The University of Sarasota
Human Subjects Review Committee (HSRC)
Internal Review Board (IRB)
May, 1999
Table of Contents
A. Section II Administrative Documents
1. Mission
2. Committee Composition............................................................................................ 2
3. Categories of Reviews............................................................................................... 4
4. Areas of Concern for Ethical-Legal Considerations.................................................... 5
5. Governing Legislation................................................................................................ 8
6. Special Subject Categories...................................................................................... 10
7. Criteria for Approval............................................................................................... 12
8. Timelines................................................................................................................. 14
9. Model Statements of Informed Consent................................................................... 16
10. HSRC Application Checklist................................................................................... 18
B. Section II Forms
1. HSRC Application Form......................................................................................... 21
2. Research Progress Report....................................................................................... 27
3. Change in Procedure Form...................................................................................... 30
4. Off-Site Adverse Incident Report............................................................................ 33
5. On-Site Adverse Incident Report............................................................................. 35
6. Project Completion Report...................................................................................... 37
The University of Sarasota
Human Subjects Review Committee (HSRC)
Internal Review Board (IRB)
A. Section II Administrative Documents
Mission Statement
The mission of the Human Subjects Review Committee (HSRC) is to review and approve any research project proposals set forth by any representative, agent, or individual affiliated with the institution in a capacity to conduct research projects involving human subjects (FDR 45 § 46.01 March 8. 1983). It is the intent of the HSRC to ascertain that ethical and professional standards are adhered to, and that the research project coordinator has provided assurances to maintain those standards throughout the research project. The research coordinator must assure that he or she takes appropriate steps to protect subjects' rights, minimize pain, provide informed consent, apply equal treatment to all subjects relative to the nature of the research project, and assures protection of all protected or vulnerable groups in accordance with Federal Register 45 (§ 46.01).
The American Psychological Association (APA) has authored a document, Ethical Principles in the Conduct of Research with Human Participants. Principles A-J involve numerous facets of conducting human research; however, principles A-C are offered to help a researcher decide For or Against Conducting A Given Research Project.
A. In planing a study, the investigator has the responsibility to make a careful evaluation of its ethical acceptability. To the extent that the weighing of scientific and human values suggests a compromise of any principle, the investigator incurs a correspondingly serious obligation to seek ethical advice and to observe stringent safeguards to protect the rights for human participants.
B. Considering whether a participant in a planned study will be a "subject at risk" or a "subject at minimal risk," according to recognized standards, of primary ethical concern to the investigator.
C. The investigator always retains the responsibility for ensuring ethical practice in research. The investigator is also responsible for the ethical treatment of research participants by collaborators, assistants, students, and employees, all of whom, however, incur similar obligations. (p.5)
Committee Composition
The HSRC Committee shall be comprised of five institutional representatives qualified to review said proposals and shall convene to review and approve the HSRC application form on all research projects conducted in connection with the institution. The HSRC shall be qualified to review proposed research in terms of institutional commitments and regulations, applicable law, and standards of professional conduct and practice. All parties proposing a research project must submit an HSRC approval form including- students, staff, faculty members, and any other individual, group, or organization working under the auspices of that institution.
Committee Members
Director......................................... Dr. Maxwell Jackson, Ed.D., Dean, College of Behavioral Sciences
Chairperson................................. F Felicia Ferrara, Ph.D., College of Behavioral Science
Committee Members................... Curtis Ames, Ed.D, College of Education
Lakshmi Narayanan, College of Behavioral Sciences
John Theodore, Ph.D., College of Business
Committee Duties
1. The Committee shall review all incoming research projects proposed by representatives of the University of Sarasota-
2. A meeting of the committee shall be convened to review regular research projects. There are three categories of approval; EXEMPT, EXPEDITED, and REGULAR based on risk/benefit ratio to the subject. The researcher must assess the level of risk or exposure to sensitive or harmful experiences due to the experiment and thereby assign a category status to the application (see HSRC forms).
The EXEMPT category can receive a signed approval by, the HSRC Chair. One HSRC member can also approve the Expedited review, however, if a question arises as to a disapproval of that application the application is to be forwarded for REGULAR review thereby requiring signatures of a majority of the Committee. A REGULAR application for renewal also requires a full HSRC review with a majority vote for either approve or disapprove the application.
