Institutionalreview Board (IRB)

Cal Poly Pomona - Human Research Protections Program

InstitutionalReview Board (IRB)

Protocol Approval Application(version: December 4, 2008)

IRB principles: respect for persons, beneficence, justice

Cal Poly Pomona (CPP) is committed both to research in advancement of teaching and science and to the protection of the individuals involved. As part of the assurance filed with regulatory agencies including the Dept. of Health and Human Services and policies from others like the State of California, the University has designated a human subjects’ committee, called the Institutional Review Board or IRB, to review proposals for research involving living persons. This application,when submitted to the IRB, will be evaluated in terms of its compliance with ethical standards regarding the treatment of subjects (participants). The type of review – full, expedited, or exempt – will be determined by the IRB. While individual researchers are ultimately responsible for their practices, the IRB’s review is designed to provide objective input as additional protection for the subjects. Further, it is of benefit to those who could be held accountable for the research practices – the researchers and the University. All research conducted by students, faculty, and individuals sponsored by faculty must have prior IRB approval.

Hints and help:

Complete all sections in yellow about your research proposal. There are bluehighlighted linksto additional information.

Submit your completed application to the IRB office within the Office of Research and Graduate Studies (ORGS). E-mail it and any attachments such as surveys and recruiting flyers to . To facilitate tracking, please include in the file name 1) your last name and 2) one or two key words describing its subject.

Print off, sign, and mail this front page to the IRB at ORGS, Building 1, room 229.

Training in the conduct of human subject research is critical and investigators must demonstrate their knowledge and awareness through the completion of appropriate coursework. As of January 1, 2007, the IRB adopted the CITI “Course in The Protection of Human Research Subjects” ( as the primary means of training and as a requirement of protocol approval. Please provide documentation of your training with this application; you may be asked to pursue additional training appropriate to your proposal.

More information about the IRB at Cal Poly Pomona is available at the ORGS web page, There are sample protocols and consent forms, links to training materials, policies and procedures, etc.

For other assistance, contact the Compliance Associate within ORGS, Bruce W. Kennedy MS RLATG CMAR, at 909-869-4215 .

Investigator information / Primary investigator (faculty, student, etc.) / Others (your faculty advisor, co-investigators, etc.)
Name: / Business Student / Business Professor
Affiliation(college/dept): / Cal Poly Graduate Student/MBA program / Professor and Advisor/ Graduate Business Department
Phone contact(office or cell): / XXX-XXX-XXXX / (909) 869-XXX
Email contact: / /
Title of protocol: New Hire Orientation and Training(An example of an IRB protocol for the College ofBusiness Administration)
Date submitted: 1/15/2009 / _X__new ___amendment ___renewal; previous number:
Vulnerable subjects (risks)?: ___minors ___pregnant women ___medically sensitive ___other:

DECLARATION BY ALLPARTICIPANTS: This proposal is guided by the ethical principles regarding research involving human subjects as set forth in the Belmont Report. I/We agree to abide by the policies and procedures of the IRB at CPP, including obtaining appropriate training in human subject research for myself and those involved in its conduct. I/We will not initiate any research associated with this proposal on or off campus until authorized by the IRB. I/We will inform the IRB of any adverse events that occur or of a need to modify the study design. I/We understand that approval, when granted, is valid for up to one year and will submit a renewal for its continuation if needed.

(send this signed page to the IRB office) / SignatureDate
primary investigator: / Business Student14 January 2009 (to be completed as fresh signature)
all others, including advisors: / Business Professor14 January 2009 (to be completed as fresh signature)
IRB office use review type: full IRB (risk involved) expedited/designated review (minimum risk/harm) exempt PEIP NA
date rc’d: revised / assigned to: / training: PI others / approval date:
protocol #: / renewal date:
copies: chair file / final: signed ICF appr-memo e-mailed
This protocol has been reviewed and approved for conduct by the IRB, CaliforniaStatePolytechnicUniversity, Pomona.
David Adams PhD
Chair, IRB Date

I.DESCRIPTION OF THE RESEARCH PROJECT

Research is defined as “a systematic investigation including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge.” (45 CFR 46.102(d))

A.Purpose -- Why are you conducting this study? What are the objective(s) and goal(s)?

I am conducting this study as a part of the curriculum for my MBA. The purpose of the study is to find out generalizable knowledge about the impact of new hire orientation training. I would like to focus my research on discovering whether a formal orientation and training program would improve employee morale, increase productivity and contribute to departments working together as a team at my current place of employment. The question is whether a formal orientation and training program would boost the self-confidence of employees so that they feel empowered to carry out their duties effectively and efficiently. My hypothesis is that a new hire orientation training program will increase employee commitment to the organization and foster a spirit of teamwork among the employees.

