IRB Application

Research Involving Human Subjects

Please complete this application as thoroughly as possible. Your application will be reviewed by a committee of Andrews University Scholars, and if approved will be for one year. Beyond the one year you will be required to submit a continuation request. It is the IRB's responsibility to assign the level of review: exempt, expedited or full. It is your responsibility to accurately complete the form and supply the required documents. Should your application fall into the exempt status, you should expect a response from the IRB office within 2 weeks; a full review will require 4-6 weeks.

Additional information is available at http://www.andrews.edu/grad/OSR/IRB/
Please complete the following application.

1. Research Project

Title

Enter a title for your research

Will this research be conducted on the AU campus?

Yes No

If no, please indicate the location(s) of the study and attach an institutional consent letter that references the researcher's study.

Funding Type

Unfunded Internal Funding External Funding

Help Message

Sponsor/Source

Enter the source or sponsor for your funding

Grant Title

Award # / Charging String

If you do not know the funding/grant information, please obtain it from your department

2. Principal Researcher (PR)

Name

Phone Number Choose Home Cell Fax Temp - -

Email

Are You a Student?

Yes No

Are You a Student?

If so, please provide information about your faculty advisor below.

Research Advisor

Email

I certify that my research advisor has read and approved this application and attached documents.

Yes

3. Co-researchers

Name

Email

Name

Email

Name

Email

Name

Email

Name

Email

Add more Remove 1

4. Cooperating Institutions

Is this research being done in cooperation with any institutions, individuals or organizations not affiliated with AU?

Yes No

If yes, please list

Have you received IRB approval from another IRB for this study?

Yes No

If yes, please attach a copy of the IRB approval

If applicable, please provide the name(s) and address(es) or any officials authorized to access human subjects in cooperating institutions not affiliated with AU.

HASH(0x55efd78e2c60)

5. Participant Recruitment

Describe how participant recruitment will be performed. Include how and by whom potential participants are introduced to the study (check all boxes below that apply)

AU Directory Postings, Flyers Radio, TV E-mail Solicitation Web-based solicitation Participant Pool. Other

If you checked E-mail, indicate how the email addresses are obtained

If you checked Web-based, specify sites

If you checked Participant Pool, specify pool

Please attach any recruiting materials you plan to use and the text of e-mail or web-based solicitations you will use.

6. Participant Compensation and Costs

Are participants to be compensated for the study?

Yes No

If yes, what is the amount, source and type of funds?

Amount

Source

Type

Will participants who are students be offered class credit?

Yes No NA

Are other inducements planned to recruit participants?

Yes No

If yes, please describe.

Are there any costs to participants?

Yes No

If yes, please explain.

7. Confidentiality and Data Security

Will personal identifiers be collected?

Yes No

Will identifiers be translated to a code?

Yes No

Will recordings be made (audio, video)?

Yes No

If yes, please describe.

Who will have access to data (survey, questionnaires, recordings, interview records, etc)?

8. Conflict of Interest

Do you (or any individual who is associated with or responsible for the design, the conduct of or the reporting of this research) have an economic or financial interest in, or act as an officer or director for, any outside entity whose interests could reasonably appear to be affected by this research project:

Yes No

If yes, please provide detailed information to permit the IRB to determine if such involvement should be disclosed to potential research subjects.

9. Results

To whom will you present results (check all that apply)

Class Conference Published Article Other

If other, please specify:

10. Description of Research Subjects

If human subjects are involved, please check any of the following that apply.

Minors Prison inmates Mentally impaired Physically disabled Institutionalized residents Anyone unable to make informed decisions about participation Vulnerable or at-risk groups, e.g., poverty, pregnant women, substance abuse population

11. Risks

Are there any potential damage or adverse consequences to researcher, participants, or environment? These include physical, psychological, mental, social, or spiritual risks whether as part of the protocol or a remote possibility. Please check all that apply (Type of risk):

Physical harm Psychological harm Mental harm Social harm Spiritual harm

12. Content Sensitivity

Does your research address culturally or morally sensitive issues?