Timelines for approval are:
> THIRTY DAYS FOR EXPEMPT
> THIRTY DAYS FOR EXPEDITED
> SIXTY DAYS FOR REGULAR REVIEWS
3. In the event any research project coordinator partakes in serious or continuing noncompliance with HSRC recommendations, the HSRC board must report that noncompliance to the institutional officials.
4. The HSRC shall have the authority to review, approve, and secure modification in the research project including the final approval or disapproval of all research activities as covered in the Federal regulations.
5. The HSRC - require that the informed consent form is in accordance with §46.117. The HSRC may cite additional requirements to the procedures, methodology, or any handling of subjects if, in the HSRC's judgment, the suggestions would enhance protection of the subjects participating in the research.
6. The HSRC shall require documentation of informed consent or may waive documentation as per § 46.117.
7. Documentation of the HSRC decisions for pending research projects shall be supplied to institutional officials.
8. In the event that the HSRC disapproves a research project, the written notice to research coordinator shall include the reasons why approval was not granted.
9. The HSRC approval shall extend for one-year duration and may be revoked if changes have been made regarding the handling of human subjects, other than those approved by this committee.
Categories of Reviews
EXEMPT
Minimal Risk to subjects typically involving adults using a non-sensitive subject matter to be conducted under non-threatening conditions. Children or students may be involved if data is collected as a secondary data analysis involves review of regular school records, or evaluation of instructional techniques already approved by the respective school district. Risks are minimal to non-existent. A formal HSRC form is submitted for review using section A of the HSR form. Thirty days s required for processing, one HSRC member signature is required.
EXPEDITED
Risks to subjects are minimal or low, subject matter may involve sensitive issues but safeguards for protection of human subjects are included; may include adults, children with written parental/guardian signatures, or other protected groups with the appropriate safeguards. Thirty days are required for review; one HSRC member signature is required.
An expedited review can prevail when:
a. Minor changes to a pre-approved project had been obtained.
b. One or more reviewers may review an expedited research project.
c. If a disapproval of an expedited review is prevalent, a full HRSC vote must be taken.
d. The HSRC must maintain a method for keeping all members advised of research proposal approvals.
e. The Federal Secretary may suspend the HSRC rights of the institution if deemed fit to protect subjects.
REGULAR
A regular review entails highly sensitive or risky research topics or methodologies and requires a full board review with a majority vote of all committee members for approval. Sixty days are required for processing. All HSRC members must review the application in a full board meeting- a majority of HSRC member's approval must prevail with all signatures required.
Criteria for using a regular review status includes any highly sensitive subject matter, i.e., HIV, sexual topics, financial disclosures, illegal activities, i.e. drug use, etc. Also, subjects of protected groups, i.e., pregnant women, prisoners, special needs children, mentally, physically, or emotionally impaired individuals that cannot make a rationale informed consent. Extreme or invasive methodology, i.e., exercises, risky activities, or use of harmful apparatus or test materials.
I-1. Risks to Subjects are minimized.
I-2. Risks to Subjects are reasonable in relation to the anticipated benefits to be obtained as an immediate outcome from the research (not long-term benefits).
I-3. Selection of subjects is equitable. Relevant to the nature of research. setting. Relevant to the environment.
I-4. The document of 'Informed Consent' for subject or guardian is included.
I-5. If necessary, means of monitoring data collection is included in the HSRC application.
I-6. Confidentiality is assured throughout the duration of the research project.
Areas of Concern for Ethical-Legal Considerations
1. Informed Consent-Adults (as noted above) and Children
Based on the Family Educational Rights and Privacy Act of P.L.19-114. To review educational records of any child under the age of eighteen a parental signature must be obtained with full disclosure as to (a) records to be reviewed, (b) purpose for the review, and (c) person(s) who will have access to the records. Exceptions to the requirement of informed consent are as follows:
a. If the individual reviewing the record has "legitimate educational interests."
\
b. If the Exceptional Student records fall under the auspices of PL 94-142.
c. Unit of Analysis is not the student (class averages, school achievement, etc.)
d. Assent of the child under 18 years of age (see above).
2. Confidentiality - Adults and Children
a. Research subjects should be told who would have access to the information.
b. Data-collection codes should be removed.
c. Maintenance of records should be acknowledged.
d. Process of record handling in the event information is subpoenaed.
e. Coding of data should consider if any link between subject and data could be made.
f. Crisis intervention strategies should be discussed up front i.e.. Suicide, homicide, harm to others, etc.
