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> Human Subjects > Investigator Guidance > Data and/or Specimen Banking and Research Use of Banked Materials

This guidance is intended for investigators who currently have IRB approval or exemption to perform the following research activities:

Background

The volume of research with data and bio-specimens has grown exponentially over recent years, and the value of analyzing large cohorts of data and/or specimens is widely recognized. Current practices have evolved nationally to place greater emphasis on the ethical obligation to obtain prospective informed consent (and in some cases also HIPAA authorization) for collection and retention of data and/or specimens for future research uses (i.e., banking) and to reconsider research uses of data and specimens (particularly identifiable materials) for which consent was never obtained.

A multidisciplinary working group representing investigators, IRB leaders, and research administrators was convened to review The Ohio State University Human Research Protection Program (HRPP) policies and practices at Ohio State regarding data and bio-banking. The working group considered existing guidance, national and international standards, and other peer institutions’ policies and practices before forwarding its recommendations to the IRB Policy Committee for final consideration and possible implementation. As a result, the HRPP policy, Research Involving Data and/or Biological Specimens (originally approved 08/29/10), was recently updated by the IRB Policy Committee to include recommendations from this working group. In addition to the revised policy, guidance was developed to help investigators comply with the revised requirements for establishing data and/or specimen banks. See cheap sale pictures discount best seller Nike SB DUNK HIGH BOOT mens boots 536182 Black Sail Ale Brown 012 discount low shipping fee pick a best for sale 4nm0z
for more information.

FAQs

1. How do I know if my research involves a bank or repository?

Ohio State HRPP policy defines a bank or repository as a

In addition to active collection and storage of materials for future research, retaining “excess” data and/or specimens (e.g., those not required for diagnosis, treatment, quality control, or education), whether originally obtained for research or non-research purposes, with the intent to use/distribute these materials for “future” research purposes (i.e., research not included in the protocol, if any, under which the data and/or specimens were originally collected) is also considered banking.

2. Does this new guidance apply to me if my research involves an external bank/repository NOT controlled by Ohio State?

This guidance applies only to current internal banks or repositories controlled by Ohio State researchers. A separate protocol for data and/or specimens collected and sent to external banks (e.g., other institutions, sponsors, NIH, NCI, cooperative groups, etc.) will not be required. However, there may be additional information requested for Ohio State protocols with ongoing data and/or specimen collection. Bella Vita Womens Channing Ballet Flat Champagne shipping discount sale discount outlet discount deals free shipping new styles 9iTyx0j2
for more information.

3. I have an existing Ohio State bank/repository. What will I need to do?

4. I have more than one IRB approved protocol that includes banking data and/or specimens as part of the research. Can I combine these collections into one banking/repository protocol?

Yes, the sources can be combined into a single repository protocol. See Chart B for guidance below.

5. I have a protocol that involves collecting data and/or specimens for a specific study and using some of these materials for ancillary studies or sub-studies. Do I need approval for a bank/repository?

Probably not. Such work does not usually constitute banking, as long as the ancillary/sub studies are specified in (and part of) the main project; there is no intent to use the data and/or specimens beyond the described work for future, unspecified research; and the materials will not be distributed to investigators for their own work separate from the main study or ancillary/sub studies.

6. Mystudyincludesaplantohold data and/or specimens for specific testing or analysis that can only occur once all materials are collected. Does holding materials for this purpose constitute banking?

No. Onlythestorageofmaterials forfutureunspecifiedresearchusesconstitutesbanking. If youareonly storingand using data and/or specimensforpurposesspecifically described intheprotocolforwhichthey were collected,youarenotcreatingarepository.

7. What if my bank/repository has outstanding requests (e.g., contractual obligations), but release of the data and/or specimens no longer meets current policy requirements?

The IRB understands that there may be current commitments for which all promised materials have not been provided and will work with you to determine how it may be possible to fulfill outstanding requests. cheap best place Ahnu Mens Del Ray Sport Sandal Black discount 2014 newest sale ebay outlet cost in China cheap price y4DQE
for assistance.

8. I do not have a bank/repository, but I am obtaining data and/or specimens from one for my research – how do these new requirements affect me?

