Application for Review of Human Research



Social and Behavioral Sciences Human Research Protocol Template [Version Date]

Please delete the blue text prior to submitting the application. This text is meant to serve as guidance for writing the protocol and addressing issues related to the criteria for IRB approval of research. Unless otherwise noted, all sections of the protocol template need to be completed.

PRINCIPAL INVESTIGATOR: Full name and degree of Principal Investigator

PROTOCOL TITLE: Full title of the protocol (should match the title provided in the electronic submission system)

INTRODUCTION AND PURPOSE:

State the name and purpose of the study. Provide the basic information concerning the rationale for the study and the previous data to support the research.

OBJECTIVES:

State the questions and goals of the research study; including the hypothesis being tested or questions to be explored. Protocols often refer to primary, and secondary objectives based on the amount of data to be collected and the breadth of area, or number of subjects to be enrolled.

BACKGROUND:

Discuss the background of the research problem, prior published data, and the nature of the research question as well as the resulting rationale for the proposed study. Summarize the available data (published or unpublished, if available) that could have significance or which is necessary to place the research in current context of our understanding of the area. Discuss how any preliminary data justifies the research.

CHARACTERISTICS OF THE STUDY POPULATION:

1. Target Population and Accrual:

Describe the target population. If applicable, describe methods for sampling larger populations and randomization procedures if conducting experimental manipulations. This section should be consistent with your statistical analysis plan and one of these sections should describe the statistical methods or theoretical justification for determining sample size or sampling approach for the study.

If applicable, describe whether the target population will be recruited (a detailed recruitment plan should still be detailed in the Subject Recruitment and Screening section) from a location outside of the University of Pennsylvania and describe how appropriate permissions/letters of support will be obtained. For example, if high school students are being enrolled in the study, the IRB will ask for a letter of support from the principal, dean, or superintendent. The location of the research and the support from the institution/corporation/school/etc. should be documented with the IRB application.

2. Key Inclusion Criteria:

Create a numbered list of eligibility criteria subjects must meet to be in the study. Include a rationale for subject selection based on review of gender or ethnicity categories particular to the research area being studied and a rationale/justification for any exclusions based on race or ethnicity. Justify the following restrictions if applicable: age, gender ethnicity and race, socioeconomic status, enrollment restrictions based on childbearing status and pregnancy and other disparities that may impact on enrollment. The distribution of men and women should be equitable so they equally share the benefits and the burden of the research. Therefore, provide justification in terms of scientific contraindications for unequal distribution of one gender.

Note: It is common in SBS to study one ethnic or racial group at the exclusion of others. Please justify why. The exclusion and inclusion criteria should be consistent with the purpose of the study.

SBS can include the study of homeless persons or persons with an active drug/alcohol dependence or substance abuse history. If such populations are included, the study procedures should reflect how follow up will be achieved given the transient nature or the difficulty in locating the subjects.

The inclusion criteria for SBS with attributes from other disciplines such as medicine and nursing must be specific for all disciplines.

3. Key Exclusion Criteria:

Create a numbered list of criteria that would exclude an individual from the research study. Generally this would include age, gender, physical or mental conditions. Please provide a justification for doing so. The exclusion of transient groups or groups that may be difficult to locate for follow up may be appropriate for some SBS research. Please explain. There may be other populations that would not be appropriate for the study, list them and explain why they should not be enrolled.

4. Subject Recruitment and Screening:

Describe how subjects will be identified and recruited for the study. If snowball method will be used discuss the process and how the first individuals will be recruited. Discuss all the methods used to identify and recruit subjects including referrals from physician offices, clinics, programs, or through advertisements and brochures.

Discuss how information is to be disseminated to subjects such as handouts, brochures, flyers and advertisements. All recruitment materials must be approved by the IRB prior to being used. Include recruiting materials with the protocol submission to the IRB. Describe the eligibility criteria and list any special test or evaluations potential subjects may have to undergo before they are actually determined to be eligible for the study.

If the proposed recruitment plan includes use of any Penn media services (communications, marketing, etc.) for outreach via social media avenues (examples include: Facebook, Twitter, blogging, texting, etc.) or direct recruitment via these social media avenues, please include the plan for use of social media and provide the information that will be included with the social media posts.

