Dec 8, read chaps 8-9 and first Chapter of Freakonomics
Dec 19, read chaps 10-11 and second Chapter of "
Jan 12 Review for final
Jan 14-15 I'll email you the final
Jan 20 Final is due by email
Jan 26, You'll have your grade in class and we'll discuss the final
Tuesday, November 17, 2009
Monday, November 9, 2009
Conflict of Interest
ETHICS in SOCIAL WORK RESEARCH
http://www.socialworkers.org/pubs/code/default.asp The NASW Code of Ethics
Click on English or Spanish.
Read through, then scroll down to
1.06 Conflicts of Interest
(a) Social workers should be alert to and avoid conflicts of interest that interfere with the exercise of professional discretion and impartial judgment. Social workers should inform clients when a real or potential conflict of interest arises and take reasonable steps to resolve the issue in a manner that makes the clients’ interests primary and protects clients’ interests to the greatest extent possible. In some cases, protecting clients’ interests may require termination of the professional relationship with proper referral of the client.
(b) Social workers should not take unfair advantage of any professional relationship or exploit others to further their personal, religious, political, or business interests.
(c) Social workers should not engage in dual or multiple relationships with clients or former clients in which there is a risk of exploitation or potential harm to the client. In instances when dual or multiple relationships are unavoidable, social workers should take steps to protect clients and are responsible for setting clear, appropriate, and culturally sensitive boundaries. (Dual or multiple relationships occur when social workers relate to clients in more than one relationship, whether professional, social, or business. Dual or multiple relationships can occur simultaneously or consecutively.)
(d) When social workers provide services to two or more people who have a relationship with each other (for example, couples, family members), social workers should clarify with all parties which individuals will be considered clients and the nature of social workers’ professional obligations to the various individuals who are receiving services. Social workers who anticipate a conflict of interest among the individuals receiving services or who anticipate having to perform in potentially conflicting roles (for example, when a social worker is asked to testify in a child custody dispute or divorce proceedings involving clients) should clarify their role with the parties involved and take appropriate action to minimize any conflict of interest.
Do you see any potential problems with research and ethics that we have to be aware of?
http://www.socialworkers.org/pubs/code/default.asp The NASW Code of Ethics
Click on English or Spanish.
Read through, then scroll down to
1.06 Conflicts of Interest
(a) Social workers should be alert to and avoid conflicts of interest that interfere with the exercise of professional discretion and impartial judgment. Social workers should inform clients when a real or potential conflict of interest arises and take reasonable steps to resolve the issue in a manner that makes the clients’ interests primary and protects clients’ interests to the greatest extent possible. In some cases, protecting clients’ interests may require termination of the professional relationship with proper referral of the client.
(b) Social workers should not take unfair advantage of any professional relationship or exploit others to further their personal, religious, political, or business interests.
(c) Social workers should not engage in dual or multiple relationships with clients or former clients in which there is a risk of exploitation or potential harm to the client. In instances when dual or multiple relationships are unavoidable, social workers should take steps to protect clients and are responsible for setting clear, appropriate, and culturally sensitive boundaries. (Dual or multiple relationships occur when social workers relate to clients in more than one relationship, whether professional, social, or business. Dual or multiple relationships can occur simultaneously or consecutively.)
(d) When social workers provide services to two or more people who have a relationship with each other (for example, couples, family members), social workers should clarify with all parties which individuals will be considered clients and the nature of social workers’ professional obligations to the various individuals who are receiving services. Social workers who anticipate a conflict of interest among the individuals receiving services or who anticipate having to perform in potentially conflicting roles (for example, when a social worker is asked to testify in a child custody dispute or divorce proceedings involving clients) should clarify their role with the parties involved and take appropriate action to minimize any conflict of interest.
Do you see any potential problems with research and ethics that we have to be aware of?
More on NASW Code of Ethics SEC 5.02
5.02 Evaluation and Research
(a) Social workers should monitor and evaluate policies, the implementation of programs, and practice interventions.
(b) Social workers should promote and facilitate evaluation and research to contribute to the development of knowledge.
(c) Social workers should critically examine and keep current with emerging knowledge relevant to social work and fully use evaluation and research evidence in their professional practice.
(d) Social workers engaged in evaluation or research should carefully consider possible consequences and should follow guidelines developed for the protection of evaluation and research participants. Appropriate institutional review boards should be consulted.
(e) Social workers engaged in evaluation or research should obtain voluntary and written informed consent from participants, when appropriate, without any implied or actual deprivation or penalty for refusal to participate; without undue inducement to participate; and with due regard for participants’ well¬being, privacy, and dignity. Informed consent should include information about the nature, extent, and duration of the participation requested and disclosure of the risks and benefits of participation in the research.
(f) When evaluation or research participants are incapable of giving informed consent, social workers should provide an appropriate explanation to the participants, obtain the participants’ assent to the extent they are able, and obtain written consent from an appropriate proxy.
(g) Social workers should never design or conduct evaluation or research that does not use consent procedures, such as certain forms of naturalistic observation and archival research, unless rigorous and responsible review of the research has found it to be justified because of its prospective scientific, educational, or applied value and unless equally effective alternative procedures that do not involve waiver of consent are not feasible.