3. Deception - Adults and Children
a. Full knowledge of the research procedures may skew or distort responses.
b. Ecological validity may be jeopardized if full disclosure was provided,
c. At times, deception reduces discomfort or pain to subjects (Milgram, 1963).
d. Deception can lead to distrust, resistance, and sabotage.
e. Creates methodological problems and deprives subject of ability to make informed consent.
4. Dehoaxing - Desensitization
a. Must remove undesirable effects on subjects if a hoax was implemented (Horvat, 1986).
b. Subjects must deal with new information acquired during the experiment-hence may need to be desensitized.
c. Subject behaves in accordance with a set of circumstances, which may be coercive and uncomfortable to them.
d. Presenting them with material that may be emotionally laden, which in turn elicits anxiety, stress, or discomfort.
5. Ethical and Moral Dilemmas
a. Any activities, questions, or procedures that are of ethical question need to be addressed.
b. Conflict of interest wherein the researcher represents a power position over the subject.
c. Use of coercion toward subjects to participate, particularly, if the subject is under duress.
d. Any procedural element of the research project that can harm the subject financially, employment, personal, or judicial manner.
Human Subjects Review Committee Internal Review Board (HSRC)
Governing Legislation: The National Research Act 1974 (Federal Register January 26, 198 1).
Essential components of The National Research Act
1. Review research proposal from the perspective of protecting human subjects from risk.
2. Assessment of Risk: Risk is defined as any exposure to physical, psychological, or social injury as a consequence
3. Subjects who are participating in a research related activity.
a. First, the HSRC establishes whether the human subject will be placed at risk due to some component of the proposed research project.
b. Second, if risk is imminent, an assessment must be made as to whether or not the risk to the subject outweighs the scientific benefits of the project.
c. Third, the HSRC must attain assurances that:
(1) The rights and welfare of participants will be adequately protected.
(2) Informed consent will be secured.
d. The HSRC is essential to institutions that receive Health and Human Services (HHS) funds. However, all institutions that conduct human subject research are expected to adhere to these Guidelines
e. "Minimal Risk-" projects are exempt from review.
(1) Educational research on instructional strategies.
(2) Educational research on effectiveness of instructional techniques, curricula, or classroom management methods.
(3) Research involving educational tests, if research is collected without revealing- student identity-
(4) Researches involving survey or interview procedures, except where all of the following conditions exist:
(a) Data collection allows for the identification of subjects either directly or through linkages.
(b) Subjects' responses, if known publicity, could induce risk of criminal or civil liability, financial risk and / or loss of employment.
(c) The research deals with sensitive aspects of the subject's behavior. i.e., alcoholism, substance abuse, sexual behavior.
(d) Subjects are elected public officials or candidates for public office.
(e) Research involving- observation of public behavior except if:
(1) Data is recorded in a manner that identifies human subjects, either directly or through linkages.
(2) If recorded observations were to be known outside of the research could place the subject at risk for social, financial, or employability status.
(3) The research deals with sensitive issues for the subject's behavior. i.e., alcoholism, substance abuse, or sexual behaviors.
f. Research involving the collection of secondary data sources, if they are public, available or that subject cannot be readily identified either directly or through linkages.
Special Subject Categories
1. Children:
a. Definition of child may differ from state to state. The definition of the jurisdiction where the research is carried out must be adhered to.
b. Informed consent must ALWAYS be obtained from the parent or guardian with written signature.
c. Assent must be obtained from the child, procedures documented in the HSRC application (right to refuse or withdraw must be considered.
(1) Mere failure to object should not be construed as assent.
(2) No greater than minimal risk is involved.
(3) If more than minimal risk in involved, the anticipated benefit to the individual subject (child) outweighs the risk to the child.
(4) The anticipated benefit is as favorable to the child as that represented by alternative approaches.
(5) Adequate provisions are made for attaining the assent of the children and permission from their parents or guardians.
(6) In the event that parental permission is not feasible, (i. e, child abuse, neglect- or abandonment) the HSRC may waive the consent form requirement. Provided an appropriate mechanism for protecting the children/subjects is included Consideration of the child's age, nature of the research project, and anticipated benefit to the subject is necessary.