5. Early Withdrawal of Subjects:

Describe the scenarios under which a subject may be withdrawn from the study prior the expected completion of the project. Such reasons might include safety of the subject, failure of subject to return for visits, failure to locate the subject and if subjects withdraw their consent. Explain any safety reasons in sufficient detail.

Describe how subjects can withdraw from the study. The requirements for the process of withdraw should be consistent with the capabilities of the subjects under study. For instance, requiring a homeless, mentally ill or illiterate subject to provide to the PI written notice of intent to withdraw may be difficult. Other options should be considered and consistent with the group under study.

Even though subjects may be withdrawn prematurely from the study, in some circumstances it is important to provide services or information such as counseling for conditions noted during the study.

6. Vulnerable Populations:

(HHS regulations 45CFR46 Subparts B, C, & D for, pregnant women, fetuses, neonates, prisoners; and FDA regulations 21CFR50 Subpart B for children) NOTE: Refer to SOP SC 501 for the definition of children.

Specify if the study involves any of the following populations:

• Pregnant women (if the study procedures may affect the condition of the pregnant woman or fetus)

• Fetuses nor neonates

• Prisoners

• Children

• If none of the above populations are to be included into the study, write: “Children, pregnant women, fetuses, neonates, or prisoners are not included in this research study.”

Note: This section is intended to elicit information regarding additional protections when specific populations are included in a research study. It is not intended to trigger an exclusion of these populations.

Note: Subjects who become imprisoned or are court-ordered to attend residential alcohol and other drug treatment facilities will be considered prisoners under Subpart C of the federal regulations 45CFR46. Such subjects cannot be continued in the research unless an amendment to the protocol is submitted and approved by the IRB and certification to the federal Office of Human Research Protections if the research is supported by the Department of Health and Human Services.

Note: Complete the supplemental form for each vulnerable population included in the study.

7. Populations vulnerable to undue influence or coercion:

When some or all of the participants were likely to be vulnerable to coercion or undue influence such as children, prisoners, pregnant women, mentally disabled persons, or economically or educationally disadvantaged persons, employees or students of Penn additional safeguards have been included in the study to protect the rights and welfare of these subjects.

NOTE: This section is intended to elicit information regarding additional protections when specific populations are included in a research study. It is not intended to trigger an exclusion of these populations.

STUDY DESIGN:

Describe and justify the research design. The study should be designed to answer a specific research question through achieving the stated objectives and aims of the study. Describe in steps how the study will be implemented.

Identify the research methods, qualitative, quantitative or mixed method that will be used to achieve the aims and objectives of the study. Be specific about the types of qualitative methods such as ethnography, survey, interview, focus group and combination thereof to be utilized in the research

Explain the significance of each research method in achieving the overall objectives of the study.

Define the duration of the study and describe how the aims of the study can be met within the specified duration of the study.

Explain where the research will be conducted and where the data will be analyzed. If the study is conducted at more than one site, such as a lab and an office include the location of both sites.

Include the expected duration of subject participation (the amount of time terms of years, months, weeks, days and hours for an individual subject to complete research participation) and a description of the sequence and duration of all trial periods involving data collection from subjects including follow-up, if any.

For complex research designs a schematic diagram is appropriate and recommended.

METHODS:

Discuss the methods that will be used to reach the objectives of the research. There may be some variability as not all of the following methods may be applicable.

1. Study Instruments:

Discuss the particulars of the research instruments, questionnaires and other evaluation instruments in detail. Provide validation documentation and/or procedures to be used to validate instruments. For well-known and generally accepted test instruments, these can be provided as a list with references; for a novel or newly developed instrument, please include the instrument, including all questions, with your application.

Please make sure the language in the study instruments is appropriate for the population and that the questions are appropriate for the research question.

For ethnographic studies, identify any study instruments to be used and describe in detail where, when and how the study will be conducted and who or what are the subjects of study. Detail whether the location is a public setting and what type of data will be observed.

For oral histories or interviews, provide the general framework for questioning and means of data collection. Interview procedures should be laid out in writing (interview guide) and clearly explained to subjects before interviews proceed.

If interviews or groups settings are to be audio or video taped, describe in detail the conditions under which it will take place.