(h) Social workers should inform participants of their right to withdraw from evaluation and research at any time without penalty.
(i) Social workers should take appropriate steps to ensure that participants in evaluation and research have access to appropriate supportive services.
(j) Social workers engaged in evaluation or research should protect participants from unwarranted physical or mental distress, harm, danger, or deprivation.
(k) Social workers engaged in the evaluation of services should discuss collected information only for professional purposes and only with people professionally concerned with this information.
(l) Social workers engaged in evaluation or research should ensure the anonymity or confidentiality of participants and of the data obtained from them. Social workers should inform participants of any limits of confidentiality, the measures that will be taken to ensure confidentiality, and when any records containing research data will be destroyed.
(m) Social workers who report evaluation and research results should protect participants’ confidentiality by omitting identifying information unless proper consent has been obtained authorizing disclosure.
(n) Social workers should report evaluation and research findings accurately. They should not fabricate or falsify results and should take steps to correct any errors later found in published data using standard publication methods.
(o) Social workers engaged in evaluation or research should be alert to and avoid conflicts of interest and dual relationships with participants, should inform participants when a real or potential conflict of interest arises, and should take steps to resolve the issue in a manner that makes participants’ interests primary.
(p) Social workers should educate themselves, their students, and their colleagues about responsible research practices.
(a) Social workers should monitor and evaluate policies, the implementation of programs, and practice interventions.
(b) Social workers should promote and facilitate evaluation and research to contribute to the development of knowledge.
(c) Social workers should critically examine and keep current with emerging knowledge relevant to social work and fully use evaluation and research evidence in their professional practice.
(d) Social workers engaged in evaluation or research should carefully consider possible consequences and should follow guidelines developed for the protection of evaluation and research participants. Appropriate institutional review boards should be consulted.
(e) Social workers engaged in evaluation or research should obtain voluntary and written informed consent from participants, when appropriate, without any implied or actual deprivation or penalty for refusal to participate; without undue inducement to participate; and with due regard for participants’ well¬being, privacy, and dignity. Informed consent should include information about the nature, extent, and duration of the participation requested and disclosure of the risks and benefits of participation in the research.
(f) When evaluation or research participants are incapable of giving informed consent, social workers should provide an appropriate explanation to the participants, obtain the participants’ assent to the extent they are able, and obtain written consent from an appropriate proxy.
(g) Social workers should never design or conduct evaluation or research that does not use consent procedures, such as certain forms of naturalistic observation and archival research, unless rigorous and responsible review of the research has found it to be justified because of its prospective scientific, educational, or applied value and unless equally effective alternative procedures that do not involve waiver of consent are not feasible.
(h) Social workers should inform participants of their right to withdraw from evaluation and research at any time without penalty.
(i) Social workers should take appropriate steps to ensure that participants in evaluation and research have access to appropriate supportive services.
(j) Social workers engaged in evaluation or research should protect participants from unwarranted physical or mental distress, harm, danger, or deprivation.
(k) Social workers engaged in the evaluation of services should discuss collected information only for professional purposes and only with people professionally concerned with this information.
(l) Social workers engaged in evaluation or research should ensure the anonymity or confidentiality of participants and of the data obtained from them. Social workers should inform participants of any limits of confidentiality, the measures that will be taken to ensure confidentiality, and when any records containing research data will be destroyed.
(m) Social workers who report evaluation and research results should protect participants’ confidentiality by omitting identifying information unless proper consent has been obtained authorizing disclosure.
(n) Social workers should report evaluation and research findings accurately. They should not fabricate or falsify results and should take steps to correct any errors later found in published data using standard publication methods.
(o) Social workers engaged in evaluation or research should be alert to and avoid conflicts of interest and dual relationships with participants, should inform participants when a real or potential conflict of interest arises, and should take steps to resolve the issue in a manner that makes participants’ interests primary.
(p) Social workers should educate themselves, their students, and their colleagues about responsible research practices.
IRB
ETHICS in SOCIAL WORK RESEARCH-3
NOW GO TO THE ICSW IRB PAGE and download the manual.
(ICSW.edu- Academic Resources-IRB)
3.0, types of submissions
Each request for IRB review will address all of the areas outlined on the IRB Application Form (www.icsw.edu). In addition to the credentials of the project personnel, this will include statements of the:
1. Specific goals and objectives of the project.
2. Significance and context of the proposed work.
3. Need for and value of the project in relation to prior work in the field.
4. Study design.
5. Selection and recruitment of subjects, including informed consent procedures.
6. Risks and benefits of the research.
7. Data collection methodology and confidentiality of data.
In addition, the primary investigator and faculty chair or faculty sponsor will give signed assurance that the application and the research described therein will be conducted in accordance with the legal, ethical and professional standards of practice as outlined.
Appendices will include copies of any interview schedule, all tests, questionnaires, inventories, consent/assent forms, and letters to participants as well as materials used to solicit participants.
3.1.2 Dissertations
All doctoral students intending to do research involving use of human subjects must submit an application for IRB review as outlined for faculty and staff in 3.1.1 1. No pilot data collection can begin nor can the proposal defense hearing be scheduled until the IRB approval is completed.
