (in Florida, the age of 18). Assent means a child's affirmative agreement to participate in research. Mere failure to object should not, absent affirmative agreement, be construed as assent. Permission means the agreement or parent(s) or guardian to the participation of their child or ward in research. Parent means a child's biological or adoptive parent. Guardian means an individual who is authorized under applicable State or local law to consent on behalf of a child to general medical care. 1. *What is the age range of the children involved in the research? 2. *What is the psychological and maturity state of the children involved in the research? 3. *Are any of the children involved in the research wards of the State? 4. *Does the research involve less than minimal risk? a. *Does the research involve greater than minimal risk but presents the prospect of direct benefit to the individual subjects? b. *Does the research involve greater than minimal risk and no prospect of direct benefit to individual subjects, but likely to yield generalizable knowledge about the subject s disorder or condition? 5. *Explain how assent of the children will be obtained in this research: 6. *Explain how permission will be obtained from the parent(s) or guardian for the participation of their child or ward in this research:

25 Appendix: Research Studies at Florida State University Seeking Volunteers HSC Number: 1. *What is the research study title? Such as title from consent form. a 2. *Give a brief study description: Such as Purpose and Procedures section of consent form. 3. *Where is the study located? Street address, bldg. name, room number, etc. 4. *What is the estimated participant study length? 5. *Will there be any compensation for the participant? 6. *Participant Criteria: *Gender: Female Male *Age Range(s): Ages: -

26 7. *Contact Information: *First Name: *Last Name: *FSU Address Only: Phone Number:

Instructions for Form: Application for Claim of Exemption

Instructions for Form: Application for Claim of Exemption Instructions for Form: Application for Claim of Exemption In order to decide whether your activity involves research that may be reviewed and approved at the exempt level, review the following information.

More information

Miami University: Human Subjects Research General Research Application Guidance

Miami University: Human Subjects Research General Research Application Guidance Miami University: Human Subjects Research General Research Application Guidance Use the accompanying Word template for completing the research description. You must provide sufficient information regarding

More information

Human Subjects Research at OSU

Human Subjects Research at OSU Office of Responsible Research Practices 300 Research Foundation 1960 Kenny Road Columbus, OH 43210-1063 Human Subjects Research at OSU Phone (614) 688-8457 Fax (614) 688-0366 www.orrp.osu.edu Behavioral

More information

MEREDITH COLLEGE INSTITUTIONAL REVIEW BOARD GUIDELINES FOR THE PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH

MEREDITH COLLEGE INSTITUTIONAL REVIEW BOARD GUIDELINES FOR THE PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH MEREDITH COLLEGE INSTITUTIONAL REVIEW BOARD GUIDELINES FOR THE PROTECTION OF HUMAN PARTICIPANTS IN RESEARCH I. Introduction Recognizing its responsibility to provide measures to reasonably protect individuals

More information

INSTITUTIONAL REVIEW BOARD (IRB) REVIEW FORM FOR PROJECTS USING HUMAN SUBJECTS

INSTITUTIONAL REVIEW BOARD (IRB) REVIEW FORM FOR PROJECTS USING HUMAN SUBJECTS INSTITUTIONAL REVIEW BOARD (IRB) REVIEW FORM FOR PROJECTS USING HUMAN SUBJECTS Investigators are responsible for ensuring that the rights and welfare of human subjects participating in research activities

More information

Considerations for Waivers of Informed Consent and Authorization

Considerations for Waivers of Informed Consent and Authorization Considerations for Waivers of Informed Consent and Authorization Contents: Waiver of Informed Consent... 1 Office for Human Research Protections (OHRP) regulations... 1 Government projects... 1 All other

More information

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol

University of Hawai i Human Studies Program. Guidelines for Developing a Clinical Research Protocol University of Hawai i Human Studies Program Guidelines for Developing a Clinical Research Protocol Following are guidelines for writing a clinical research protocol for submission to the University of

More information

SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS

SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS BACKGROUND SAN DIEGO COMMUNITY COLLEGE DISTRICT INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the SDCCD Institutional Review Board (IRB)

More information

State University of New York at Canton Institutional Review Board. Sample Informed Consent Document

State University of New York at Canton Institutional Review Board. Sample Informed Consent Document State University of New York at Canton Institutional Review Board Sample Informed Consent Document The following sample informed consent document includes instructions to the person writing the document,

More information

Email Address Co-Principal Investigator Information Co- Principal Investigator Faculty Staff Grad. Student Undergrad. Student

