Tips for Submission

Tips for Submission
The IRB Application Form should be prepared so that the reviewers can understand your research plan. Information should be brief and concise, but complete.

Tips for Submission

The materials submitted to the IRB for review must demonstrate the researcher understands federal regulations and university policies regarding the protection of human subjects. The researcher is responsible for protecting humans used as subjects in the study. These tips for submission will ensure your IRB application is complete:

If the subjects used in your research are children, prisoners, mentally disabled persons, economically or educationally disadvantaged persons, pregnant women, fetuses, (or other vulnerable persons such as victims of abuse, HIV positive persons), your application should thoroughly describe plans for obtaining informed consent and/or assent.

If a written consent form is required of your research subjects, follow the guidelines for informed consent, and submit a copy of the Consent Form with your application.

If an initial deception is involved in the research procedure, explain what information will be withheld from subjects, and why incomplete disclosure is justified. Also, describe the debriefing procedure to be used.

If the research subjects are to receive payment or other compensation for participation, describe the compensation. If the participants are students and course credit is given as compensation, list alternative ways for students to receive course credit.

If access to research subjects is gained through cooperating institutions not under the control of the university (for example, elementary or secondary schools, child care or nursing home facilities), identify the institutions, and describe the method for ensuring that the authorized official of that institution is informed of the study. You should provide a letter from an authorized official on their letterhead of the cooperating institution (including title, official signature, and telephone number of the authorized official). If such participants are placed at more than minimal risk, documentation of the institution’s approval will be required.

Projects that place participants at more than minimal risk require the following additional information:

Provide the basis for the researcher's assessment of benefits/risks, and precautions to be taken to minimize risks. (Citation of relevant prior work is helpful.)

Attach a copy of the Consent Form that will be used and any written or oral scripts of explanation to be given to the participants.

If children, 5-18 years of age, are the subjects of your research, explain the method to be used in obtaining assent and include a copy of the Assent Form with your application. Note: Children should be cognitively capable of giving assent (normally, beginning at 5 years of age). Assent from children does not eliminate the need for obtaining consent from the parents and/or legal guardians.

If the research presents risks of physical injury, the Consent Form must include a statement as to whether any compensation or medical treatment is available if injury occurs, and where further information may be obtained. Note: UNK is not responsible for emergency or other medical care relating to research activities.

If drugs are to be administered, identify the drug, indicate whether or not it is FDA-certified for this purpose; state the dosage to be administered, who will administer the drug, the period of administration, and the anticipated effects.

The IRB may require additional information for research posing greater-than-minimal risk or for vulnerable participant populations.