1) Research proposals should be submitted first to the student’s Dissertation Committee for review of the academic merit and ethical issues of the proposal. Upon completion of this initial informal review of the research proposal by the Committee, the student completes an IRB Application Form (see Section 5.1) and the Chair reviews and signs it.
2) Application for IRB review must be submitted to the IRB before the proposal defense is scheduled.
3) Documentation of each aspect of the research process must be included with the application:
(a) If applicable, include copies of any materials used in the recruitment of subjects.
(b) Informed consent protocol and forms must include:
(c) Include copies of all data collection tools such as interview schedules, tests or other forms to be completed by subjects or others related to the research.
(d) Original signed forms must be kept on file by researcher.
4) Annual Report forms (see Section 5.3) should be submitted to IRB no less than once a year. The researcher will receive an Annual Report Form approximately 11 months after initial approval was received
5) Submission of injury reports and reports of unanticipated problems involving risks must be made to the Chair of the IRB or other designated responsible person as they occur in the most expeditious manner possible. Any delay in reporting or failure to report injury or unexpected negative consequences may result in the student being removed from the program and/or the project being stopped immediately.
6) A prompt report should be made whenever there is change in the research protocol.
7) The researcher and/or the Dissertation Committee Chair are independently responsible for reporting to the IRB by phone, if urgent or by email and/or other written report any noncompliance with agreed upon process for research.
Students should submit one electronic copy or two paper copies of the appropriate IRB Application Form (See 5.1) or the Request for IRB Review of Course-Related Research (See 5.2), following the same format as that for faculty and staff as outlined in section 3.1.1.1. Each area of concern must be addressed:
1. Specific goals and objectives of the project
2. Significance and context of the proposed work
3. Need for and value of the project in relation to prior work in the field
4. Study design
5. Selection and recruitment of subjects, including informed consent procedures
6. Risks and benefits of the research
7. Data collection methodology and confidentiality of data
Appendices will include copies of any interview schedule, all tests, questionnaires, inventories, consent/assent forms, and letters to participants as well as materials used to solicit participants.
See detailed explanations in the Proposal Outline Guidelines, Section 3.3.1, and/or the Informed Consent Guidelines, in Section 3.3.2.
NOW GO TO THE ICSW IRB PAGE and download the manual.
(ICSW.edu- Academic Resources-IRB)
3.0, types of submissions
Each request for IRB review will address all of the areas outlined on the IRB Application Form (www.icsw.edu). In addition to the credentials of the project personnel, this will include statements of the:
1. Specific goals and objectives of the project.
2. Significance and context of the proposed work.
3. Need for and value of the project in relation to prior work in the field.
4. Study design.
5. Selection and recruitment of subjects, including informed consent procedures.
6. Risks and benefits of the research.
7. Data collection methodology and confidentiality of data.
In addition, the primary investigator and faculty chair or faculty sponsor will give signed assurance that the application and the research described therein will be conducted in accordance with the legal, ethical and professional standards of practice as outlined.
Appendices will include copies of any interview schedule, all tests, questionnaires, inventories, consent/assent forms, and letters to participants as well as materials used to solicit participants.
3.1.2 Dissertations
All doctoral students intending to do research involving use of human subjects must submit an application for IRB review as outlined for faculty and staff in 3.1.1 1. No pilot data collection can begin nor can the proposal defense hearing be scheduled until the IRB approval is completed.
1) Research proposals should be submitted first to the student’s Dissertation Committee for review of the academic merit and ethical issues of the proposal. Upon completion of this initial informal review of the research proposal by the Committee, the student completes an IRB Application Form (see Section 5.1) and the Chair reviews and signs it.
2) Application for IRB review must be submitted to the IRB before the proposal defense is scheduled.
3) Documentation of each aspect of the research process must be included with the application:
(a) If applicable, include copies of any materials used in the recruitment of subjects.
(b) Informed consent protocol and forms must include:
(i) Written consent/assent forms for each participant
(ii) Procedures for reading forms or describing contents or providing participants with adequate time to read and question contents of form
(iii) Assurances should be provided that participants are provided copy of the signed form.
(c) Include copies of all data collection tools such as interview schedules, tests or other forms to be completed by subjects or others related to the research.
(d) Original signed forms must be kept on file by researcher.
4) Annual Report forms (see Section 5.3) should be submitted to IRB no less than once a year. The researcher will receive an Annual Report Form approximately 11 months after initial approval was received
5) Submission of injury reports and reports of unanticipated problems involving risks must be made to the Chair of the IRB or other designated responsible person as they occur in the most expeditious manner possible. Any delay in reporting or failure to report injury or unexpected negative consequences may result in the student being removed from the program and/or the project being stopped immediately.
6) A prompt report should be made whenever there is change in the research protocol.
7) The researcher and/or the Dissertation Committee Chair are independently responsible for reporting to the IRB by phone, if urgent or by email and/or other written report any noncompliance with agreed upon process for research.
Students should submit one electronic copy or two paper copies of the appropriate IRB Application Form (See 5.1) or the Request for IRB Review of Course-Related Research (See 5.2), following the same format as that for faculty and staff as outlined in section 3.1.1.1. Each area of concern must be addressed:
1. Specific goals and objectives of the project
2. Significance and context of the proposed work
3. Need for and value of the project in relation to prior work in the field
4. Study design
5. Selection and recruitment of subjects, including informed consent procedures
6. Risks and benefits of the research
7. Data collection methodology and confidentiality of data
Appendices will include copies of any interview schedule, all tests, questionnaires, inventories, consent/assent forms, and letters to participants as well as materials used to solicit participants.