2. Group Modifications:

Describe necessary changes that will or have been made to the study instruments for different groups.

3. Method for Assigning Subjects to Groups:

Describe how subjects will be randomized to groups.

4. Administration of Surveys and/or Process:

Describe the approximate time and frequency for administering surveys and/or evaluations.

For surveys, questionnaires and evaluations presented to groups and in settings such as high schools, focus group sessions or community treatment centers explain how the process will be administered and who will oversee the process. For instance, discuss the potential issues of having teachers and other school personnel administer instruments to minors who are students especially if the content is sensitive in nature. Describe the procedure for audio and videotaping individual interviews and/or focus groups and the storage of the tapes. For instance, if audio tape recording is to be used in a classroom setting, describe how this will be managed if individuals in the class are not participating in the study. Explain if the research involves the review of records (including public databases or registries) with identifiable private information. If so, describe the type of information gathered from the records and if identifiers will be collected and retained with the data after it is retrieved. Describe the kinds of identifiers to be obtained, (i.e. names, social security numbers) and how long the identifiers will be retained and justification for use.

5. Data Management:

Describe how and who manages and collects confidential data, including how and where it will be stored and analyzed. For instance, describe if paper or electronic report forms will be used, how corrections to the report form will be made, how data will be entered into any database, and the person(s) responsible for creating and maintaining the research database. Describe the use of pseudonyms, code numbers and how listing of such identifiers will be kept separate from the research data.

Detail if any data will be disclosed to personnel not listed on the study protocol.

Note: It may be appropriate to discuss your plans for collecting, storing, and securing data with your LSP (local service provider). The IRB may ask that you consult with Penn Computing to make a security and privacy impact assessment. This plan should also be adequately represented in your Subject Confidentiality plan.

6. **If Applicable (if not delete the section): Management of Information for Multi-Site Research where a Penn Investigator is the Lead Investigator of a Multi-Site Study, or Penn is the Lead Site or Coordinating Center in a Multi-Site Study.

Provide a plan for the management of multi-site information that may be relevant to the protection of human research participants, such as (but not limited to):

▪ Reporting unanticipated problems involving risks to participants or others.

▪ Reporting of Interim results.

▪ Coordination of protocol modifications.

7. Subject Follow-up:

Note: For SBS research that includes transient groups; describe how follow-up will be managed.

If multiple visits are required discuss methods to contact subjects and what will happen if the subject is lost to the study before all data is collected. Describe if and how the researcher will assess and track subject compliance with the requirements of the research. For studies involving prisoners not confined to jail, and in consideration of the high rate of recidivism, describe the process for follow-up should the subject commit a crime that results in confinement in a penal institution.

Describe the follow-up process in the event that while participating in the study a subject is imprisoned, committed to a mental hospital, hospitalized for long term care, admitted to a drug/alcohol residential program, a residential living facility or alike. Describe the follow-up process in the event that the subject falls under the guardianship of another, the guardianship of the state or in the case of minors becomes a ward or the state

STUDY PROCEDURES:

1. Detailed Description:

Explain sequentially the study procedure, including all the visits, contacts, and interactions. Also, for research of a sensitive psychological or emotional nature that recruits subjects vulnerable to the study questions or procedures, describe how professional attention will be provided for subjects if necessary. If necessary, use bullet points or create a study procedures flowchart/table that describes the activities and procedures to be followed at each contact with the subject. Describe the procedures to be performed to monitor the safety or inconvenience of the procedure. Describe assessments that can be performed to detect and report unanticipated events that could affect the subject’s willingness to continue in the study.

Note: The Methods section should be tailored towards the research objectives. The Procedures section should focus on how the research will be executed. For example, if your research will utilize both surveys and focus groups, the procedures section should outline when these methods will take place and how they will be implemented.

2. Data Collection:

If the research involves analysis of existing data, please provide a brief description of the data that will be used and/or collected. Please include the source of the data which will be analyzed and specify whether it is obtained through prospective research methods or if the data is existing at the time of your IRB application.