Email Address Co-Principal Investigator Information Co- Principal Investigator Faculty Staff Grad. Student Undergrad. Student Illinois State University Institutional Review Board Research with Human Subjects Protocol Submission Form IRB Number (Number to be completed by REC) Federal regulations and Illinois State University policy

More information

INSTRUCTIONS TO RESEARCHERS INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS

INSTRUCTIONS TO RESEARCHERS INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS INSTRUCTIONS TO RESEARCHERS INSTITUTIONAL REVIEW BOARD HUMAN SUBJECTS The Federal Requirement. As of 2001 Duquesne University maintains a relationship with federal research and funding agencies known as

More information

Clarkson College Institutional Review Board Application Manual

Clarkson College Institutional Review Board Application Manual 1 Clarkson College Institutional Review Board Application Manual This manual is intended as a guide to implement Clarkson College Policy OG-8: Institutional Review of Research Involving Human Subjects

More information

IRB Application for Medical Records Review Request

IRB Application for Medical Records Review Request Office of Regulatory Research Compliance Institutional Review Board FORM B1 : Medial Records Review Application FORM B1 IRB Application for Medical Records Review Request Principal Investigator: Email:

More information

Section One: Application Information. Principal Investigator: Department: Title: Phone/Pager: Fax: address: % Time/Effort:

Section One: Application Information. Principal Investigator: Department: Title: Phone/Pager: Fax:  address: % Time/Effort: Howard University Institutional Review Board Application (Protocol) for IRB Review (A-1) Funded and/or Drugs and/or Devices and/or Greater than Minimal Risk Research Section One: Application Information

More information

Student Classroom Projects Involving Human Subjects (Guidance for Faculty)

Student Classroom Projects Involving Human Subjects (Guidance for Faculty) University of New England Institutional Review Board (IRB) Student Classroom Projects Involving Human Subjects (Guidance for Faculty) The University of New England (UNE) supports a wide range of both undergraduate

More information

Institutional Review Board for the Use of Human Subjects in Research GUIDELINES FOR A PROPOSAL NARRATIVE

Institutional Review Board for the Use of Human Subjects in Research GUIDELINES FOR A PROPOSAL NARRATIVE Institutional Review Board for the Use of Human Subjects in Research GUIDELINES FOR A PROPOSAL NARRATIVE In your narrative, address each of the topics outlined below. Every application for IRB review must

More information

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers

Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Principal Investigator Responsibilities for Education and Social/Behavioral Researchers Introduction The purpose of this module is to provide a basic understanding of the responsibilities of the principal

More information

Code of Federal Regulations. TITLE 45 PUBLIC WELFARE Department of Health and Human Services PART 46 PROTECTION OF HUMAN SUBJECTS

Code of Federal Regulations. TITLE 45 PUBLIC WELFARE Department of Health and Human Services PART 46 PROTECTION OF HUMAN SUBJECTS Code of Federal Regulations TITLE 45 PUBLIC WELFARE Department of Health and Human Services PART 46 PROTECTION OF HUMAN SUBJECTS * * * Revised January 15, 2009 Effective July 14, 2009 SUBPART A Basic HHS

More information

RESEARCH STUDY PROTOCOL. Study Title. Name of the Principal Investigator

RESEARCH STUDY PROTOCOL. Study Title. Name of the Principal Investigator RESEARCH STUDY PROTOCOL Study Title Name of the Principal Investigator For research involving human subjects, certain elements must be included with each new IRB submission to ensure an effective review

More information

Submission Date: Project Start Date: Approximate Project End Date:

Submission Date: Project Start Date: Approximate Project End Date: APPLICATION FOR INITIAL APPROVAL Submission Date: Project Start Date: Approximate Project End Date: Research Protocol Title: Principal Investigator: Research Study Contact: Email: Institution: Phone: SENIOR/KEY

More information

Institutional Review Board

Institutional Review Board Institutional Review Board Ethical Principles of Informed Consent Informed Consent Guidelines The principle of respect for persons requires that people be given the opportunity to choose what will or will

More information

HIPAA COMPLIANCE INFORMATION. HIPAA Policy

HIPAA COMPLIANCE INFORMATION. HIPAA Policy HIPAA COMPLIANCE INFORMATION HIPAA Policy Use of Protected Health Information for Research Policy University of North Texas Health Science Center at Fort Worth Applicability: All University of North Texas

More information

Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination

Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination Section 5: Recordkeeping, Reporting, Non-Compliance, Unanticipated Problems, Adverse Events, Suspension, Termination 5.1. Recordkeeping Policy In accordance with federal regulations (45 CFR 46.115 and

