Sample Appendix A

APPENDIX A

SINGLE PROJECT APPROVAL

Statement by Principal Investigator

This form must be typed. Do not leave any blank spaces. If any questions are not applicable, please indicate by “N/A”. If you intend to utilize a questionnaire, please append it to this application. If there is not sufficient space for the answering of any question, please attach additional pages.

1. Principal Investigator: Doreen Arcus

Co-Researcher(s) if applicable: Meghan McCarthy

Home Address of Principal Investigator: 189 Spring St., Arlington, MA 02476

E-mail Address of Principal Investigator: Doreen_Arcus@uml.edu

Daytime Phone #: 978-934-4172 (x 4377 lab) Home Phone #: 781-646-6326

Specify with X: _X_ Faculty/Staff ___ Graduate Student(s) ___ Undergraduate Student(s)

Title (if Faculty/Staff): Associate Professor

2. Department: Psychology

3. College: Arts and Sciences (Division Fine Arts, Social Sciences, & Humanities)

4. Research Project Title: Other Children in the Family

5. Date Research is scheduled to begin: April 1, 2006

6. Are you applying for funding through the Office of Research Administration, and/or what is your

expected source of funds, if any? Meghan McCarthy Senior Research Grant, UML Honors Program; PI research funds.

7. Date proposal must be submitted to funding agency (if applicable): N/A

8. Abstract or summarize your proposed research. (Appended copy of an abstract or summary may be

used to respond to this question.) Please see appended summary

9. Who will be the subjects of the research? 18-25 year old individuals recruited from the University and local community

10. How many participants do you plan to have in your study? 45

11. a. Does the research involve: (respond to each category) YES NO

Children under 8 years of age? ____ __X__

Children 8 to 17 years of age (under 18)? ____ __X__

Students in elementary, middle, or high school? ____ __X__

College students under the age of 18? ____ __X__

Older adults who are over 65 years of age and have cognitive

impairment and/or are institutionalized? ____ __X__

Inmates in penal institutions? ____ __X__

Patients in mental institutions? ____ __X__

Physically handicapped? ____ __X__

Mentally or emotionally handicapped? ____ __X__

Persons incapable of informed consent? ____ __X__

NOTE: If you have checked YES to any of the above-listed categories and your research study involves at least minimal risk; the proposal must receive Full Review.

b. If you have checked YES to any category listed above, could the research possibly be done with subjects not included in the above-listed categories? Not applicable

12. How will the subjects be recruited? (Be specific). Participants will be recruited through flyers posted on campus and in public places in the community (appended). Postings in community events sections of local newspapers will read: “18-25 year olds who grew up in families that provided foster care to non-related children are needed to participate in focus groups to explore their experiences with foster siblings. For more information contact Dr. Doreen Arcus, Dept. Psychology, UMass Lowell, 978-934-4377”

13. Will you utilize recruitment advertising materials, such as, flyers, newspaper advertisements, etc.?

YES _X__ NO ___ If so, they must be submitted to the IRB at this time.

14. a. Which of the following will you do with your subjects? (Check all the relevant activities.)

_____ Analyze data previously recorded about them

_____ Analyze tissues or fluids previously taken from them

__X Contact by mail *

__X Contact by E-mail *

_____ Contact by telephone

_____ Meet face-to-face in the field

__X Meet in laboratory

__X Interview

__X Administer questionnaire

_____ Test performance

_____ Manipulate psychological treatment/conditions

_____ Manipulate physiological treatment/conditions

_____ Manipulate subjects' behavior

__X Record "spontaneous" behavior (audiotape for transcription of comments)

_____ Record physiological measures

_____ Other. Explain:

* Method of contact for follow-up questionnaires to be indicated by participants

b. Describe in lay terms what you will do with your subjects

Participants will be recruited for focus groups in which they will be invited to talk about their experiences growing up with siblings, with the focus on foster siblings for those participants whose families fostered unrelated children and on birth siblings for participants who grew up in families with only biologically related siblings. The PI will lead the focus groups, asking open-ended questions. A running record of all comments will be kept by a researcher taking notes, and the sessions will be audiotaped to check for accuracy in the transcribed comments.

At the end of the focus group, participants will be asked to complete three short questionnaires, one asking about their personality style as children, one asking about the stresses that might have been associated with siblings, and one asking basic demographic information.

