Research Assignment: IRB Proposal This is connected to previous assignments. This wil connect to my final proposal. Use your research to complete the IRB Proposal. Please complete and upload your inf

MC IRB Protocol No.: ________________________

Date of IRB Review: ________________________

For office use only

2

Check the proposed research category:

Category I (Administrative Review) Email the application packet to [email protected]

Category II (Expedited Review) Email the application packet to [email protected]

Category III (Full Review) Email the application packet to [email protected]

Check all of the appropriate boxes for funding sources for this research. Include pending funding source(s).

Federal Grant

Faculty Development Grant

Personal Funds

Department

Gift

Commercial - company name:

Other: None

Attach the research proposal/protocol that was sent to the agency, committee, or sponsor for peer-review of scientific merit if applicable.

If the participants are to be recruited from an institution or organization (e.g., hospital, social service agency, prison, school, etc.) or from a privately owned business (private practice, local sports gym, etc.), documentation of permission from the institution must be submitted to the committee before final approval can be given. Letters of permission (on organization’s letterhead) from a senior office of the institution, organization, or business should authorize the investigator(s) to contact potential participants, to use the facilities, or access the records of that entity.

If this project is being reviewed by any other human participants research review group (e.g., hospital institutional review board), a copy of the approval of that institutional must be attached or a statement of the status of the review must be noted.

1. Briefly state the problem, the present knowledge relevant to it, and the aims and significance of the proposed research. Cite appropriate literature.

Differences between genders have been studied through multiple topics. Most recently, gender differences based on time management and the levels of stress variance between females and males have become prominent. According to a study at Buffalo University, 25 % of students become chronic procrastinators by the time they reach college. Academic futures are the concern of the students, yet behaviors such as academic failure, lack of motivation, and unsure career paths deter college level students from completing assignments by the due dates or deadlines (Heibutzki, 2009). In addition to procrastination increasing, the levels of stress have also increased. Time management is planning one’s time effectively in order to be productive at one’s greatest potential (Woods, 2005). When students’ lack time management skills, their stress increases, which affects their health and well-being.

Stress has been linked to poor time management skills through empirical studies and literature. Studying habits, for example, is one. In one study, in-coming freshmen were asked on their study habits; findings were as follows: Men reported having poorer studying habits than females. Furthermore, males reported to have a higher dislike towards reading than females. With the rate of more females in college than males, in the United States specifically, females also react more positively to studying for all their classes, even the ones they dislike, more than males (Sigler, 2012). Previous studies have used broad surveys across community colleges and universities which lead to the conclusions that women have better time management skills, yet have a higher stress levels.

The empirical study that will be conducted will be surveying Mercy College Students in Dobbs Ferry in order to investigate the relationship between gender and time management skills. Stress will also be measured in order to see if stress can be linked to these differences. It is hypothesized that females utilize their stress in order to motivate themselves through tasks, while males find alternate routes to alleviate their stress.

Works Cited

Heibutzki, R. (2009). How Lack of Time Management Affects College Students. Seattle PI, Retrieved October 19, 2015.

Sigler, E. (2012). Male academic performance in college: The possible role of study strategies. Psychology of Men & Masculinity, 13, 227-241.

Tremayne, K. (2014). Time Management Survey. My Time Management, Retrieved October 26, 2015.

Weinstein, C. (1987). LASSI (Learning and Study Strategies Inventory). H&H Publising Company, INC. Retrieved October 26, 2015.

Woods, C. (2005). What is Time Management? Study.com,  Retrieved October 19, 2015.

1. Describe the tasks/tests or procedures participants will be asked to complete.

A study on time management and stress will be conducted with a convenience sample of at least 50 Mercy College students. An anonymous survey questionnaire will be given to the participants with ten closed ended questions and one open ended question. Participants will be asked to read the waiver form and complete the survey. This survey will take five to ten minutes to complete. In early November, the study will be given to Mercy College students’ prior to class.

1. If participants will come in contact with any mechanical, electrical or other equipment, the form entitled Utilizing Research Equipment with Human Participants must be completed by the investigator and a verified safety check.

N/A

1. Participant Population

   1. Anticipated number: Male 25 Female 25 Total 50

   2. Age Range (check all that apply):

0 - 7 yrs. (submit parental permission form)

8 - 17 yrs. (submit child's assent form, parental permission form)

18 - 64 yrs. (submit consent form)

65+ yrs. (submit consent form)

1. 1. Source/type of participants: (check all that apply)

Mercy College Employees

Mercy College Students

Inpatients or Outpatients

Community Volunteers

Other: Specify

State any relationship (past or present) the researcher may have with the potential participants:

The researcher is a Mercy College student and participants may be familiar with her as a classmate.

1. 1. Location of participants during research data collection (check all that apply):

Participant’s home

Mercy College locations: specify Dobbs Ferry

Local hospitals: specify

Community settings: specify

Other institutions: specify

Elementary schools: specify

Secondary schools: specify

Other: specify

1. 1. Describe populations to be excluded from the research. NONE

1. 1. Special populations to be included in the research (check all that apply):

minors under age 18 pregnant women

fetus/fetal tissue prisoners

economically disadvantaged

other: specify

1. 1. Provide rationale for using special populations.

The groups listed in (f) above are considered “vulnerable” or require special consideration by the federal regulatory agencies and by the IRB.

1. Recruitment Procedures

   1. 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, email, electronic, TV, or Internet).

As a training study, students will be selected from other social science classes arranged by the professor. (Classes taught by Professor Martin Kelly, Mary Kraetzer, Ellen Sperber, or Kevin Kulik). Researcher will contact social science faculty.

1. 1. Initial Contact. Student investigator will approach classmates before class starts.