If the research involves analysis of existing blood, or tissue specimens, please provide a brief description of the specimens. Relate if blood and human tissue specimens are to be obtained for research and if the specimens:

• were collected during regular clinical care (for treatment or diagnosis)

• would have otherwise been discarded

• are publicly available

Provide the protocol number if the source is from a previously approved Penn IRB approved study.

Note: If the study does not involve analysis of existing specimens, write: “Not applicable.” If the research is primarily focused on improving clinical care through the analysis of specimens, a biomedical protocol template may be more appropriate.

3. Genetic Testing:

If genetic testing is involved, describe the nature of the tests, including if the testing is predicative or exploratory in nature. If predictive, please describe plan for disclosing results to subjects and provision of genetic counseling.

• Describe how subject confidentiality will be protected

Note: If the study does not involve genetic testing, write: “Not applicable.” If genetic testing is the primary outcome of the research study, a biomedical protocol template may be more appropriate.

4. Use of Deception:

• Deception/incomplete disclosure are typically only acceptable in studies with no more than minimal risk. Please detail why this study is minimal risk.

• The deception/incomplete disclosure should have no adverse effects on welfare. Please outline how all adverse effects are minimized.

• The IRB must determine that the value of the study is sufficient to warrant waiving some aspects of the requirement for full disclosure in the informed consent process.

• Please outline the scientific validity for using deception in this instance. There is no alternative to address the scientific question in a valid manner but to use deception/incomplete disclosure. Other effective, non-deceptive approaches are not feasible. Please detail why alternatives are not feasible.

• Debriefing is done, when appropriate, and the deception/incomplete disclosure are explained to the participant before the end of participation in the research. Please detail if you are debriefing participants, and if not, why not.

• When appropriate, subjects could be informed prospectively of the use of deception/incomplete disclosure and consent to its use: see the suggested consent language: "In some research studies, the investigators cannot tell you exactly what the study is about before you participate in the study. We will describe the tasks in the study in a general way, but we can't explain the real purpose of the study until after you complete these tasks. When you are done, we will explain why we are doing this study, what we are looking at, and any other information you should know about this study. You will also be able to ask any questions you might have about the study's purpose and the tasks you did. Though we may not be able to explain the real purposes of the study until after you complete the tasks, there are no additional risks to those that have been described in this consent form."

5. Statistical Analysis:

Describe the statistical methods used to analyze the data.

Describe the statistical methods or theoretical justification for determining sample size or sampling approach for the study.

RISK/BENEFIT ASSESSMENT:

1. Risks:

Typically, SBS does not pose severe or life threatening risks to subjects. However, the risk of harm can occur and should not be underappreciated. Some risks of harm are foreseeable and others unforeseeable. For example, a foreseeable risk may include; psychological distress during and after a study of post-traumatic stress syndrome (PTSD) that involves subjects diagnosed with PTSD. Another example, a psychological test that in and of itself is routine and poses no more than minimal risk, may be considered more than minimal risk if taken by a person who suffers from a mental illness, severe anxiety or depression. If applicable, comment specifically on risks of imposing an intervention on someone who may have an existing psychological condition or disorder.

Other foreseeable risks may include risks associated with a possible loss of confidentiality. Investigators should be sensitive to the vulnerabilities of the population under study and how a breach of confidentiality may impact a subject’s standing with the community, employer, spouse, school, etc.

For SBS with attributes of other disciplines such as medicine and nursing where the subject needs to undergo a blood draw, MRI, DEXA scan, CAT scan or other medical tests, the risks associated with those tests should be fully described.

For observational studies, consider whether the observation could include sensitive information. Consider the impact of the presence of a researcher. Detail whether individuals will be identifiable based on the data collected.

2. Benefits:

Describe the benefits of study participation. If subjects are not expected to gain any benefit participation in the study then this should be stated here.

Note: Financial compensation for participating in study is not considered a benefit and may not be described as such. Include any potential for benefit to the participant, to society and/or to the research community.

3. Subject Privacy:

Privacy is a subject’s ability to control how other people see, touch, or obtain information about the subject. Violations of privacy can involve circumstances such as being photographed or videotaped without consent, being asked personal questions in a public setting, being seen without clothing, being observed while conducting personal behavior, or disclosing information about abortions, HIV status, illegal drug use, etc.