The company stands to benefit the most from this research project. Both primary and secondary data will provide the company with the necessary information to evaluate its current new hire orientation program, to determine whether it meets the needs of the organization or whether it should be modified. The company has an extensive new hire orientation program but lacks statistical data for evaluating the effectiveness of its current program. This project will provide the company with the appropriate data, including statistical analysis, to evaluate its program and possibly justify hiring several employees dedicated to the training of new and existing employees.

B.State specifically the relationship of your proposed research to other,previous scientific investigations in the field. Provide full citations (APA style is a good format).

The purpose of orientation is to create a good first impression, relieve anxiety, set expectations, encourage socialization and team building, build identification with the employer and prevent problems. By fostering teamwork, retention of information, higher productivity and innovations, a good orientation program can help to lower turnover (1). For new employees to be successful, they need to be welcomed into the team and the organization (2). While rules and policies are important, it is understanding things like company values that help people feel like they are part of the organization they work for. This increases their sense of belonging and their commitment (3). Once the researcher has a clear idea of what kind of orientation program the organization wants to create, then the researcher should follow the four goals of:

1) making sure that the program provides employees with a positive, memorable first impression;

2) history, vision, mission and culture of the organization;

3) awareness of the company’s expectations; and

4) acquaint employees with their managers, supervisors and/or training coaches.

This study will attempt to show the relationship between a new hire orientation training program and employee commitment to the organization and a spirit of cooperation and teamwork fostered by the training. I plan to conduct exploratory research using secondary data to obtain information on new hire orientation programs and their impact upon the competence of new hires. I then plan to obtain primary data by surveying employees to find out how new hire orientation or the lack thereof has affected them.

I will also seek information pertaining to what key policies and procedures new employees must be aware of on their first day of employment. I am interested in finding out what positive experiences each department can provide for new employees that would make them feel valued by the organization. After interviewing the key personnel in the college, I will obtain primary data by surveying each employee through the use of questionnaires. Upon analyzing the data, I will present this information to Human Resources and make recommendations about their current new hire training orientation program.

References:

1. Starke, Alice M. HR Magaine. November 1996, Vol. 1, Pages 107-109.
2. Friedman, Laurie. T + D, November 2006, 60 no 11, 25, 27.
3. Hicks, Sheila, Peters, Mary, Smith, Marilyn. T + D, July 2006, 60 no 7, 43-5.

C.Methods -- Summarize the study design. Describe in detail all procedures to be performed with human subjects. What will be done? Includewhen and where the research will occur and who will conduct it. Define terms, abbreviations, and procedures for the understanding of the IRB reviewer.

The method of my study design is in the form of surveys. Each survey will be attached to an envelope to be used to seal the participants’ responses after completion. The participant can either return their responses through the interoffice mail or through the U.S. postal service. We will be placing the surveys along with the cover letter, consent forms and Starbucks card in the mailboxes of the employees that are located in the mailroom. We have no information as to the dept of each employee and thus I feel that I am randomly selecting employees within various departments of the company. I am funding the Starbucks cards.

II.AFFILIATIONS

These questions ask about how you are related to the institution and subjects where the research project is to be conducted. For example, you are a teacher using your students in a classroom setting as your subjects, or you work for the company where a marketing survey is to be conducted, or you have a financial interest in a product being tested, or you are working with a colleague in another country.

A.Are you collaborating with another group such as a school, community association, government agency, etc.? Is IRB approval necessary, or being obtained, elsewhere (domestically or internationally)? Is the project being sponsored or supported through a grant, contract, or other financial arrangement? Describe as appropriate.

I am not collaborating with another group. I work for the company where I will administer the survey.

B.Financial interest– Do you, as an investigator involved with the project, or any family member (spouse or dependent child) have a financial interest in this study? If yes, describe.

No

C.Are you a student? Is this project part of a classroom experience or a graduate program? Has your advisor/mentor reviewed your IRB application? Describe as appropriate.

Yes, I am a student and this project is part of my MBA graduate program. My advisor has reviewed my IRB application.

D.Do you have any pre-existing relationships of any kind with the subjects (participants) or institutions involved in conducting this study? If so, please describe them.

I am an employee at the company where I am conducting the survey. I am a graduate student at Cal Poly in their MBA program. I have obtained approval from the company to conduct the surveys on the grounds.

E.If you are not affiliated with Cal Poly Pomona, who is your sponsor on campus?

X not applicable name and phone number of sponsor: .

F.Though there may not be one, could there be the perception of a conflict of interest for either you, as the investigator, or for the subjects in this study? If so, how will you manage that?

No, I don’t think there would be a conflict of interest. If there is, I will contact another organization to conduct the study, where I am not employed. I am not in a position of authority at the company.

III.DATA COLLECTION

Collection methodologies include, but are not limited to: surveys, interviews, focus groups, oral histories, participant observation, observations of public behavior, research in public schools, and the analysis of existing data. Data include: survey sheets and questionnaires, biological samples, audio and video tapes, transcripts of verbal communication, photographs, paper and electronic records, previously collected (existing) information, etc.