See detailed explanations in the Proposal Outline Guidelines, Section 3.3.1, and/or the Informed Consent Guidelines, in Section 3.3.2.
IRB APPLICATION FORM
IRB Application Form
INSTITUTE FOR CLINICAL SOCIAL WORK
Incomplete application packets or applications with omitted may result in review delays.
Checklist of Supporting Material for Investigators:
[ ] Resume or CV of principal investigator or faculty sponsor
[ ] Flyers, advertisements, oral scripts (including telephone scripts), other recruitment materials
[ ] Consent/assent forms
[ ] Surveys, questionnaires, interview questions/guides
[ ] Debriefing information, if applicable
[ ] Letters of collaboration, if applicable
[ ] Funding Proposals, if applicable. For federally funded research include all sections of the proposal or grant except the budget pages.
Dissertation or Faculty Research
[For completing this application, use only Courier or Times New Roman font, 11+ pt.]
Step I: Project Personnel
Project Title:
Principal Investigator: (attach resume or CV)
Address:
Phone: E-mail:
List all co-investigators and/or faculty sponsors below, including those from other institutions.
NOTE: If this is dissertation research, list dissertation chair.
Name, Degree, Address, Phone and email or other contact information:
1.
2.
3.
Contact Information
Who should be contacted for further information about this application?
Name: Position on the project:
Phone: E mail:
Step II: Funding Sources & Performance Sites
[If this project is funded by an outside source, complete Step II]
Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
[ ] Federal – If federally funded, provide name and address of individual to whom certification of IRB should be sent:
[ ] Extramural (non-federal funding sources) – Provide name and address of individual to whom certification of IRB should be sent:
Principal Investigator of Grant or Contract:
Name of Funding Source:
Grant or Contract Number (If available):
Grant, Contract, or Project Title:
Performance Sites:
List all collaborating sites:
Provide letters of cooperation or support: [ ] Attached [ ] Pending [ ] Not Applicable
Provide letter of IRB approval from other site: [ ] Attached [ ] Pending [ ] Not Applicable
Step III: Specific Aims, Goals, and Objectives of the Project (no more than 200 words)
Summarize the specific aims, goals, and objectives of the proposed research using non-technical language that can be understood by any generally informed layperson.
Step IVa: Significance and Context of the Work, Including Any New Information to Be Obtained (no more than one page)
Using non-technical language that can be understood by any generally informed layperson, describe the significance and context of the work, including new information the Principal Investigator intends to obtain. In the case of classroom instructional activities, what types of skills or knowledge is the research intended to provide for the students?
Step IVb: Need for and value of the Project in Relation to Prior Work in the Field (one page)
Demonstrate that the goals and objectives described are worthy of investigation and require the use of human research participants.
Step IVc: Study Design (one page)
Include a detailed description of the specific study design to be used demonstrating a logically derived connection between the design, the significance of the project and the need for the project. NOTE: Sample selection, protection of participants, and data collection methodology are covered below.
Step V: Participant Population
Please indicate the total number of participants anticipated for inclusion in this project. This number should be the number of participants you will enroll in order to get the adequate data sets you will need. If multiple sites are to be used, provide an estimate of the number in each category to be recruited from each site. In addition, if you plan to study only one gender, provide detailed rationale in the inclusion/exclusion section (Step VI, C, 1and 2) of this application.
A. Number of Participants Required:
Male:
Female:
Total:
B. Age range (check all that apply):
[ ] 0 7 yrs. (submit parental permission form – template C)
[ ] 8 17 yrs. (submit child’s assent form – template D and parental permission form – template C)
[ ] 18 64 yrs. (submit informed consent form – templates B)
[ ] 65+ yrs. (submit informed consent form – template B)
C. Source/Type of Participants (check all that apply): [ICSW students and faculty may not be subjects]
[ ] medical patients
[ ] volunteers from the general population
[ ] community institutions, please specify:
[ ] other, please specify:
D. Participant location during research data collection (check all that apply):
[ ] participant’s home
[ ] hospital or clinic, please specify:
[ ] community location, please specify:
[ ] elementary or secondary school, please specify:
[ ] other, please specify:
E. Special populations to be included in the research (check all that apply):
[ ] minors under age 18
[ ] pregnant women
[ ] prisoners
[ ] economically disadvantaged
[ ] developmentally delayed
[ ] severe and/or chronically mentally ill
[ ] other, please specify:
F. Several groups listed in (E) above are considered “vulnerable” or require special consideration by the federal regulatory agencies and by the IRB. Provide the rationale for using special populations.
Step VI: Recruitment Procedures (no more than one page)
A. Describe how participants will be identified and recruited. Attach all recruitment information, e.g., advertisements, bulletin board notices, and recruitment letters for all types of media (printed, radio, electronic, TV, or Internet).