What precautions will be used to ensure subject privacy is protected? For example, comment on where the consent process or research interviews will take place.

4. Subject Confidentiality:

Confidentiality refers to the subject’s understanding of, and agreement to, the ways identifiable information will be stored and shared.

How will confidentiality of data be maintained? Check all that apply.

Paper-based records will be kept in a secure location and only be accessible to personnel involved in the study.

Computer-based files will only be made available to personnel involved in the study through the use of access privileges and passwords.

Prior to access to any study-related information, personnel will be required to sign statements agreeing to protect the security and confidentiality of identifiable information.

Whenever feasible, identifiers will be removed from study-related information.

A Certificate of Confidentiality will be obtained, because the research could place the subject at risk of criminal or civil liability or cause damage to the subject’s financial standing, employability, or liability.

A waiver of documentation of consent is being requested, because the only link between the subject and the study would be the consent document and the primary risk is a breach of confidentiality. (This is not an option for FDA-regulated research.)

Precautions are in place to ensure the data is secure by using passwords and encryption, because the research involves web-based surveys.

Audio and/or video recordings will be transcribed and then destroyed to eliminate audible identification of subjects.

Other (specify):

Describe how the confidentiality of subject will be maintained. Describe if and how the data will be de-identified. Explain how the data will be kept confidential throughout the course of the research identifying those persons in possession of and/or who will have access to the data. Explain where and how the data will be stored and protected during the active research process. Explain what will happen to the data at the conclusion of the study: if the data will be destroyed, retained and/or shared with other investigators for future research. If video and/or audiotapes were used in the data collection process describe the disposition of the tapes and/or discs at the conclusion of the study. For data that is retained or shared with other researchers explain under what conditions personal identifiers will be used, if at all. Explain under what conditions the data may become part of the subject’s permanent record, such as an employment or academic record. Explain how this can be mitigated if possible.

For focus groups, submit the oral instructions in additional to written consent forms when needed. Consider avoiding personal questions and/or very sensitive questions. Detail whether pseudonyms or nametags or nicknames will be used. Be aware that confidentiality may not be protected for focus groups as participants may talk about the discussion outside of the focus group.

For interviews, interviewees should not be named (unless their permission has been explicitly sought, and this should only be done where a name is essential for the pursuit of the research in question). Any recorded contribution, in written form, on tape etc., or in notes taken from the interview by the interviewer, should be used in accordance with the permission of the interviewee.

5. Protected Health Information

Describe any identifiable private information that will be collected. Describe if data to be collected contain any protected health information (PHI) and specify which PHI is to be collected. Health information is determined to be PHI if it contains any of the following identifiers:

|Name |Social security numbers |Web addresses (URLs) |

|Street address, city, county, precinct, zip code, and |Medical record numbers |Internet IP addresses |

|equivalent geocodes |Health plan ID numbers |Biometric identifiers, including finger and voice |

|All elements of dates (except year) for dates directly|Account numbers |prints |

|related to an individual and all ages over 89 |Certificate/license numbers |Full face photographic images and any comparable |

|Telephone numbers |Vehicle identifiers and serial numbers, including |images |

|Fax numbers |license plate numbers |Any other unique identifying number, |

|Electronic mail addresses |Device identifiers/serial numbers |characteristic, or code |

Note: If no PHI is to be collected, write: “No protected health information is to be collected.”

6. Compensation:

Explain the types of payments to subjects including justification for the amounts. This includes re-imbursements for travel, meals and alike. Be specific about the nature of each type of payment making a distinction between compensation for participating in the research versus re-imbursements for expenses. For study related compensation, state the form the compensation will take such as cash, gift certificate, tickets, coupons and alike. Explain when and how subjects will be compensated. Be specific for studies taking place over a long time where compensation is disbursed periodically. Compensation is not a benefit to participating in the research and should not be stated as such.

7. Data and Safety Monitoring:

Describe the provisions in place to monitor the data for the safety of participants, if appropriate.

Summarize how safety, privacy, and data integrity will be assessed during the course of the study, including any planned interim analyses. Describe specific stopping rules, or study intervention un-blinding requirements if applicable.

Comment on what will occur in the event that a participant scores high on a depression or suicidal scale.