When all of the focus groups have been conducted, a compilation of all comments will be sent to participants so that they can indicate the extent to which they agreed with each item.

c. If you will be asking questions, testing performance, or manipulating the subject, have you submitted examples of the types of questions, types of tests, and types of manipulations or treatment conditions you will use? (Append copies of questionnaires, tests, interview protocols, or the methods sections of your grant proposal in answer to this item. If you have yet to pick the exact procedures you will be using, then attach specific, concrete examples of the types of test items, treatments, or questions you will use.) All materials must receive IRB approval prior to their use. YES__X NO___ N/A___

d. If you will be utilizing outside agencies to conduct your research, have you appended the appropriate authorization letters on the agencies’ letterheads indicating their willingness to cooperate with your research? YES___ NO___ N/A__X If not, please explain:

15. Will you be recording any private information, which is identifiable, about individual subjects?

YES ___ NO __X If you have answered YES, all Researchers listed in Item 1 of this form should read the following statement and sign below:

I understand that I am obligated to protect and keep confidential any identifiable, private information gathered about individual subjects through the conduct of my research; and I agree to keep such information confidential, unless I obtain the subject's express written permission to do otherwise.

Signed: ________N/A________________________________

________N/A________________________________

16. Will you be utilizing audiotapes or videotapes in your research? YES __X NO ____

If you answered YES, these tapes must be destroyed by a date certain, not to exceed three years from the completion of the research project. You will also need to inform the subject of your intent to utilize audiotape and/or videotape by including this information on the Informed Consent Form.

If the answer to Question 16 is YES:

a. Please describe in detail what you are doing and the purpose thereof :

Each focus group will be audiotaped. Participants will be informed of the taping and its purpose: to obtain a record of the comments made during the session so that a transcription of those comments can be accurate.

b. What will be the disposition of the recorded tapes after completion of your research? As soon as written transcripts are finished, tapes will be destroyed.

It is the policy of the IRB that research data will be destroyed no later than three years after termination of the research project. Under special circumstances the IRB will entertain individual applications to extend the period of retention of the data from a research project previously approved by the IRB. Such extensions will be granted on an annual basis. Any extension that may be granted is with the provision that, if a further annual extension is not sought or not approved by the IRB, such data will be destroyed prior to the expiration of the ensuing twelve months.

17. a. Describe any and all potential risks or discomfort that could result to human subjects as a result of this research other than the risk of disclosure: It is possible that discussing aspects of family life related to the provision of foster care might be uncomfortable for some participants. It is also possible that some participants will be reminded of incidents that caused them discomfort.

b. What safeguards will you employ to minimize these risks or discomfort? We will use an informed consent form that clearly identifies the risks. The PI will be able to provide resources to any participants who contact her (as indicated on the informed consent) with concerns; each participant will receive the PI’s business card for easy reference, as well as their copy of the informed consent form.

c. Are there any alternative ways to acquire your research information from human subjects that may avoid the risks identified above? YES ___ NO __X N/A ___ If YES, explain why the alternatives are not being used:

d. Could this information be obtained from animals or other laboratory models? YES ___ NO_X_

18. If your research involves any conceivable risk or discomfort to subjects, or if your subject pool includes any of the groups identified in Item 11a or any similarly vulnerable group, then you MUST obtain informed, written consent from your subjects and/or a legally responsible guardian (for children and persons incapable of informed consent). If the above is applicable, have you attached an Informed Consent Form signed and dated by all Researchers (and the Faculty Advisor if applicable)?

YES __X NO ___ N/A ___

19. If any of your potential human participants have a language other than English as their primary language of communication or do not have a good comprehension of English, are you providing a translation of the materials, including the Informed Consent Form, together with a “back translation” and Appendix F? YES ___ NO ___ N/A __X If not, please explain:

20. When you have completed your contact with the research participant, will there be a debriefing session? YES__X NO___ N/A___ If your answer is YES, please describe the procedure that you will utilize: A letter will be included with the movie ticket honorarium that summarizes the study and its goals and provides initial findings. A brief list of resources for dealing with sibling issues, children in foster care, and traumatic stress will also be enclosed.

21. To weigh the direct or potential benefit of this research against the inherent risk to the individual, the IRB requires brief and concise answers to the following questions:

a. What specific information will this activity provide, and what is the significance of that information? This activity will provide the first account of adult recollections of their experiences when non-related children were living in their family through foster care. It will suggest sources of individual differences with respect to children’s personal styles for further study and collect the first information about potential secondary traumatic stress. It will make an important methodological contribution in permitting a comparison of data through both qualitative and quantitative lenses.

b. Indicate what, if any, benefits may accrue to the human subjects involved: As our experience suggests, individuals who volunteer for focus groups tend to enjoy the experience. These participants are likely to enjoy sharing their stories with other individuals whose families provided foster care. All participants should benefit from their perceived contributions to social science.

c. Indicate what, if any, benefits may accrue to individuals who are not subjects, but who are similar: There is a national shortage of families available to provide foster care to children who need it. At the same time, there is a dearth of information that directly addresses the impact of providing care on children already existing in the family. The results of this study may be able to so, offering much needed guidance to families and social workers.

