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Stockton University

INSTITUTIONAL REVIEW BOARD

APPLICATION FOR PROTOCOL REVIEW

1.Date submitted: / 3/29/2017 / 2. Project Duration–Start Date: / 4/8/2017 / End Date: / 5/8/2017
* If your study extends past 1 year you will need to resubmit a new cover page (with signatures) to renew the application.
3. Title of Project: / An Exploration of Older Adults Needs for Quality Healthcare and Successful Aging
4. Project Director/Faculty Sponsor: / Megan Foti / School: / SHS
5. Funding Agency – is review required for outside funding? / YES / NO
As the principal investigator, my signature testifies that I pledge to conform to the following:
·  As one engaged in study utilizing human participants, I acknowledge the rights and welfare of the human participant involved.
·  I acknowledge my responsibility as an investigator to secure the informed consent of the participant by explaining the procedures, in so far as possible, and by describing the risks as weighed against the potential benefits of the investigation.
·  I assure the Review Board that all procedures performed under the project will be conducted in accordance with those Federal regulations and University policies which govern research involving human participants. Any deviation from the project (e.g., change in principal investigator, research methodology, participant recruitment procedures, and so on) will be submitted to the IRB using the Change in Research Form for IRB approval prior to implementation.
·  As the faculty sponsor, my signature testifies that I will oversee the research to its entirety, through to its termination. I understand that I am subject to random document checks. I will complete the CITI training and submit my certificates with the IRB application. If my data collection continues past the expiration date, I will renew my application.
Project Director/Faculty Sponsor
Megan Foti / 3/29/17
(typed/printed name) / (signature) / (date)
Co-Investigators
Stacy Cassel
(typed/printed name) / (signature) / (date)
Kristina Brenner
(typed/printed name) / (signature) / (date)
(typed/printed name) / (signature) / (date)
(typed/printed name) / (signature) / (date)
(typed/printed name) / (signature) / (date)
6. Review
This protocol for the use of human participants has been reviewed and approved by Stockton University Institutional Review Board for the Protection of Human Participants.
Exempt Review
(refer to Guidelines) Paragraph # / Expedited Review
(refer to Guidelines) Paragraph #
Citi Training Completed / Full Review
Citi Training Completed / Renewal *
*are there any changes to original project? Yes No
** Citi Training is Required ** / If yes, include description of changes
7. The research will be carried out in cooperation with the following institution(s): (the box below expands as needed)
N/A
8a. Categories of Human Subjects to be studied:
Proposed Age Group of Subjects (range): / 60-100 / Proposed # of Subjects: / 30 / # Males: / Unknown
8b. Is your research study targeting any of the following?:
Minors (If so, include Informed Consent Form for the guardian and an Assent Form for the child.) / Yes / No
Non-English Speaking (If so, include all documents including the Informed Consent Form, survey, questionnaire, recruitment flyer and any other materials in English and the second language). / Yes / No
Your Own Students (If so, you’ll need to be very clear about the benefits, risks, and inducements that will be given to students). / Yes / No
Mentally/Physically Challenged (Be sure to discuss how these participants will be protected. Include an Informed Consent form for the guardian if the participant is not considered his or her own guardian). / Yes / No
Minorities (Explain why you will target a specific group.) / Yes / No
Prisoners (If so, you’ll need to be very clear about the benefits, risks, and inducements that will be given to prisoners). / Yes / No
*Note: If any of these populations will be included in your study, fully explain the rationale for including these vulnerable populations and the ways in which they will be protected in section #13 below.
9. Conflict of Interest Statement:
Do any of the investigators have a direct or indirect personal financial interest or advisory relationship to the sponsor, manufacturer; or to the owner of the test materials?
Yes / No / Not Applicable
10. Type of Research Activity
At what location will this research be conducted? / Stockton University
- / Will there be an advertisement for subject recruitment? / Yes / No
If yes, it must also be submitted for approval in English and any other languages needed.
- / Is there a survey/questionnaire? / Yes / No
If yes, attach document(s):
- / Will data banks, data archives or medical record be used? / Yes / No
If yes, please indicate in #15 where the data will be stored behind two sets of lock and key.
- / Will there be filming or video recording of subjects: / Yes / No
If yes, please indicate in #15 where the data will be stored behind two sets of lock and key.
- / Will there be audio or voice recording of subjects? / Yes / No
If yes, please indicate in #15 where the data will be stored behind two sets of lock and key.
- / Will there be a subject inducement/payment? / Yes / No
If yes, dollar ($) amount:
- / Will a placebo be used in this study? / Yes / No
- / Will a subject control group be used? / Yes / No
If yes, (describe source, number, sex, age and special characteristics, if any)
STUDY DESIGN
In order to review applications in an adequate and timely way, the Committee wishes to see the highlights of your proposal. We encourage you to use bullet formatting whenever possible, while providing complete and accurate information.
Note: IRB review focuses on the scientific merit and adequacy of experimental design as well as on issues of safety and protection of anonymity or confidentiality.
**Please note all boxes below expand as needed**
11. Background and Purpose of Proposed Study: State briefly the reason for doing the study. What question(s) is it designed to answer and why is the question being asked? Please include some current literature and references to support this project. Please limit this to no more than 3 pages. Please do not attach research proposals, grant applications or any other documents in lieu of a brief literature review.
As the older adult population grows and lives longer, it is essential for professionals to promote health, wellbeing, and successful aging (Tkatch, Musich, MacLeod, Alsgaard, Hawkins, Yeh, 2016). Successful aging, sometimes referred to as positive or productive aging, has been a term used since the 1950’s. Although commonly used, there are no universally accepted definitions and determinants of successful aging and how to achieve it (Tovel & Karmel, 2014). Rowe and Kahn (2016) define successful aging by low probability of disease, high cognition and physical function, and being actively engaged in life. According to Kelly and Lazarus (2015) some common themes of successful aging include health, wisdom, financial stability, activity, and overall well-being. Other theorists value the subjective perception of well-being as a way to measure successful aging (Tovel & Karmel, 2014). Regardless of the definition, it is essential that professionals understand what is valuable to older adults so that they can continue to promote successful aging and overall well-being.