More information

Human Subjects Research (HSR) Series

Human Subjects Research (HSR) Series Human Subjects Research (HSR) Series CITI Program s HSR series consists of modules from two basic tracks, Biomedical (Biomed) and Social- Behavioral- Educational (SBE), and a set of Additional Modules

More information

Guidance on IRB Continuing Review of Research

Guidance on IRB Continuing Review of Research NOTE: THIS GUIDANCE SUPERSEDES OHRP S JANUARY 15, 2007 GUIDANCE ENTITILED GUIDANCE ON CONTINUING REVIEW. CLICK HERE FOR THE JANUARY 15, 2007 GUIDANCE. Office for Human Research Protections Department of

More information

The Health Insurance Portability and Accountability Act (HIPAA) Excerpted from the UTC IRB Policy

The Health Insurance Portability and Accountability Act (HIPAA) Excerpted from the UTC IRB Policy The Health Insurance Portability and Accountability Act (HIPAA) Excerpted from the UTC IRB Policy June 2008 Table of Contents PART V: The Health Insurance Portability and Accountability Act (HIPAA)...

More information

Claim of Exemption Form Page 1 of 6

Claim of Exemption Form Page 1 of 6 Claim of Exemption Form Page 1 of 6 Principal Investigator: Phone: Project or Protocol Title: Contact Person: Address: Phone: Fax: E-mail: Copy of Principal Investigator s CV attached SPONSOR / FUNDING

More information

IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM

IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM 1 IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM Wednesday, April 23, 2014 Cohen Lounge Hila Berger, MPH, CIP Research Compliance Administrator Amy Krenzer, CIP IRB Coordinator 2 Objectives What is the IRB

More information

12.0 Investigator Responsibilities

12.0 Investigator Responsibilities v. 5.13.13 12.0 Investigator Responsibilities 12.1 Policy Investigators are ultimately responsible for the conduct of research. Research must be conducted according to the signed Investigator statement,

More information

Hamline University Graduate School of Education Human Subjects Research: Non-Exempt (Long) Form

Hamline University Graduate School of Education Human Subjects Research: Non-Exempt (Long) Form Directions: 1. Before any student research project involving living human subjects can proceed, it must be reviewed by the Hamline University degree-granting unit subcommittee (MAT, MA in ESL, MAED/EDD).

More information

SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS

SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS BACKGROUND SAN DIEGO CITY COLLEGE RESEARCH COMMITTEE INSTITUTIONAL REVIEW BOARD (IRB) INVESTIGATOR GUIDELINES FOR RESEARCH USING HUMAN SUBJECTS The first priority of the San Diego City College Research

More information

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): FACT SHEET FOR NEUROPSYCHOLOGISTS Division 40, American Psychological Association

HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): FACT SHEET FOR NEUROPSYCHOLOGISTS Division 40, American Psychological Association HEALTH INSURANCE PORTABILITY AND ACCOUNTABILITY ACT (HIPAA): FACT SHEET FOR NEUROPSYCHOLOGISTS Division 40, American Psychological Association DISCLAIMER This general information fact sheet is made available

More information

MENTOR IRB User Guidelines

MENTOR IRB User Guidelines MENTOR IRB User Guidelines Mentor IRB is the IRB web based application recently adopted by Duquesne University. This IRB software tracking system will enable the IRB to better serve the Duquesne research

More information

USE OF HUMAN SUBJECTS IN RESEARCH PRESENTED BY BRIAN WEIMER TULANE UNIVERSITY RESEARCH COMPLIANCE OFFICER

USE OF HUMAN SUBJECTS IN RESEARCH PRESENTED BY BRIAN WEIMER TULANE UNIVERSITY RESEARCH COMPLIANCE OFFICER USE OF HUMAN SUBJECTS IN RESEARCH PRESENTED BY BRIAN WEIMER TULANE UNIVERSITY RESEARCH COMPLIANCE OFFICER June 14, 2011 Objectives of Presentation What is the role of the Research Compliance Officer? Why

More information

MENTOR IRB User Guidelines

MENTOR IRB User Guidelines MENTOR IRB User Guidelines Mentor IRB is the IRB web based application recently adopted by Duquesne University. This IRB software tracking system will enable the IRB to better serve the Duquesne research

More information

What is Covered under the Privacy Rule? Protected Health Information (PHI)