(7) Children who are wards of the state may be included in a research project provided the research is:
(a) related to their status as wards.
(b) conducted in schools, hospitals, or other institutions in which the other subjects are not wards of the state.
(c) An advocate is appointed to the child as recommended by the HSRC board. The advocate may be advocate for more than one child and must have some expertise in an area of best interest for the child.
2. Pregnant Women
a. All HSRC applications are subject to all Department of Health, Education, and Welfare grants and contracts supporting research, development, and related activities involving the fetus, pregnant women, and human in vitro fertilization.
b. All Federal, State and Local laws in jurisdiction of where research is to be carried out supercede procedures for protection of all subjects.
c. Any research projects involving the safety and welfare of pregnant women. fetus, viable fetuses, and nonviable fetus, dead fetus, and in vitro fertilization projects are all subject to HSRC approval.
3. Prisoners
a. Due to constraints imparted on prisoners they may not be free to make a truly voluntary and uncoerced decision as to whether or not to participate as subjects in research, therefore, all research projects are subject to HSRC approval. Additionally, emphasis is placed on procedures used in the acquisition of subject participation. The HSRC committee members shall have no association with prisoners involved and at least one member of the Board shall be a prisoner, or prisoner representative.
b. Research must be allowable under § 46.306(a)(2).
c. Any advantages to the prisoner for his participation, when compared to the general living conditions, are not of such a magnitude that his/her ability to weigh the risks of the research in the limited choice environment of the prison is impaired.
d. Procedures for selection of subjects within the prison are fair to all prisoners and immune from arbitrary intervention by prison authorities or prisoners i.e., control subjects must be selected randomly.
e. Information is in language comprehensible to the prisoners.
f. Assurance that parole boards will not consider participation in research as a condition regarding parole decisions.
g. Adequate follow-up treatment is established, given the limited time duration some participants may be incarcerated, and the prisoner is so informed.
Criteria for HSRC Approval
1. Risks to Subjects are minimized.
2. Risks to Subjects are reasonable in relation to the anticipated benefits to be obtained as an immediate outcome from the research (not long-term benefits).
3. Selection of Subjects is equitable, relevant to the nature of research, setting, and environment.
4. The document of 'Informed Consent' for subject or guardian is included.
5. If necessary, means of monitoring data collection is included in the HSRC application.
6. Maintenance of confidentiality is assured.
Informed Consent
1. Must be legally effective (subject not in impaired psychological state).
2. Opportunity to participate or to refuse to participate (not coerced by virtue of imprisonment, student status, etc.)
3. Language is comprehensible to the subject (relevant to subject's dominant language, reading level, etc.)
4. No exculpatory language should be included, i.e., waiver of rights or release of investigator, sponsor, or institution from negligence.
Elements of Consent
1. Statement that the study involves research.
a. Purpose of the research.
b. Duration of the subject's involvement.
c. Description of procedures
d. Identification procedures for subjects whom are and are not exposed to the treatment, intervention, or procedure, etc.
e. Foreseeable risk or discomforts to subjects, if any, or foreseeable benefits.
f. Disclosure of alternate treatments, if any, and advantage to the subject.
g. Describing efforts to ensure confidentiality.
h. Compensation for risk, if any, such as medical or therapeutic interventions.
i. Contact person in the event of risk.
j. Statement that participation is voluntary, without penalty.
k. Miscellaneous concerns, which may need to be included in the consent form:
l. Risk in case of pregnancy.
m. Criteria/circumstances for participating
n. Cost to subject, if any, due to participation.
o. Consequences, if any, for subject to withdraw.
p. Provisions for communicating new information relevant to the research project.
2. The HSRC can approve consent forms without all elements provided that:
a. Programs fall under the Social Security Act or public benefits program.
b. Research could not be carried out with the immediate waivers.
c. Research involving no more than minimal risk.
d. Federal, State and local laws prevail.
e. Participation does not limit emergency medical care if needed.
3. Informed Consent form variation.
a. Short-Form. If orally presented to subject with a witness and a summary of statements is provided to the HSRC.
b. Waiver of the Informed Consent form is allowed if:.
(1) The informed consent form itself would link the subject to the record.
(2) The research project involved minimal risk.
