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The HRRC Review & Approval Process

What happens to my protocol after it is submitted to the HRRC?

The HRRC staff performs an administrative review of the submitted protocol, and assigns members of the board to review the protocol on a rotating basis and in accord with their areas of expertise. Investigators are notified as soon as possible of the decisions relating to their protocol (i.e. request for revisions or approval).

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What are the differences between the three levels of HRRC review (exempt, expedited, and full board)?

Research in the exempt category is not subject to federal regulations, although review by the HRRC is still required by GVSU policy. Exempt research must be of no greater than minimal risk and meet at least one of the following criteria:

1. Educational settings involving normal educational procedures

2. Educational tests, survey procedures, interview procedures or observations of public behavior UNLESS a) subjects can be identified AND b) such disclosure results in risk (NOTE: this exemption does not apply to minors)

3. Education tests, survey procedures, interview procedures or observation of public behavior not exempt under (2) if subjects are public officials or where confidentiality is required by law

4. Study of existing data or records IF a) sources are publicly available OR b) subjects cannot be identified

5. Federally funded research and demonstration project designed to study public benefit or service programs

6. Taste and food quality evaluation and consumer acceptance studies

Note: The HRRC Office makes the initial decision about what type of review is necessary; the IRB may request more extensive review.

Research in the expedited category is that which poses no more than minimal risk to the subjects involving:

1. Clinical studies of drugs or medical devices only when

a. an investigational new drug (IND) application is not required OR

b. an investigational device exemption application is not required OR

c. the medical device is cleared/approved for marketing and the medical device is used in accordance with its cleared/approved labeling.

2. Collection of blood samples by finger stick, heel stick, ear stick or venipuncture of healthy, non-pregnant adults weighing at least 110 pounds with total volume collected not exceeding 550 mml in an 8-week period and collection occurring no more frequently than twice per week OR from other adults and children, considering the age, weight, and the health of the subject, the collection procedure, the volume of blood to be collected, and frequency with which it will be collected not exceeding the lesser of 50 ml or 3 ml/kg in an 8-week period and collection occurring no more frequently than twice per week.

3. Prospective collection of biological specimens for research purposes by noninvasive means, such as hair and nail clippings in non disfiguring manner, teeth at the time of exfoliation or if routine patient care indicates a need for extraction, excreta and external secretions (including sweat), uncannulated saliva, placenta removed at delivery, amniotic fluid obtained at time of rupture of the membrane prior to or during labor, supra-or sub gingival dental plaque and calculus, mucosal and skin cells (collected by buccal scraping or swab, or mouth washings), or sputum collected after saline mist nebulization.

4. Collection of data through noninvasive procedures (no involving general anesthesia or sedation) routinely employed in clinical practice, excluding procedures involving x-rays or microwaves.  Where medical devices are employed, they must be cleared/approved for marketing.  (Studies intended to evaluate the safety and effectiveness of the medical device are not generally eligible for expedited review, including studies of cleared medical devices for new indications.)  Examples include (a) physical sensors that are applied either to the surface of the body or at a distance and do not involve input of significant amounts of energy into the subject or an invasion of the subjects privacy; (b) weighing or testing sensory acuity; (c) magnetic resonance imaging; (d) electrocardiography, electroencephalography, thermography, detection or nationally occurring radioactivity, electroretinography, ultrasound, diagnostic infrared imaging, doppler blood flow, and echocardiography; (e) moderate exercise, muscular strength testing, body composition assessment, and flexibility testing where appropriate given the age, weight, and health of the individual.

5. Research involving materials (data, documents, records, or specimens) that have been collected or will be collected solely for non-research purposes (such as medical treatment or diagnosis) that are not publicly available.

6. Collection of data from voice, video, digital, or image recordings made for research purposes.

7. Research on individual or group characteristics or behavior (including, but not limited to, research on perception, cognition, motivation, identity, language, communication, cultural beliefs or practices, and social behavior) or research employing survey, interview, oral history, focus groups, program evaluation, human factors evaluation, or quality assurance methodologies.

8. Continuing review of research previously approved by the full HRRC at a convened meeting.

9. Continuing review of research, not conducted under an investigational new drug application or investigational device exemption where categories (2) through (8) do not apply but the HRRC has determined and documented at the convened meeting that the research involves no more than minimal risk and no additional risks have been identified.

Research which is neither exempt nor expedited requires the full board category of review.  All research which does not clearly fit into exempt or expedited categories of review should be submitted to the HRRC, assuming it will need full board review.

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Why does the HRRC review the design of the research?

As part of the risk-benefit analysis, the HRRC must be concerned with the design of the research.  If the research is poorly designed, and the information to be gained is likely to have little or no value, the HRRC cannot justify any risks or inconveniences to the subject. Sometimes members of the HRRC are able to suggest modifications to the research design which reduce the level of risk and/or increase the benefits to the subjects.

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How is exempt research protocols handled differently from other protocols?

Exempt protocols are reviewed by the HRRC Office and one additional committee member.  If protocols submitted as exempt do not meet exemption criteria they will be subjected to either expedited or full review. Protocols that are approved as exempt do not require formal renewal, but do submit annual updates and protocol completion reports when the project is finished.

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What kind of timeline should I expect for being able to begin data collection?

Remember, no research may begin until the HRRC has given your research protocol full approval.  All protocols submitted undergo an initial administrative review.  If changes to the protocol are requested, the Principle Investigator is responsible for a timely response.  The protocol is then submitted for review by one or more HRRC board members.  Exempt and expedited review is usually complete within 2 weeks. Full board review can take one month or longer to complete.  Responses to tabling decisions for required modifications or information requested are typically reviewed within one week.

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What if I need to make changes to my research protocol after it has been approved?

All changes to a research protocol must be approved before the change is incorporated into the protocol. These proposed changes should be submitted to the HRRC office on the change in protocol form that is found on the HRRC website.

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How long is HRRC approval of my protocol effective?

The HRRC issues approvals for up to but not exceeding one calendar year from the date the protocol was initially approved. The termination date of that approval period is specified on the approval letter. If subject enrollment, data collection or data analysis needs to continue beyond that termination date, a continuing review (CR) form must be submitted for review and approval. It is important that the CR approval process be completed prior to the expiration date of the initial approval, or subject enrollment and data collection must cease. In general, CR takes less than 2 weeks to process.

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