B. Initial Contact: Describe who will make initial contact and how. If participants are chosen from records, indicate who gave approval for the use of the records. If records are “private” medical or student records, provide the release forms, consent forms, letters, and HIPAA if appropriate for securing consent of the participants for the records. Written documentation for cooperation/permission from the holder or custodian of the records should be attached. (Initial contact of participants identified through a records search must be made by the official holder of the record, such as, primary physician, therapist, school official.)
C. List criteria for inclusion and exclusion of participants in this study. Describe populations to be excluded from the research. Please describe procedures to assure equitable selection of participants. Researchers should not select participants on the basis of discriminatory criteria. Selection criteria that exclude a sex, racial, or ethnic group require a clear scientific rationale for the exclusion. By whom will the inclusion/exclusion criteria be determined in the selection of the subjects? (For example, principal investigator, research assistant, school official.)
D. Will participants receive financial or other compensation before or after the study? If yes, explain. (NOTE: this information must be outlined in the consent document.)
Step VII: Informed Consent Process
Simply giving a consent form to a participant does not constitute informed consent. The following questions pertain to the process. Researchers are cautioned that consent forms should be written in simple declarative sentences. Forms should be jargon free (see consent form templates). Foreign language versions should be prepared and included for all materials that the participants needing translations will encounter in the research.
A. Capacity to consent: Will all adult participants have the capacity to give informed consent?
[ ] Yes [ ] No
If No: describe the likely range of impairment and explain how, and by whom, their capacity to consent will be determined. NOTE: in research involving more than minimal risk, capacity to consent should be determined by a psychiatrist, psychologist, or other qualified professional not otherwise involved in the research. Individuals who lack the capacity to consent may participate in research only if a legally authorized representative gives consent on their behalf.
B. Describe what will actually be said to the participants to explain the research. (NOTE: do not say “see consent form.”) Write the explanation in lay language. If you are using telephone surveys, telephone scripts are required. If you will include participants not fluent in English, please provide an appropriate translation.
C. How will participants’ understanding be assessed? What questions will be asked to assess the participants’ understanding? If you will include participants not fluent in English, please provide an appropriate translation.
NOTE: the purpose of this question is to have you describe how you will assess participants’ understanding of the consent process. Questions requiring “yes or no” answers are not appropriate. Please ask participants to explain the purpose of the study to you along with the risks and benefits to themselves as participants. Their answers to these questions should allow you to determine whether they understand the study and their part in it. It they do not understand, informed consent has not been achieved irrespective of whether the participant signed the consent document.
D. In relation to the actual data gathering, when and where will consent be discussed and documentation obtained, for example several days before? Be specific.
E. Will the Investigator(s) be securing all of the Informed consents? [ ] Yes [ ] No [ ] N/A
If no, name the specific individuals who will obtain informed consent and include their job title and a brief description of your plans to train these individuals to obtain consent and answer participants’ questions:
F. Consent and Assent Forms (see templates C & D)
Prepare and attach the appropriate consent/assent form(s) for IRB review. If you intend to use participants that are not fluent or literate in English, have appropriate translations and back translations been developed and attached to this application? [ ] Yes [ ] No
Step VIII: Risks and Benefits of the Research
A. Does the research involve (check all that apply):
[ ] use of private records (medical, mental health or educational records)
[ ] possible invasion of privacy of participant or family
[ ] the collection of personal or sensitive information in surveys or interviews
[ ] use of a deceptive technique (If use of deception is part of the protocol, the protocol must include a “debriefing procedure” [provide this procedure for IRB review] which will be followed upon completion of the study, or withdrawal of the participants.)
[ ] presentation of materials that participants might consider offensive, threatening, or degrading
[ ] other risks, specify:
NOTE: Respond to VII B-E in written form, not more than 2 pages.
B. Identify the risks (current and potential) and describe the expected frequency, degree of severity, and potential reversibility. Include any potential late effects. (NOTE: Risks can be psychological, physical, social, economic, or legal.)
C. Describe the precautions taken to minimize risk.
D. Why are the risks mentioned above reasonable? What is the expected scholarly yield from the project? Justify the risks in relation to the anticipated benefits to the participants and in relation to the importance of the knowledge that may reasonably be expected to result from the research.
E. Benefits of participation: List any anticipated direct benefits of participation in this research project. If none, state that fact here and in the consent form. The knowledge gained from the study could produce a benefit to society. Payment or course credit is not considered to be a benefit of participation. Any benefits of the specific research procedures should be listed as potential benefits.
Step IX: Data Collection Methodology
Describe the tasks, tests, or other procedures, including the interview process, participants will be asked to complete. (Suggestion: explain step by step what the participants will be asked to do and distinguish those which are experimental from those which comprise routine tasks encountered in everyday life). Specify exactly how these tasks, tests, or procedures will generate the data that will permit achievement of the goals and objectives of this research.
Step X: Confidentiality of Data
A. Describe provisions made to maintain confidentiality of data.
1. Who will have access to raw data?
2. Will raw data be made available to anyone other than the Principal Investigator and immediate study personnel (e.g., school officials, medical personnel)? [ ] Yes [ ] No
If yes, who, how, and why?
3. If applicable, describe the procedure for sharing data.
4. If applicable, describe how the participant will be informed that the data may be shared.
5. If data are collected, stored, or analyzed on computers, describe the actual security measures used to ensure confidentiality.