Timelines (To be followed prior to data collection)
Once the method/procedure section of your project is discussed with and approved by your Dissertation Chairperson, it is possible to complete and submit the HSRC application form Dissertation Block I or 11, but it MUST be submitted and approved prior to the Dissertation Proposal Defense. If any substantial changes are made concerning the design or procedures for collecting data, the HSRC application must be reprocessed. Approved HSRC applications are effective for one (1) year-
All applications will be logged in and processed as of the first of the month.
All applications submitted during the month will be logged in for processing the first and third Tuesday of the month. The HSRC committee will not be active during scheduled intercessions.
Routing:
Upon completion of the HSRC application, forward the application and supporting documents to your committee chairperson for review and signature. Once it is reviewed for accuracy and all required attachments, it will be forwarded to the HSRC for processing.
Informed Consent Letter:
All letters of informed consent should contain the following elements:
1. The purpose and brief description of the research.
2. Duration of the subject's involvement.
3. Procedures for protecting confidentiality and anonymity.
4. Potential risks and benefits and l or costs to the subject for participating.
5. Contact person and compensation for participation, if any.
6. Criteria l circumstances for participating.
7. Acknowledgment that participation is voluntary and the subject may withdraw at any time.
Instructions to Subjects Completing Survey Research
Note: The following statement may be included on the .first page of the survey.
The purpose of this research is to (fill in the blank - e.g., "compare opinions, examine perceptions, etc.'). By completing and turning in this survey you are giving your consent for the researcher to include your responses in his/her data analysis. Your participation in this research is strictly voluntary, and you may choose not to participate without fear of penalty or any negative consequences. Individual responses will be treated confidentially. No individually identifiable information will be disclosed or published, and all results will be presented as aggregate, summary data. If you wish, you may request a copy of the results of this research by writing to the researcher at: (fill in your name and address here).
Model Statements of Informed Consent to Participate in Research
The purpose of this research is (briefly describe the purpose of your study). If you participate in this research, you will be asked to (describe what your subjects will be asked to do, what information they will be asked to provide - demographic, attitudinal, test scores, physical measures, etc., and describe any potential risks or discomforts to the subject):
Your participation will take approximately (insert approx. length of time needed to participate and l or duration of the project itself:
Your participation in this research is strictly voluntary. You may refuse to participate at all, or choose to stop your participation at any point in the research, without fear of penalty or negative consequences of any kind.
The information/data you provide for this research will be treated confidentially, and all raw data will be kept in a secured file by the researcher. Results of the research will be reported as aggregate summary data only, and no individually identifiable information will be presented. (Note - These statements must be true. If you cannot abide by these procedures for assuring confidentiality, you must describe the procedures you will follow.)
You also have the right to review the results of the research if you wish to do so. A copy of the results may be obtained by contacting the researcher at the address below:
(Insert your name and mailing address here.)
There will be personal benefits from your participation in this research. *Describe any benefits to the subject personally, if any exist. Otherwise, insert 'No direct or immediate" in the space indicated. However, the results of the research may contribute Describe any potential benefits (practical or theoretical) to the field, the profession, or to society as a whole.
Written signature is not required for minimal risk participation, such as interviews or survey questionnaire completion-unless the subject is a minor, thus requiring parental permission.
1, , have read and understand the foregoing information explaining the purpose of this research and my rights and responsibilities as a subject My signature below designates my consent to participate in this research, according to the terms and conditions outlined above.
Signature Date
Print Name:
If signing for a Minor Child, Print Child's Name:
Relationship to Child (circle) Male Parent Female Parent
Male Grandparent Female Grandparent
Other Male Relative Other Female Relative
(specify) (specify)
Legal Guardian (appointed by)
Note: All informed consent statements should be designed to meet the need of each individual research project and l or sample group and are therefore, subject to change as needed
HSRC Application Form Checklist
Please review the documents listed below that pertain to your research project, In the event that your project does require the use of any of the listed documents, you MUST attach a copy of the original form to the application submitted for HSRC approval. Your cooperation in this matter is appreciated and it will hasten the approval turn-around time significantly.
Please be advised that ALL research project applications must have an Informed Consent Form Attached.
If a minor or incapacitated individual of any age is involved, parent permission forms MUST be attached with signature line included.
If you are conducting a research project in another institution (e.g., a hospital or school), you must attach a signed permission letter from a supervisor l administrator who is in a position to grant you permission to conduct the research at that site.