What is Covered under the Privacy Rule? Protected Health Information (PHI) HIPAA & RESEARCH What is Covered under the Privacy Rule? Protected Health Information (PHI) Health information + Identifier = PHI Transmitted or maintained in any form (paper, electronic, forms, web-based,

More information

Health Insurance Portability & Accountability Act (HIPAA) Compliance Application

Health Insurance Portability & Accountability Act (HIPAA) Compliance Application Health Insurance Portability & Accountability Act (HIPAA) Compliance Application IRB Office 101 - Altru Psychiatry Center 860 S. Columbia Rd, Grand Forks, North Dakota 58201 Phone: (701) 780-6161 PROJECT

More information

PLEASE BE AWARE that you cannot begin the project until you have received notification that the exemption has been granted.

PLEASE BE AWARE that you cannot begin the project until you have received notification that the exemption has been granted. Revised 11/08 RESEARCH EEMPTION REQUEST Ref. # (Category 1) Purdue University Institutional Review Board Exemption under Title 45 CFR 46.101 (b)(1) exempts research conducted in established or commonly

More information

Winthrop-University Hospital

Winthrop-University Hospital Winthrop-University Hospital Use of Patient Information in the Conduct of Research Activities In accordance with 45 CFR 164.512(i), 164.512(a-c) and in connection with the implementation of the HIPAA Compliance

More information

Special Categories of Research: Pregnant Women, Human Fetuses, and Neonates

Special Categories of Research: Pregnant Women, Human Fetuses, and Neonates Special Categories of Research: Pregnant Women, Human Fetuses, and Neonates Content Applies To Mayo Clinic Human Research Protection Program Research for which Mayo Clinic IRB is the IRB of Record Policy

More information

Hobart and William Smith Colleges. Colleges of the Seneca Form C. Application to Conduct Course-based Student Research with Human Subjects

Hobart and William Smith Colleges. Colleges of the Seneca Form C. Application to Conduct Course-based Student Research with Human Subjects Colleges of the Seneca Form C Directions for Faculty: Please fill out one application for each course-based research assignment. Note that one application is good for all students engaged in the assignment

More information

IRB Process & Medical Devices. Sandra Rogers IRB Pacific University

IRB Process & Medical Devices. Sandra Rogers IRB Pacific University + IRB Process & Medical Devices Sandra Rogers IRB Pacific University + IRB Review of Research: Criteria n Informed Consent (Respect for Persons) n Will be sought prospectively n Includes required elements

More information

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues

Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues Office for Human Research Protections (OHRP) Department of Health and Human Services (HHS) Guidance on Withdrawal of Subjects from Research: Data Retention and Other Related Issues This guidance represents

More information

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities

Human Research Protection Program Good Clinical Practice Guidance for Investigators Investigator & Research Staff Responsibilities This Guidance Document is to ensure that investigators and research personnel recognize their responsibilities associated with the conduct of human subject research by outlining their responsibilities,

More information

INSTITUTIONAL REVIEW BOARD OTTERBEIN UNIVERSITY

INSTITUTIONAL REVIEW BOARD OTTERBEIN UNIVERSITY INSTITUTIONAL REVIEW BOARD OTTERBEIN UNIVERSITY GUIDELINES FOR SUBMISSION OF PROTOCOLS CONTENTS Statement of Purpose Criteria for Review Submission Procedure Expedited Review Sample Informed Consent Models

More information

Reporting of Adverse Events and Unanticipated Problems

Reporting of Adverse Events and Unanticipated Problems Reporting of Adverse Events and Unanticipated Problems Policy date: 12/2011 Purpose The purpose of this policy is to ensure that the review, reporting and analysis of adverse events and unanticipated problems

More information

FILLING OUT YOUR HUMAN ETHICS APPLICATION Please consult these specific notes

FILLING OUT YOUR HUMAN ETHICS APPLICATION Please consult these specific notes FILLING OUT YOUR HUMAN ETHICS APPLICATION Please consult these specific notes Please download a fresh application template from our website for each new application, to ensure you have the correct updated

More information

Principal Investigator and Sub Investigator Responsibilities

Principal Investigator and Sub Investigator Responsibilities Principal Investigator and Sub Investigator Responsibilities I. Purpose To define the roles and responsibilities of Principal Investigators conducting research at GRU. II. Definition The term Principal

More information

Do I need IRB Review? If your research meets one of the following criteria, it needs IRB Review:

Do I need IRB Review? If your research meets one of the following criteria, it needs IRB Review: Do I need IRB Review? If your research meets one of the following criteria, it needs IRB Review: Designed to generate generalizable knowledge; Puts participants at risk greater than the minimal risks of