   2. List criteria for inclusion and exclusion of participants in this study.

      1. Inclusion: All students present that are 18 years old or older and are Mercy College students will be asked to participate.

      2. Exclusion: People under 18 years old and non- Mercy College students.

      3. How will the inclusion/exclusion criteria be assessed and by whom?

The primary investigator will review the inclusion/exclusion criteria.

1. 1. Will participants receive incentives before or rewards after the study (e.g., academic credit, money)? If yes, explain. (Note: this information must be outlined in the consent document.)

Yes No

1. 1. Will the participants be charged for research-related procedures? For example, will participants be charged for extra tests/services related to the research? If yes, explain charges, including estimated amounts. Will there be financial coverage for the extra costs? If yes, explain. (Note: this

information must be included in the consent document.) Yes No

1. Identify the risks (current and potential) and describe the expected frequency, degree of severity, and potential reversibility.

This study involves minimal risk.

1. Does the research involve (check all that apply):

administration of drugs, and chemical or biological agents administration of physical stimuli changes in diet or exercise use of private records (medical or educational records) possible invasion of privacy of participant or family

deprivation of physiological requirements such as nutrition or sleep

manipulation of psychological or social variables such as sensory deprivation, social isolation,

psychological stresses

the collection of personal or sensitive information in surveys or interviews

use of a deceptive technique (If use of deception is part of the experimental 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

1. Describe the precautions taken to minimize risk:

Participants can withdraw at any time.

1. Care of participants in case of an accident: Describe the provisions that have been made for the care of the participant in the event of an accident or complication related to the research procedure.

Students that state they feel distressed by their participation will be referred to Mercy College counseling center.

1. Why are the risks and inconveniences are mentioned above reasonable? What is the expected scientific yield from the project? The results will provide a deeper understanding of college students, differences between gender, and reasons procrastination has increased.

2. Benefits of participation:

Increased knowledge of social science research procedures.

1. Describe provisions made to maintain confidentiality of data. Only the researcher will have access to the data. Data will be coded and analyzed by myself. The coding will relate to Claire E. Weinstein’s LASSI questionnaire. Data will be store in a locked file cabinet in the office of the course instructor, Dr. Kraetzer. Study participants will be informed of this procedure in the Cover Letter.

2. Where will the data be kept and for how long? How will audio and video tapes be disposed of?
   Data will be locked in the office of Dr. Kraetzer until the end of the academic school year 2015-2016.

3. Will the research data and information be part of the medical chart, academic record, or other permanent record? (Explain here and in the consent form.) Yes No

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. The forms should be jargon-free. Foreign language versions should be prepared for any applicable research.

1. Capacity to consent. Will all adult participants have the capacity to give informed consent? Yes No

If not, 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, clinical 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.

1. 1. Is the informed consent document attached? Yes No

1. How will participants’ understanding be assessed? What questions will be asked to assess the participants’ understanding; will there be written responses; will understanding be assessed at other points in time? Participants’ understanding will be assessed through answering the survey. Using SPSS, a cross tabulation will be used to analyze which gender procrastinates more, and what distracts each gender. The data will assessed across a few months.

1. In relation to the actual data gathering, when and where will consent be discussed and documentation obtained, for example, immediately prior to the data collection or several days before? Consent will be gathered immediately prior to the survey. The form will be given first and participants will be asked to read the form. If agree to the research, a survey will be handed to them after.

2. Will the investigator(s) be securing all of the informed consents? Yes No

1. Are you requesting Waiver or Alteration of Informed Consent? Yes No

An IRB may approve a consent which does not include, or alters, some or all of the elements of informed consent (e.g., oral consent). Provide justifications for the following questions for requesting a waiver of written informed consent – answer a – d only if you are requesting a waiver.

1. 1. Why does the proposed research present no more than minimal risk to the participants? The study is of a non-sensitive topic of Time Management and Stress. Data will be collected using paper anonymous questionnaires which will be returned to the investigator in a box.

1. 1. Why will a waiver of informed consent not adversely affect the rights and welfare of participants?

Time Management is interesting but not sensitive.

1. 1. Why is it impracticable to carry out the research without a waiver or alteration of informed consent?

Having the name of respondent offers less protection to the respondent than an anonymous questionnaire with a cover letter, does.

1. 1. How will pertinent information be provided to the participants, if appropriate, at a later date? No plan to provide information.

Even if waiver of written informed consent is granted, you may be required to obtain verbal permission which reflects elements of the written consent (if appropriate). Please specify below the information to be read/given to the research participants.

1. Describe the investigator(s) training and experience to conduct the research

All students have participated in the NIH Ethics Course and have received certification for completing course as well as discussion of issues in class.

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 Mercy College 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 MC IRB certified protocol,

• No changes will be made in the protocol or consent form until approved by the MC IRB, • Legally effective informed consent will be obtained from human participants if applicable, and

• Adverse events will be reported to the MC IRB in a timely manner.

I have completed the required educational program on ethical principles and regulatory requirements.

I further certify that the proposed research is not currently underway and will not begin until approval has been obtained.

__Stephanie M. Cope_________ __11/18/15_

Principal Investigator Date

By my signature as 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 insure that the investigator will promptly report significant or untoward adverse effects to the MC 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 MC IRB by letter of such arrangements, and

• I have insured that the investigator completed the required educational program on ethical principles and regulatory requirements.

I further certify that the proposed research is not currently underway and will not begin until approval has been obtained.

_____________________________________________________________________________ ________________________

Faculty Sponsor* (if PI is a student or a fellow) Date

*The faculty sponsor must be a member of the MC faculty. The faculty member is considered the responsible party for legal and ethical performance of the project.

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