If that institution also has a Human subjects Review Committee (often referred to as the internal Review Board (IRB), then written permission from the participating institution's IRB must be attached to your HSRC application.
If you are conducting the research outside the geographical location of the United States, then a letter of assurance that you will abide by the laws and regulations of the governing bodies that preside over the state or country local of the location where the research is being conducted.
_____ Letter of Informed Consent
_____ Institutional Permission Letter (where research is taking place)
_____ Assurance of Adherence to Governmental Regulations Concerning Human Subjects (if research project is conducted outside the US
_____ Parental Permission Letter (must have provision for written signature)
_____ Oral statement of Assurance (used with minors)
_____ Survey(s) or Questionnaire(s) (if included in research project)
_____ Observation Instrument
_____ Interview Questions (structured or semi-structured)
Also required. on your applications,
Dissertation Chairperson's signature
Primary Investigator's signature
HSRC APPLICATION FORMS AND PROCEDURES
University of Sarasota
Human Subjects Review - Institutional Review Board
Application for IRB Review of Research Involving the Use of Human Subjects
**Application Status Exempt_______(Minimal Risk – HSRC Chair)
Expedited _____(Moderate Risk-1 HSRC Member)
Regular _______(High Risk - Full HSRC Member Review)
Investigator's Name: ;
Social Security Number:
Address: ;
Title of Research Project:
Name of Chair/Co-Chair:
College and Department: BUS COBS
EDUC OTHER
Program and Degree of Study:
Project Proposed Start Date: Project Proposed Completion Date:
Approval Signatures: ;
Dissertation Committee Chair/Co-Chair/Date /
Principal Investigator/Date /
DO NOT PROCEED TO COLLECT DATA PRIOR TO RECEIVING IRB APPROVAL
Important Notice:
· Please complete this form in detail, acquire signatures of the Principal Investigator and the Dissertation Chair, then submit the form to the HSRC Chairperson with attachments relevant to this project (letter of informed consent, questionnaires, test protocol, interview questions, observational charts, institutional permission from site where research is to be conducted, parental permission if subject is under 18, completed HSRC form, designated IRB category).
· Do not proceed with any research work with subjects until IRB approval is obtained.
· If any change occurs in the procedure, sample size, research subject, or other element of the project impacts subjects, the HSRC must be notified in writing with the appropriate form (see ancillary forms).
· Please allow 30 days for processing Exempt and Expedited Forms, and 60 days processing for Regular
HSRC contact: Date Logged In: Date Approved: Date Expires:
Section A, Exempt Status: Read and complete the following: If you answer yes to any of the following, your research does NOT qualify for exempt status and must be checked either Expedited or Regular based on risk/benefit ratio to subjects (If your project does NOT qualify for exempt status, proceed to Section B for Expedited or Regular Status)
a. Any research with minors or students, except where it only involves the observation of public behavior when investigator(s) do(es) not participate in the activities being observed. Y N
b. Research involving prisoners, fetuses, pregnant women, in vitro fertilization, or any protected groups. Y N
c. Research involving intellectually, mentally, or physically challenged members of protected groups. Y N
d. Research involving subject deception of any kind. Y N
Note: Exempt status must be approved by HSRC and does NOT mean exempt from use of informed consent.
Please complete Section A below:
1. Study Site and Participants:
2. Brief but detailed summary of the Project (Attach extra page if needed).
3. Describe the nature of the involvement of human subjects in the project (personal interview, mailed questionnaire, observation, etc. (Attach copy of any instrument, chart, or questionnaire that will be used with subjects).
4. Attach a copy of the letter of informed consent.
5. Describe how confidentiality will be maintained: Be Specific, if using secondary documents, audio/video tapes, etc.
6. Describes the exempt category(s) of the project
7. Signatures and date of review:
Principal Investigator / Date /
Dissertation Committee Chair/Co-Chair / Date /
Attach any other forms, tests, institutional permission slips, etc, relative to this study. Failure to do so will result in delayed processing of the approval form.
Section B, Expedited or Regular Review Status
Research with minors, prisoners, mentally/emotionally/physically challenged persons, pregnant women, fetuses, in vitro fertilization, and/or individual or group studies where the investigator manipulates the subjects/ behavior or the subject is exposed to stressful or invasive experiences do(es) not qualify for expedited status.
