Initial Application

To obtain initial Institutional Review Board for Protection of Human Participants approval for research with human participants fill out the IRBPHP Initial Application.

The IRBPHP Initial Application is found in Appendix A, and in a separate link for interactive completion https://www.dominican.edu/directory/academic-affairs/institutional-review-board-irb. It can be completed online or printed and scanned for electronic submission.

The following is a detailed description of the requirements for successfully completing the initial application form:

8.1 Application Information

This section identifies who you are, your school and department, your local and home address, your email and phone number, and names of co-investigators if applicable.

8.2 Faculty Advisor Information

This section identifies your faculty advisor’s name and contact information for your research project.

8.3 Project Information

This section requests the title and duration of your research project.

8.4 Background and Rationale

This is a summary of your research project. It is NOT a review of the literature. This section should focus on describing the nature of the research problem and purpose of current study. It should be concise, and provide clear and compelling justification as to why the research is important. This section may be no more that 300 words. All cited references should be included immediately following the summary.

8.5 Description of Sample

The description of sample should include:

detailed description of sample including age, gender, and ethnicity;
special characteristics of participant population (e.g., prisoners, children, dependent adults);
describe any dual relationships applicant has with the participants or the institution in which the participants work or attend school (e.g. Is applicant an employee or manager? Is applicant a member of the same community?) (See Appendices I, J, K for model letters)

8.6 Recruitment Procedure

The recruitment procedure section should include how the researcher will solicit participation from participants (e.g., face-to-face, phone contact, mail) and provide copies of memos, email messages, facebook or other social media postings, cover letters, flyers, etc. that will be used to recruit potential participants. If recruiting through social media it should be stated clearly that participants must be 18 or older.

method researcher is using to obtain access to participants (e.g., co-workers, students in classroom, mailing lists);
if participants are employees of a corporation, students in a particular school or some other type of captive audience (e.g. preschool students, prisoners,) provide a letter from appropriate member of the institutional management indicating awareness and support of the research project;

if participants are persons for whom English is not their primary language and/or who are not proficient in reading speaking, and writing English at the 8^th grade level, the applicant must provide documentation that written correspondence, consent documents, and measurement instruments will be provided to the participant in his or her preferred language (include copies of the translated documents as well as qualifications of the translator of the documents along with a signed statement from the translator that the non-English versions of the written documents are equivalent to the English versions)

8.7 Participant Consent Process

8.7.1 Human Participants’ Rights

Individuals who agree to participate in a research study have certain rights. These rights are outlined in Appendix F. It is the responsibility of each researcher to ensure that every participant contacted and recruited to participate in a research project is guaranteed these rights. It should be concise, and provide clear and compelling justification as to why the research is important. A copy of the Research Participants Bill of Rights must be provided at time of recruitment. For research that involves no more than minimal risk it is up to the researcher and her/his advisor to determine whether to provide a copy of the document to participants.

8.7.2 Informed Consent Forms Needed

Informed Consent Forms must be signed. Extra scrutiny will be paid to the consent process where the research involves

participants younger than 18 years of age, mentally disabled, or prison inmates or other institutionalized persons;
face-too-face interviewing between researcher and participant or any videotaping of the participant;
“moderate or high risk” involving sensitive or emotional issues or any possible physical risk to the participant;
situations where participant is potentially identifiable on the basis of demographic information. (See sample letters Appendix G, H, I, J, K).

If participants are younger than 18 years of age (or unable to consent for themselves),

Describe the procedure for obtaining parental (guardian) consent
- Include a copy of the Parental/Guardian Consent Form (see Appendix H).

In addition to parental (guardian) consent, describe the procedure for obtaining child assent
- Include a copy of the Child Assent Form (see Appendices I and J ) or Script (see Appendix K).

Documentation of assent by children who are deemed capable can be documented via:

Assent form signed by child (see Appendices I and J), retained with the study records.
Assent form signed by person conducting the assent discussion (primary investigator or research assistant), retained with the study records.
Verification of verbal assent can be asserted by the person conducting the assent discussion (primary investigator or research assistant) via signature added to parental permission/proxy consent form (Appendix H) or assent script (Appendix K) and retained with the study records.