In addition to updating the guidelines for establishing banks to collect, store, and distribute data and/or specimens for research purposes, the working group also made recommendations that have been adopted by the IRB Policy Committee regarding requirements for “secondary research” activities, which use materials obtained from established banks. Depending on the source of your data and/or specimens, there may be changes to the way the bank/repository operates and the types of materials that can be released (e.g., identifiable v. de-identified materials).

9. When will I need to comply with this guidance?

The revised standards will be applied to approved studies at continuing review during 2015.

Chart A – Transitioning an Existing Internal (Ohio State) Stand-Alone Banking Protocol

Chart B – Transitioning an Existing Protocol Including Both Banking and Other Research Activities (where a separate stand-alone protocol for the internal bank does not exist)

Questions or Assistance

Ellen Patricia, Quality Improvement Program Director Office of Responsible Research Practices 300 Research Administration Building 1960 Kenny Road Columbus, OH 43210 Phone:614-688-5556 Fax: 614-688-0366 Email: patricia.1@osu.edu

How do I know if my research involves a bank or repository? Medication-overuse headaches

Medication-overuse headaches are the most common cause of secondary headache. Read more about medication-overuse headaches .

Exertional headaches/sexual headaches Exertional headaches are headaches associated with physical activity. They can become severe very quickly after a strenuous activity such as running, coughing, having sex (intercourse), and straining with bowel movements. They are more commonly experienced by patients who also have migraines, or who have relatives with migraine.

Exertional headaches/sexual headaches

Headaches related to sex particularly worry patients. They can occur as sex begins, at orgasm, or after sex is over. Headaches at orgasm are the most common type. They tend to be severe, at the back of the head, behind the eyes or all over. They last about twenty minutes and are not usually a sign of any other problems.

Exertional and sexual intercourse-related headaches are not usually a sign of serious underlying problems. Very occasionally they can be a sign that there is a leaky blood vessel on the surface of the brain. Therefore, if they are marked and repeated, it is sensible to discuss them with your doctor.

Primary stabbing headaches Primary stabbing headaches are sometimes called 'ice-pick headaches' or 'idiopathic stabbing headache'. The term 'idiopathic' is used by doctors for something that comes without a clear cause. These are short, stabbing headaches which are very sudden and severe. They usually last between 5 and 30 seconds, at any time of the day or night. They feel as if a sharp object (like an ice pick) is being stuck into your head. They often occur in or just behind the ear and they can be quite frightening. Although they are not migraines they are more common in people who have migraines - almost half of people who experience migraines have primary stabbing headaches. They are often felt in the place on the head where the migraines tend to occur.

Primary stabbing headaches

Primary stabbing headaches are too short to treat, although migraine prevention medications may reduce their number.

Hemicrania continua Hemicrania continua is a primary chronic daily headache. It typically causes a continuous but fluctuating pain on one side of your head. The pain is usually continuous with episodes of more severe pain, which can last between 20 minutes and several days. During these episodes of severe pain there may be other symptoms such as watering or redness of the eye, runny or blocked nose, and drooping of the eyelid, all on the same side as the headache. Similar to migraine, there may also be sensitivity to light, feeling sick (nausea) and being sick (vomiting). The headaches do not go away but there may be periods when you don't have any headaches. However hemicrania continua headaches respond to a medicine called indometacin .

“This is a crazy thing to happen two days from delivering a satellite,” says Manchester. “We had already been vetted by the NASA office that actually does this for a living. It wasn’t a problem before and it’s not really a technical problem. It’s more of an unfortunate bureaucratic situation... regulation gone awry.”

While Manchester attempted to reason with the FCC, his NASA contacts tried to pull strings within the federal government, but to no avail. As months ticked into years, Manchester realized that an FCC license might never be forthcoming.

Eventually, NASA adopted KickSat-2 as an official NASA mission. Due to a regulatory quirk, NASA’s own satellites are overseen by the National Telecommunications and Information Administration (NTIA) rather than the FCC. KickSat-2 is now slated for launch late this year or early next. “But it’s taken us three years and lots of lawyers to figure out,” says Manchester.