B. Where will the data be kept? (Data must be secured for five years after graduation.) How will data stored on audio and videotapes be disposed of? (Disposition of audio and video tapes should be included in consent form.)
C. Will data identifying the participants be made available to anyone other than the principal investigator, that is, study sponsor, Institutional Review Board? [ ] Yes [ ] No
If yes: Who:
D. Will the research data and information be part of any permanent record? (Explanation must be in the consent form.) [ ] Yes [ ] No
E. If participants are students, will school officials receive the data with identifiers attached? (Explain here and in the consent form using appropriate language.) [ ] Yes [ ] No
Investigator’s Assurance
I certify that the information provided in this application is complete and correct.
I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human participants, conduct of the study and the ethical performance of the project. I agree to comply with all IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research, including, but not limited to, the following:
• The project will be performed by qualified personnel according to the ICSW IRB certified protocol.
• No changes will be made in the protocol or consent form until approved by the ICSW IRB.
• Legally effective informed consent will be obtained from human participants if applicable.
• Adverse events will be reported to the ICSW IRB in a timely manner.
I further certify that the proposed research is not currently underway (except for those protocols of research previously approved and currently seeking renewal) and will not begin until approval has been obtained.
Principal Investigator’s Signature: Date: _
Dissertation Chair or Faculty Assurance for Student or Guest Investigators
By my signature as Chair or Sponsor on this research application, I certify that the student or guest investigator is knowledgeable about the regulations and policies governing research with human participants and has sufficient training and experience to conduct this particular study in accord with the approved protocol. In addition,
• I agree to meet with the investigator on a regular basis to monitor study progress.
• Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in solving them.
• I ensure that the investigator will promptly report significant or untoward adverse effects to the ICSW IRB in a timely manner.
If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence and I will advise the ICSW IRB by letter of such arrangements. I further certify that the proposed research is not currently underway and will not begin until approval is obtained.
Faculty Sponsor’s Signature: _____________ Date:_____
NOTE: The faculty sponsor must be a member of the ICSW faculty. The faculty member is the responsible party for legal and ethical performance of the project.
Submit this application to the office in either hard copy or as attachment to an email.
Send questions to: Dan Rosenfeld, Chair, ICSW IRB: DanR61@aol.com
INSTITUTE FOR CLINICAL SOCIAL WORK
Incomplete application packets or applications with omitted may result in review delays.
Checklist of Supporting Material for Investigators:
[ ] Resume or CV of principal investigator or faculty sponsor
[ ] Flyers, advertisements, oral scripts (including telephone scripts), other recruitment materials
[ ] Consent/assent forms
[ ] Surveys, questionnaires, interview questions/guides
[ ] Debriefing information, if applicable
[ ] Letters of collaboration, if applicable
[ ] Funding Proposals, if applicable. For federally funded research include all sections of the proposal or grant except the budget pages.
Dissertation or Faculty Research
[For completing this application, use only Courier or Times New Roman font, 11+ pt.]
Step I: Project Personnel
Project Title:
Principal Investigator: (attach resume or CV)
Address:
Phone: E-mail:
List all co-investigators and/or faculty sponsors below, including those from other institutions.
NOTE: If this is dissertation research, list dissertation chair.
Name, Degree, Address, Phone and email or other contact information:
1.
2.
3.
Contact Information
Who should be contacted for further information about this application?
Name: Position on the project:
Phone: E mail:
Step II: Funding Sources & Performance Sites
[If this project is funded by an outside source, complete Step II]
Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).
[ ] Federal – If federally funded, provide name and address of individual to whom certification of IRB should be sent:
[ ] Extramural (non-federal funding sources) – Provide name and address of individual to whom certification of IRB should be sent:
Principal Investigator of Grant or Contract:
Name of Funding Source:
Grant or Contract Number (If available):
Grant, Contract, or Project Title:
Performance Sites:
List all collaborating sites:
Provide letters of cooperation or support: [ ] Attached [ ] Pending [ ] Not Applicable
Provide letter of IRB approval from other site: [ ] Attached [ ] Pending [ ] Not Applicable
Step III: Specific Aims, Goals, and Objectives of the Project (no more than 200 words)
Summarize the specific aims, goals, and objectives of the proposed research using non-technical language that can be understood by any generally informed layperson.
Step IVa: Significance and Context of the Work, Including Any New Information to Be Obtained (no more than one page)
Using non-technical language that can be understood by any generally informed layperson, describe the significance and context of the work, including new information the Principal Investigator intends to obtain. In the case of classroom instructional activities, what types of skills or knowledge is the research intended to provide for the students?
Step IVb: Need for and value of the Project in Relation to Prior Work in the Field (one page)
Demonstrate that the goals and objectives described are worthy of investigation and require the use of human research participants.
Step IVc: Study Design (one page)
Include a detailed description of the specific study design to be used demonstrating a logically derived connection between the design, the significance of the project and the need for the project. NOTE: Sample selection, protection of participants, and data collection methodology are covered below.
Step V: Participant Population
Please indicate the total number of participants anticipated for inclusion in this project. This number should be the number of participants you will enroll in order to get the adequate data sets you will need. If multiple sites are to be used, provide an estimate of the number in each category to be recruited from each site. In addition, if you plan to study only one gender, provide detailed rationale in the inclusion/exclusion section (Step VI, C, 1and 2) of this application.