Yes No

If yes, please describe:

13. Please provide (type in or cut-and-paste) the following documentation in the boxes below:

Protocol(maximum 1500 words):

Surey instrument or interview protocol:

Institutional approval letter (if off AU campus):

Consent form (for interviews and focus groups):

Recruitment documents:

Principal Researcher's Assurance Statement for Using Human Subjects in Research

I certify that the information provided in this IRB application is complete and accurate.

I understand that as Principal Researcher, I have ultimate responsibility for the conduct of IRB approved studies, the ethical performance of protocols, the protection of the rights and welfare of human participants, and strict adherence to the study's protocol and any stipulation imposed by Andrews University Institutional Review Board.

I understand that it is my responsibility to ensure that the human participants' involvement as described in the funding proposal(s) is consistent in principle to that contained in the IRB application. I will submit modifications and / or changes to the IRB as necessary.

I agree to comply with all Andrews University's 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:

• Ensuring that protocols are conducted by qualified personnel following the approved IRB application;
• Implementing no changes in approved IRB applications without prior IRB approval in accordance with Andrews University policy (except in an emergency, if necessary to safeguard the well-being of a human participant, and will report to the IRB within 1 day of such change);
• Informing participants of any relevant new information regarding their participation in the research that becomes available;
• Promptly reporting to the IRB any new information involving risks to research participants, including reporting to the IRB, Data Safety and Monitoring Boards, sponsors and appropriate federal agencies any adverse experiences and all unanticipated problems involving risks to human subjects and to others that occur in the course of the research;
• Assuring that if unavailable to conduct research personally, as when on leave or vacation, arrangements will be made for another investigator to assume direct responsibility for studies and that modification requests will be made to the IRB;
• Promptly providing the IRB with any information requested relative to protocols;
• Promptly and completely complying with IRB decisions to suspend or withdraw approval for projects;
• Obtaining Continuing Review approval prior to the date the approval for a study expires (approval for the study will automatically expire after one year);
• Maintaining accurate and complete research records, including, but not limited to, all informed consent documents for 3 years from the date of study completion;
• Informing the Andrews University IRB of all locations in which human participants will be recruited for protocols and being responsible for obtaining and maintaining current IRB approvals/letters of cooperation when applicable;
• Complying with federal, state and local laws and regulations and sponsor terms and conditions, and
• Complying with Andrews University policies on the responsible conduct of research.

I have read and understand the above assurance statement for using human subjects in research, and commit to following the above guidelines.

Yes

(An auto message response will be generated acknowledging receipt of the application and will state: "Your application has been received and you will hear from the IRB committee regarding level of review within 7-10 days". In the case of student researchers, a simultaneous copy will be sent to the faculty advisor stating "If you do not respond to this email, the IRB will assume you have approved the application".

How To Create A Research PROTOCOL

Please note that your protocol should not be more than 3 pages-single spaced or 1500 words

The protocol is a statement of the researcher's project design and a description of his/her responsibilities toward the human subjects inolved in the research.

Every researcher planning to conduct research involving human subjects is required to submit a protocol describing the research to the I.R.B. The research protocol should contain the following elements:

1. A brief description of purpose and methods
2. A statement of the benefits of the research to the human subjects, if any, and of the benefits to humanity and/or scientific knowledge.
3. A detailed explanation of how the subjects will give informed consent.
4. A description of the risks and discomforts, if any, to the subjects. Such deleterious effects may be physical, psychological, or social. If your research involves more than minimal risks or greater than those encountered in daily life then, you must describe the means taken to minimize the deleterious effects.
5. Describe how you will ensure privacy of subjects and confidentiality of subjects. If any identification information will be released, specify the recipient of the information. Describe and explain how confidentiality of data will be maintained.

How To Create An INFORMED CONSENT FORM

Your informed Consent Form must be a separate document from your other documents.

Except as provided in sections 4, 5 and 6 below, informed consent shall be documented by the use of a written consent form approved by the I.R.B. and signed by the subject or the subjects' legally authorized representative. A copy shall be given to the person signing the form.