8. Investigator’s Risk/Benefit Assessment:

Assess the ratio of the benefit to be obtained from the study relative to the risks involved. The risks of participation in the research must be balanced by the potential benefits of the research to potential subjects and/or society.

Note: "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 life or during the performance of routine physical and psychological examinations or tests.

INFORMED CONSENT:

1. Consent Process:

Summarize how informed consent will be obtained, including how, when, where, and by whom it will be obtained.

• Informed consent is an ongoing process that takes place between the investigator/study staff and study participants. In most cases, this process is initiated with written informed consent at the start of the study; however, it also takes place as an ongoing dialogue between the investigator/study staff and subjects during the entire duration of their participation.

• Describe any waiting period between informing the prospective participant and obtaining the consent.

• Describe any steps taken to minimize the possibility of coercion or undue influence.

• Describe the language used by those obtaining consent.

• Describe the language understood by the prospective participant or the legally authorized representative.

• If children or adolescents are enrolled, describe the consent process includes parental permission and subject assent.

• Will all adult subjects be competent to give informed consent? If not, respond to the following:

o What is the likely degree of impairment? How will competency be assessed (eg, informal assessment by the investigator, mini-mental status exam, formal psychiatric evaluation)? Note: The methods of assessment of competence should be based on the population to be studied and the likelihood of cognitive or decisional impairment in that population.

o Will consent be obtained from a legally authorized representative, from whom will consent be obtained? Refer to the IRB Policy 705, Surrogate Consent/Authorization for guidance.

o Will subject assent be obtained? If no, provide justification. Note: Respect for persons requires that assent (or at least lack of active dissent) be obtained in most cases.

2. Waiver of Informed Consent:

If waiver of authorization is sought, summarize the key elements of the justification for a request for the waiver. Such a justification must conform to one of the three waiver scenarios below.

Waiver or alteration of required elements of consent: According to HHS CFR 45.46.116(d): An IRB may approve a consent procedure which does not include, or which alters, some or all of the elements of informed consent, or waive the requirements to obtain informed consent. In order to qualify for a waiver or alteration to the informed consent process, please justify each of the following:

• the research involves no more than minimal risk to the subjects;

• the waiver or alteration will not adversely affect the rights and welfare of the subjects;

• the research could not practicably be carried out without the waiver or alteration;

Explain why this research would not be possible to conduct if the IRB required informed consent of participants by completing the following statement, If the IRB required informed consent of participants, this research would not be possible because…

Also, estimate the number or percentage of participants for whom obtaining consent is anticipated to be impracticable.

• Whenever appropriate, the subjects will be provided with additional pertinent information after participation.

Note: For studies involving deception, a waiver/alteration of informed consent is being sought because subjects are either not informed of research participation or one of the elements of consent is not present (i.e. description of the purpose of the study).

Waiver of written documentation of informed consent: According to HHS CFR 45.46.117(c)(1), an IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern. In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research.

Waiver of written documentation of informed consent: HHS CFR 45.46.117(c)(2) and (where the research is subject to FDA regulations) FDA 21 CFR 56.109(c)(1): An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that the research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context (e.g. telephone survey). In cases in which the documentation requirement is waived, the IRB may require the investigator to provide subjects with a written statement regarding the research. If requesting a waiver of documentation of informed consent, provide the script or information sheet that will be used.

When requesting a waiver of documentation of consent, it is important to remember that the consent process itself is not being waived. Describe the information that will be provided to the subjects. You may provide a separate informed consent script or information sheet.

If the consent process will take place online or over the phone and the research is minimal risk, the IRB would consider a waiver of written documentation of consent under scenario 2.

RESOURCES NECESSARY FOR HUMAN RESEARCH PROTECTION:

Describe research staff and justify that the staff are adequate in number and qualifications to conduct the research. Describe how you will ensure that all staff assisting with the research is adequately informed about the protocol and their research related duties. Describe access to a population that would allow recruitment of the targeted number of subjects. If medical or psychological services as a consequence of the research, describe how the subject will be referred to those services. Describe your facilities and justify that the facilities are adequate. Verify that there is sufficient time to conduct and complete the research.

................
................

In order to avoid copyright disputes, this page is only a partial summary.

Google Online Preview   Download