A. Number of Participants Required:
Male:
Female:
Total:
B. Age range (check all that apply):
[ ] 0 7 yrs. (submit parental permission form – template C)
[ ] 8 17 yrs. (submit child’s assent form – template D and parental permission form – template C)
[ ] 18 64 yrs. (submit informed consent form – templates B)
[ ] 65+ yrs. (submit informed consent form – template B)
C. Source/Type of Participants (check all that apply): [ICSW students and faculty may not be subjects]
[ ] medical patients
[ ] volunteers from the general population
[ ] community institutions, please specify:
[ ] other, please specify:
D. Participant location during research data collection (check all that apply):
[ ] participant’s home
[ ] hospital or clinic, please specify:
[ ] community location, please specify:
[ ] elementary or secondary school, please specify:
[ ] other, please specify:
E. Special populations to be included in the research (check all that apply):
[ ] minors under age 18
[ ] pregnant women
[ ] prisoners
[ ] economically disadvantaged
[ ] developmentally delayed
[ ] severe and/or chronically mentally ill
[ ] other, please specify:
F. Several groups listed in (E) above are considered “vulnerable” or require special consideration by the federal regulatory agencies and by the IRB. Provide the rationale for using special populations.
Step VI: Recruitment Procedures (no more than one page)
A. Describe how participants will be identified and recruited. Attach all recruitment information, e.g., advertisements, bulletin board notices, and recruitment letters for all types of media (printed, radio, electronic, TV, or Internet).
B. Initial Contact: Describe who will make initial contact and how. If participants are chosen from records, indicate who gave approval for the use of the records. If records are “private” medical or student records, provide the release forms, consent forms, letters, and HIPAA if appropriate for securing consent of the participants for the records. Written documentation for cooperation/permission from the holder or custodian of the records should be attached. (Initial contact of participants identified through a records search must be made by the official holder of the record, such as, primary physician, therapist, school official.)
C. List criteria for inclusion and exclusion of participants in this study. Describe populations to be excluded from the research. Please describe procedures to assure equitable selection of participants. Researchers should not select participants on the basis of discriminatory criteria. Selection criteria that exclude a sex, racial, or ethnic group require a clear scientific rationale for the exclusion. By whom will the inclusion/exclusion criteria be determined in the selection of the subjects? (For example, principal investigator, research assistant, school official.)
D. Will participants receive financial or other compensation before or after the study? If yes, explain. (NOTE: this information must be outlined in the consent document.)
Step VII: Informed Consent Process
Simply giving a consent form to a participant does not constitute informed consent. The following questions pertain to the process. Researchers are cautioned that consent forms should be written in simple declarative sentences. Forms should be jargon free (see consent form templates). Foreign language versions should be prepared and included for all materials that the participants needing translations will encounter in the research.
A. Capacity to consent: Will all adult participants have the capacity to give informed consent?
[ ] Yes [ ] No
If No: describe the likely range of impairment and explain how, and by whom, their capacity to consent will be determined. NOTE: in research involving more than minimal risk, capacity to consent should be determined by a psychiatrist, psychologist, or other qualified professional not otherwise involved in the research. Individuals who lack the capacity to consent may participate in research only if a legally authorized representative gives consent on their behalf.
B. Describe what will actually be said to the participants to explain the research. (NOTE: do not say “see consent form.”) Write the explanation in lay language. If you are using telephone surveys, telephone scripts are required. If you will include participants not fluent in English, please provide an appropriate translation.
C. How will participants’ understanding be assessed? What questions will be asked to assess the participants’ understanding? If you will include participants not fluent in English, please provide an appropriate translation.
NOTE: the purpose of this question is to have you describe how you will assess participants’ understanding of the consent process. Questions requiring “yes or no” answers are not appropriate. Please ask participants to explain the purpose of the study to you along with the risks and benefits to themselves as participants. Their answers to these questions should allow you to determine whether they understand the study and their part in it. It they do not understand, informed consent has not been achieved irrespective of whether the participant signed the consent document.
D. In relation to the actual data gathering, when and where will consent be discussed and documentation obtained, for example several days before? Be specific.
E. Will the Investigator(s) be securing all of the Informed consents? [ ] Yes [ ] No [ ] N/A
If no, name the specific individuals who will obtain informed consent and include their job title and a brief description of your plans to train these individuals to obtain consent and answer participants’ questions:
F. Consent and Assent Forms (see templates C & D)
Prepare and attach the appropriate consent/assent form(s) for IRB review. If you intend to use participants that are not fluent or literate in English, have appropriate translations and back translations been developed and attached to this application? [ ] Yes [ ] No
Step VIII: Risks and Benefits of the Research
A. Does the research involve (check all that apply):
[ ] use of private records (medical, mental health or educational records)
[ ] possible invasion of privacy of participant or family
[ ] the collection of personal or sensitive information in surveys or interviews
[ ] use of a deceptive technique (If use of deception is part of the protocol, the protocol must include a “debriefing procedure” [provide this procedure for IRB review] which will be followed upon completion of the study, or withdrawal of the participants.)