A.What data about the subjects will be collected? How will it be coded or identified? Will social security numbers be used? What will become of the data at the end of the study (returned, destroyed, archived)?

How long they have worked for the company, their position title and whether they have participated in new hire orientation training. No identifying personal data will be collected. The data will be shredded upon completion of the project.

B.If applicable, have you submitted a copy of the survey or questionnaire to the IRB? Provide the URL for electronic surveys(it will be tested during IRB review; discard those data before ‘going live’).

X yes in developmentcomment: .

C.Who will have access to the data? To whom will the raw data be disclosed? How will the data be kept protected and secure? (per California law, CC 1798.24, the researcher must provide a plan sufficient to protect personal information from improper use and disclosures, including sufficient administrative, physical, and technical safeguards to protect personal information from reasonable anticipated threats to the security or confidentiality of the information.)

Only my advisor will have access to the data. The data will be kept in my home and then destroyed upon completion of the project.

D.Does the research project have provisionsor plans for the ongoing monitoring of data collection to ensure safety of subjects? If so, describe the plan.

No because it is only a five minute survey.

E.For studies involving medical records, explain compliance with the HIPAA privacy rule (Health Insurance Portability and Accountability Act) and disclosure of protected health information (PHI). (see for the “Experimental subject’s bill of rights – Medical research“ consent form if invasive procedures are to be performed)

X not applicable comment: .

IV.SUBJECTS

A human subject is a “living individual about whom an investigator (whether professional or student) conducting research obtains data through intervention or interaction with the individual or identifiable private information.” (Dept. of Health and Human Services)

A.How many subjects (or participants) will be involved in the research project? It is acceptable to have a range, but it must be a close approximation.

My goal is 80 participants.

B.Briefly describe the subject group(s).

Employees of the company.

C.What are the benefits, if any, to the subjects from participating?

The benefits are valuable information for the HR department on the impact of new hire orientation programs or the lack thereof. The results will determine whether the existing program needs to be modified to meet the needs of the employees.

D.Will the subjects be compensated? If yes, in what way (token of appreciation, money, gift, cash card, course credit, etc.)?

Starbucks gift card of $3. I will be personally funding the gift cards as a token gift of my appreciation.

E.Describe the control and/or comparison group(s), if any.

Not applicable

V.VULNERABLE SUBJECTS

When a subject has limitations, is coerced or manipulated, there is a loss of capability to volunteer, and the subject may be vulnerable. Research conducted with vulnerable subjects may require demonstration of training with that population.

A.Minors – Will children, minors, or wards be recruited for this research? If so, explain in what way. How will their assent to participate be obtained? Children in most circumstances are those less than 18 years of age. Research with children involving no greater than minimal risk requires the permission of one parent and the assent of the child (45 CFR 46.404).

No

B.Others – Explain research involving other vulnerable subjects such as prisoners, pregnant women, or culturally or medically vulnerable groups?

None

VI.POTENTIAL RISKS AND THEIR ASSESSMENT

Definition of risk: A potential harm, discomfort, or inconvenience associated with your research that a reasonable volunteer would be likely to consider significant in deciding whether or not to participate. Risks include legal, social, emotional, or psychological issues, physical or biological hazards, revealing an identity, damage to reputation, exposure of behavior or medical character, illness, injury, side effects of applied or consumed products,revealing or loss of private information, etc.

A.What are the risks? Discuss them, however minimal, as would explain them to the subjects.

The only risk that I see is asking the person’s title. This may be identifying information. I feel that the risk is very small because the company is very large and has thousands of employees. It would be difficult to identify employees because of the number of employees.

B.Describeyour procedures for protecting against or minimizing potential risks.

I have intentionally refrained from asking any questions about a participants age, race, gender etc. that may have potential risks.

C.Discuss why the risks are reasonable in relation to the anticipated benefits, if any, to the subjects and the importance of the knowledge that may reasonably be expected to risk confidentiality.

The company will have valuable information in order to review, implement or modify its existing new hire orientation program.

D.Describe in detail all procedures to assure the confidentiality or anonymity of subject information. (See the CPP IRB web page for a discussion of what is confidential and what is anonymous.)

I have excluded any questions that may reveal identifying information of the participant.

VII.RECRUITMENT

As applicable, attach copies of flyers, e-mail text, etc.,to be used for the recruitment of subjects in order to facilitate review by the IRB. Include the statement as follows: The Cal Poly Pomona Institutional Review Board has reviewed and approved for conduct this research involving human subjects under protocol YY - ### (meaning year and sequence number).

A.How will you recruit your subjects to participate in the study? Will translation of materials be necessary to other languages or to a different reading and comprehension level?

B.Describe the inclusion and exclusion criteria you will apply when enrolling subjects into the study.