Investigator's Guide
  Waivers
  Upcoming IRB Meetings
  Required Training
  Human Subjects Review Form
  Informed Consent Document Template
      - Added language regarding the need for documentation for compensation.
      - Added information regarding auditing of records by Iowa State University officials.
      - New wording for documentation requirements for compensation.
  Application for Use of Protected Health Information form
  Continuing Review and/or Modification Form
      - Added information regarding Section III (Modifications).
  Exempt Categories
  Project Closure Form
  Adverse Event Form

  What's new

Please submit all documents to: IRB, 1138 Pearson Hall, Ames, IA 50011-2207

Note: These forms are in Microsoft Word. For this form to function properly, Macros need to be ENABLED in Microsoft Word. If macros are not already enabled, please refer the Instructions to enable them. After the macros are enabled, [a one time process], clicking on the link will help you open or save the form. Please make sure the form is opened in Microsoft Word (In browsers like Firefox or Safari, there will be an option to choose a program to open the form with. Please choose Microsoft Word).To save the form, click the "save" button. Please choose a location on your computer to save it. To fill out the form, open the form from the saved location on your computer. If have any difficulties or questions regarding the form, please call the IRB Administrator at 294-4566.

Required Training

TRAINING: All key personnel listed on a human subjects form must complete human subject training assurance before a protocol will be approved.

Human subject training assurance sessions offered during Fall of 2000 or taken through one of the on-line training modules available through our web site are accepted. Certification of training from other sources must be submitted and will be evaluated on an indiviudal basis.

Key Personnel includes the principal investigator, co-principal investigators, supervising faculty member and any other individuals who will have contact with the participants or the participants' data (e.g., interviewers, transcribers, coders, etc.).

Human Subjects Review Form - please submit one fully signed original.

At Iowa State University, the Human Subjects Review Committee reviews any research involving human participants, including proposals to gather data from participants for theses, dissertations, and other student projects.

The signed original application and all accompanying materials (i.e., a copy of the grant for all federally funded research, advertisements, phone scripts, survey instruments, letters of information) are to be submitted for each research project involving human participants, which is conducted by persons associated with Iowa State University.

Proposals are forwarded daily to the IRB Chair(s) for review and a determination of the status of the study (i.e., exempt from the requirements of the human subject regulations, may be reviewed through expedited measures, or must be reviewed by the full committee). Due to the number of protocols reviewed by the IRB Chair(s), be sure to allow a minimum of four to six weeks for a new proposal and a minimum of three weeks for a modification to or continuing review of a previously approved study.

STUDENTS: For student submissions, the major professor or supervising faculty member's contact information must be included on the consent form.

Informed consent documents should use an 11pt. font or higher. Please leave a margin of 1 – 1 ½ inches at the top of the document to accommodate the IRB approval stamp. A template has been developed to assist you in creating your informed consent document and to help you assure that all of the consent elements required by the regulations are included in your document. This template is only a guide and you may modify the document to meet the needs of your research. However, it is very important that you include all of the elements in your document, if all of the participant related activities in your study do not fit into one or more of the exempt categories of research.

Studies that fit into the exempt categories of research are not required to include all of the elements of consent. However, the IRB requires that the following items be included in an informed consent document or letter of introduction:

• a statement that the project involves research;
• a statement that participation is voluntary;
• a statement that the participant may skip any questions they do not feel comfortable answering in a survey; and
• the measures that will be used to ensure confidentiality of data collected in the research.

Please do not include titles such as Attachment or Appendix on the consent form, as the approved document will be stamped with the IRB approval stamp. The stamped document should then be copied for use in your study. Please leave a 1½ inch margin at the top of the document to accommodate the stamp. Using the stamped document will help assure that the current IRB approved document is being used and will serve as a reminder when IRB approval expires. The stamp on advertisements also assures the public that the study has been reviewed by the IRB.

As a reminder, if you reference the Office of Research Assurances in your document (e.g., in the Questions section), please be sure to use our current address: 1138 Pearson Hall.