1. Requested Review (see instructions) Expedited________Regular________
2. Purpose of the Study:
3. Summary of the Study. Methodology (Be Specific-attach extra page if needed).
4. Subject/participant Demographics:
a. Anticipated Sample Size:
b. Special Ethnic Groups (describe):
c. Institutionalized Y N Protected Group (describe):
;
d. Age group:
e. General State of Health:
f. Other details to describe sample group.
5. Will deception be used in the study? Y N (please describe)
6. Will audio or videotapes be used in the study? Y N (please explain)
7. Confidentiality protection issues (pertains to audio and video as well as written documents.)
a. What precautions will be taken to insure the privacy and anonymity of the subjects? (i.e. closed doors, private rooms, handling of materials where subject's identify could be discovered, etc.).
b. What specific precautions will be taken to safeguard and protect subject's confidentiality while handling the data (audio/video/paper) both in researcher's possession and in reporting the findings? (i.e., coding, removal of identifying data).
c. Describe procedures where confidentiality may be broken by law (e.g., child abuse, suicidal intent).
8. Review by institutions outside of University of Sarasota Y N
9. Informed Consent and Assent (Attach copies of all relevant forms). If consent is not necessary (e.g.) anonymous interview), describe how you will inform all subjects of the elements of consent (see instructions).
10. If informed consent, written consent is required, describe the manner in which consent and/or assent was obtained for each category).
a. Adult Subjects (18 years and older – written consent required).
b. Child Subjects (under 18 – parent/guardian consent required).
c. Child Subjects (under 7 years old- child assent required).
d. Institutionalized subjects (parent/guardian/conservator).
11. Describe any possible physical, psychological, social, legal, economic or other risks to participants (Attach another page if needed).
a. If there are any potential risks, describe the precautions taken to minimize risk to participants.
b. Describe procedures implemented for correcting harm caused by participating in the study (e.g., follow up calls, referral to appropriate agencies).
12. Potential benefit of the study:
a. Assess the potential benefit(s) of the study for the participants:
b. Assess the potential benefits(s) to the professional audience in the study:
As the primary investigator, I attest that all of the information on this form is accurate, and that every effort has been made to provide the reviewers with complete information related to the nature and procedures to be followed in the research project. Additional forms will be immediately filed with the HSRC to report any: change in subject(s), selection process, change of primary investigator, change in faculty dissertation chair, adverse incidents, and final completion date of project. I also attest to abide by any other governmental regulations that apply to this study, particularly as applies to research work conducted in countries other than the United States
;
Signature Primary Investigator Date
Signature Advisor/Committee Chair Date
Attach any other forms, tests, institutional permission slips, etc., relative to this study. Failure to do so will result in delayed processing of the approval form.
Human Subjects Review - Institutional Review Board
Research Progress Report
Type all answers
;
NOT TO BE USED TO CHANGE PROCEDURES.
IRB File No. Continuing Review: Final Report:
1. General Information
Principal Investigator:
Address: ;
Telephone: FAX:
Department / College
Committee Members
;
2. Project Information
Title of Project:
;
3. Continuing/Final Report Information
Does this research involve primary data collection? Y N
If yes, answer the following:
Number of participants participating since last review, if any:
Total number of subjects invited to participate in this project:
Are you continuing to recruit new participants? Y: N:
If yes, attach most current informed consent(s).
How many recruited subjects have withdrawn/dropped out? Explain why:
4. Summarize the research hypothesis or purpose of this project and procedures:
5. Summarize the progress/steps completed from inception to date and/or attach any data summaries, progress reports, etc. pertinent to this study.
6. Were benefits of this research expected? Were they realized? Explain:
7. At this time, are you revising the Informed Consent to include any significant new information which may relate to the participants' willingness to continue participating? Y N . If yes, please attach a copy of the revised consent form and highlight all revisions.
8. Have there been any changes in Dissertation Committee Membership?
Your acknowledgment is requested to assure the University of Sarasota
Committee Chair (Print Name) Committee Chair Signature Date
Committee Member (Print Name) Committee Member Signature Date
Committee Member (Print Name) Committee Member Signature Date
Committee Member (Print Name) Committee Member Signature Date
9. Principal Investigator Statement of Assurance
"I understand that additions to or changes in procedures involving human subjects, as well as any problems connected with the use of human subjects once the study has been approved for continuation by the Institutional Review Board, must be brought to the attention of the IRB."