More information

Standard Operating Procedures

Standard Operating Procedures Standard Operating Procedures Ffff H a r v a r d L o n g w o o d M e d i c a l A r e a Office of Human Research Administration 90 Smith St. Suite 335 Boston, MA 02120 617-432-3071/ 617-432-2157 www.hsph.harvard.edu/ohra

More information

The George Washington University Office of Human Research IRB Forum June 20, 2012

The George Washington University Office of Human Research IRB Forum June 20, 2012 The George Washington University Office of Human Research IRB Forum June 20, 2012 Types of Chart Reviews Exempt vs. Expedited Protected Health Information Consent Requirements HIPAA Chart reviews are a

More information

STANDARDS OF PRACTICE (2013)

STANDARDS OF PRACTICE (2013) STANDARDS OF PRACTICE (2013) COLLEGE OF ALBERTA PSYCHOLOGISTS STANDARDS OF PRACTICE (2013) 1. INTRODUCTION The Health Professions Act (HPA) authorizes and requires the College of Alberta Psychologists

More information

HIPAA Authorization (Health Information Privacy Rights)

HIPAA Authorization (Health Information Privacy Rights) ALBANY MEDICAL CENTER ALBANY, NY 12208 PERMISSION TO TAKE PART IN A HUMAN RESEARCH STUDY AND HIPAA Authorization (Health Information Privacy Rights) Title of research study: Prospective Database Multidisciplinary

More information

HIPAA COMPLIANCE. What is HIPAA?

HIPAA COMPLIANCE. What is HIPAA? HIPAA COMPLIANCE What is HIPAA? The Health Insurance Portability and Accountability Act (HIPAA) also known as the Privacy Rule specifies the conditions under which protected health information may be used

More information

Texas A&M International University

Texas A&M International University Texas A&M International University Institutional Review Board Policy and Procedures Manual Updated: 12 November 2007 TAMIU IRB Policy Manual Page 1 Table of Contents Page 1. General Overview 4 1.1 Institutional

More information

Institutional Review Board Human Research Approval Form

Institutional Review Board Human Research Approval Form Institutional Review Board (submit completed form to Chair of the University IRB) Departmental Review Committee (submit completed form to Department Committee Chair) Institutional Review Board Human Research

More information

SOP Number: OCR-HIP-001 Effective Date: August 2013 Page 1 of 5

SOP Number: OCR-HIP-001 Effective Date: August 2013 Page 1 of 5 Title: HIPAA Research Policy: General Nova Southeastern University Standard Operating Procedure for GCP Version # 1 SOP Number: OCR-HIP-001 Effective Date: August 2013 Page 1 of 5 PURPOSE: Federal privacy

More information

Memorandum. Factual Background

Memorandum. Factual Background Memorandum TO: FROM: SUBJECT: Chris Ianelli and Jill Mullan, ispecimen, Inc. Kristen Rosati and Ana Christian, Polsinelli, PC ispecimen Regulatory Compliance DATE: January 26, 2014 You have asked us to

More information

Institutional Review Board

Institutional Review Board Institutional Review Board Collection and/or Study of Human Specimens Policy APPLICABILITY These guidelines apply to: 1. De-Identified, coded, and identified specimens. 2. Existing and prospectively collected

More information

Human Research Seminar Series: Informed Consent Process & HIPAA Authorization Requirements

Human Research Seminar Series: Informed Consent Process & HIPAA Authorization Requirements Institutional Review Board Human Research Seminar Series: Informed Consent Process & HIPAA Authorization Requirements Thursday, October 14, 2010 Presented by: Chester Edelmann, MD Chairman Jacqueline Rowan,

More information

HIPAA Compliance And Participation in the National Oncologic Pet Registry Project

HIPAA Compliance And Participation in the National Oncologic Pet Registry Project HIPAA Compliance And Participation in the National Oncologic Pet Registry Project Your facility has indicated its willingness to participate in the National Oncologic PET Registry Project (NOPR) sponsored

More information

Ethical Principles in Clinical Research. Christine Grady Department of Bioethics NIH Clinical Center

Ethical Principles in Clinical Research. Christine Grady Department of Bioethics NIH Clinical Center Ethical Principles in Clinical Research Christine Grady Department of Bioethics NIH Clinical Center 1 Ethical principles Are these studies ethical? How do we know? Ethics of clinical research The goal