1. Content of the Written Informed Consent Form.
   The full informed consent form must include:
   1. A statement that the activity involves research and a description of where the research activity will occur.
   2. An explanation of the scope, aims, and purposes of he research, and the procedures to be followed (including identification of any treatments or procedures which are experimental) and the nature of the expected duration of the subjects' participation.
   3. A description of any reasonably foreseeable benefits, if any, to the subjects or others that may result from the research.
   4. A disclosure of appropriate alternative procedures or course of treatment (in instances where therapeutic procedures are involved), if any that might be advantageous to the subjects.
   5. A statement describing the extent to which confidentiality or records identifying the subjects will be maintained except in unusual cases.
   6. An offer to answer any questions the subjects may have about the research, the subject's rights or related matters, and the name of the person (together with address and telephone number) to whom the subjects may direct questions or must report an injury.
   7. A Statement that participation is voluntary, that refusal to participate involves no penalty or loss of benefit to which the subjects are otherwise entitled, and that the subjects may discontinue participation at any time without penalty or loss to which the subjects are otherwise entitled if they had completed their participation in the research.
   8. For research which may involve more than minimal risk of injury the subject should be informed of the following statement which must appear in the consent form: (to be modified for off-campus research)
      "In the unlikely event of injury resulting form this research, Andrews University is not able to offer financial compensation nor to absorb the costs of medical treatment. However, assistance will be provided to research subjects in obtaining emergency treatment and professional services that are available to the community generally at nearby facilities. My signature below acknowledges my consent to voluntarily participate in this research project. Such participation does o release the investigator(s), sponsor(s) or granting agency(ies) from their professional and ethical responsibility to me."
   9. A space for the dated signatures of the subject, the principal investigator, and a witness. In the case of a minor (the child must also sign if seven years of age or older) or a person unable to sign, a second authorizing signature is required from the parent, guardian, or other responsible person. The relationship must be specified.
2. Format of the Written Consent Form
   1. The consent form should clearly identify the relationship of the researcher to Andrews University. The name of Andrews University should appear centered at the top of the consent form together with the name of the department with which the researcher is affiliated. In cases where an anonymously returned questionnaire substitutes as a form of implied consent, the cover letter accompanying the questionnaire should clearly identify how the research is connected with Andrews University and one of its academic departments.
   2. The consent from should clearly indicate the name, address, and phone number of the investigator and an advisor or impartial third party whom the research subject may contact for additional information if desired.
   3. Places for the dated signatures of the subject (and/or parent/guardian, if applicable), investigator, and witness should be included at the bottom of the consent form.
3. Retention of the Signed Informed Consent Form.
   1. A copy of the Informed Consent Form should be returned to the subject or the person legally appointed to sign the Informed Consent Form to retain for his/her review.
   2. The responsibility for retaining signed copies of the Informed Consent Form lies with the principal investigator(s). These Informed Consent Forms should be kept in a secure depository along with the researcher's other records for a reasonable amount of time (not normally to exceed three years).
4. Use of Alternate and/or Simplified Consent Forms.
   Certain situations may justify the use of alternate and/or simplified consent forms. However, in all cases the investigator must demonstrate how the anonymity or confidentiality of the subject and his/her voluntary participation in the project t will be assured and maintained.
   1. Oral Instructions Read to a Group. In the case of no risk or minimal risk research where instructions are read to a group of subjects (e.g. a questionnaire passed out in a classroom setting, with prior written authorization of the instructor), a short form to document the oral instructions presented to the subjects may be used. A witness who heard the oral instructions read to the group must co-sign the short form along with the researcher. A written copy of the oral instructions that are to be read to the group must be submitted with the protocol. The items listed in Section 1 above should be included in the oral instructions.
      Research using surveys or questionnaires and dealing with sensitive areas of the respondent's own behavior (illegal conduct, drug/alcohol use, sexual behavior, etc. See Appendix A, Exempt Review, item 4) require special consideration. Although the purpose and use of surveys or questionnaires in such research may be explained in a classroom setting (with prior documented permission of the instructor(s) involved), requesting respondents to actually complete survey instruments in the classroom setting is not appropriate. Alternative methods of collecting forms completed at the discretion of the respondent and which thus insure the respondent's anonymity should be employed.
   2. Anonymous Surveys or Questionnaires. In the case of risk or minimal risk research involving the use of surveys or questionnaires which are distributed individually and returned anonymously, the cover letter explaining the purposes and procedures of the research project may substitute for the consent form. Such a cover letter must be submitted with the protocol and should contain reference to the items mentioned in section 1 above. It should state in the cover letter as well as on the survey form itself that the return of the survey or questionnaire serves as a form of implied consent.
   3. Simplified Oral Interviews. Investigators conducting simple oral interviews, the content of which qualifies as exempt from review, may submit an alternate form of written documentation in place of an informed consent form. Such documentation should describe how the interwar will explain his/her research to the interviewee and how the researcher is prepared to insure the interviewee's confidentiality and his/her right to refuse participation in the interview.
      In all cases, the researcher is responsible for the filing of all proof of compliance with the above procedures and to keep them for a period of three years
5. Waving of Signed Consent Documentation. The I.R.B. may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds that either of the following conditions exists:
   1. The only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether he/she wants documentation linking the subject with the research, and the subject's wishes will govern.
   2. The research presents no more than minimal risk of harm to subjects and involves no procedures for which written consent is normally required outside of the research context.
6. Waving the Consent Process.
   The I.R.B. may under certain special circumstances approve a consent procedure which does not include or which alters some or all of the elements motioned above or may waive the requirement to obtain consent provided the Board verifies and documents each of the following items:
   1. The research involves no more than minimal risk to the subjects
   2. The waiver or alteration of consent will not adversely affect the rights and welfare of the subjects.
   3. The research could not practicably be carried out without the waiver or alteration.
   4. When ever appropriate, the subjects will be provided with additional pertinent information after participation.
7. Consent form Attending Physician and/or Other Health Care Professionals.
   In situations where an individual is currently being treated/evaluated by a physician and/or other health care professional for a condition related to the objective of the research study, the researcher is required to obtain the consent of the physician and/or health care professional prior to involving such research subjects in the study.
   