Additional Guidelines:

If project involves a survey or questionnaire that will be distributed and collected through mail or hand-delivered and hand-collected, submit a copy of the Consent Cover Letter that will accompany the survey or questionnaire.
If project involves telephone interview provide a copy of the introductory letter sent to participants and describe the verbal protocol used at the start of the telephone interview for purposes of obtaining informed consent.
If project involves a survey or questionnaire given to a large group of people simultaneously (e.g. a classroom) provide a copy of the Consent Cover Letter that will accompany the survey or questionnaire or describe the verbal protocol used prior to distributing the survey or questionnaire.
If it is not possible to obtain informed consent provide rationale for lack of informed consent and describe methods for ensuring voluntary participation of participants (e.g. implied consent when one completes a questionnaire).
An informed consent checklist may be found at: http://www.hhs.gov/ohrp/policy/consentckls.html

8.7.3 Informed Consent Forms Not Needed

Informed consent forms are not needed for anonymous survey research with adults (18 or over). This research poses minimal risk to participants and a returned questionnaire is considered as evidence of implied consent. If informed consent forms are not required it must clearly be stated in the “Participant Consent” section of the application and questionnaires must be returned in a manner that no recognizable connection may be made between a questionnaire and a participant or be clear that participants are identifiable and return is in a manner that will insure confidentiality.

8.8 Procedures

Describe in detail what your participants will experience as a result of their participation in the research including all experimental activities or manipulations (e.g. treatments, exposure to music or film, stress tests), completion of surveys or questionnaires, telephone contacts, etc. Include copies of all written materials that participants will see including surveys/tools, questionnaires/tests, interview questions, etc. If the researcher is using a previously developed test, permission to use test must be documented (appendix L) or a statement included that the tool is in public domain. If a researcher plans to use test scores or other data about human participants that has been previously collected, the researcher should be aware that use of that individual’s standardized test scores or grades without a participant’s permission is prohibited by FERPA (Family Educational Rights and Privacy Act of 1974.) Research studies that use such data must include a signed consent document unless the person’s name is not included with the test score and it is anonymous and confidential unless proxy consent will be obtained for the inclusion of minors. All anonymous surveys should include a statement indicating that participants must be 18 or older.

8.9 Potential Risks to Participants

All research projects involve some potential risks to participants. Describe in detail all potential risks to participants including such risks as emotional discomfort, boredom, frustration, loss of confidentiality, as well as any risks inherent in the particular research project. This section must be addressed or the researcher will be asked to resubmit the proposal.

8.10 Minimization of Potential Risk

Describe the ways in which the potential risks described in the Potential Risks to Participants section above will be minimized by the researcher and any debriefing procedure to be used with participants who experience more than minimal risk.

8.11 Potential Benefits to Participants

Describe in detail all potential benefits to individual participants. While you may include benefits of the research, the focus here is on the participant. If there are no benefits, state this fact but most research has some benefit to the participant and should be carefully considered.

8.12 Costs to the Participants

Describe any costs to participants such as monetary fees, costs of treatment, medications, psychological testing, cost of transportation, as well as costs in terms of time and effort.

8.13 Reimbursement or Compensation to Participants

Describe completely and provide a rationale for any reimbursements or compensations to be made to participants in response to their participation in the research.

8.14 Confidentiality of Records

State whether the data will be anonymous or not anonymous. If data will not be anonymous, describe how the data will be kept confidential. Indicate how raw data and computerized data will be stored as well as a method for keeping participant’s identity separate from participant’s data. Maintaining confidentiality of information collected from research participants means that only the investigator(s) or individuals of the research team can identify the responses of individual subjects; however, the researchers must make every effort to prevent anyone outside of the project from connecting individual subjects with their responses. (for example face to face experiments, interviews, oral histories). Providing anonymity of information collected from research participants means that either the project does not collect identifying information of individual subjects (e.g., name, address, Email address, etc.), or the project cannot link individual responses with participants’ identities. Collecting identifying information of research participants is most often unnecessary. (for example, survey research, online research using online survey platforms (e.g. survey monkey).

8.15 Signature Page

All applications must be submitted with a scanned copy of the Signature Page, available at: https://www.dominican.edu/directory/academic-affairs/institutional-review-board-irb. Applications will not be reviewed without the completed signature page.

Applicant must sign and date the Signature Page. When the applicant is a student, the faculty advisor must also sign and date the Signature Page. The Category of Review (i.e. Exempt, Expedited or Full Board review) as explained in section 5.3 of this Handbook is determined by the faculty advisor or faculty researcher.

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