For assistance in creating the informed consent document, consult the Checklist for Easy-to-Read Informed Consent Documents Text from the National Cancer Institute.

LETTER OF INTRODUCTION (Previously called Modified informed consent)

This letter is used when an informed consent document is not applicable (e.g., for exempt studies). This letter must include the following elements of consent and can be put on letterhead.

• a statement that the project involves research;
• a statement that participation is voluntary;
• a statement that the participant may skip any questions they do not feel comfortable answering in a survey; and
• the measures that will be used to ensure confidentiality of data collected in the research.

Iowa Tort Claims statement:

This is to be used and added to the consent document if there is potential for physical risk(s) to the subject(s). This is valid for ISU student participants only.

Application for Use of Protected Health Information Form

The Health Insurance Portability and Accountability Act (HIPPA) established the conditions under which protected health information may be used or disclosed for research purposes. Starting April 15, 2003, if your project will involve the use of a health care provider's records concerning past, present, or future physical, dental, or mental health information about a subject you must complete and submit the Application for Use of Protected Health Information.

Continuing Review and/or Modification Form

The IRB is required to review and approve all non-exempt research projects at intervals appropriate to the degree of risk, but no less than once a year. This is called “continuing review.” As described above, the Informed Consent Document(s) indicate the project’s expiration date. If a project initially received expedited review and risks to participants remain minimal, the continuing review may be expedited (reviewed by the chair alone). If a project initially received full board review, the project generally requires full board continuing review. Investigators should allow three to four weeks from date of submission for full board review and approval or expedited review and approval.

It is the Principal Investigator’s responsibility to submit an application for continuing review in sufficient time to permit the IRB chair or full board to review and approve the application prior to its expiration date. As a service to investigators, reminders will be sent to the Principal Investigator prior to the continuing review date. If a continuing review form is not received prior to the continuing review date, the Principal Investigator will receive notice that the project approval has lapsed and that no human research activity may take place after the expiration date, which includes the enrollment and follow-up of participants and the collection and/or use of research data date unless there is an over-riding safety concern (as determined by the IRB Chair).

Modifications

Any change in the conduct of a study must be reviewed and approved by the IRB prior to implementing the change. The only exception to this is when the change is necessary to eliminate apparent immediate hazards to participants. Your approval memo notifies you of this responsibility.

Modifications include, but are not limited to:

• procedural changes to a protocol;
• adding or removing investigators or research team members;
• changing the title of the project;
• requesting additional participants beyond the original approved number;
• change in funding sources;
• changes in how you are recruiting or following participants;
• new or revised advertisements;
• changes to Informed Consent Documents, surveys, questionnaires, correspondence with potential or current participants, or additional new items;
• protocol changes.

Modification to an approved project should be submitted using the “Continuing Review and/or Modification” Form. Please allow a minimum of three weeks for review of a modification.

Minor modifications are modifications to a research project and/or consent document that pose no additional risk to participants, such as changes in title, co-investigator(s), and/or funding sources; addition or modification of procedures that fall into one of the categories eligible for expedited review. These minor modifications may be approved by the chair alone using the expedited review procedures. More extensive modifications may require full board review. In either case, revisions or clarifications may be required.

Change of the Principal Investigator (PI) requires submission of a new Human Subjects Review form. Please reference the IRB ID for the existing study when changing PI's.

Please note that all modifications must be approved by the IRB or IRB Chair prior to implementation.

Exempt Research
All research involving human participants must be submitted for review by the IRB. Only the IRB may make the determination of exemption, even if you conduct a study in the future that is exactly like this study.
Any modification to exempt research should be submitted to the IRB on a Continuation and/or Modification form, prior to making any changes, to determine if the project still meets the Federal criteria for exemption. If it is determined that exemption is no longer warranted, then an IRB proposal will need to be submitted and approved before proceeding with data collection.