More information

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure

Subject: No. Page PROTOCOL AND CASE REPORT FORM DEVELOPMENT AND REVIEW Standard Operating Procedure 703 1 of 11 POLICY The Beaumont Research Coordinating Center (BRCC) will provide advice to clinical trial investigators on protocol development, content and format. Upon request, the BRCC will review a

More information

A. HIPAA Privacy Authorizations and Exceptions for Use of Identifiable Protected Health Information

A. HIPAA Privacy Authorizations and Exceptions for Use of Identifiable Protected Health Information Protected Health Information and the JHSPH The Health Insurance Portability and Accountability Act (HIPAA) protects individually identifiable health information, or Protected Health Information ( PHI ),

More information

Institutional Review Board for Protection of Human Subjects Policies and Procedures Manual for Faculty, Staff, and Student Researchers

Institutional Review Board for Protection of Human Subjects Policies and Procedures Manual for Faculty, Staff, and Student Researchers Page 1 of 152 Institutional Review Board for Protection of Human Subjects Policies and Procedures Manual for Faculty, Staff, and Student Researchers Office of Research and Economic Development University

More information

To IRB, or Not to IRB? That Is the Question!

To IRB, or Not to IRB? That Is the Question! To IRB, or Not to IRB? That Is the Question! A presentation by Mary Sapp, Ph.D. Assistant Vice President, Planning & Institutional Research University of Miami and Thomas K. Martin, Ph.D. Associate Vice

More information

Nova Southeastern University Institutional Review Board Policies and Procedures

Nova Southeastern University Institutional Review Board Policies and Procedures Nova Southeastern University Institutional Review Board Policies and Procedures Monitoring of Approved Research, Approval Duration, and Continuing Review Effective 03/08/2007; Revised 10/14/2010; 8/29/2011;

More information

CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE

CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE CODE OF FEDERAL REGULATIONS TITLE 45 PUBLIC WELFARE DEPARTMENT OF HEALTH AND HUMAN SERVICES NATIONAL INSTITUTES OF HEALTH OFFICE FOR PROTECTION FROM RESEARCH RISKS PART 46 PROTECTION OF HUMAN SUBJECTS

More information

The following list consists of a few tips and tricks to use when navigating eirb.

The following list consists of a few tips and tricks to use when navigating eirb. TIPS/TRICKS The following list consists of a few tips and tricks to use when navigating eirb. GENERAL Submitting applications Only the PI can submit applications. However, the Study Coordinator can submit

More information

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB)

Investigator responsibilities for research conducted under the authority of the UTHSCSA Institutional Review Board (IRB) March 1, 2006 M E M O R A N D U M F O R R E C O R D TO: FROM: SUBJECT: Deans Department Chairs Principal Investigators Brian Herman, Ph.D. Vice President for Research Investigator responsibilities for

More information

WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ}

WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ} IRB forms and materials to be submitted WHEN I WANT TO: I NEED TO SUBMIT: {for CIRB studies, see the specific FAQ} 1 2 Request a determination as to whether AHC is the appropriate IRB of record (i.e. is

More information

If you are signing for a minor child, you refers to your child throughout the consent document.

If you are signing for a minor child, you refers to your child throughout the consent document. CONSENT TO PARTICIPATE IN A CLINICAL RESEARCH STUDY Adult Patient or Parent, for Minor Patient INSTITUTE: National Cancer Institute PRINCIPAL INVESTIGATOR: Raffit Hassan, M.D. STUDY TITLE: Tissue Procurement

More information

Office for Human Subject Protection. University of Rochester. Research Subjects Review Board Effective Date: 10/28/2014

Office for Human Subject Protection. University of Rochester. Research Subjects Review Board Effective Date: 10/28/2014 POLICY 1. Purpose Ensure that University of research activities comply with the national standards for the protection of certain health information that apply to the use and disclosure of individuals health

More information

Connecticut Pipe Trades Health Fund Privacy Notice. 2013 Restatement

Connecticut Pipe Trades Health Fund Privacy Notice. 2013 Restatement Connecticut Pipe Trades Health Fund Privacy Notice 2013 Restatement Section 1: Purpose of This Notice and Effective Date THIS NOTICE DESCRIBES HOW MEDICAL INFORMATION ABOUT YOU MAY BE USED AND DISCLOSED

More information

RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS

RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS RESEARCH INVOLVING DATA AND/OR BIOLOGICAL SPECIMENS 1. Overview IRB approval and participant informed consent are required to collect biological specimens for research purposes. Similarly, IRB approval

More information

PROTECTED HEALTH INFORMATION AND THE JHSPH

PROTECTED HEALTH INFORMATION AND THE JHSPH PROTECTED HEALTH INFORMATION AND THE JHSPH The Health Insurance Portability and Accountability Act (HIPAA) protects individually identifiable health information, or Protected Health Information ( PHI ),

More information

South Dakota Parental Rights and Procedural Safeguards

South Dakota Parental Rights and Procedural Safeguards South Dakota Parental Rights and Procedural Safeguards Special Education Programs Revised July 2011 Prior Written Notice... 1 Definition of Parental Consent... 3 Definition of a Parent... 3 Parental Consent...