How To Create An INSTITUTIONAL CONSENT LETTER

1. It should be written on an Institution's/Company's letterhead;
2. It should mention the researcher/investigator by name;
3. It should mention the title of the study for which institutional consent is being given;
4. It should be dated;
5. It should include the name and the title/office of the individual within the institution providing the consent;
6. It should be signed.
7. It should be addressed to:

Institutional Review Board
Andrews University
Berrien Springs, MI 49104-0355

Or faxed to:
9269) 471-6246 (Attention: I.R.B.)

1. E-mail Letters:
   1. Letters may be sent as scanned e-mail attachments.

Creating A SURVEY INSTRUMENT (Questionnaire)

Your Survey Instrument must be a separate document from your other documents.

1. If your research falls under the category: 'Exempt from Full Review', your research might be of a nature that allows you to opt to go with an Informed Consent Letter (please see layout samples). If you do opt to do this, please be sure that you include the following statement near the beginning of your survey instrument, before the fist application:
   
   I have (received/read/had the Informed Consent Letter read to me)* and recognize that by completing and returning this survey, that I am giving my informed consent to participate. *Please adjust the wording in parenthesis to meet your needs.
   
   
2. If your research involves face to face interviews, and your questions are open-ended, please provide the head-off questions and a brief statement assuring the Institutional Review Board that any further questions arising from the initial questions will remain within the framework of the research approval that you seek.
3. Otherwise, your whole survey instrument must reflect in both content and layout the survey that will be received by your human subjects.
4. Survey questions need to be clear and well-constructed and should result in answers that will give you reliable results, especially in instances where there is a diversity of respondents.
5. Please be sure that spelling and grammar reflect high standard that honors both you and Andrews University.

If the survey is conducted in a language other than English, please provide the Institutional Review Board with a copy of the alternate language original and an accurate English translation. This also applies to the Informed Consent Form/letter.