Exempt Categories

1. Research conducted in established or commonly accepted educational settings, involving normal educational practices, such as (i) research on regular and special education instructional strategies, or (ii) research on the effectiveness of or the comparison among instructional techniques, curricula, or classroom management methods.
2. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures or observation of public behavior, unless: (i) information obtained is recorded in such a manner that human subjects can be identified, directly or through identifiers linked to the subjects; and (ii) any disclosure of the human subjects' responses outside the research could reasonably place the subjects at risk of criminal or civil liability or be damaging to the subjects' financial standing, employability, or reputation.
3. Research involving the use of educational tests (cognitive, diagnostic, aptitude, achievement), survey procedures, interview procedures, or observation of public behavior that is not exempt under paragraph (b)(2) of this section, if: (i) the human subjects are elected or appointed public officials or candidates for public office; or (ii) Federal statute(s) require(s) without exception that the confidentiality of the personally identifiable information will be maintained throughout the research and thereafter.
4. Research involving the collection or study of existing data, documents, records, pathological specimens, or diagnostic specimens, if these sources are publicly available or if the information is recorded by the investigator in such a manner that subjects cannot be identified, directly or through identifiers linked to the subjects.
5. Research and demonstration projects which are conducted by or subject to the approval of Department or Agency heads, and which are designed to study, evaluate, or otherwise examine: (i) Public benefit or service programs; (ii) procedures for obtaining benefits or services under those programs; (iii) possible changes in or alternatives to those programs or procedures; or (iv) possible changes in methods or levels of payment for benefits or services under those programs.
6. Taste and food quality evaluation and consumer acceptance studies, (i) if wholesome foods without additives are consumed or (ii) if a food is consumed that contains a food ingredient at or below the level and for a use found to be safe, or agricultural chemical or environmental contaminant at or below the level found to be safe, by the Food and Drug Administration or approved by the Environmental Protection Agency or the Food Safety and Inspection Service of the U.S. Department of Agriculture.

Project Closure Form is to be submitted when the project has been completed or cancelled.
If a Project Closure Form or Continuation form has not been submitted by the expiration date, IRB approval will lapse and, in accordance with Federal regulations, all research activity, including enrollment of participants, must cease pending the receipt, review, and approval of a Continuing Review form.

Adverse Event Form
Reporting Requirements for Serious and/or Unexpected Adverse Event Form Instructions: Adverse experiences that are unexpected and/or serious must be promptly reported to the IRB using the Serious and/or Unexpected Adverse Experience Form. Other unanticipated problems resulting in risks to participants should be documented on the Continuing Review/Modification Human Subjects Form.

New Items

IRS Regulations on Compensation of Research Participants

The Controller’s, Purchasing, and Research Assurances offices are working to find ways to help researchers deal with these regulations.

The Controller’s Office has introduced a new standardized Research Participant Receipt Form (RPRF). The form is required to document receipt of payment, regardless of the payment type or amount. The form will be confidential and not imaged into public records. Participants will complete the forms with their contact information and signatures. They will also need to provide their social security numbers if they receive compensation worth $75 or more. More details are available at http://www.controller.iastate.edu/controller/what_new.htm.

If you have a currently approved study that will require social security numbers for future payments, you will need to update your informed consent document. Please submit your updated document to the IRB with the Continuing Review and/or Modification Form. It will be reviewed as a minor change and will not require full-board review. If modifying your consent form will make it impracticable to complete your study, please contact the ORA to discuss the possibility of a waiver.

Letters of introduction or informational documents for studies declared exempt by the IRB do not need to be changed.

Upcoming IRB Meetings
Material for review at a full committee meeting must be submitted one full week in advance of the meeting. Please allow a minimum of four to six weeks for review and processing of a protocol by the full committee.
Location: 1116 Pearson Hall, 2:15 p.m.

Meeting date
August 01, 2007
August 15, 2007
September 05, 2007
September 19, 2007
October 17, 2007
November 07, 2007
December 05, 2007

Investigator's Guide

• Consent Process
• Elements of Consent
• New Consent Form Templater
• Assent Process

Waivers

• Waivers of the Consent Process
• Waiver of Documentation of Consent Form
• Waiver of Elements of Consent Form

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