Appendices, Guidelines and Forms

Appendix A - Recruitment Statements

How are you going to get participants to join your study?

A Recruitment Statementis what you plan to communicate with prospective participants to encourage them to participate and/or flyer you plan to post on campus.

Include contact information, why the study is being conducted, location, total time commitment, risks, and a statement that participants may choose not to answer questions they are uncomfortable with and can withdraw at any time. Please remember that you cannot recruit in your own classes for your study and must have someone else come in and recruit to mask the fact that it is your study.

There arethreetypes of Recruitment Statements:

Astandard recruitment statementis for participation in interviews, confidential studies, etc.

ATear-off Cover Sheetwhich is to recruit participants foranonymoussurveys, etc

AnOnline Cover Sheetwhich is used to recruit participants foronline, anonymoussurveys.

Appendix B - Informed Consent Form

Are your subjects informed?

Informed consent is not just a form to be signed; it is an educational process that takes place between the investigator and the prospective participants.

The basic elements of the consent process include:

  • full disclosure of the nature of the research and the participant's involvement,
  • adequate comprehension on the part of the potential participant, and
  • the participant's voluntary choice to participate.

USE the informed consent form for EVERYTHING BUT

***NewInformed Consent Formsthat reflect changes to the federal guidelines (implemented on January 21, 2019) are now available.***

Plan to conduct ananonymous survey? You do not need an Informed Consent Form. Simply place the information that participants will read before they take the survey and label itOnline Cover Sheet(for online surveys) orTear-Off Cover Page(for paper surveys).

Appendix C

Appendix C refers to all survey instruments such as questions, scales, tests, etc.

All applications will bedeemed incompleteif they are not accompanied by the appropriate appendices.

Helpful Hints

  • Use common,ordinary languageinstead of technical, academic terms. Ideally, we would like consent forms to be written at an8th-gradereading level.

  • Try to keep the sentences asshort and simpleas possible.

  • Write in thesecond personusing you/your pronouns. For example: "You are being asked to participate in a research project…," "If you have questions later, you may contact…,"

  • Useadequate white spaceso that the form is easy to read, and avoid using small fonts to squeeze all the text onto one page.

  • Headingsfor paragraphs arehelpfuland make the form easier to read and understand.

Guidelines, Notice of Completion, HIPPA

Additional forms may be needed to complete the application or to close out the research study:

Notice of Completion of Human Participants Research Form

The Notice of Completion Form must be filled out after the data has been collected and when the risk to human participants is completed. Please note that the review/approval of future proposals is contingent upon submission of this form.*If you have submitted a protocol through Axiom Mentor, you will need to complete your protocol there.

HIPPA Form - Health Insurance Portability and Accountability Act

The Health Insurance Portability and Accountability Act (HIPAA), also known as “The Privacy Rule,” sets standards and regulations to protect patients from inappropriate disclosures of their “protected health information” (PHI) that could cause harm to their insurability, employability, and their privacy.

Federal Guidelines:

Department of Health and Human Services (DHHS) Belmont Report

Office for Human Research Protections(OHRP)

National Institutes of Health (NIH) Policy Bioethics

National Science Foundation (NSF) Policy of Research with Human Subjects

Additional Forms