In Our September, 2017 Issue:

Human Subjects Review Board protects research participants

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Before an exper­i­ment can be con­ducted on human beings at Metro State, it must pass muster with the Human Sub­jects Review Board (HSRB).The HSRB is respon­si­ble for review­ing research pro­pos­als from fac­ulty and stu­dents. The board deter­mines whether any eth­i­cal con­cerns must be addressed by the researcher.

Dr. Therissa Libby, incom­ing chair of the HSRB and assis­tant pro­fes­sor of Human Ser­vices, strongly believes in the impor­tance of the HSRB’s role in pro­tect­ing vul­ner­a­ble pop­u­la­tions. The HSRB was estab­lished by uni­ver­sity pol­icy #2060 and requires that research study “par­tic­i­pants must also be guar­an­teed free­dom from coer­cion and unde­sir­able con­se­quences.” The board is an advo­cate against exploita­tion and malfea­sance in all research stud­ies, Libby said.

The HSRB con­sists of one rep­re­sen­ta­tive from each col­lege, plus a Metro State senior or grad­u­ate stu­dent, an admin­is­tra­tive mem­ber, and an indi­vid­ual who is not affil­i­ated or related to some­one within the uni­ver­sity. Train­ing is pro­vided to the mem­bers, and they are expected to serve three years to gain mas­tery of the review process. The board meets monthly.

Are stu­dent research pro­pos­als sub­ject to review?

Yes.

Inde­pen­dent stu­dent research projects involv­ing human sub­jects must be sub­mit­ted to the HSRB:

  • Senior or cap­stone theses
  • Under­grad­u­ate or Master’s research projects

Even if stu­dents are the pri­mary inves­ti­ga­tors, fac­ulty advi­sors or instruc­tors will sign the pro­posal as the Respon­si­ble Project Inves­ti­ga­tor (RPI).

Class assign­ments that gather and ana­lyze data from par­tic­i­pants out­side class are con­sid­ered research and must be sub­mit­ted to the HSRB:

  • Sur­veys
  • Exper­i­ments
  • Focus groups
  • Inter­views

Source: Met­ro­pol­i­tan State Uni­ver­sity Human Sub­jects Review Board web­site

Research pro­pos­als are cat­e­go­rized based on their assumed risk fac­tor to par­tic­i­pants, and then reviewed by the HSRB in smaller groups. This speeds up the review process in an effi­cient and effec­tive way.

Full board review is very rare at Metro,” said Libby. “Most projects are expe­dited — min­i­mal risk— or exempt. Last year, we had one full board review. About two-​thirds of our reviews were expe­dited.” The HSRB reviewed 90 pro­pos­als in the past year.

Most pro­pos­als are exempt because they do not require the direct or indi­rect col­lec­tion of human data. Exempt pro­pos­als are required to fill out a sep­a­rate exemp­tion form to be sub­mit­ted to the review board. Expe­dited review occurs when min­i­mal risk is per­ceived in an experiments.

Ani­mal test­ing is not con­ducted at Metro State, but a rig­or­ous review process is required for it.

The only ani­mal research cur­rently done is on organ­isms that do not fall into review­able cat­e­gories. For exam­ple, flies and worms,” said Libby. “We don’t cur­rently have the type of ani­mal care and use facil­i­ties that sup­port research on, say, rodents. If research at Metro heads in that direc­tion, we will cre­ate an ani­mal care and use com­mit­tee to review those proposals.”

Trans­parency and acces­si­bil­ity are essen­tial for suc­cess of researchers enter­ing the review process, said Libby. The HSRB web­site pro­vides answers to fre­quently asked ques­tions and an overview of the review process.

Fed­eral reg­u­la­tions require edu­ca­tional insti­tu­tions to oper­ate review boards to pro­tect the rights of indi­vid­u­als par­tic­i­pat­ing in exper­i­ments and guar­an­tee informed consent.

The reg­u­la­tions aim to pre­vent exploita­tive exper­i­ments like the U.S. Pub­lic Health Ser­vice Syphilis Study at Tuskegee. Sub­si­dized by the fed­eral gov­ern­ment, researchers recruited impov­er­ished, illit­er­ate black men in rural Alabama to par­tic­i­pate in a study in exchange for free health care. From 1932 to 1972, researchers stud­ied the men yet did not inform them that they were being infected with syphilis. The men were not given peni­cillin, a drug proven suc­cess­ful in treat­ing syphilis. This not only affected the men par­tic­i­pat­ing in the study, but also fam­ily mem­bers con­se­quently exposed to the disease.

The HSRB is a proac­tive mea­sure to secure the health and well­be­ing of those par­tic­i­pat­ing in research stud­ies at Metro State.

But Libby sees the work of the HSRB as far more than a safe­guard against abuse. “I see the process as not just pre­ven­ta­tive, but educa­tive. It’s an oppor­tu­nity for stu­dents to engage in crit­i­cal think­ing,” she said.