Tips for Preparing a Successful IRB Submission

RESEARCH WITH HUMAN SUBJECT FORM

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Faculty Sponsor, if applicable, must sign the protocol.

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Date:

Start date - should be after the date of the IRB meeting. End Date – It is always better to allow yourself more time than you need to cover any unforeseen obstacle or delays. Giving yourself a year for a 2 month project is suggested so that you will not have to request an extension if you are delayed.

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The main responsibility of the IRB is to protect human subjects. When a vulnerable population is involved, (such as children, pregnant women, and prisoners) the IRB will expect your protocol to be very clear on how this population will be protected.

If you check yes to any of the categories on this page, you will need to be very specific and clear in your narrative about your recruitment methodology, benefits and risks. You may wish to seek advice from your faculty sponsor or the IRB representative before finalizing your section of the protocol in relation to this. Total number of Participants – Use the highest number, e.g., if you expect 50-100 participants, this response should reflect 100.

Check your protocol for consistency to ensure the same number is reflected in your narrative and cover letter or consent.

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The abstract should be brief, precise and concise.

Consider an introductory sentence with the background, e.g.” There have been few studies that address whether…” The next sentence should summarize your project, e.g., “The project calls for a survey of 100 elementary school teachers….”

Recruitment

This section needs to be very clear. Before writing it, you might make a list of steps as to how you would do this, e.g.,

  1. Obtain permission from School Board
  2. Meet with individual principals at each of 2 schools (name them)
  3. Post flyers in teachers’ lunchroom (copy of flyer would have to be attached to the protocol)
  4. Once contacted by interested participants, hold a general information meeting to explain the project (script for meeting should be attached to the protocol)
  5. Those who decide to participate will be asked to sign the Consent Form (consent must be included in submission)
  6. A convenient time and place will be set for data collection.

Once you are perfectly clear on the steps and the order in which you will do your recruitment, your summary will fall into place.

PITFALLS

If you know the people who are being asked to participate, they may feel obligated. This could be considered coercive and the IRB would consider it problematic unless you have already planned a manner of approaching them (such as having someone else in a neutral position do that).

The IRB would take objection to anyone in a position of power recruiting participants. The participant’s employer, administrator, supervisor would not be appropriate people to help with your recruitment as this could be perceived as coercive.

Doctors, nurses, PA’S, NP’s, cannot approach their own patients to ask them to participate. This would be considered coercive.

Methods

Just as you outlined the steps for your recruitment, you might draw up a list of steps that clarify exactly how your research will be conducted. This will enable you to write a specific and clear summary, e.g.,

  1. Once consents are signed, a convenient time and place will be agreed upon for data collection.
  2. The investigator will meet with each participant for an open ended interview
  3. The interview will last no more than 1 hour
  4. The interview will be audio tape recorded (this should be mentioned in the consent letter). Each interviewee will choose a pseudonym.
  5. The audio tapes will be transcribed by a research assistant who will sign a confidentiality agreement (this form would be attached to the protocol).
  6. Audio tapes and transcripts will be stored in the investigator’s office in a locked file and maintained for 5 years after the completion of the study. Consent form will be filed separately.

Page 5 – Alternative Procedure

Nearly all protocols can state the following:

The alternative is to choose not to participate. Participants may withdraw at any time without adverse consequences.

Benefits

Nearly all protocol can say the following:

There are no direct benefits to the participant.

If you are offering a small gift to participants, you need to be clear on whether they still get the gift if they withdraw from the study.

Risks

This section required careful consideration before you write it.

Are there in fact potential risks to the participants?

Is there, e.g., a 1 in 1 million chance they could drop dead in your exercise research lab?

If there is a physical risk, you should quantify it as best you can, e.g., “This study has been done with 10,000 college athletes and there were no adverse consequences. The risk of sudden death from this exercise in the general population is 1 in 100,000. It is expected the risk in college athletes is less but that number is not known.

When you have a risk that is serious, even if the incident is infinitesimally small, you will need to say how you will try to minimize the risk.

Once you begin to ask about health information or ask for a medical clearance from a practitioner, you enter the HIPAA privacy area. These protocols nearly always need to be restructured. If you do not need health information, it is best not to ask for it.

Other Physical Risks

If physical risks are minor such as muscle soreness and if they can be minimized by warm-up and cool-down exercises, this should be stated, e.g., “there will be a ten minute warm-up period …”

Domestic Violence

Care must be taken if you are conducting research on the victims of domestic violence. Could their participation in your study subject them to further violence? This would be considered a significant risk and your protocol would need to demonstrate how this will be eliminated.

Emotional Risk

This can include the risk of unpleasant memories, embarrassment, etc. If the emotional risk requires debriefing or referral, you need to be quite clear on how the problem will be recognized, where referral will be made and how the session will be paid for.

Pitfalls: Even if you are a trained counselor, you may not counsel your own research participants. This is a conflict with your role as an investigator.

Anonymity and Confidentiality

This is frequently confusing to applicants.

Anonymous – this is when no one can identify a participant. 10,000 people dropped unsigned surveys into a collection box. There is no way to identify the participants. These potential participants are given a cover letter (which must be included).

Confidential – These participants are known. Efforts will need to be made to protect their identity. These people sign consent forms (which must be appended)

Cover Letter or Consent (see above)
Be sure to include a clear explanation of what the participant will be doing, how much total time is involved, summary of risks and benefits, how you will protect confidentiality, where and how long you will store the data, etc. This should reflect identical information in the protocol and you should check the letter against protocol to avoid inconsistencies.

IRB Meeting

Please try to attend the IRB meetings prior to your date of submission as well as when your protocol is being considered. In some cases, your presence and ability to answer questions and make clarifications may make the difference between a vote of “approved with changes” versus “rejected”. Meetings are now conducted with other Barry campuses via interactive videoconferencing. Once your changes are resubmitted, they will be compared to the list of recommended changes and, if complete, you will receive a letter authorizing you to begin your data collection.