[ ] presentation of materials that participants might consider offensive, threatening, or degrading
[ ] other risks, specify:
NOTE: Respond to VII B-E in written form, not more than 2 pages.
B. Identify the risks (current and potential) and describe the expected frequency, degree of severity, and potential reversibility. Include any potential late effects. (NOTE: Risks can be psychological, physical, social, economic, or legal.)
C. Describe the precautions taken to minimize risk.
D. Why are the risks mentioned above reasonable? What is the expected scholarly yield from the project? Justify the risks in relation to the anticipated benefits to the participants and in relation to the importance of the knowledge that may reasonably be expected to result from the research.
E. Benefits of participation: List any anticipated direct benefits of participation in this research project. If none, state that fact here and in the consent form. The knowledge gained from the study could produce a benefit to society. Payment or course credit is not considered to be a benefit of participation. Any benefits of the specific research procedures should be listed as potential benefits.
Step IX: Data Collection Methodology
Describe the tasks, tests, or other procedures, including the interview process, participants will be asked to complete. (Suggestion: explain step by step what the participants will be asked to do and distinguish those which are experimental from those which comprise routine tasks encountered in everyday life). Specify exactly how these tasks, tests, or procedures will generate the data that will permit achievement of the goals and objectives of this research.
Step X: Confidentiality of Data
A. Describe provisions made to maintain confidentiality of data.
1. Who will have access to raw data?
2. Will raw data be made available to anyone other than the Principal Investigator and immediate study personnel (e.g., school officials, medical personnel)? [ ] Yes [ ] No
If yes, who, how, and why?
3. If applicable, describe the procedure for sharing data.
4. If applicable, describe how the participant will be informed that the data may be shared.
5. If data are collected, stored, or analyzed on computers, describe the actual security measures used to ensure confidentiality.
B. Where will the data be kept? (Data must be secured for five years after graduation.) How will data stored on audio and videotapes be disposed of? (Disposition of audio and video tapes should be included in consent form.)
C. Will data identifying the participants be made available to anyone other than the principal investigator, that is, study sponsor, Institutional Review Board? [ ] Yes [ ] No
If yes: Who:
D. Will the research data and information be part of any permanent record? (Explanation must be in the consent form.) [ ] Yes [ ] No
E. If participants are students, will school officials receive the data with identifiers attached? (Explain here and in the consent form using appropriate language.) [ ] Yes [ ] No
Investigator’s Assurance
I certify that the information provided in this application is complete and correct.
I understand that as Principal Investigator, I have ultimate responsibility for the protection of the rights and welfare of human participants, conduct of the study and the ethical performance of the project. I agree to comply with all IRB policies and procedures, as well as with all applicable federal, state and local laws regarding the protection of human participants in research, including, but not limited to, the following:
• The project will be performed by qualified personnel according to the ICSW IRB certified protocol.
• No changes will be made in the protocol or consent form until approved by the ICSW IRB.
• Legally effective informed consent will be obtained from human participants if applicable.
• Adverse events will be reported to the ICSW IRB in a timely manner.
I further certify that the proposed research is not currently underway (except for those protocols of research previously approved and currently seeking renewal) and will not begin until approval has been obtained.
Principal Investigator’s Signature: Date: _
Dissertation Chair or Faculty Assurance for Student or Guest Investigators
By my signature as Chair or Sponsor on this research application, I certify that the student or guest investigator is knowledgeable about the regulations and policies governing research with human participants and has sufficient training and experience to conduct this particular study in accord with the approved protocol. In addition,
• I agree to meet with the investigator on a regular basis to monitor study progress.
• Should problems arise during the course of the study, I agree to be available, personally, to supervise the investigator in solving them.
• I ensure that the investigator will promptly report significant or untoward adverse effects to the ICSW IRB in a timely manner.
If I will be unavailable, as when on sabbatical leave or vacation, I will arrange for an alternate faculty sponsor to assume responsibility during my absence and I will advise the ICSW IRB by letter of such arrangements. I further certify that the proposed research is not currently underway and will not begin until approval is obtained.
Faculty Sponsor’s Signature: _____________ Date:_____
NOTE: The faculty sponsor must be a member of the ICSW faculty. The faculty member is the responsible party for legal and ethical performance of the project.
Submit this application to the office in either hard copy or as attachment to an email.
Send questions to: Dan Rosenfeld, Chair, ICSW IRB: DanR61@aol.com
Monday, November 2, 2009
SECOND CLASS 11-3-09
We'll be discussing Rubin and Babbie, chaps 4-6, with much focus on ethics, primarily the IRB, what is it, why should you care, and why you better pay attention to this class.
Click on this link to find the NASW Code of Ethics. Please read through it. Pay attention to 1.06, Conflicts of Interest and 5.02, Evaluation and Research.
Then go to the ICSW website, ICSW.edu. Click on Academic Resources, then IRB.
Download the manual.
READ IT!
Pay close attention to 3.0 and 3.12.
See you in class.
Click on this link to find the NASW Code of Ethics. Please read through it. Pay attention to 1.06, Conflicts of Interest and 5.02, Evaluation and Research.
Then go to the ICSW website, ICSW.edu. Click on Academic Resources, then IRB.
Download the manual.
READ IT!
Pay close attention to 3.0 and 3.12.
See you in class.
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