Clear Skies?

IEEE Spectrum could find no record of any satellite smaller than 10 cm on any side having been licensed for launch by the FCC since the KickSat-2 fiasco. We gave the FCC multiple opportunities to explain its inconsistent approach to licensing small satellites, but it has yet to reply.

Tom Walkinshaw, founder and CEO of Alba Orbital , a start-up based in Scotland that develops and sells PocketQube satellites, calls the FCC’s erratic picosat licensing decisions “a head-scratcher.” He says, “Is one part of the organization acting one way, and another part another? I don’t think anyone’s too sure right now. Everyone’s looking for clarification.”

The FCC attempted to shed some light on its thinking last month, with a proposed rule-making for streamlining the licensing procedures for small satellites. The main aim of the new rules, welcomed by every expert IEEE Spectrum spoke to, is to reduce the paperwork and time needed to license the launches of small, experimental satellites and CubeSats. But the rules explicitly exclude picosats, requiring satellites to be no less than 10 cm on any side “to ensure that the satellite will be trackable as a space object.”

Walkinshaw points out that not only are all of today’s PocketQube satellites (and Swarm’s SpaceBees ) being successfully tracked by existing technology, a new S-Band “ Space Fence ” due to be deployed by the United States later this year will explicitly monitor objects with dimensions as small as 5 cm.

A bigger problem, thinks Manchester, is that “the FCC has been unwilling to consider licensing anything smaller than a CubeSat through the normal application process, and this new process does not seem to address that broader issue in any way.”

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initiative approached Manchester in 2015 offering to develop his Sprites into miniscule interstellar spacecraft for a journey to Alpha Centauri, it wanted to test them in Earth orbit first. “We didn’t even try to go through the FCC,” says Manchester. “We got an export licence from the State Department, which took a couple of weeks, and then I just took the satellites to Germany in my carry-on.”

The net result of these attitudes is that men are divided in their self-identification -- 47% pro-life and 46% pro-choice, while women tilt toward describing themselves as pro-choice, 50% to 44%.

Among College Graduates, Women More Likely to Favor Abortion Being Legal

Educational attainment is a significant predictor of Americans' position on abortion, with college graduates more likely than those with less education to favor abortion being legal in all circumstances.

There has been and continues to be a significant gender gap on this measure among college graduates, with female graduates more likely than male graduates to favor abortion being legal in all circumstances. This pattern has been constant over the past decades, despite modest fluctuations in the overall percentages favoring legalized abortion. Most recently, over the past four years, 42% of female college graduates have chosen the "legal in all" alternative, versus 32% of male college graduates.

Over the past four years, only one or two points have separated the percentages of men and women with some college education, as well as men and women with a high school education or less, who support abortion being legal in all circumstances. In prior years, the gap was slightly larger.

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Implications

There are significant gender gaps on a number of political and social issues in American society today, including political party identification, presidential job approval, views of the death penalty, and views of the moral acceptability of pornography, stem cell research, marijuana and cloning animals -- but abortion is not one of these issues. Women are slightly more likely to favor abortion being completely legal and slightly more likely to personally identify as pro-choice than men are, but these differences are quite small -- as has generally been the case for decades.

One exception to this pattern occurs within the ranks of Americans with college degrees, with female college graduates over the years consistently more likely than male graduates to favor completely legal abortion. Gender differences among those with less formal education are much smaller.

Other research shows that abortion attitudes differ significantly along political and ideological dimensions, and by age, the latter the topic of a forthcoming Gallup analysis.

Survey Methods

Results for this Gallup poll are based on telephone interviews conducted May 1-10, 2018, with a random sample of 1,024 adults, aged 18 and older, living in all 50 U.S. states and the District of Columbia. For results based on the total sample of national adults, the margin of sampling error is ±4 percentage points at the 95% confidence level. All reported margins of sampling error include computed design effects for weighting.

Each sample of national adults includes a minimum quota of 70% cellphone respondents and 30% landline respondents, with additional minimum quotas by time zone within region. Landline and cellular telephone numbers are selected using random-digit-dial methods.

Learn more about how the Gallup U.S. Poll works.

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