More information

focus on Medical Privacy June 2001 HIPAA and the Federal Privacy Standards for Health Information Overview

focus on Medical Privacy June 2001 HIPAA and the Federal Privacy Standards for Health Information Overview focus on Medical Privacy June 2001 HIPAA and the Federal Privacy Standards for Health Information Overview On December 28, 2001, the Department of Health and Human Services ("HHS") published the long-awaited

More information

INDIANA UNIVERSITY SCHOOL OF OPTOMETRY HIPAA COMPLIANCE PLAN TABLE OF CONTENTS. I. Introduction 2. II. Definitions 3

INDIANA UNIVERSITY SCHOOL OF OPTOMETRY HIPAA COMPLIANCE PLAN TABLE OF CONTENTS. I. Introduction 2. II. Definitions 3 INDIANA UNIVERSITY SCHOOL OF OPTOMETRY HIPAA COMPLIANCE PLAN TABLE OF CONTENTS I. Introduction 2 II. Definitions 3 III. Program Oversight and Responsibilities 4 A. Structure B. Compliance Committee C.

More information

BUSINESS ASSOCIATE ADDENDUM

BUSINESS ASSOCIATE ADDENDUM BUSINESS ASSOCIATE ADDENDUM This Business Associate Addendum ( Addendum ) adds to and is made a part of the Q- global Subscription and License Agreement by and between NCS Pearson, Inc. ( Business Associate

More information

UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTIONS PROGRAM. DoD/DON-funded Research

UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTIONS PROGRAM. DoD/DON-funded Research UNIVERSITY OF CALIFORNIA, SAN DIEGO HUMAN RESEARCH PROTECTIONS PROGRAM DoD/DON-funded Research Policy In 2006, the Department of the Navy (DON) enhanced its human subject protection requirements, including

More information

INSTITUTIONAL REVIEW BOARD

INSTITUTIONAL REVIEW BOARD INSTITUTIONAL REVIEW BOARD Policies and Procedures Manual January 2015 Revision 5.0 TABLE OF CONTENTS 1.0 Purpose, Regulatory Overview, and Institutional Policy 1.1 Introduction and Purpose 1.2 Laws, Regulations,

More information

Health Insurance Portability and Accountability Policy 1.8.4

Health Insurance Portability and Accountability Policy 1.8.4 Health Insurance Portability and Accountability Policy 1.8.4 Appendix C Uses and Disclosures of PHI Procedures This Appendix covers procedures related to Uses and Disclosures of PHI. Disclosures to Law

More information

2.1. Study Personnel and their roles: Last Name First Name Organization Study Role Certifications Obtain Consent

2.1. Study Personnel and their roles: Last Name First Name Organization Study Role Certifications Obtain Consent Version: 1.0 Application Version Date: 4/26/2012 Date: Thursday, September 20, 2012 7:40:03 AM 1. Project Identification Information 1.1. * Type of Submission: Research Protocol or Study on Human Subjects

More information

The Health and Benefit Trust Fund of the International Union of Operating Engineers Local Union No. 94-94A-94B, AFL-CIO. Notice of Privacy Practices

The Health and Benefit Trust Fund of the International Union of Operating Engineers Local Union No. 94-94A-94B, AFL-CIO. Notice of Privacy Practices The Health and Benefit Trust Fund of the International Union of Operating Section 1: Purpose of This Notice Notice of Privacy Practices Effective as of September 23, 2013 THIS NOTICE DESCRIBES HOW MEDICAL

More information

IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM

IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM 1 IRB 101: HUMAN SUBJECTS PROTECTION PROGRAM Wednesday, September 30, 2015 Hila Berger, MPH, CIP Research Compliance Officer Amy Krenzer, CIP IRB Coordinator 4 Objectives What is the IRB responsible for?