When older adults have the support to adapt to age-related limitations, they are able to participate in meaningful physical activities, which also substantially influences health (Jannsen & Stube, 2013). Traditionally interventions tend to be disease, risk, or behavior specific and cannot always be applied to a general population, such as aging adults (Tkatch et al, 2016). However, by better understanding the needs of the aging population, professionals can provide more general interventions that will serve many individuals. To gain a better understanding of the needs and opinions of older adults in the community, Stockton students will be providing questionnaires and completing interviews related to health promotion and successful aging. Students and faculty will use insight obtained from these methods for older adult programming. Therefore, the purpose of this study is to learn more about the needs of older adults as it relates to promoting successful aging, quality of life, and overall well-being.
References:
Janssen, S, Stube, J. (2013). Older adults perception of physical activity: A qualitative study. Occupational Therapy International, 21(2), 53-62. doi: 10.1002/oti.1361.
Kelly, G., Lazarus, J. (2015). Perceptions of successful aging. The International Journal of Aging and Human Development, 80(3), 233-247.
Rowe, J., Kahn, R. (2016). Successful aging. The Gerontologist, 37(4), 433-440. doi: 10.1093/geront/37.4.433.
Tkatch, S., Musich, S., MacLeod, K., Alsgaard, K., Hawkins, C., Yeh, R. (2016). Promoting successful aging: Population health management for older adults. The Gerontologist, 56(Supplemental 3), 137-138. doi: https://doi-org.ezproxy.stockton.edu/10.1093/geront/gnw162.552
Tovel, H. & Karmel, S. (2014). Maintaining successful aging: The role of coping patterns and resources. Journal of Happiness Studies, 15(2), 255-270.
12. Outline of Proposed Study: State briefly but precisely what is to be done, and the methods to be used. If the study involves the use of a questionnaire or structured interview, attach the text of such instruments as an appendix.
Purpose: The primary purpose of this proposed study is to is to identify the interests and needs of older adults as it relates to promoting successful aging, quality of life, and overall well-being.
Study Design: Older adults who will be attending an event at Stockton University titled Listening, Learning, Lunching: An Intergenerational Event in which participants will have an opportunity share their thoughts and experiences with Stockton University students. College students in various fields of study (including, but not limited to communication disorders, occupational therapy, nursing, social work, health sciences, psychology). Students will be asking questions during a luncheon interview as outlined in Appendix 2. Additionally, older adult guests will be asked to voluntarily fill out an informal, non-standardized questionnaire to gain further insight (Appendix 3).
Participants: This study consists of male and female older adults between the ages of 60 and 100 attend the SCOSA-hosted event at Stockton on April 8th. It is anticipated there will be 30 participants in this study.
Data Collection: Data will be collected via interview answers and feedback provided on the questionnaire as described above (Appendices 2 and 3).
Data Analysis: Researchers will use descriptive statistics to analyze the responses from the participant questionnaires. Content analysis will be done on scribed interview answers to determine if there are any consistent themes in the needs and interests of older adults. The findings from this study will be submitted for publication and shared at relevant professional venues.
13. Participants/Subjects: Explain your rationale for including vulnerable populations, if any, and ways they will be protected. The exclusion of women and minorities in research studies must be specifically justified. If certain populations are intentionally excluded in your study, this needs to be well-documented. Indicate on the rationale which justifies their exclusion. Indicate also the composition of control groups.
We will not be using vulnerable population(s) in this study. No populations are intentionally excluded.
14. Safety: State in adequate detail any anticipated physical, mental, or emotional risk to the subjects of this research activity and the degree of likelihood that it may occur. If no such risk is anticipated, state why this is so.
No anticipated physical, mental, or emotional risks are associated with this study. Participation in this study is voluntary, and individuals will not be penalized for refusing to participate. Additionally, participation in this study will have no influence on relationship with Stockton, SCOSA, or any other parties.
15. Confidentiality: Please indicate in adequate detail what measures will be taken to protect the confidentiality of the data to be obtained and the subject’s rights to privacy. You are required to store all data behind two (2) sets of lock and key. One set may be a password protected computer or locked cabinet. Please specify the location where your data will be securely stored.
All documents and information pertaining to this research study will be kept confidential in accordance with all applicable federal, state, and local laws and regulations. All data will be stored in a locked file cabinet in the researcher’s office when not in use by the researcher and the key will be retained by the researcher at all times. The information collected during participation in this study will be kept for three years. In addition, all the electronic data files will be password protected. Confidentiality will be protected by not requiring student to add their name to the evaluation forms.
16. Informed Consent: Complete and attach an appropriate consent form in 6th grade language utilizing the checklist on the web. Identify where (building and room #) the records containing the signed consent forms will be located.
Name those responsible for obtaining informed consent and their role in this project.
The research assistants listed above are responsible for distributing and collecting signed consents from all participants. All signed consents will be kept in a locked office (K154) at Stockton University.
Please refer to Appendix A for the informed consent form.