"I agree to provide whatever surveillance is necessary to ensure that the rights and welfare of the human subjects are properly protected."
"I understand that I cannot initiate any contact with human subjects before I have received approval and/or complied with all contingencies made in connection with the approval."
Signature of Principal Investigator Date
Please return this application and any attachments to:
Attn: Institutional Review Board
Human Subjects Review - Institutional Review Board
Change in Procedure Application
Type all answers
;
NOT TO BE USED TO CHANGE PRINCIPAL INVESTIGATOR
Date of last IRB review:
Was Additional Institutional Approval originally obtained? (e.g., from School, Hospital, etc.)
Y N (If Yes, please attach).
Please check appropriate changes: _____ Addition
_____ Revision
_____ New Title
_____ Revised Informed Consent
_____ Other
(Attach a complete copy with all additions/revisions/changes highlighted.)
1. General Information
Principal Investigator:
Address: ;
Telephone/Fax #:
Committee Members
;
2. Project Information
Title of Project:
;
3. Amendment Information - Please Complete Entire Section
a. Describe the proposed additions/revisions in appropriate detail:
b. Describe any significant change in the risk/benefits for the participants from these additions/revisions:
c. Have you revised the Informed Consent to include any of the additions/revisions?
Y N If yes, please attach a copy of the revised consent form and highlight all revisions.
4. Change in Dissertation Committee Membership
Your acknowledgment is requested to assure the University of Sarasota
Committee Chair (Print Name) Committee Chair Signature Date
Committee Member (Print Name) Committee Member Signature Date
Committee Member (Print Name) Committee Member Signature Date
Committee Member (Print Name) Committee Member Signature Date
5. Principal Investigator Statement of Assurance
"I understand that I cannot initiate any changes in my approved protocol before I have received approval and/or complied with all contingencies made in connection with that approval."
Signature of Principal Investigator Date
Please return this application and any attachments to:
Attn: Institutional Review Board
Human Subjects Review - Institutional Review Board
Off-Site Adverse Report
Type all answers
Adverse event refers to any event, circumstance, or occurrence that was not anticipated, or accounted for, in the original HSRC application and may have a negative impact on the research project as a whole.
1. General Information
Principal Investigator:
Address: ;
College: Telephone/Fax:
Chairperson: ;
2. Information
Title of Project
;
3. Adverse Event Information
a. In the space below, please list all attached report numbers applicable to the report of the AE, i.e., Sponsor's Letter, etc.
b. Does this AE significantly change the risk/benefit? ____Yes ___No Explain
c. Does this Adverse Event require change in the Informed Consent? ___Yes ___No
If yes, attach a copy of the revised consent form and highlight all revisions.
4. Principal Investigator Statement of Assurance
"I understand that I cannot initiate this project before I have received approval and/or complied with all contingencies made in connection with that approval."
Signature of Principal Investigator Date
Please return this application and any attachments to:
Chairperson
Human Subjects Review - Institutional Review Board
On-Site Adverse Report
Type all answers
Adverse event refers to any event, circumstance, or occurrence that was not anticipated, or accounted for, in the original HSRC application and may have a negative impact on the research project as a whole.
1. General Information
Principal Investigator:
Address: ;
College: Telephone/Fax:
Chairperson: ;
2. Information
Title of Project:
3. Adverse Event Information
Describe the Adverse Event(s). Please provide details if the AE occurred in your participants. Submit all written materials applicable to the report of the AE.
Is the Adverse Event related to the study? Explain why or why not.
Does this AE significantly alter the risk/benefits ration to participants?
Does this Adverse Event require change in the Informed Consent? Y N:
If yes, please attach a copy of the revised consent form and highlight all revisions.
Additional comments:
4. Principal Investigator Statement of Assurance
"I understand that I cannot initiate this project before I have received approval and/or complied with all contingencies made in connection with that approval."
Signature of Principal Investigator Date
Please return this application and any attachments to:
Chairperson
Human Subjects Review - Institutional Review Board
Project Completion Report
Type all answers
1. General Information
Principal Investigator:
Address: ;
College: Telephone/Fax:
Chairperson: ;
2. Information
Title of Project:
3. Date of Completion
4. Summary of Outcome:
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