More information

Nova Southeastern University IRB - Consent Form Checklist Version Date: 02/17/2010

Nova Southeastern University IRB - Consent Form Checklist Version Date: 02/17/2010 Nova Southeastern University IRB - Consent Form Checklist Version Date: 02/17/2010 This form is intended to assist researchers in creating consent and assent forms. Informed consent is one of the primary

More information

IRB Guidelines 1.3 HIPAA Research Implications Version 1.1: Created 4/20/2016

IRB Guidelines 1.3 HIPAA Research Implications Version 1.1: Created 4/20/2016 Institutional Review Board (IRB) IRB Guidelines 1.3 HIPAA Research Implications Version 1.1: Created 4/20/2016 Overview The Health Insurance Portability and Accountability Act of 1996 (HIPAA) and its regulations,

More information

Disclaimer. Objectives 5/30/2016

Disclaimer. Objectives 5/30/2016 Good Clinical Practice Informed Consent Training Presented by Jacqueline Everett Clinical Trial Governance Manager, Research Integrity Disclaimer The material in this presentation has been prepared by

More information

Population Health Management Program Notice of Privacy Practices from Piedmont WellStar HealthPlans, Inc.

Population Health Management Program Notice of Privacy Practices from Piedmont WellStar HealthPlans, Inc. Population Health Management Program Notice of Privacy Practices from Piedmont WellStar HealthPlans, Inc. Piedmont WellStar HealthPlans, Inc. (PWHP) provides population health management services to its

More information

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Executive Summary

Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Executive Summary Research Involving Human Biological Materials: Ethical Issues and Policy Guidance Executive Summary Introduction Biomedical researchers have long studied human biological materials such as cells collected

More information

The JSU IRB. IRB Membership

The JSU IRB. IRB Membership The JSU IRB The Institutional Review Board exists because federal regulations require that federal departments and federal agencies scrutinize all human subject research conducted or sponsored by each

More information

University of Mississippi Medical Center Office of Integrity and Compliance

University of Mississippi Medical Center Office of Integrity and Compliance Office of Integrity and Effective Date: 2005 By: Committee 1.0 PURPOSE The purpose of this policy is to guide (UMMC) employees, who are involved with research, in obtaining an authorization for the use

More information

HIPAA Privacy Board Overview

HIPAA Privacy Board Overview Defense Health Agency Privacy and Civil Liberties Office HIPAA Privacy Board Overview April 30, 2015 1 Objectives The purpose of this presentation is to: Provide an overview of the DHA Privacy and Civil

More information

Minimum Education Requirements for DoD Personnel Involved in Human Research Protection

Minimum Education Requirements for DoD Personnel Involved in Human Research Protection Minimum Education Requirements for DoD Personnel Involved in Human Research Protection The Department of Defense (DoD) is committed to conducting high-quality and ethical research, development, test, and

More information

HOSPITAL ADMINISTRATIVE POLICY

HOSPITAL ADMINISTRATIVE POLICY HOSPITAL ADMINISTRATIVE POLICY INSTITUTIONAL REVIEW BOARD GOVERNANCE POLICY Document No.: Revision: Original Date: Effective Date: NUH-HAP-ROF-004 00 08-Apr-2013 08-Apr-2013 : Description of Content/Change:

More information

Introduction to Institutional Review Boards (IRBs) Holly Taylor, MPH, PhD Johns Hopkins University

Introduction to Institutional Review Boards (IRBs) Holly Taylor, MPH, PhD Johns Hopkins University This work is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike License. Your use of this material constitutes acceptance of that license and the conditions of use of materials on this

More information

Children's Hospital, Boston (Draft Edition)

Children's Hospital, Boston (Draft Edition) Children's Hospital, Boston (Draft Edition) The Researcher's Guide to HIPAA Evervthing You Alwavs Wanted to Know About HIPAA But Were Afraid to Ask 1. What is HIPAA? 2. What is the Privacy Rule? 3. What

More information

Assessing Risk in Social and Behavioral Sciences

Assessing Risk in Social and Behavioral Sciences Tracy Arwood, MS Clemson University Sangeeta Panicker, PhD American Psychological Association Assessing Risk in Social and Behavioral Sciences Assessing Risk in Social and Behavioral Sciences Content Authors

More information

Investigator Handbook to Human Research Activities. South Shore Hospital

Investigator Handbook to Human Research Activities. South Shore Hospital Investigator Handbook to Human Research Activities South Shore Hospital 1 INVESTIGATOR HANDBOOK CONTENTS WHO IS INVOLVED IN RESEARCH Principal Investigator... 6 Site PI 6 Co-investigators 6 Biostatistician

More information