22. Are the subjects being offered any incentives such as academic credit, monetary compensation, or thing of value, including the chance to participate in a lottery for a prize? YES_X_ NO___ N/A___

If the answer is YES, please describe in detail: Two movie tickets will be mailed to participants at the end of their participation.

23. The following requirement must be completed prior to submitting your Single Project Approval application:

a. If you are a Faculty/Staff Researcher, have you attached a copy of certification (“Investigator 101” Course Module or NIH) for educational training on human subject research including ethics? YES_X_ NO___ N/A___ If not, please explain: N/A

b. If you are a Student Researcher, have you attached a copy of certification (“Investigator 101”

Course Module or NIH) or, in lieu of certificates, an Attestation of Student Competency in Human Subject Research and Ethics form signed by your Faculty Advisor?

YES_X_ NO___ N/A___ If not, please explain:

24. If your research project is being conducted at an institution that is covered by Health Insurance Portability and Accountability Act (HIPAA), have you followed the HIPAA procedures for that institution? YES____NO___ N/A_X_

It is understood that I will keep on file (for at least three years from the project completion date) and make available, on request by the IRB, copies of signed Informed Consent Forms of all subjects participating in this research.

It is understood that any medical procedures or medical treatments of human subjects for the purposes of the present research will be performed by, or under the supervision of, a person who is licensed or certified to perform that particular procedure.

It is understood that students at the University of Massachusetts Lowell should be initially recruited as research subjects by public announcement and not by personal solicitation.

It is understood that, if there are any changes, modifications, or revisions either in the research protocol, title, or names of Researchers, the IRB must be immediately notified and prior permission must be received before proceeding.

Graduate Students are advised that it is the policy of the University that all IRB requirements and stipulations must be fulfilled prior to graduation. Failure to complete such requirements and obligations will result in the withholding of a student’s diploma and transcripts.

Any project which exceeds a period of one year in duration must be reviewed and receive IRB approval prior to the beginning of the second and any successive years of the research project. It is the responsibility of the Principal Investigator to submit a Request for Continuing Review approximately two months prior to the expiration date of the existing approval and, also, to ensure that a Final Report is filed when the project is completed.

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I have read the entire Manual of Instructions and Procedures for Research Projects Involving Human Subjects. I have enclosed the following items from the list below, have checked off and initialed each item enclosed, and collated them in the order listed:

_X_ Original and copies of cover letter requesting review and specifying whether Exempt, Expedited or Full.

_X_ Original and copies of this form (Single Project Approval Statement).

_X_ If using an Informed Consent Form, original and copies signed and dated by the Researcher(s).

_X_ If a questionnaire is to be utilized, copies of the actual questions that will be used.

_X_ Copies of any recruitment advertising material; such as, flyers, newspaper advertisements, etc.

___ If translation is required, original and copies of the required version and “back translation” as well as Appendix F.

___ Original and copies of each official authorization from cooperating agencies or institutions on their

letterhead.

_X_ Copies of complete research proposal or project description, including Abstract and Methods sections.

_X_ If submitting for funding or you have already been approved for funding, complete copies of entire grant

application (or equivalent if it is not a grant; e.g. contract).

_X_ Copy of “Investigator 101” Course Module Certificate or NIH Certificate for educational training on human subject research. In the case of a student, copy of “Investigator 101” Course Module Certificate or NIH Certificate, or in lieu of certificates, an Attestation of Student Competency Form signed by the Faculty Advisor.

(Refer to sections of IRB Manual on Exempt, Expedited, and Full Review for number of copies that will be needed.)

In signing this statement, I certify to the accuracy and veracity of the information provided and I agree to abide by the University policies and procedures governing research involving human subjects, including all IRB decisions, conditions and requirements.

SIGNATURE OF PRINCIPAL INVESTIGATOR: DATE:

_______________________________________________ _____________________

SIGNATURE(S) OF CO-RESEARCHER(S): DATE:

_______________________________________________ _____________________

[Every individual listed as a Researcher must sign this form.]